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‫ادارة موقع الكتروني‬

‫‪zithromax capsules‬‬
‫موقع لطلب االدوية‬
‫‪azithromycin oral suspension‬‬
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‫‪azithromycin suspension‬‬
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‫عالج ‪zetron‬‬
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 ‫أزيثروميسين ‪ 500‬ملغ‬
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 ‫أزيثرومايسين ‪250‬‬
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‫وضع رابط لصفحات متعلقة و لكن يدويا في كل الصفحات‬
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 ‫صفحة الدعاية ؟‬
‫االخطار‬
‫هل فعل خطر‬
‫االعراض الجانبية‬
‫طريقة االستعمال الصحيحة‬

Azithromycin (systemic): Pediatric drug information

Copyright 1978-2017 Lexicomp, Inc. All rights reserved.

(For additional information see "Azithromycin (systemic): Drug information" and see
"Azithromycin (systemic): Patient drug information ")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US

 Zithromax;

 Zithromax Tri-Pak;

 Zithromax Z-Pak;

 Zmax

Brand Names: Canada

 ACT-Azithromycin;
 Apo-Azithromycin;

 Apo-Azithromycin Z;

 Azithromycin for Injection;

 Azithromycin for Injection, USP;

 Dom-Azithromycin;

 GD-Azithromycin;

 Mylan-Azithromycin;

 Novo-Azithromycin;

 PHL-Azithromycin;

 PMS-Azithromycin;

 PRO-Azithromycine;

 Riva-Azithromycin;

 Sandoz-Azithromycin;
 Zithromax;

 Zithromax For Intravenous Injection;

 Zmax SR

Therapeutic Category

 Antibiotic, Macrolide

Dosing: Neonatal
Note: Extended release suspension (Zmax) is not interchangeable with immediate-release
formulations. All oral doses are expressed as immediate release azithromycin unless
otherwise specified. With oral therapy, monitor for infantile hypertrophic pyloric stenosis
(IHPS).

General dosing, susceptible infection (Red Book [AAP 2012]):

Oral: 10 to 20 mg/kg once daily

IV: 10 mg/kg once daily

Chlamydial conjunctivitis or chlamydial pneumonia: Limited data available: Oral: 20

mg/kg once daily for 3 days (CDC [Workowski 2015]; Hammerschlag 1998)

Pertussis, treatment and postexposure prophylaxis: Oral, IV: 10 mg/kg once daily for 5
days (Red Book [AAP 2012])

Dosing: Usual
(For additional information see "Azithromycin (systemic): Drug information")

Note: Extended release suspension (Zmax) is not interchangeable with immediate-release

formulations. All doses are expressed as immediate release azithromycin unless otherwise
specified.

Pediatric:

General dosing, susceptible infection (Red Book [AAP] 2012): Infants, Children, and
Adolescents:

Mild to moderate infection: Oral: 5 to 12 mg/kg/dose; typically administered as 10

to 12 mg/kg/dose on day 1 followed by 5 to 6 mg/kg once daily for remainder
 of treatment duration; usual maximum dose for the total course: 1,500 to
2,000 mg

Serious infection: IV: 10 mg/kg once daily; maximum dose: 500 mg/dose

Babesiosis: Infants, Children, and Adolescents: Oral: 10 mg/kg once on day 1

(maximum dose: 500 mg/dose), then 5 mg/kg once daily on days 2 to 10
(maximum dose: 250 mg/dose) in combination with atovaquone; longer duration of
therapy may be necessary in some cases; in immunocompromised patients,
higher doses (eg, adults: 600 to 1,000 mg daily) may be required (Red Book [AAP]
2012; Wormser 2006)

Bartonellosis: Oral:

Cat scratch disease (B. henselae) with extensive lymphadenopathy (IDSA

[Stevens] 2014): Non-HIV-exposed/-positive:

Infants, Children, and Adolescents ≤45 kg: 10 mg/kg once on day 1

(maximum dose: 500 mg/dose), followed by 5 mg/kg once daily on days
2 to 5 (maximum dose: 250 mg/dose)

Children and Adolescents >45 kg: 500 mg as a single dose on day 1, then
250 mg once daily for 4 additional days

Cutaneous bacillary angiomatosis (B. henselae or B. quintana): HIV- exposed/-

positive: Infants, Children, and Adolescents: 5 to 12 mg/kg once daily;
maximum dose: 600 mg/dose; usual treatment duration: 3 months (CDC
2009)

Chancroid (CDC 2010; Red Book [AAP] 2012): Oral:

<45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose

≥45 kg: 1,000 mg as a single dose

Chlamydial infections:

Cervicitis, urethritis (C. trachomatis): Children and Adolescents ≥45 kg: Oral: 1,000
mg as a single dose (CDC 2010; Red Book [AAP] 2012)

Conjunctivitis: Infants: Oral, IV: 20 mg/kg once daily for 3 days (Red Book [AAP]
2012)

Pneumonia, community-acquired (Bradley 2011): Infants >3 months, Children, and

Adolescents:

Mild infection or step-down therapy: Oral: 10 mg/kg once on day 1 (maximum

dose: 500 mg/dose) followed by 5 mg/kg once daily on days 2 to 5
(maximum dose: 250 mg/dose)
 Severe infection: IV: 10 mg/ kg once daily for at least 2 days, then transition
to oral route with a single daily dose of 5 mg/kg to complete course of
therapy; maximum dose: 500 mg/dose

Cystic fibrosis; improve lung function, reduce exacerbation frequency: Limited

data available; dosing regimen variable (Mogayzel 2013; Saiman 2003; Saiman
2010): Children ≥6 years and Adolescents: Oral:

18 to 35.9 kg: 250 mg three times weekly (Monday, Wednesday, Friday)

≥36 kg: 500 mg three times weekly (Monday, Wednesday, Friday)

Diarrhea, infectious:

Campylobacter: Infants, Children, and Adolescents: Oral: 10 mg/kg once daily for
3 days; maximum dose: 500 mg/dose (Red Book [AAP] 2012)

Shigellosis: Infants, Children, and Adolescents: Oral:

AAP Recommendation: 12 mg/kg once on day 1 (maximum dose: 500

mg/dose), followed by 6 mg/kg once daily on days 2 to 5 (maximum
dose: 250 mg/dose) (Red Book [AAP] 2012)

Alternate dosing: 10 mg/kg once daily for 3 days (Dupont 2009; Mackell
2005); WHO Guidelines recommend up to 20 mg/kg/dose and in some
cases, a wider range of duration of therapy (eg, 1 to 5 days) (WHO
2005)

Endocarditis; prophylaxis: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose

30 to 60 minutes before procedure; maximum dose: 500 mg/dose (Wilson 2007)

Gonococcal infection; uncomplicated (cervicitis, urethritis, anorectal): Oral:

Children <45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose (Red
Book [AAP] 2012)

Children > 8 years and ≥45 kg and Adolescents: 1,000 mg as a single dose (CDC
2012; Red Book [AAP] 2012)

Group A streptococcal infection; treatment of streptococcal tonsillopharyngitis:

Manufacturer's labeling and AHA/AAP recommendations: Infants, Children, and

Adolescents: Oral: 12 mg/kg/dose once daily for 5 days; maximum dose: 500
mg/dose (Gerber 2009; Red Book [AAP] 2012)

Alternate dosing:

IDSA reconmendations: Note: Recommended as an alternative agent for

group A streptococcal pharyngitis in penicillin-allergic patients. Infants,
Children, and Adolescents: Oral: 12 mg/kg (maximum: 500 mg/dose) on
 day 1 followed by 6 mg/kg/dose (maximum: 250 mg/dose) once daily on
days 2 through 5 (Shulman 2012); Recommended by the Infectious
Disease Society of America (IDSA) as an alternative agent for group A
streptococcal pharyngitis in penicillin-allergic patients (Shulman 2012).

Three-day regimen: Limited data available: Children and Adolescents: Oral:

20 mg/kg/dose once daily for 3 days; maximum dose: 1000 mg/dose
(Cohen 2004; O’Doherty 1996)

Meningococcal disease, chemoprophylaxis of high-risk contacts: Infants, Children,

and Adolescents: Oral: 10 mg/kg as a single dose; maximum dose: 500
mg/dose; Note: Not routinely recommended; may consider if fluoroquinolone
resistance detected (Red Book [AAP] 2012)

Mycobacterium avium complex (MAC) infection (HIV-exposed/-positive):

Infants and Children (DHHS [pediatric] 2013): Oral:

Treatment: 10 to 12 mg/kg once daily in combination with ethambutol, with or

without rifabutin; maximum dose: 500 mg/dose; treatment duration at
least 12 months; dependent upon clinical response

Primary prevention of first episode: Preferred: 20 mg/kg

once weekly (maximum dose: 1,200 mg/dose) or alternatively, 5 mg/kg
once daily (maximum dose: 250 mg/dose)

Secondary prevention of recurring episodes: 5 mg/kg once daily in

combination with ethambutol, with or without rifabutin; maximum dose:
250 mg/dose

Adolescents (DHHS [adult] 2013): Oral:

Treatment: 500 to 600 mg daily in combination with ethambutol

Primary prophylaxis: 1,200 mg once weekly or alternatively, 600 mg twice

weekly

Secondary prophylaxis: 500 to 600 mg daily in combination with ethambutol

Otitis media, acute (AOM): Infants ≥6 months, Children, and Adolescents:

Oral: Note: Due to increased S pneumonia and H. influenzae resistance,
azithromycin is not routinely recommended as a treatment option (AAP [Lieberthal
2013])

Single dose regimen: 30 mg/kg as a single dose; maximum dose: 1,500 mg/dose;
if patient vomits within 30 minutes of dose, repeat dosing has been
administered although limited data available on safety

Three-day regimen: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose
 Five-day regimen: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose),
followed by 5 mg/kg (maximum dose: 250 mg/dose) once daily on days 2 to 5

Peritonitis (peritoneal dialysis), prophylaxis for patients receiving peritoneal

dialysis who require dental procedures: Infants, Children, and Adolescents:
Oral: 15 mg/kg administered 30 to 60 minutes before dental procedure; maximum
dose: 500 mg/dose (Warady [ISPD 2012])

Pertussis (CDC 2005; Red Book [AAP] 2012): Oral, IV:

Infants 1 to 5 months: 10 mg/kg/dose once daily for 5 days

Infants ≥6 months, Children, and Adolescents: 10 mg/kg once on day 1 (maximum

dose: 500 mg/dose), followed by 5 mg/kg once daily on days 2 to 5
(maximum dose: 250 mg/dose)

Pneumonia, community-acquired (excluding mycobacterial [mycoplasma

pneumoniae] and chlamydial infections):

Oral:

Immediate release: Infants >3 months, Children, and Adolescents: 10 mg/kg

once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg
(maximum dose: 250 mg/dose) once daily on days 2 to 5 (Bradley 2011)

Extended release oral suspension (Zmax): Infants ≥6 months, Children, and

Adolescents: 60 mg/kg as a single dose; maximum dose: 2,000 mg/dose

IV: Infants >3 months, Children, and Adolescents: 10 mg/kg once daily for at least
2 days, follow IV therapy by the oral route with a single daily dose of 5 mg/kg
to complete a 5-day course of therapy; maximum dose: 500 mg/dose (Bradley
2011)

Pneumonia, community acquired; mycoplasma pneumoniae, or chlamydial

infection (Bradley 2011): Infants >3 months, Children, and Adolescents:

Mild infection or step-down therapy: Oral: 10 mg/kg once on day 1 (maximum

dose: 500 mg/dose) followed by 5 mg/kg once daily on days 2 to 5 (maximum
dose: 250 mg/dose)

Severe infection: IV: 10 mg/kg once daily for at least 2 days (maximum dose: 500
mg/dose), then transition to oral route with a single daily dose of 5 mg/kg to
complete course of therapy (maximum dose: 250 mg/dose)

Rhinosinusitis, bacterial: Oral: Infants ≥6 months, Children, and Adolescents: 10

mg/kg once daily for 3 days; maximum dose: 500 mg/dose; Note: Although FDA
approved, macrolides are not recommended for empiric therapy due to high rates
of resistance (Chow 2012).
 Sexual victimization, prophylaxis: Oral: Note: Use in combination with cefixime or
ceftriaxone and completion of hepatitis B virus immunization; also consider
prophylaxis for trichomoniasis and bacterial vaginosis (CDC 2010; Red
Book [AAP] 2012).

Children <45 kg: 20 mg/kg as a single dose

Children ≥45 kg and Adolescents: 1,000 mg as a single dose

Toxoplasma gondii, encephalitis (HIV-exposed/-positive); treatment and

prevention: Oral: Adolescents: 900 to 1,200 mg once daily in combination with
pyrimethamine/leucovorin; treatment duration: 6 weeks or longer if extensive
disease or incomplete response at 6 weeks (DHHS [adult] 2013)

Adult:

Rhinosinusitis, bacterial: Oral: 500 mg once daily for 3 days. Note: Although FDA
approved, macrolides are not recommended for empiric therapy due to high rates
of resistance (Chow 2012).

Alternate regimen: Extended release suspension (Zmax): 2,000 mg as a single

dose

Chancroid due to H. ducreyi: Oral: 1000 mg as a single dose (CDC 2010)

Cervicitis, urethritis: Nongonococcal Chlamydia trachomatis: Oral: 1,000 mg as a

single dose

Gonococcal infection, uncomplicated (cervix, rectum, urethra): Oral: 1,000 mg as

a single dose in combination with ceftriaxone (preferred) or cefixime (only if
ceftriaxone unavailable); if cefixime is used, test-of-cure in 7 days is recommended
(CDC 2012). Note: Monotherapy with azithromycin single dose of 2,000 mg has
been associated with resistance and/or treatment failure; however, may be
appropriate for treatment of a gonococcal infection in pregnant women who cannot
tolerate a cephalosporin (CDC 2010).

Patients with severe cephalosporin allergy: 2,000 mg as a single dose and test-of-
cure in 7 days (CDC, 2012)

Gonococcal infection, uncomplicated (pharynx): Oral: 1,000 mg as a single dose in

combination with ceftriaxone (CDC 2012)

Gonococcal infection, expedited partner therapy: Oral: 1,000 mg as a single dose in

combination with cefixime (CDC 2012). Note: Only used if a heterosexual partner
cannot be linked to evaluation and treatment in a timely manner; dose delivered to
partner by patient, collaborating pharmacy, or disease investigation specialist.

Granuloma inguinale (donovanosis): Oral: 1000 mg once a week for at least 3 weeks
and until lesions have healed (CDC 2010)
Endocarditis prophylaxis: Oral: 500 mg 30 to 60 minutes before
procedure. Note: American Heart Association (AHA) guidelines now recommend
prophylaxis only in patients undergoing invasive procedures and in whom
underlying cardiac conditions may predispose to a higher risk of adverse outcomes
should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures
is no longer recommended by the AHA (Wilson 2007).

Mild to moderate respiratory tract, skin, and soft tissue infections: Oral: 500 mg in
a single loading dose on day 1 followed by 250 mg daily as a single dose on days
2 to 5

Alternative regimen: Bacterial exacerbation of COPD: 500 mg daily for a total of 3

days

Mycobacterium avium complex disease, disseminated, in patients with advanced

HIV infection: Oral:

Treatment: 600 mg daily in combination with ethambutol

Primary prophylaxis: 1,200 mg once weekly (preferred), with or without rifabutin or

alternatively, 600 mg twice weekly (DHHS [adult] 2013)

Secondary prophylaxis: 500 to 600 mg daily in combination with ethambutol

(DHHS [adult] 2013)

Pelvic inflammatory disease: IV: 500 mg as a single dose for 1 to 2 days, follow IV
therapy by the oral route with a single daily dose of 250 mg to complete a 7-day
course of therapy

Pharyngitis/tonsillitis, group A streptococci:

Manufacturer labeling: Oral: 500 mg on day 1 followed by 250 mg once daily on

days 2 to 5

IDSA guidelines: Oral: 12 mg/kg (maximum: 500 mg) on day 1 followed by 6

mg/kg/dose (maximum: 250 mg) once daily days 2 to 5. Note: Recommended
by the Infectious Disease Society of America (IDSA) as an alternative agent
for group A streptococcal pharyngitis in penicillin-allergic patients (Shulman
2012).

Pneumonia, community-acquired:

Oral: 500 mg on day 1 followed by 250 mg once daily on days 2 to 5

Alternate regimen: Extended release suspension (Zmax): 2,000 mg as a

single dose

IV: 500 mg as a single dose for at least 2 days; follow IV therapy by the oral route
with a single daily dose of 500 mg to complete a 7- to 10-day course of
therapy
 Pertussis: Oral: 500 mg on day 1 followed by 250 mg once daily on days 2 to 5 (CDC
2005)

Prophylaxis against sexually transmitted diseases following sexual assault: Oral:

1,000 mg as a single dose (in combination with a cephalosporin and
metronidazole) (CDC 2010)

Dosing adjustment in renal impairment: Infants ≥6 months, Children, Adolescents, and

Adults:

Use with caution in patients with GFR <10 mL/minute (AUC increased by 35%
compared to patients with normal renal function); however, no dosage adjustment
is provided in the manufacturer's labeling.

No supplemental dose or dosage adjustment necessary, including patients on

intermittent hemodialysis, peritoneal dialysis, or continuous renal replacement
therapy (eg, CVVHD) (Aronoff 2007; Heintz 2009).

Dosing adjustment in hepatic impairment: Azithromycin is predominantly hepatically

eliminated; however, there is no dosage adjustment provided in the manufacturer's
labeling. Use with caution due to potential for hepatotoxicity (rare); discontinue
immediately for signs or symptoms of hepatitis.

Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult
specific product labeling. [DSC] = Discontinued product

Packet, Oral:

Zithromax: 1 g (3 ea, 10 ea) [cherry-banana flavor]

Generic: 1 g (3 ea, 10 ea)

Solution Reconstituted, Intravenous:

Zithromax: 500 mg (1 ea)

Generic: 500 mg (1 ea); 2.5 g (1 ea [DSC])

Solution Reconstituted, Intravenous [preservative free]:

Generic: 500 mg (1 ea)

Suspension Reconstituted, Oral:

Zithromax: 100 mg/5 mL (15 mL) [cherry-vanilla-banana flavor]

Zithromax: 200 mg/5 mL (15 mL, 22.5 mL, 30 mL) [cherry flavor]
 Zmax: 2 g (1 ea) [cherry-banana flavor]

Generic: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL, 30 mL)

Tablet, Oral:

Zithromax: 250 mg, 500 mg, 600 mg

Zithromax Tri-Pak: 500 mg

Zithromax Z-Pak: 250 mg

Generic: 250 mg, 500 mg, 600 mg

Tablet, Oral, as monohydrate:

Generic: 500 mg, 600 mg

Generic Availability (US)

Yes

Administration
Oral:

Immediate release: May administer without regard to food; do not administer with
antacids that contain aluminum or magnesium.

Oral suspension, multiple doses: Shake well before use.

Oral suspension 1,000 mg packet for a single dose: Administer the entire contents
immediately after mixing; add an additional 60 mL of water, mix, and drink. Do not
use to administer any other dose except 1,000 mg or 2,000 mg.

Extended release oral suspension: Shake suspension well before use; administer on an
empty stomach 1 hour before or 2 hours after a meal; must be administered within
12 hours of reconstitution. May be administered without regard to antacids
containing aluminum or magnesium.

Parenteral: Do not give IM or by direct IV injection. Administer IV infusion at a final

concentration of 1 mg/mL over 3 hours; for a 2 mg/mL concentration, infuse over 1
hour; do not infuse over a period of less than 60 minutes.

Storage/Stability
Injection (Zithromax): Store intact vials of injection at room temperature. Reconstituted
solution is stable for 24 hours when stored below 30°C (86°F). The diluted solution
D5W, D5LR, D51/4NS, D51/3NS, D51/2NS (with or without 20 mEq/L KCl), Normosol-M in
D5, Normosol-R in D5, LR, NS, or 1/2NS is stable for 24 hours at or below room
temperature (30°C [86°F]) and for 7 days if stored under refrigeration (5°C [41°F]).
Suspension, immediate release (Zithromax): Store dry powder below 30°C (86°F). Store
reconstituted suspension at 5°C to 30°C (41°F to 86°F) and use within 10 days.

Suspension, extended release (Zmax): Store dry powder ≤30°C (86°F). Following
reconstitution, store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to
86°F); do not refrigerate or freeze. Should be consumed within 12 hours following
reconstitution.

Tablet (Zithromax): Store between 15°C to 30°C (59°F to 86°F).

Use
Oral:

Immediate release; oral suspension, tablets: Treatment of acute otitis media due to H.
influenzae, M. catarrhalis, or S. pneumoniae (FDA approved in pediatric patient
ages ≥6 months); treatment of pharyngitis/tonsillitis due to S. pyogenes (FDA
approved in ages ≥2 years and adults); treatment of community-acquired
pneumonia due to susceptible organisms, including C. pneumoniae, M.
pneumoniae, H. influenzae, S. pneumoniae (FDA approved in ages ≥6 months and
adults). [Oral azithromycin is not indicated for use in patients with pneumonia who
have moderate to severe disease and judged to be inappropriate for oral therapy
or have any risk factors such as cystic fibrosis, nosocomial infection, known or
suspected bacteremia, hospitalization, elderly or debilitated patients, or patients
with significant underlying health problems that may compromise their ability to
respond to their illness (including immunodeficiency or functional asplenia)];
treatment of sinusitis or COPD exacerbation due to H. influenzae, M. catarrhalis,
or S. pneumoniae (FDA approved in adults); treatment of infections of the skin and
skin structure, acute pelvic inflammatory disease, chancroid, and urethritis and
cervicitis due to susceptible strains of C. trachomatis, N. gonorrhoeae, M.
catarrhalis, H. influenzae, S. aureus, S. pyogenes, S. pneumoniae, Mycoplasma
pneumoniae, M. avium complex, C. psittaci, and C. pneumoniae (FDA approved in
adults). Has also been used for treatment of babesiosis, pertussis, endocarditis
prophylaxis in penicillin allergic patients, for prophylaxis of peritonitis in patients
undergoing invasive dental procedures, and cystic fibrosis lung disease

Extended release (Zmax); oral suspension: Treatment of community-acquired

pneumonia due to C. pneumoniae, M. pneumoniae, H. influenzae, S.
pneumonia (FDA approved in ages ≥6 months and adults); treatment of acute
bacterial sinusitis due to H. influenzae, M. catarrhalis, or S. pneumoniae (FDA
approved in adults)

Parenteral: Treatment of community-acquired pneumonia due to susceptible C.

pneumoniae, L. pneumophilia, M. pneumoniae, H. influenzae, S. aureus, S.
pneumoniae; treatment of pelvic inflammatory disease due to susceptible C.
pneumonia, N. gonorrhoeae, or M. hominis (FDA approved in adults)

Medication Safety Issues

Sound-alike/look-alike issues:

Azithromycin may be confused with azathioprine, erythromycin

Zithromax may be confused with Fosamax, Zinacef, Zovirax

Adverse Reactions
Cardiovascular: Chest pain, palpitations

Central nervous system: Dizziness, drowsiness, fatigue, headache, vertigo

Dermatologic: Dermatitis (children), pruritus, skin photosensitivity, skin rash (single-dose

regimens tend to be associated with increased incidence)

Endocrine & metabolic: Decreased serum bicarbonate (adults), decreased serum glucose
(adults), increased gamma-glutamyl transferase, increased lactate dehydrogenase,
increased serum potassium

Gastrointestinal: Abdominal pain (single-dose regimens tend to be associated with increased

incidence), anorexia, diarrhea (more common with single dose regimens), dysgeusia,
dyspepsia, flatulence, gastritis, loose stools (single-dose regimens tend to be
associated with increased incidence), melena (adults, multiple-dose regimens),
mucositis, nausea (more common with single dose regimens), oral candidiasis,
vomiting (children: Single-dose regimens tend to be associated with increased
incidence; adults: More common with single 2 g dose)

Genitourinary: Genital candidiasis (adults, multiple-dose regimens), vaginitis

Hematologic & oncologic: Change in neutrophil count (children), decreased hematocrit

(adults), decreased hemoglobin (adults), decrease in absolute neutrophil count
(children: 500 to 1500 cells/mm3), eosinophilia, increased neutrophils (adults),
lymphocytopenia, thrombocythemia (adults)

Hepatic: Cholestatic jaundice, increased serum ALT, increased serum AST, increased
serum bilirubin

Local (adults with IV administration): Local inflammation, pain at injection site

Neuromuscular & skeletal: Increased creatine phosphokinase

Renal: Increased blood urea nitrogen, increased serum creatinine, nephritis (adults, multiple-
dose regimens)

Respiratory: Bronchospasm

Miscellaneous: Fever (children)

Rare but important or life-threatening: Abnormal stools, acute renal failure, ageusia,
aggressive behavior, agitation, alteration in sodium, altered sense of smell, altered
serum glucose, anaphylaxis, anemia, angioedema, anosmia, anxiety, arthralgia,
 asthma, basophilia, bronchitis, cardiac arrhythmia, Clostridium difficile associated
diarrhea, conjunctivitis (children), constipation, convulsions, cough, deafness,
decreased serum potassium (children), decreased serum sodium, diaphoresis, DRESS
syndrome, dyspnea, dysuria, eczema, edema, emotional lability, enteritis, erythema
multiforme, exacerbation of myasthenia gravis, facial edema, flu-like symptoms
(children), fungal dermatitis (children), fungal infection (children), gastrointestinal
disease, hearing loss, hepatic failure, hepatic insufficiency, hepatic necrosis, hepatitis,
hepatotoxicity (idiosyncratic) (Chalasani 2014), hostility, hyperactivity, hyperkinesia,
hypersensitivity reaction, hypotension, increased monocytes, increased serum alkaline
phosphatase, increased serum bicarbonate, increased serum phosphate, interstitial
nephritis, insomnia, irritability, jaundice, Lambert-Eaton syndrome, leukopenia,
maculopapular rash, malaise, nervousness, neutropenia, otitis media, pain,
pancreatitis, paresthesia, pharyngitis, pleural effusion, prolonged Q-T interval on ECG,
pseudomembranous colitis, pyloric stenosis, pyloric stenosis (infantile hypertrophic),
rhinitis, seizure, Stevens-Johnson syndrome, syncope, thrombocytopenia, tinnitus,
tongue discoloration, toxic epidermal necrolysis, urticaria, ventricular tachycardia,
vesiculobullous dermatitis, weakness

Contraindications
Hypersensitivity to azithromycin, erythromycin, other macrolide (eg, azalide or ketolide)
antibiotics, or any component of the formulation; history of cholestatic jaundice/hepatic
dysfunction associated with prior azithromycin use

Note: The manufacturer does not list concurrent use of pimozide as a contraindication;
however, azithromycin is listed as a contraindication in the manufacturer’s labeling for
pimozide.

Warnings/Precautions
Concerns related to adverse effects:

• Hypersensitivity reactions: Allergic reactions (eg, angioedema, anaphylaxis, Stevens-

Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia
and systemic symptoms [DRESS]) have been reported (rare), including fatalities;
reappearance of allergic reaction may occur shortly after discontinuation of
symptomatic treatment without further azithromycin exposure.

• Altered cardiac conduction: Macrolides (especially erythromycin) have been

associated with rare QTc prolongation and ventricular arrhythmias, including
torsade de pointes; consider avoiding use in patients with prolonged QT interval,
congenital long QT syndrome, history of torsade de pointes, bradyarrhythmias,
uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia,
uncompensated heart failure, or concurrent use of Class IA (eg, quinidine,
procainamide) or Class III (eg, amiodarone, dofetilide, sotalol) antiarrhythmic
agents or other drugs known to prolong the QT interval.
 • Cardiac risk: A retrospective cohort study done in Tennessee Medicaid patients
demonstrated an increased cardiac risk with azithromycin relative to amoxicillin or
ciprofloxacin, and similar risk compared to levofloxacin; notably, increased cardiac
mortality (an estimated 47 additional deaths per 1 million 5-day courses of
treatment compared to amoxicillin) was associated with higher baseline
cardiovascular risk (Ray 2012); however, these data may not be generalizable to
the population as a whole (Ray 1989). In another retrospective population study of
US veterans, azithromycin was shown to significantly increase the risk of mortality
and arrhythmia on days 1 to 5, but not on days 6 to 10 after dispensing the
prescription (Rao 2014). In contrast, 2 additional large retrospective cohort studies
did not demonstrate an increased risk of cardiovascular events, including all-
cause mortality or cardiovascular death (Svanstrom 2013, Mortensen 2014). The
implications of these data have yet to be determined.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection,

including C. difficile-associated diarrhea (CDAD); CDAD has been observed >2
months postantibiotic treatment.

Disease-related concerns:

• Gonorrhea/syphilis: May mask or delay symptoms of incubating gonorrhea or syphilis,

so appropriate culture and susceptibility tests should be performed prior to
initiating a treatment regimen.

• Hepatic impairment: Use with caution in patients with preexisting liver disease;
hepatocellular and/or cholestatic hepatitis, with or without jaundice, hepatic
necrosis, failure, and death have occurred. Discontinue immediately if symptoms
of hepatitis occur (malaise, nausea, vomiting, abdominal colic, fever).

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation
and new onset of symptoms have occurred.

• Renal impairment: Use with caution in patients with severe renal impairment (GFR
<10 mL/minute); increased gastrointestinal adverse effects may occur.

Special populations:

• Infants: Use of azithromycin in neonates and infants (treatment up to 42 days of life)

has been associated with infantile hypertrophic pyloric stenosis (IHPS); observe
for non-bilious vomiting or irritability with feeding (Eberly 2015).

Dosage form specific issues:

• Oral suspensions: Immediate release and extended release suspensions are not
interchangeable.

Metabolism/Transport Effects
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on
clinically relevant drug interaction potential; Inhibits P-glycoprotein

Drug Interactions
(For additional information: Launch drug interactions program)

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib.

Management: Per US labeling: reduce afatinib by 10mg if not tolerated. Per Canadian
labeling: avoid combination if possible; if used, administer the P-gp inhibitor
simultaneously with or after the dose of afatinib. Risk D: Consider therapy modification

Amiodarone: Azithromycin (Systemic) may enhance the QTc-prolonging effect of

Amiodarone. Management: The concomitant use of amiodarone, which has a high risk
for QTc prolongation, with azithromycin, which may also prolong the QT interval, should
be avoided. Risk X: Avoid combination

AtorvaSTATin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect

of AtorvaSTATin. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG

(Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG
Vaccine (Immunization). Risk C: Monitor therapy

Betrixaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Betrixaban. Management: Decrease the betrixaban dose to an initial single dose of 80
mg followed by 40 mg once daily if combined with a P-glycoprotein inhibitor. Risk D:
Consider therapy modification

Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Bilastine. Management: Consider alternatives when possible; bilastine should be
avoided in patients with moderate to severe renal insufficiency who are receiving p-
glycoprotein inhibitors. Risk D: Consider therapy modification

Brentuximab Vedotin: P-glycoprotein/ABCB1 Inhibitors may increase the serum

concentration of Brentuximab Vedotin. Specifically, concentrations of the active
monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor
therapy

Cardiac Glycosides: Macrolide Antibiotics may increase the serum concentration of Cardiac
Glycosides. Risk C: Monitor therapy

Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Celiprolol. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Risk X:
Avoid combination
Cisapride: Macrolide Antibiotics may enhance the QTc-prolonging effect of Cisapride.
Macrolide Antibiotics may decrease the metabolism of Cisapride. Risk X: Avoid
combination

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be
increased. Management: Colchicine is contraindicated in patients with impaired renal or
hepatic function who are also receiving a p-glycoprotein inhibitor. In those with normal
renal and hepatic function, reduce colchicine dose as directed. Risk D: Consider
therapy modification

CycloSPORINE (Systemic): Azithromycin (Systemic) may increase the serum concentration

of CycloSPORINE (Systemic). Risk C: Monitor therapy

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of

the active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose
reductions may be needed. Specific recommendations vary considerably according to
US vs Canadian labeling, specific P-gp inhibitor, renal function, and indication for
dabigatran treatment. Refer to full monograph or dabigatran labeling. Risk D: Consider
therapy modification

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum

concentration of DOXOrubicin (Conventional). Management: Seek alternatives to P-
glycoprotein inhibitors in patients treated with doxorubicin whenever possible. One U.S.
manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Risk D:
Consider therapy modification

Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Edoxaban. Management: See full monograph for details. Reduced doses are
recommended for patients receiving edoxaban for venous thromboembolism in
combination with certain inhibitors. Similar dose adjustment is not recommended for
edoxaban use in atrial fibrillation. Risk D: Consider therapy modification

Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Everolimus. Management: Everolimus dose reductions are required for patients being
treated for subependymal giant cell astrocytoma or renal cell carcinoma. See
prescribing information for specific dose adjustment and monitoring
recommendations. Risk D: Consider therapy modification

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance
the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Risk X: Avoid
combination

Hydroxychloroquine: May enhance the QTc-prolonging effect of Moderate Risk QTc-

Prolonging Agents. Risk X: Avoid combination

Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination
Ivermectin (Systemic): Azithromycin (Systemic) may increase the serum concentration of
Ivermectin (Systemic). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and
Estriol. Risk C: Monitor therapy

Lovastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of

Lovastatin. Risk C: Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination

Mizolastine: Macrolide Antibiotics may increase the serum concentration of Mizolastine. Risk
X: Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other
Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when
possible. Use should be accompanied by close monitoring for evidence of QT
prolongation or other alterations of cardiac rhythm. Risk D: Consider therapy
modification

Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Naldemedine. Risk C: Monitor therapy

Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Naloxegol. Risk C: Monitor therapy

Nelfinavir: May increase the serum concentration of Azithromycin (Systemic). Risk C:

Monitor therapy

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

PAZOPanib. Risk X: Avoid combination

P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inhibitors may increase the serum

concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also
enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs
where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes,
etc.). Risk C: Monitor therapy

Pimozide: Macrolide Antibiotics may enhance the QTc-prolonging effect of Pimozide.

Macrolide Antibiotics may decrease the metabolism of Pimozide. This mechanism may
not apply to azithromycin. Risk X: Avoid combination

Probucol: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination

Promazine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination
Prucalopride: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of
Prucalopride. Risk C: Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-
prolonging effect of Moderate Risk QTc-Prolonging Agents. Risk C: Monitor therapy

QuiNINE: Macrolide Antibiotics may increase the serum concentration of QuiNINE. Risk X:
Avoid combination

Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Ranolazine. Risk C: Monitor therapy

RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

RifAXIMin. Risk C: Monitor therapy

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Silodosin. Risk X: Avoid combination

Simvastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of

Simvastatin. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate.
Management: Consider using an alternative product for bowel cleansing prior to a
colonoscopy in patients who have recently used or are concurrently using an
antibiotic. Risk D: Consider therapy modification

Tacrolimus (Systemic): Azithromycin (Systemic) may increase the serum concentration of

Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Topical): Macrolide Antibiotics may increase the serum concentration of

Tacrolimus (Topical). Risk C: Monitor therapy

Terfenadine: Macrolide Antibiotics may enhance the QTc-prolonging effect of Terfenadine.

Macrolide Antibiotics may increase the serum concentration of Terfenadine. Risk X:
Avoid combination

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Topotecan. Risk X: Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only
the live attenuated Ty21a strain is affected. Management: Vaccination with live
attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with
systemic antibacterial agents. Use of this vaccine should be postponed until at least 3
days after cessation of antibacterial agents. Risk D: Consider therapy modification

Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients
requiring these combinations. Risk D: Consider therapy modification
VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum
concentration of VinCRIStine (Liposomal). Risk X: Avoid combination

Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Macrolide Antibiotics may increase the serum
concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Xipamide: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk C: Monitor therapy

Food Interactions
Rate and extent of GI absorption may be altered depending upon the formulation.
Azithromycin suspension, not tablet form, has significantly increased absorption (46%) with
food. Management: Immediate release suspension and tablet may be taken without regard
to food; extended release suspension should be taken on an empty stomach (at least 1 hour
before or 2 hours following a meal).

Pregnancy Risk Factor

B (show table)

Pregnancy Implications
Adverse events were not observed in animal reproduction studies. Azithromycin crosses the
placenta (Ramsey 2003). The maternal serum half-life of azithromycin is unchanged in early
pregnancy and decreased at term; however, high concentrations of azithromycin are
sustained in the myometrium and adipose tissue (Fischer 2012; Ramsey 2003).
Azithromycin is recommended for the treatment of several infections, including chlamydia,
gonococcal infections, and Mycobacterium avium complex (MAC) in pregnant patients
(consult current guidelines) (CDC [Workowski 2015]; HHS [opportunistic; adult] 2015).

Monitoring Parameters
Liver function tests, WBC with differential; number and type of stools/day for diarrhea;
monitor patients receiving azithromycin and drugs known to interact with erythromycin (ie,
theophylline, digoxin, anticoagulants, triazolam) since there are still very few studies
examining drug-drug interactions with azithromycin. When used as part of alternative
treatment for gonococcal infection, test-of-cure 7 days after dose (CDC, 2012).

Mechanism of Action
Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S
ribosomal subunit resulting in blockage of transpeptidation

Pharmacodynamics/Kinetics (Adult data unless noted)

Absorption: Oral: Rapid from the GI tract
Distribution: Extensive tissue; distributes well into skin, lungs, sputum, tonsils, and cervix;
penetration into CSF is poor; Vd: 31 to 33 L/kg

Protein binding (concentration dependent and dependent on alpha1-acid glycoprotein

concentrations): Oral, IV: 7% to 51%

Metabolism: Hepatic to inactive metabolites

Bioavailability: Oral: Tablet, immediate release oral suspension: 34% to 52%; extended
release oral suspension: 28% to 43%; variable effect with food (increased with
immediate or delayed release oral suspension, unchanged with tablet)

Half-life elimination: Terminal: Oral, IV:

Infants and Children 4 months to 15 years: 54.5 hours

Adults: Immediate release: 68 to 72 hours; Extended release: 59 hours

Time to peak, serum: Oral: Immediate release: ~2 to 3 hours; Extended release: 3 to 5 hours

Excretion: Oral, IV: Biliary (major route 50%, unchanged); urine (6% to 14% unchan

Azithromycin (Systemic)
You must carefully read the "Consumer Information Use and Disclaimer" below in order to understand and correctly use this information

Pronunciation
(az ith roe MYE sin)

Brand Names: US
 Zithromax
 Zithromax Tri-Pak
 Zithromax Z-Pak
 Zmax

Brand Names: Canada

 ACT-Azithromycin
 Apo-Azithromycin
 Apo-Azithromycin Z
 Azithromycin for Injection
 Azithromycin for Injection, USP
 Dom-Azithromycin
 GD-Azithromycin
 Mylan-Azithromycin
 Novo-Azithromycin
  PHL-Azithromycin
 PMS-Azithromycin
 PRO-Azithromycine
 Riva-Azithromycin
 Sandoz-Azithromycin
 Zithromax
 Zithromax For Intravenous Injection
 Zmax SR

What is this drug used for?

 •It is used to treat or prevent bacterial infections.

What do I need to tell the doctor BEFORE my child takes this drug?
 •If your child has an allergy to this drug or any part of this drug.
 •If your child is allergic to any drugs like this one or any other drugs, foods, or other
substances. Tell the doctor about the allergy and what signs your child had, like rash; hives;
itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any
other signs.
 •If your child has any of these health problems: Long QT on ECG, low magnesium levels, low
potassium levels, or slow heartbeat.
 •If your child has turned yellow or has had liver side effects with this drug before.
 •If your child is taking any drugs that can cause a certain type of heartbeat that is not normal
(prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist
if you are not sure.
 This is not a list of all drugs or health problems that interact with this drug.
 Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural
products, vitamins) and health problems. You must check to make sure that it is safe for your
child to take this drug with all of his/her drugs and health problems. Do not start, stop, or
change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes

this drug?
 For all patients taking this drug:
 •Tell all of your child's health care providers that your child is taking this drug. This includes
your child's doctors, nurses, pharmacists, and dentists.
 •Do not give to your child longer than you have been told. A second infection may happen.
 •If your child is taking warfarin, talk with the doctor. Your child may need to have blood work
checked more closely while taking it with this drug.
 •A very bad and sometimes deadly reaction has happened with this drug. Most of the time,
this reaction has signs like fever, rash, or swollen glands with problems in body organs like
the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
 •This drug may cause a type of abnormal heartbeat (prolonged QT interval). If this happens,
the chance of other unsafe and sometimes deadly abnormal heartbeats may be raised. Talk
with the doctor.
 •If your child has myasthenia gravis, talk with the doctor. Call the doctor if your child's signs
get worse. Signs of myasthenia gravis have also happened in people who do not have it. Call
the doctor right away if your child has new or worse muscle weakness, trouble chewing or
swallowing, trouble breathing, droopy eyelids, or change in eyesight like blurred eyesight or
seeing double.
 If your child is pregnant or breast-feeding a baby:
 •Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby.
You will need to talk about the benefits and risks of using this drug.
 Newborns:
  •A very bad stomach problem has happened in newborns taking this drug. Call the doctor
right away if your child throws up or gets irritable with feeding.

What are some side effects that I need to call my child's doctor
about right away?
 WARNING/CAUTION: Even though it may be rare, some people may have very bad and
sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help
right away if your child has any of the following signs or symptoms that may be related to a
very bad side effect:
 All products:
 •Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin
with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking;
unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
 •A heartbeat that does not feel normal.
 •Change in hearing.
 •Hearing loss.
 •Chest pain or pressure or a fast heartbeat.
 •Ringing in ears.
 •Seizures.
 •Very bad dizziness or passing out.
 •Trouble swallowing or speaking.
 •Fever.
 •Swollen gland.
 •Vaginal itching or discharge.
 •It is common to have diarrhea when taking this drug. Rarely, a very bad form of diarrhea
called Clostridium difficile (C diff)-associated diarrhea (CDAD) may occur. Sometimes, this
has led to a deadly bowel problem (colitis). CDAD may happen while your child is taking this
drug or within a few months after he/she stops taking it. Call your child's doctor right away if
your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not
try to treat loose stools without first checking with the doctor.
 •Very bad and sometimes deadly liver problems have happened with this drug. Call your
child's doctor right away if your child has signs of liver problems like dark urine, feeling tired,
not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or
eyes.
 •A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may
happen. It can cause very bad health problems that may not go away, and sometimes death.
Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin
(with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
 Shot:
 •Redness or swelling where the shot is given.

What are some other side effects of this drug?

 All drugs may cause side effects. However, many people have no side effects or only have
minor side effects. Call your child's doctor or get medical help if any of these side effects or
any other side effects bother your child or do not go away:
 •Belly pain.
 •Upset stomach or throwing up.
 •Loose stools (diarrhea).
 •Headache.
 •Itching.
 •Not hungry.
 These are not all of the side effects that may occur. If you have questions about side effects,
call your child's doctor. Call your child's doctor for medical advice about side effects.
 You may report side effects to your national health agency.
How is this drug best given?
 Give this drug as ordered by your child's doctor. Read all information given to you. Follow all
instructions closely.
 Zmax®:
 •Give on an empty stomach. Give 1 hour before or 2 hours after meals.
 •Shake well before use.
 •Use within 12 hours of making.
 •If your child throws up within 1 hour of taking this drug, call the doctor to find out what to do.
 All other oral products:
 •Give this drug with or without food. Give with food if it causes an upset stomach.
 •Do not give antacids within 2 hours of this drug.
 Packets:
 •Empty powder packet in1/4 cup (60 mL) of water. Mix well and give to your child to drink.
Rinse cup with more water and have your child drink.
 Tablets and liquid (suspension):
 •To gain the most benefit, do not miss giving your child doses.
 •Keep giving this drug to your child as you have been told by your child's doctor or other
health care provider, even if your child feels well.
 Liquid (suspension):
 •Shake well before use.
 •Measure liquid doses carefully. Use the measuring device that comes with this drug. If there
is none, ask the pharmacist for a device to measure this drug.
 Shot:
 •It is given as an infusion into a vein over a period of time.

What do I do if my child misses a dose?

 Packets:
 •Only 1 dose of this drug is needed. If your child missed the dose, give it as soon as you think
about it.
 Zmax®:
 •Only 1 dose of this drug is needed. If your child missed the dose, give it as soon as you think
about it.
 All other oral products:
 •Give a missed dose as soon as you think about it.
 •If it is close to the time for your child's next dose, skip the missed dose and go back to your
child's normal time.
 •Do not give 2 doses at the same time or extra doses.
 Shot:
 •Call your child's doctor to find out what to do.

How do I store and/or throw out this drug?

 Zmax®:
 •Store at room temperature. Do not refrigerate or freeze.
 Tablets:
 •Store at room temperature.
 Liquid (suspension):
 •Store liquid (suspension) at room temperature or in a refrigerator. Throw away any unused
portion after 10 days.
 •Store in original container.
 Packets:
 •Store in the original container at room temperature.
 All oral products:
 •Store in a dry place. Do not store in a bathroom.
  Shot:
 •If you need to store this drug at home, talk with your child's doctor, nurse, or pharmacist
about how to store it.
 All products:
 •Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
 •Check with your pharmacist about how to throw out unused drugs.

General drug facts

 •If your child's symptoms or health problems do not get better or if they become worse, call
your child's doctor.
 •Do not share your child's drug with others and do not give anyone else's drug to your child.
 •Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you.
Give this list to your child's doctor.
 •Talk with your child's doctor before giving your child any new drug, including prescription or
OTC, natural products, or vitamins.
 •Some drugs may have another patient information leaflet. If you have any questions about
this drug, please talk with your child's doctor, nurse, pharmacist, or other health care provider.
 •If you think there has been an overdose, call your poison control center or get medical care
right away. Be ready to tell or show what was taken, how much, and when it happened.

Printed on 2017-08-25
ectly use this information

‫النطق‬
(az ith roe MYE sin)

‫أسماء العالمات التجارية األمريكية‬

 Zithromax
 Zithromax Tri-Pak
 Zithromax Z-Pak
 Zmax

‫أسماء العالمات التجارية الكندية‬

 ACT-Azithromycin
 Apo-Azithromycin
 Apo-Azithromycin Z
 Azithromycin for Injection
 Azithromycin for Injection, USP
 Dom-Azithromycin
 GD-Azithromycin
 Mylan-Azithromycin
 Novo-Azithromycin
 PHL-Azithromycin
 PMS-Azithromycin
 PRO-Azithromycine
 Riva-Azithromycin
 Sandoz-Azithromycin
 Zithromax
 Zithromax For Intravenous Injection
 ‫‪‬‬ ‫‪Zmax SR‬‬

‫ما هي أوجه استعمال هذا الدواء؟‬

‫‪‬‬ ‫‪.‬يُستخدم هذا العقار لعالج العديد من أنواع العدوى البكتيرية أو الوقاية منها•‬

‫ما الذي أحتاج أن أقوله للطيب قبل أن يتناول طفلي هذا العقار؟‬
‫‪.‬إذا كان طفلك يعاني من حساسية تجاه هذا العقار أو أي من مكوناته• ‪‬‬
‫‪‬‬ ‫إذا كان طفلك يعاني من الحساسية تجاه أي عقاقير مثل هذا العقار أو أي عقاقير أخرى أو أطعمة أو مواد أخرى‪ .‬أخبر •‬
‫طبيبك عن نوع الحساسية والعالمات التي تظهر على الطفل مثل الطفح الجلدي أو الشرى أو الحكة أو ضيق النفس أو‬
‫‪.‬الصفير عند التنفس أو السعال أو تورم الوجه أو الشفتين أو اللسان أو الحلق أو أي عالمات أخرى‬
‫أو )‪ (ECG‬طويلة على مخطط كهربائية القلب ‪ QT‬إذا كان طفلك يعاني من إحدى المشكالت الصحية التالية‪ :‬فترات• ‪‬‬
‫‪.‬انخفاض مستويات الماغنسيوم أو انخفاض مستويات البوتاسيوم أو انخفاض معدل ضربات القلب‬
‫‪.‬إذا ما تحولت بشرة الطفل إلى اللون األصفر أو كان قد تعرض ألعراض جانبية كبدية إثر تناوله لهذا العقار ُمسبقًا• ‪‬‬
‫إذا كان طفلك يتناول أي عقاقير يمكن أن تسبب شكال معينًا من عدم انتظام ضربات القلب (فاصل زمني طويل بين • ‪‬‬
‫‪.‬توجد الكثير من العقاقير التي يمكنها القيام بذلك‪ .‬استشر الطبيب أو الصيدلي إذا لم تكن متأكدًا ‪ QT).‬فترات‬
‫‪.‬هذه ليست قائمة بكل العقاقير أو المشاكل الصحية التي تتفاعل مع هذا العقار ‪‬‬
‫‪‬‬ ‫أخبر الطبيب والصيدلي الذي تتعامل معه عن كل العقاقير التي يتناولها طفلك (المصروفة بوصفة طبية أو المتاحة دون‬
‫وصفة طبية أو المستحضرات الطبيعية أو الفيتامينات) والمشكالت الصحية التي يعاني منها‪ .‬يجب أن تتحقق من أنه من‬
‫اآلمن لطفلك تناول هذا العقار إلى جانب جميع العقاقير األخرى التي يتناولها والمشكالت الصحية التي يعاني منها‪ .‬تجنب‬
‫‪.‬البدء في إعطاء جرعة أي عقار لطفلك أو إيقافها أو تغييرها دون الرجوع إلى الطبيب‬

‫ما هي األشياء التي يجب أن أعلمها أو أقوم بها خالل الفترة التي يتناول فيها طفلي هذا العقار؟‬
‫‪:‬بالنسبة للمرضى ممن يتناولون هذا العقار ‪‬‬
‫‪‬‬ ‫أخبري جميع مقدمي الرعاية الصحية لطفلك بأن طفلك يتناول هذا العقار‪ .‬وهذا يشمل األطباء‪ ،‬والممرضات‪ ،‬والصيادلة‪• ،‬‬
‫‪.‬وأطباء األسنان‬
‫‪.‬يُحظر إعطاء العقار لطفلك لفترة أطول مما أمرك به الطبيب‪ .‬قد تحدث عدوى ثانية• ‪‬‬
‫‪‬‬ ‫إذا كان طفلك يتناول الوارفارين‪ ،‬فأخبر الطبيب‪ .‬قد يحتاج طفلك إلى إجراء فحص للدم عن كثب أثناء تناول الوارفارين •‬
‫‪.‬مع هذا العقار‬
‫‪‬‬ ‫ً‬
‫لقد حدث ردود فعل خطيرة جدًا وأحيانا مميتة عند استخدام هذا العقار‪ .‬في أغلب األحوال‪ ،‬يكون لرد الفعل هذا أعراض •‬
‫مثل الحمى أو الطفح الجلدي أو تورم الغدد مع مشكالت في أعضاء الجسم مثل الكبد أو الكلية أو الدم أو القلب أو‬
‫‪.‬العضالت والمفاصل أو الرئة‪ .‬تحدث إلى الطبيب‬
‫مطولة)‪ .‬وفي حالة حدوث ذلك‪ ،‬قد ترتفع احتمالية ‪ QT‬قد يسبب هذا العقار نوعًا من ضربات القلب غير الطبيعية (فترة• ‪‬‬
‫‪.‬التعرض ألنواع أخرى غير آمنة أو مميتة من ضربات القلب غير الطبيعية‪ .‬استشر الطبيب‬
‫إذا كان طفلك يعاني من مرض الوهن العضلي الوبيل‪ ،‬يرجى استشارة الطبيب‪ .‬اتصل بالطبيب إذا ازدادت أعراض • ‪‬‬
‫طفلك سو ًءا‪ .‬قد تظهر أعراض الوهن العضلي الوبيل أيضًا لدى األشخاص غير المصابين بهذا المرض‪ .‬اتصل بالطبيب‬
‫فورا إذا شعر طفلك بشكل جديد أو أكثر سو ًءا من ضعف العضالت أو مشكلة في المضغ أو البلع أو صعوبة في التنفس‬ ‫ً‬
‫‪.‬أو ارتخاء جفون العين أو تغيير في اإلبصار‪ ،‬مثل عدم وضوح الرؤية أو ازدواج الرؤية‬
‫‪:‬إذا كانت طفلتك حامالً أو ترضع طفالً ‪‬‬
‫تحدث إلى الطبيب إذا كانت طفلتك حامالً أو تخطط للحمل أو تُرضع طفالً رضاعة طبيعية‪ .‬تحدث إلى الطبيب بشأن • ‪‬‬
‫‪.‬الفوائد والمخاطر المرتبطة باستخدام هذا العقار‬
‫‪:‬حديثي الوالدة ‪‬‬
‫فورا إذا تقيأ • ‪‬‬
‫حدثت مشكلة خطيرة للغاية في المعدة لدى األطفال حديثي الوالدة الذين يتناولون هذا العقار‪ .‬اتصل بطبيبك ً‬
‫‪.‬طفلك أو يكون سريع االنفعال عند إطعامه‬

‫ما هي بعض األعراض الجانبية التي أحتاج إلى االتصال بطبيب طفلي بشأنها على الفور؟‬
‫‪‬‬ ‫نادرا‪ ،‬قد تظهر لدى بعض األشخاص آثار جانبية خطيرة للغاية وأحيا ًنا ‪:‬تحذير‪/‬تنبيه‬‫على الرغم من أن ذلك قد يكون ً‬
‫مميتة عند تناول أحد العقاقير‪ .‬أخبري الطبيب المعالج لطفلك أو التمسي مساعدة طبية على الفور إذا ظهرت لدى طفلك‬
‫‪:‬أي من العالمات أو األعراض التالية التي قد تكون مرتبطة بأثر جانبي خطير للغاية‬
‫‪:‬جميع األشكال ‪‬‬
 ‫‪‬‬ ‫قد تحدث عالمات على رد الفعل التحسسي‪ ،‬مثل الطفح الجلدي أو الشرى أو الحكة؛ أو احمرار البشرة أو تورمها أو •‬
‫انتشار البثور عليها أو تقشرها‪ ،‬ويصاحب ذلك حمى أو بدون حمى؛ أو إحداث صفير أثناء التنفس أو ضيق في الصدر أو‬
‫الحلق‪ ،‬أو صعوبة في التنفس أو الكالم؛ أو حدوث بحة غير عادية أو تورم في الفم أو الوجه أو الشفتين أو اللسان أو‬
‫‪.‬الحلق‬
‫‪.‬عدم انتظام ضربات القلب• ‪‬‬
‫‪.‬تغير في مستوى القدرة على السمع• ‪‬‬
‫‪.‬الصمم• ‪‬‬
‫‪.‬آالم أو ضغط في الصدر أو تسارع في ضربات القلب• ‪‬‬
‫‪.‬صفير في األذنين• ‪‬‬
‫‪.‬نوبات مرضية• ‪‬‬
‫‪.‬دوار شديد أو إغماء• ‪‬‬
‫‪.‬صعوبة البلع أو الكالم• ‪‬‬
‫‪.‬الحمى• ‪‬‬
‫‪.‬غدة متضخمة• ‪‬‬
‫‪.‬حكة أو إفراز مهبلي• ‪‬‬
‫نادرا ما يحدث نوع سيء جدًا من اإلسهال يسمى اإلسهال • ‪‬‬ ‫ً‬ ‫العقار‪.‬‬ ‫هذا‬ ‫تناول‬ ‫عند‬ ‫تشيع اإلصابة باإلسهال‬
‫أدى هذا في بعض األحيان إلى مشكلة مفضية إلى الوفاة باألمعاء (التهاب ‪ (CDAD).‬للمطثية العسيرة المصاحب‬
‫القولون)‪ .‬قد يصاب طفلك باإلسهال المرتبط بالمطثية العسيرة أثناء تناول هذا العقار أو خالل بضعة شهور من التوقف‬
‫عن تناوله‪ .‬اتصل بطبيب طفلك على الفور إذا عانى الطفل من أي آالم في المعدة أو تقلصات أو إسهال شديد أو سائل‬
‫‪.‬للغاية أو مدمم‪ .‬ال تحاول معالجة اإلسهال دون مناقشة األمر مع الطبيب ً‬
‫أوال‬
‫فورا عند ظهور • ‪‬‬ ‫ً‬ ‫طفلك‬ ‫بطبيب‬ ‫اتصل‬ ‫حدثت مشكالت خطيرة جدًا وأحيانًا مميتة في الكبد عند استخدام هذا العقار‪.‬‬
‫أعراض على طفلك تشير إلى وجود مشكلة في الكبد مثل لون البول الداكن أو الشعور بالتعب وعدم الجوع أو اضطراب‬
‫‪.‬المعدة أو آالم المعدة أو براز فاتح اللون أو القيء أو اصفرار الجلد أو العينين‬
‫‪‬‬ ‫قد يحدث رد فعل جلدي خطير (متالزمة ستيفنز‪-‬جونسون‪/‬انحالل البشرة النخري السمي)‪ .‬ويمكن أن يتسبب في مشكالت •‬
‫فورا إذا ظهرت على‬ ‫صحية خطيرة ال تزول بسهولة وأحيانًا يؤدي إلى الوفاة‪ .‬ينبغي الحصول على المساعدة الطبية ً‬
‫طفلك أعراض مثل احمرار الجلد أو تورمه أو تقرحه أو تقشره (يصاحب ذلك حمى أو بدون حمى)؛ أو احمرار العينين‬
‫‪.‬أو تهيجهما أو قروح في الفم أو الحلق أو األنف أو العينين‬
‫‪:‬الحقن ‪‬‬
‫‪.‬احمرار أو تورم في موضع الحقن• ‪‬‬

‫ما هي بعض اآلثار الجانبية األخرى لهذا العقار؟‬

‫‪‬‬ ‫قد تتسبب جميع العقاقير في حدوث أعراض جانبية‪ .‬ومع ذلك‪ ،‬ال تظهر أي أعراض جانبية على العديد من األفراد أو قد‬
‫تظهر بعض األعراض الجانبية البسيطة‪ .‬اتصلي بالطبيب المعالج لطفلك أو اطلب المساعدة الطبية إذا تسببت هذه‬
‫‪:‬األعراض الجانبية أو أي أعراض جانبية أخرى في إزعاج الطفل أو تختف‬
‫‪.‬ألم في البطن• ‪‬‬
‫‪.‬اضطراب المعدة أو قيء• ‪‬‬
‫‪.‬اإلسهال أو البراز المتقلقل• ‪‬‬
‫‪.‬الصداع• ‪‬‬
‫‪.‬الحكة• ‪‬‬
‫‪.‬عدم الشعور بالجوع• ‪‬‬
‫‪‬‬ ‫هذه ليست جميع اآلثار الجانبية واردة الحدوث‪ .‬إذا كان لديك أي أسئلة بشأن اآلثار الجانبية‪ ،‬اتصلي بالطبيب ال ُمعالج‬
‫‪.‬لطفلك‪ .‬استشيري الطبيب ال ُمعالج لطفلك للحصول على المشورة الطبية بخصوص اآلثار الجانبية‬
‫‪.‬يمكنك اإلبالغ عن اآلثار الجانبية إلى وكالة الصحة المحلية لديك ‪‬‬

‫ما هي أفضل طريقة لتناول الدواء؟‬

‫‪‬‬ ‫قم بإعطاء هذا العقار حسب تعليمات الطبيب ال ُمعالج لطفلك‪ .‬واقرأ جميع المعلومات المقدمة لك‪ .‬واتبع كافة اإلرشادات‬
‫‪.‬بعناية‬
‫‪®:‬زامكس ‪‬‬
‫‪.‬أعط هذا العقار على معدة فارغة‪ .‬أعط العقار قبل الوجبات بساعة أو بعدها بساعتين• ‪‬‬
‫‪.‬رج جيدًا قبل االستعمال• ‪‬‬
‫‪.‬يستخدم خالل ‪ 12‬ساعة من اإلعداد• ‪‬‬
‫‪.‬إذا تقيأ طفلك خالل ساعة واحدة من تناول هذا العقار‪ ،‬فعليك االتصال بالطبيب لمعرفة ما يجب أن تفعله• ‪‬‬
 ‫‪:‬جميع المنتجات األخرى التي تؤخذ بالفم ‪‬‬
‫‪‬‬ ‫‪.‬يؤخذ هذا العقار مع الطعام أو بدونه‪ .‬يؤخذ مع الطعام‪ ،‬إذا كان يسبب اضطرابًا في المعدة•‬
‫‪.‬يحظر إعطاء مضادات الحموضة خالل ساعتين من تناول هذا العقار• ‪‬‬
‫‪:‬من خالل أكياس ‪‬‬
‫‪‬‬ ‫كوب (‪ 60‬ملل) من الماء‪ .‬وامزجه جيدًا وأعطه لطفلك ليشربه‪ .‬اشطف الكوب بمزيد من ‪1/4‬أفرغ عبوة المسحوق في•‬
‫‪.‬الماء ثم اجعل طفلك يشربه‬
‫‪):‬األقراص والسائل (معلق ‪‬‬
‫‪.‬للحصول على أقصى استفادة‪ ،‬ال تغفل عن إعطاء الجرعات لطفلك• ‪‬‬
‫‪‬‬ ‫احرص على إعطاء هذا العقار لطفلك حسب تعليمات الطبيب المعالج لطفلك أو مقدم آخر للرعاية الصحية‪ ،‬حتى لو شعر •‬
‫‪.‬طفلك بتحسن‬
‫‪):‬السائل (محلول معلق ‪‬‬
‫‪.‬رج جيدًا قبل االستعمال• ‪‬‬
‫قس جرعات السائل بدقة‪ .‬استخدم جهاز القياس المرفق بهذا العقار‪ .‬وفي حالة عدم وجود الجهاز‪ ،‬أطلب من الصيدلي • ‪‬‬
‫‪.‬الحصول على جهاز لقياس العقار‬
‫‪:‬الحقن ‪‬‬
‫‪.‬يتم إعطاء هذا الدواء كحقن في الوريد على مدى فترة معينة من الوقت• ‪‬‬

‫ماذا أفعل إذا فاتت طفلي إحدى الجرعات؟‬

‫‪:‬من خالل أكياس ‪‬‬
‫‪‬‬ ‫‪.‬ال تحتاج إال لجرعة واحدة فقط من هذا العقار‪ .‬إذا فوت طفلك جرعة‪ ،‬فأعطها له فور تذ ُّكرها•‬
‫‪®:‬زامكس ‪‬‬
‫‪‬‬ ‫‪.‬ال تحتاج إال لجرعة واحدة فقط من هذا العقار‪ .‬إذا فوت طفلك جرعة‪ ،‬فأعطها له فور تذ ُّكرها•‬
‫‪:‬جميع المنتجات األخرى التي تؤخذ بالفم ‪‬‬
‫‪.‬قم بإعطاء الجرعة الفائتة فور تذكرك• ‪‬‬
‫‪.‬إذا اقترب موعد جرعة طفلك التالية‪ ،‬فتخط الجرعة الفائتة وارجع لمواعيد طفلك العادية• ‪‬‬
‫‪.‬يحظر إعطاء جرعتين في نفس الوقت أو جرعات إضافية• ‪‬‬
‫‪:‬الحقن ‪‬‬
‫‪.‬اتصل بطبيب طفلك لمعرفة ما يتعين عليك فعله• ‪‬‬

‫ما هي طريقة تخزين هذا الدواء و‪/‬أو التخلص منه؟‬

‫‪®:‬زامكس ‪‬‬
‫‪‬‬
‫‪.‬يُحفظ في درجة حرارة الغرفة‪ .‬ال تحفظه في الثالجة أو تجمده•‬
‫‪:‬أقراص ‪‬‬
‫‪.‬يُخزن في درجة حرارة الغرفة• ‪‬‬
‫‪):‬السائل (محلول معلق ‪‬‬
‫‪.‬يُخزن السائل (القطرة) عند درجة حرارة الغرفة أو في الثالجة‪ .‬ويجب التخلص من الكمية غير المستعملة بعد ‪ 10‬أيام• ‪‬‬
‫‪.‬يُخزن في الحاوية األصلية• ‪‬‬
‫‪:‬من خالل أكياس ‪‬‬
‫‪.‬يُخزن في الحاوية األصلية في درجة حرارة الغرفة• ‪‬‬
‫‪:‬جميع المنتجات التي تؤخذ بالفم ‪‬‬
‫‪.‬احفظ العقار في مكان جاف‪ .‬يحظر التخزين في الحمام• ‪‬‬
‫‪:‬الحقن ‪‬‬
‫إذا كنت تريد تخزين هذا العقار في المنزل‪ ،‬فتحدث إلى الطبيب أو الممرضة أو الصيدلي المعالج لطفلك حول كيفية • ‪‬‬
‫‪.‬تخزينه‬
‫‪:‬جميع األشكال ‪‬‬
‫‪.‬احتفظ بجميع العقاقير في مكان آمن‪ .‬احتفظ بجميع العقاقير بعيدًا عن متناول األطفال والحيوانات األليفة• ‪‬‬
‫‪.‬استشر الصيدلي بخصوص كيفية التخلص من العقاقير غير المستخدمة• ‪‬‬

‫إرشادات عامة‬
‫‪‬‬ ‫‪.‬إذا لم تتحسن األعراض أو المشكالت الصحية لدى طفلك أو إذا ازدادت سو ًءا‪ ،‬فاتصلي بالطبيب المعالج لطفلك•‬
  •‫ ويحظر كذلك إعطاء طفلك أي عقار خاص بشخص آخر‬،‫يحظر مشاركة عقار طفلك مع أشخاص آخرين‬.
 • ‫احتفظ بقائمة بالعقاقير الخاصة بطفلك (الوصفات الطبية والمستحضرات الطبيعية والفيتامينات والعقاقير المتاحة بدون‬
‫ قدم هذه القائمة للطبيب المعالج لطفلك‬.‫وصفة وطبية) معك‬.
 • ‫ بما في ذلك العقاقير المتاحة بوصفة أو بدون وصفة طبية‬،‫يرجى استشارة الطبيب قبل البدء في استخدام أي عقار جديد‬
‫أو المستحضرات الطبيعية أو الفيتامينات‬.
 • ‫ يُرجى استشارة‬،‫ إذا كانت لديك أي أسئلة حول هذا العقار‬.‫بعض العقاقير قد تحتوي على نشرة معلومات مريض مختلفة‬
‫الطبيب أو الممرض أو الصيدلي الخاص بطفلك أو غيرهم من مقدمي الرعاية الصحية‬.
 • ‫ كن‬.‫ اتصل بمركز مكافحة السموم لديك أو احصل على الرعاية الطبية على الفور‬،‫إذا اعتقدت أنك تناولت جرعة زائدة‬
ً
‫جاهزا لعرض أو اإلخبار عن ما تتناوله وكميته ومتى حدث ذلك‬ .

Azithromycin (Systemic) (Pediatric and Neonatal Lexi-Drugs)

Pronunciation

(az ith roe MYE sin)

Brand Names: US
Zithromax; Zithromax Tri-Pak; Zithromax Z-Pak; Zmax

Brand Names: Canada

ACT-Azithromycin; Apo-Azithromycin; Apo-Azithromycin Z; Azithromycin for Injection; Azithromycin
for Injection, USP; Dom-Azithromycin; GD-Azithromycin; Mylan-Azithromycin; Novo-Azithromycin;
PHL-Azithromycin; PMS-Azithromycin; PRO-Azithromycine; Riva-Azithromycin; Sandoz-Azithromycin;
Zithromax; Zithromax For Intravenous Injection; Zmax SR

Therapeutic Category
Antibiotic, Macrolide

Dosing: Neonatal
Note: Extended release suspension (Zmax) is not interchangeable with immediate-release
formulations. All oral doses are expressed as immediate release azithromycin unless otherwise
specified. With oral therapy, monitor for infantile hypertrophic pyloric stenosis (IHPS).

General dosing, susceptible infection (Red Book [AAP 2012]):

Oral: 10 to 20 mg/kg once daily

IV: 10 mg/kg once daily

Chlamydial conjunctivitis or chlamydial pneumonia: Limited data available: Oral: 20 mg/kg once
daily for 3 days (CDC [Workowski 2015]; Hammerschlag 1998)

Pertussis, treatment and postexposure prophylaxis: Oral, IV: 10 mg/kg once daily for 5 days (Red
Book [AAP 2012])

Dosing: Usual
Note: Extended release suspension (Zmax) is not interchangeable with immediate-release
formulations. All doses are expressed as immediate release azithromycin unless otherwise specified.

Pediatric:

General dosing, susceptible infection (Red Book [AAP] 2012): Infants, Children, and
Adolescents:

Mild to moderate infection: Oral: 5 to 12 mg/kg/dose; typically administered as 10 to 12

mg/kg/dose on day 1 followed by 5 to 6 mg/kg once daily for remainder of treatment
duration; usual maximum dose for the total course: 1,500 to 2,000 mg

Serious infection: IV: 10 mg/kg once daily; maximum dose: 500 mg/dose

Babesiosis: Infants, Children, and Adolescents: Oral: 10 mg/kg once on day 1 (maximum dose:
500 mg/dose), then 5 mg/kg once daily on days 2 to 10 (maximum dose: 250 mg/dose) in
combination with atovaquone; longer duration of therapy may be necessary in some cases;
in immunocompromised patients, higher doses (eg, adults: 600 to 1,000 mg daily) may be
required (Red Book [AAP] 2012; Wormser 2006)

Bartonellosis: Oral:

Cat scratch disease (B. henselae) with extensive lymphadenopathy (IDSA [Stevens]
2014): Non-HIV-exposed/-positive:

Infants, Children, and Adolescents ≤45 kg: 10 mg/kg once on day 1 (maximum dose:
500 mg/dose), followed by 5 mg/kg once daily on days 2 to 5 (maximum dose:
250 mg/dose)

Children and Adolescents >45 kg: 500 mg as a single dose on day 1, then 250 mg
once daily for 4 additional days

Cutaneous bacillary angiomatosis (B. henselae or B. quintana): HIV- exposed/-

positive: Infants, Children, and Adolescents: 5 to 12 mg/kg once daily; maximum
dose: 600 mg/dose; usual treatment duration: 3 months (CDC 2009)

Chancroid (CDC 2010; Red Book [AAP] 2012): Oral:

<45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose

≥45 kg: 1,000 mg as a single dose

Chlamydial infections:

Cervicitis, urethritis (C. trachomatis): Children and Adolescents ≥45 kg: Oral: 1,000 mg as
a single dose (CDC 2010; Red Book [AAP] 2012)

Conjunctivitis: Infants: Oral, IV: 20 mg/kg once daily for 3 days (Red Book [AAP] 2012)

Pneumonia, community-acquired (Bradley 2011): Infants >3 months, Children, and

Adolescents:

Mild infection or step-down therapy: Oral: 10 mg/kg once on day 1 (maximum dose:
500 mg/dose) followed by 5 mg/kg once daily on days 2 to 5 (maximum dose:
250 mg/dose)
 Severe infection: IV: 10 mg/ kg once daily for at least 2 days, then transition to oral
route with a single daily dose of 5 mg/kg to complete course of therapy;
maximum dose: 500 mg/dose

Cystic fibrosis; improve lung function, reduce exacerbation frequency: Limited data
available; dosing regimen variable (Mogayzel 2013; Saiman 2003; Saiman 2010): Children
≥6 years and Adolescents: Oral:

18 to 35.9 kg: 250 mg three times weekly (Monday, Wednesday, Friday)

≥36 kg: 500 mg three times weekly (Monday, Wednesday, Friday)

Diarrhea, infectious:

Campylobacter: Infants, Children, and Adolescents: Oral: 10 mg/kg once daily for 3 days;
maximum dose: 500 mg/dose (Red Book [AAP] 2012)

Shigellosis: Infants, Children, and Adolescents: Oral:

AAP Recommendation: 12 mg/kg once on day 1 (maximum dose: 500 mg/dose),

followed by 6 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose)
(Red Book [AAP] 2012)

Alternate dosing: 10 mg/kg once daily for 3 days (Dupont 2009; Mackell 2005); WHO
Guidelines recommend up to 20 mg/kg/dose and in some cases, a wider range
of duration of therapy (eg, 1 to 5 days) (WHO 2005)

Endocarditis; prophylaxis: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose 30 to 60

minutes before procedure; maximum dose: 500 mg/dose (Wilson 2007)

Gonococcal infection; uncomplicated (cervicitis, urethritis, anorectal): Oral:

Children <45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose (Red
Book [AAP] 2012)

Children > 8 years and ≥45 kg and Adolescents: 1,000 mg as a single dose (CDC
2012; Red Book [AAP] 2012)

Group A streptococcal infection; treatment of streptococcal tonsillopharyngitis:

Manufacturer's labeling and AHA/AAP recommendations: Infants, Children, and

Adolescents: Oral: 12 mg/kg/dose once daily for 5 days; maximum dose: 500
mg/dose (Gerber 2009; Red Book [AAP] 2012)

Alternate dosing:

IDSA reconmendations: Note: Recommended as an alternative agent for group A

streptococcal pharyngitis in penicillin-allergic patients. Infants, Children, and
Adolescents: Oral: 12 mg/kg (maximum: 500 mg/dose) on day 1 followed by 6
mg/kg/dose (maximum: 250 mg/dose) once daily on days 2 through 5 (Shulman
2012); Recommended by the Infectious Disease Society of America (IDSA) as
an alternative agent for group A streptococcal pharyngitis in penicillin-allergic
patients (Shulman 2012).
 Three-day regimen: Limited data available: Children and Adolescents: Oral: 20
mg/kg/dose once daily for 3 days; maximum dose: 1000 mg/dose (Cohen 2004;
O’Doherty 1996)

Meningococcal disease, chemoprophylaxis of high-risk contacts: Infants, Children, and

Adolescents: Oral: 10 mg/kg as a single dose; maximum dose: 500 mg/dose; Note: Not
routinely recommended; may consider if fluoroquinolone resistance detected (Red
Book [AAP] 2012)

Mycobacterium avium complex (MAC) infection (HIV-exposed/-positive):

Infants and Children (DHHS [pediatric] 2013): Oral:

Treatment: 10 to 12 mg/kg once daily in combination with ethambutol, with or without

rifabutin; maximum dose: 500 mg/dose; treatment duration at least 12 months;
dependent upon clinical response

Primary prevention of first episode: Preferred: 20 mg/kg once weekly (maximum

dose: 1,200 mg/dose) or alternatively, 5 mg/kg once daily (maximum dose: 250
mg/dose)

Secondary prevention of recurring episodes: 5 mg/kg once daily in combination with

ethambutol, with or without rifabutin; maximum dose: 250 mg/dose

Adolescents (DHHS [adult] 2013): Oral:

Treatment: 500 to 600 mg daily in combination with ethambutol

Primary prophylaxis: 1,200 mg once weekly or alternatively, 600 mg twice weekly

Secondary prophylaxis: 500 to 600 mg daily in combination with ethambutol

Otitis media, acute (AOM): Infants ≥6 months, Children, and Adolescents: Oral: Note: Due to
increased S pneumonia and H. influenzae resistance, azithromycin is not routinely
recommended as a treatment option (AAP [Lieberthal 2013])

Single dose regimen: 30 mg/kg as a single dose; maximum dose: 1,500 mg/dose; if patient
vomits within 30 minutes of dose, repeat dosing has been administered although
limited data available on safety

Three-day regimen: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose

Five-day regimen: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5
mg/kg (maximum dose: 250 mg/dose) once daily on days 2 to 5

Peritonitis (peritoneal dialysis), prophylaxis for patients receiving peritoneal dialysis who
require dental procedures: Infants, Children, and Adolescents: Oral: 15 mg/kg
administered 30 to 60 minutes before dental procedure; maximum dose: 500 mg/dose
(Warady [ISPD 2012])

Pertussis (CDC 2005; Red Book [AAP] 2012): Oral, IV:

Infants 1 to 5 months: 10 mg/kg/dose once daily for 5 days

 Infants ≥6 months, Children, and Adolescents: 10 mg/kg once on day 1 (maximum dose:
500 mg/dose), followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250
mg/dose)

Pneumonia, community-acquired (excluding mycobacterial [mycoplasma pneumoniae]

and chlamydial infections):

Oral:

Immediate release: Infants >3 months, Children, and Adolescents: 10 mg/kg once on
day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg (maximum dose: 250
mg/dose) once daily on days 2 to 5 (Bradley 2011)

Extended release oral suspension (Zmax): Infants ≥6 months, Children, and

Adolescents: 60 mg/kg as a single dose; maximum dose: 2,000 mg/dose

IV: Infants >3 months, Children, and Adolescents: 10 mg/kg once daily for at least 2 days,
follow IV therapy by the oral route with a single daily dose of 5 mg/kg to complete a 5-
day course of therapy; maximum dose: 500 mg/dose (Bradley 2011)

Pneumonia, community acquired; mycoplasma pneumoniae, or chlamydial

infection (Bradley 2011): Infants >3 months, Children, and Adolescents:

Mild infection or step-down therapy: Oral: 10 mg/kg once on day 1 (maximum dose: 500
mg/dose) followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250
mg/dose)

Severe infection: IV: 10 mg/kg once daily for at least 2 days (maximum dose: 500
mg/dose), then transition to oral route with a single daily dose of 5 mg/kg to complete
course of therapy (maximum dose: 250 mg/dose)

Rhinosinusitis, bacterial: Oral: Infants ≥6 months, Children, and Adolescents: 10 mg/kg once
daily for 3 days; maximum dose: 500 mg/dose; Note: Although FDA approved, macrolides
are not recommended for empiric therapy due to high rates of resistance (Chow 2012).

Sexual victimization, prophylaxis: Oral: Note: Use in combination with cefixime or ceftriaxone
and completion of hepatitis B virus immunization; also consider prophylaxis for
trichomoniasis and bacterial vaginosis (CDC 2010; Red Book [AAP] 2012).

Children <45 kg: 20 mg/kg as a single dose

Children ≥45 kg and Adolescents: 1,000 mg as a single dose

Toxoplasma gondii, encephalitis (HIV-exposed/-positive); treatment and prevention: Oral:

Adolescents: 900 to 1,200 mg once daily in combination with pyrimethamine/leucovorin;
treatment duration: 6 weeks or longer if extensive disease or incomplete response at 6
weeks (DHHS [adult] 2013)

Adult:

Rhinosinusitis, bacterial: Oral: 500 mg once daily for 3 days. Note: Although FDA approved,
macrolides are not recommended for empiric therapy due to high rates of resistance (Chow
2012).

Alternate regimen: Extended release suspension (Zmax): 2,000 mg as a single dose

Chancroid due to H. ducreyi: Oral: 1000 mg as a single dose (CDC 2010)

Cervicitis, urethritis: Nongonococcal Chlamydia trachomatis: Oral: 1,000 mg as a single

dose

Gonococcal infection, uncomplicated (cervix, rectum, urethra): Oral: 1,000 mg as a single

dose in combination with ceftriaxone (preferred) or cefixime (only if ceftriaxone
unavailable); if cefixime is used, test-of-cure in 7 days is recommended (CDC
2012). Note: Monotherapy with azithromycin single dose of 2,000 mg has been associated
with resistance and/or treatment failure; however, may be appropriate for treatment of a
gonococcal infection in pregnant women who cannot tolerate a cephalosporin (CDC 2010).

Patients with severe cephalosporin allergy: 2,000 mg as a single dose and test-of-cure in 7
days (CDC, 2012)

Gonococcal infection, uncomplicated (pharynx): Oral: 1,000 mg as a single dose in

combination with ceftriaxone (CDC 2012)

Gonococcal infection, expedited partner therapy: Oral: 1,000 mg as a single dose in

combination with cefixime (CDC 2012). Note: Only used if a heterosexual partner cannot
be linked to evaluation and treatment in a timely manner; dose delivered to partner by
patient, collaborating pharmacy, or disease investigation specialist.

Granuloma inguinale (donovanosis): Oral: 1000 mg once a week for at least 3 weeks and
until lesions have healed (CDC 2010)

Endocarditis prophylaxis: Oral: 500 mg 30 to 60 minutes before procedure. Note: American

Heart Association (AHA) guidelines now recommend prophylaxis only in patients
undergoing invasive procedures and in whom underlying cardiac conditions may
predispose to a higher risk of adverse outcomes should infection occur. As of April 2007,
routine prophylaxis for GI/GU procedures is no longer recommended by the AHA (Wilson
2007).

Mild to moderate respiratory tract, skin, and soft tissue infections: Oral: 500 mg in a single
loading dose on day 1 followed by 250 mg daily as a single dose on days 2 to 5

Alternative regimen: Bacterial exacerbation of COPD: 500 mg daily for a total of 3 days

Mycobacterium avium complex disease, disseminated, in patients with advanced HIV

infection: Oral:

Treatment: 600 mg daily in combination with ethambutol

Primary prophylaxis: 1,200 mg once weekly (preferred), with or without rifabutin or

alternatively, 600 mg twice weekly (DHHS [adult] 2013)

Secondary prophylaxis: 500 to 600 mg daily in combination with ethambutol (DHHS [adult]
2013)

Pelvic inflammatory disease: IV: 500 mg as a single dose for 1 to 2 days, follow IV therapy by
the oral route with a single daily dose of 250 mg to complete a 7-day course of therapy

Pharyngitis/tonsillitis, group A streptococci:

Manufacturer labeling: Oral: 500 mg on day 1 followed by 250 mg once daily on days 2 to 5
 IDSA guidelines: Oral: 12 mg/kg (maximum: 500 mg) on day 1 followed by 6 mg/kg/dose
(maximum: 250 mg) once daily days 2 to 5. Note: Recommended by the Infectious
Disease Society of America (IDSA) as an alternative agent for group A streptococcal
pharyngitis in penicillin-allergic patients (Shulman 2012).

Pneumonia, community-acquired:

Oral: 500 mg on day 1 followed by 250 mg once daily on days 2 to 5

Alternate regimen: Extended release suspension (Zmax): 2,000 mg as a single dose

IV: 500 mg as a single dose for at least 2 days; follow IV therapy by the oral route with a
single daily dose of 500 mg to complete a 7- to 10-day course of therapy

Pertussis: Oral: 500 mg on day 1 followed by 250 mg once daily on days 2 to 5 (CDC 2005)

Prophylaxis against sexually transmitted diseases following sexual assault: Oral: 1,000
mg as a single dose (in combination with a cephalosporin and metronidazole) (CDC 2010)

Dosing adjustment in renal impairment: Infants ≥6 months, Children, Adolescents, and Adults:

Use with caution in patients with GFR <10 mL/minute (AUC increased by 35% compared to
patients with normal renal function); however, no dosage adjustment is provided in the
manufacturer's labeling.

No supplemental dose or dosage adjustment necessary, including patients on intermittent

hemodialysis, peritoneal dialysis, or continuous renal replacement therapy (eg, CVVHD)
(Aronoff 2007; Heintz 2009).

Dosing adjustment in hepatic impairment: Azithromycin is predominantly hepatically eliminated;

however, there is no dosage adjustment provided in the manufacturer's labeling. Use with
caution due to potential for hepatotoxicity (rare); discontinue immediately for signs or symptoms
of hepatitis.

Use
Oral:

Immediate release; oral suspension, tablets: Treatment of acute otitis media due to H.
influenzae, M. catarrhalis, or S. pneumoniae (FDA approved in pediatric patient ages ≥6
months); treatment of pharyngitis/tonsillitis due to S. pyogenes (FDA approved in ages
≥2 years and adults); treatment of community-acquired pneumonia due to susceptible
organisms, including C. pneumoniae, M. pneumoniae, H. influenzae, S.
pneumoniae (FDA approved in ages ≥6 months and adults). [Oral azithromycin is not
indicated for use in patients with pneumonia who have moderate to severe disease and
judged to be inappropriate for oral therapy or have any risk factors such as cystic
fibrosis, nosocomial infection, known or suspected bacteremia, hospitalization, elderly or
debilitated patients, or patients with significant underlying health problems that may
compromise their ability to respond to their illness (including immunodeficiency or
functional asplenia)]; treatment of sinusitis or COPD exacerbation due to H.
influenzae, M. catarrhalis, or S. pneumoniae (FDA approved in adults); treatment of
infections of the skin and skin structure, acute pelvic inflammatory disease, chancroid,
and urethritis and cervicitis due to susceptible strains of C. trachomatis, N.
gonorrhoeae, M. catarrhalis, H. influenzae, S. aureus, S. pyogenes, S.
pneumoniae, Mycoplasma pneumoniae, M. avium complex, C. psittaci, and C.
pneumoniae (FDA approved in adults). Has also been used for treatment of babesiosis,
 pertussis, endocarditis prophylaxis in penicillin allergic patients, for prophylaxis of
peritonitis in patients undergoing invasive dental procedures, and cystic fibrosis lung
disease

Extended release (Zmax); oral suspension: Treatment of community-acquired pneumonia due

to C. pneumoniae, M. pneumoniae, H. influenzae, S. pneumonia (FDA approved in ages
≥6 months and adults); treatment of acute bacterial sinusitis due to H. influenzae, M.
catarrhalis, or S. pneumoniae (FDA approved in adults)

Parenteral: Treatment of community-acquired pneumonia due to susceptible C. pneumoniae, L.

pneumophilia, M. pneumoniae, H. influenzae, S. aureus, S. pneumoniae; treatment of pelvic
inflammatory disease due to susceptible C. pneumonia, N. gonorrhoeae, or M. hominis (FDA
approved in adults)

Clinical Practice Guidelines: Pediatric

Community-Acquired Pneumonia:

IDSA/PIDS, Management of Community-Acquired Pneumonia in Infants and Children Older

Than 3 Months of Age, October 2011

Cystic Fibrosis:

CF Foundation, Chronic Medications for Maintenance of Lung Health, April 2013

CF Foundation, Management of Infants With Cystic Fibrosis, December 2009

Encephalitis:

IDSA, Management of Encephalitis, August 2008

Endocarditis:

AHA, Prevention of Infective Endocarditis, October 2007

AHA, Infective Endocarditis: Diagnosis, Antimicrobial Therapy, and Management of

Complications, June 2005

AHA, Unique Features of Infective Endocarditis in Childhood, April 2002

Opportunistic Infections:

DHHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-
Exposed and HIV-Infected Patients, Adolescents and Adults, May 2013;
Children, November 2013

Peritonitis:

ISPD, Prevention and Treatment of Catheter Related Infections and Peritonitis in Pediatric
Patients Receiving Peritoneal Dialysis, June 2012

Pertussis:

CDC, Treatment and Postexposure Prophylaxis of Pertussis, December 2005

Rhinosinusitis:
 IDSA, Acute Bacterial Rhinosinusitis in Children and Adults, April 2012

Sexually Transmitted Diseases:

CDC, Sexually Transmitted Diseases Treatment Guidelines, June 2015; Note: Information
contained within this monograph is pending revision based on these more recent
guidelines.

Shigellosis:

WHO, Guidelines for the Control of Shigellosis, Including Epidemics Due to Shigella
dysenteriae Type 1, 2005

Skin and Soft Tissue Infections:

IDSA, Diagnosis and Management of Skin and Soft-Tissue Infections, July 2014

Streptococcal Infections:

AHA, Prevention of Rheumatic Fever and Diagnosis and Treatment of Acute Streptococcal
Pharyngitis, March 2009

IDSA, Diagnosis and Management of Group A Streptococcal Pharyngitis, November 2012

Tick-borne Diseases:

IDSA, Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human

Granulocytic Anaplasmosis, and Babesiosis, November 2006

Preparation for Administration

Oral:

Immediate release oral suspension: Reconstitute powder for oral suspension with appropriate
amount of water as specified on the bottle. Shake vigorously until suspended.

Oral suspension 1,000 mg packet for a single dose: Prepare by mixing contents of 1 packet
with approximately 60 mL of water.

Extended release oral suspension: Prepare 2,000 mg azithromycin suspension by

reconstituting with 60 mL of water to a final concentration of 27 mg/mL

Parenteral: Prepare initial solution by adding 4.8 mL of SWFI to the 500 mg vial resulting in a
concentration of 100 mg/mL. Use of a standard syringe is recommended due to the vacuum
in the vial (which may draw additional solution through an automated syringe).

The initial solution should be further diluted to a concentration of 1 mg/mL to 2 mg/mL in NS, D 5W,
or LR.

Administration
Oral:

Immediate release: May administer without regard to food; do not administer with antacids
that contain aluminum or magnesium.
 Oral suspension, multiple doses: Shake well before use.

Oral suspension 1,000 mg packet for a single dose: Administer the entire contents
immediately after mixing; add an additional 60 mL of water, mix, and drink. Do not use
to administer any other dose except 1,000 mg or 2,000 mg.

Extended release oral suspension: Shake suspension well before use; administer on an
empty stomach 1 hour before or 2 hours after a meal; must be administered within 12
hours of reconstitution. May be administered without regard to antacids containing
aluminum or magnesium.

Parenteral: Do not give IM or by direct IV injection. Administer IV infusion at a final concentration

of 1 mg/mL over 3 hours; for a 2 mg/mL concentration, infuse over 1 hour; do not infuse over
a period of less than 60 minutes.

Storage/Stability
Injection (Zithromax): Store intact vials of injection at room temperature. Reconstituted solution is
stable for 24 hours when stored below 30°C (86°F). The diluted solution D5W, D5LR,
D51/4NS, D51/3NS, D51/2NS (with or without 20 mEq/L KCl), Normosol-M in D5, Normosol-R in
D5, LR, NS, or 1/2NS is stable for 24 hours at or below room temperature (30°C [86°F]) and for
7 days if stored under refrigeration (5°C [41°F]).

Suspension, immediate release (Zithromax): Store dry powder below 30°C (86°F). Store
reconstituted suspension at 5°C to 30°C (41°F to 86°F) and use within 10 days.

Suspension, extended release (Zmax): Store dry powder ≤30°C (86°F). Following reconstitution,
store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not refrigerate
or freeze. Should be consumed within 12 hours following reconstitution.

Tablet (Zithromax): Store between 15°C to 30°C (59°F to 86°F).

IV Compatibility
See Trissel’s IV Compatibility Database

Open Trissel's IV Compatibility

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS:
During this hospital stay, were you given any medicine that you had not taken before? Before
giving you any new medicine, how often did hospital staff tell you what the medicine was for?
How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, diarrhea, headache, nausea, vomiting, itching, or lack of
appetite. Have patient report immediately to prescriber tachycardia, abnormal heartbeat,
hearing impairment, angina, muscle pain, joint pain, tinnitus, seizures, severe dizziness,
passing out, difficulty swallowing, difficulty speaking, enlarged lymph nodes, vaginitis, signs
of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe
diarrhea or watery stools, or bloody stools), signs of liver problems (dark urine, fatigue, lack of
appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney
problems (urinary retention, hematuria, change in amount of urine passed, or weight gain),
signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing,
shortness of breath, or a cough that is new or worse), signs of Stevens-Johnson
syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without
 fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), or injection site irritation
(HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching;
bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is
not a comprehensive list of all side effects. Patient should consult prescriber for additional
questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is
intended to serve as a concise initial reference for health care professionals to use when discussing
medications with a patient. You must ultimately rely on your own discretion, experience and judgment
in diagnosing, treating, and advising patients.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications
Hypersensitivity to azithromycin, erythromycin, other macrolide (eg, azalide or ketolide) antibiotics,
or any component of the formulation; history of cholestatic jaundice/hepatic dysfunction
associated with prior azithromycin use

Note: The manufacturer does not list concurrent use of pimozide as a contraindication; however,
azithromycin is listed as a contraindication in the manufacturer’s labeling for pimozide.

Warnings/Precautions
Concerns related to adverse effects:

• Hypersensitivity reactions: Allergic reactions (eg, angioedema, anaphylaxis, Stevens-

Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and
systemic symptoms [DRESS]) have been reported (rare), including fatalities;
reappearance of allergic reaction may occur shortly after discontinuation of symptomatic
treatment without further azithromycin exposure.

• Altered cardiac conduction: Macrolides (especially erythromycin) have been associated with
rare QTc prolongation and ventricular arrhythmias, including torsade de pointes;
consider avoiding use in patients with prolonged QT interval, congenital long QT
syndrome, history of torsade de pointes, bradyarrhythmias, uncorrected hypokalemia or
hypomagnesemia, clinically significant bradycardia, uncompensated heart failure, or
concurrent use of Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone,
dofetilide, sotalol) antiarrhythmic agents or other drugs known to prolong the QT
interval.

• Cardiac risk: A retrospective cohort study done in Tennessee Medicaid patients

demonstrated an increased cardiac risk with azithromycin relative to amoxicillin or
ciprofloxacin, and similar risk compared to levofloxacin; notably, increased cardiac
mortality (an estimated 47 additional deaths per 1 million 5-day courses of treatment
compared to amoxicillin) was associated with higher baseline cardiovascular risk (Ray
2012); however, these data may not be generalizable to the population as a whole (Ray
1989). In another retrospective population study of US veterans, azithromycin was
shown to significantly increase the risk of mortality and arrhythmia on days 1 to 5, but
not on days 6 to 10 after dispensing the prescription (Rao 2014). In contrast, 2
additional large retrospective cohort studies did not demonstrate an increased risk of
cardiovascular events, including all-cause mortality or cardiovascular death (Svanstrom
2013, Mortensen 2014). The implications of these data have yet to be determined.
 • Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD); CDAD has been observed >2 months
postantibiotic treatment.

Disease-related concerns:

• Gonorrhea/syphilis: May mask or delay symptoms of incubating gonorrhea or syphilis, so

appropriate culture and susceptibility tests should be performed prior to initiating a
treatment regimen.

• Hepatic impairment: Use with caution in patients with preexisting liver disease;
hepatocellular and/or cholestatic hepatitis, with or without jaundice, hepatic necrosis,
failure, and death have occurred. Discontinue immediately if symptoms of hepatitis
occur (malaise, nausea, vomiting, abdominal colic, fever).

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation and
new onset of symptoms have occurred.

• Renal impairment: Use with caution in patients with severe renal impairment (GFR <10
mL/minute); increased gastrointestinal adverse effects may occur.

Special populations:

• Infants: Use of azithromycin in neonates and infants (treatment up to 42 days of life) has
been associated with infantile hypertrophic pyloric stenosis (IHPS); observe for non-
bilious vomiting or irritability with feeding (Eberly 2015).

Dosage form specific issues:

• Oral suspensions: Immediate release and extended release suspensions are not
interchangeable.

Pregnancy Risk Factor

B

Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Azithromycin crosses the placenta
(Ramsey 2003). The maternal serum half-life of azithromycin is unchanged in early pregnancy and
decreased at term; however, high concentrations of azithromycin are sustained in the myometrium
and adipose tissue (Fischer 2012; Ramsey 2003). Azithromycin is recommended for the treatment of
several infections, including chlamydia, gonococcal infections, and Mycobacterium avium complex
(MAC) in pregnant patients (consult current guidelines) (CDC [Workowski 2015]; HHS [opportunistic;
adult] 2015).

Breast-Feeding Considerations
Azithromycin is excreted in breast milk.

The relative infant dose (RID) of azithromycin is 4% to 8% when calculated using the highest breast
milk concentration located and compared to an infant therapeutic dose of 5 to 10 mg/kg/day. In
general, breast-feeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).
Using the highest milk concentration (2.8 mcg/mL), the estimated daily infant dose via breast milk is
0.42 mg/kg/day. This milk concentration was obtained following maternal administration of oral
azithromycin as a 1 g loading dose followed in 48 hours by azithromycin 500 mg for 3 days; milk
concentrations increased over time and reached a peak 30 hours after the last oral dose (Kelsey
1994).

Following a single dose of IV azithromycin 500 mg, azithromycin was measurable in breast milk for up
to 48 hours. The median half-life in breast milk was 15.6 hours (Sutton 2015).

Decreased appetite, diarrhea, rash, and somnolence have been reported in nursing infants exposed
to macrolide antibiotics (Goldstein 2009). In general, antibiotics that are present in breast milk may
cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).
In addition, an increased risk for infantile hypertrophic pyloric stenosis (IHPS) may be present in
infants who are exposed to macrolides via breast milk, especially during the first 2 weeks of life (Lund
2014); however, data is conflicting (Goldstein 2009). The manufacturer recommends that caution be
exercised when administering azithromycin to breast-feeding women.

The CDC's Sexually Transmitted Diseases Treatment Guidelines state that azithromycin is one of the
recommended agents for the treatment of granuloma inguinale in lactating women. For
lymphogranuloma venereum, azithromycin may be considered as an alternative agent in this patient
population (CDC [Workowski 2015]).

Lexicomp Pregnancy & Lactation, In-Depth

 Azithromycin (Systemic)

Briggs' Drugs in Pregnancy & Lactation

 Azithromycin

Adverse Reactions
Cardiovascular: Chest pain, palpitations

Central nervous system: Dizziness, drowsiness, fatigue, headache, vertigo

Dermatologic: Dermatitis (children), pruritus, skin photosensitivity, skin rash (single-dose regimens
tend to be associated with increased incidence)

Endocrine & metabolic: Decreased serum bicarbonate (adults), decreased serum glucose (adults),
increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum
potassium

Gastrointestinal: Abdominal pain (single-dose regimens tend to be associated with increased

incidence), anorexia, diarrhea (more common with single dose regimens), dysgeusia,
dyspepsia, flatulence, gastritis, loose stools (single-dose regimens tend to be associated with
increased incidence), melena (adults, multiple-dose regimens), mucositis, nausea (more
common with single dose regimens), oral candidiasis, vomiting (children: Single-dose
regimens tend to be associated with increased incidence; adults: More common with single 2
g dose)

Genitourinary: Genital candidiasis (adults, multiple-dose regimens), vaginitis

Hematologic & oncologic: Change in neutrophil count (children), decreased hematocrit (adults),
decreased hemoglobin (adults), decrease in absolute neutrophil count (children: 500 to 1500
 cells/mm3), eosinophilia, increased neutrophils (adults), lymphocytopenia, thrombocythemia
(adults)

Hepatic: Cholestatic jaundice, increased serum ALT, increased serum AST, increased serum
bilirubin

Local (adults with IV administration): Local inflammation, pain at injection site

Neuromuscular & skeletal: Increased creatine phosphokinase

Renal: Increased blood urea nitrogen, increased serum creatinine, nephritis (adults, multiple-dose
regimens)

Respiratory: Bronchospasm

Miscellaneous: Fever (children)

Rare but important or life-threatening: Abnormal stools, acute renal failure, ageusia, aggressive
behavior, agitation, alteration in sodium, altered sense of smell, altered serum glucose,
anaphylaxis, anemia, angioedema, anosmia, anxiety, arthralgia, asthma, basophilia,
bronchitis, cardiac arrhythmia, Clostridium difficile associated diarrhea, conjunctivitis
(children), constipation, convulsions, cough, deafness, decreased serum potassium
(children), decreased serum sodium, diaphoresis, DRESS syndrome, dyspnea, dysuria,
eczema, edema, emotional lability, enteritis, erythema multiforme, exacerbation of
myasthenia gravis, facial edema, flu-like symptoms (children), fungal dermatitis (children),
fungal infection (children), gastrointestinal disease, hearing loss, hepatic failure, hepatic
insufficiency, hepatic necrosis, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014),
hostility, hyperactivity, hyperkinesia, hypersensitivity reaction, hypotension, increased
monocytes, increased serum alkaline phosphatase, increased serum bicarbonate, increased
serum phosphate, interstitial nephritis, insomnia, irritability, jaundice, Lambert-Eaton
syndrome, leukopenia, maculopapular rash, malaise, nervousness, neutropenia, otitis media,
pain, pancreatitis, paresthesia, pharyngitis, pleural effusion, prolonged Q-T interval on ECG,
pseudomembranous colitis, pyloric stenosis, pyloric stenosis (infantile hypertrophic), rhinitis,
seizure, Stevens-Johnson syndrome, syncope, thrombocytopenia, tinnitus, tongue
discoloration, toxic epidermal necrolysis, urticaria, ventricular tachycardia, vesiculobullous
dermatitis, weakness

Allergy and Idiosyncratic Reactions

 Macrolide Allergy

Drug Interactions: Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically
relevant drug interaction potential; Inhibits P-glycoprotein

Drug Interactions Open Interactions

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib.
Management: Per US labeling: reduce afatinib by 10mg if not tolerated. Per Canadian
labeling: avoid combination if possible; if used, administer the P-gp inhibitor simultaneously
with or after the dose of afatinib. Risk D: Consider therapy modification

Amiodarone: Azithromycin (Systemic) may enhance the QTc-prolonging effect of Amiodarone.

Management: The concomitant use of amiodarone, which has a high risk for QTc
prolongation, with azithromycin, which may also prolong the QT interval, should be
avoided. Risk X: Avoid combination
AtorvaSTATin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of
AtorvaSTATin. Risk C: Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X:
Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine
(Immunization). Risk C: Monitor therapy

Betrixaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Betrixaban.

Management: Decrease the betrixaban dose to an initial single dose of 80 mg followed by 40
mg once daily if combined with a P-glycoprotein inhibitor. Risk D: Consider therapy
modification

Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bilastine.

Management: Consider alternatives when possible; bilastine should be avoided in patients
with moderate to severe renal insufficiency who are receiving p-glycoprotein inhibitors. Risk
D: Consider therapy modification

Brentuximab Vedotin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E
(MMAE) component may be increased. Risk C: Monitor therapy

Cardiac Glycosides: Macrolide Antibiotics may increase the serum concentration of Cardiac
Glycosides. Risk C: Monitor therapy

Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Celiprolol. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Risk X: Avoid
combination

Cisapride: Macrolide Antibiotics may enhance the QTc-prolonging effect of Cisapride. Macrolide
Antibiotics may decrease the metabolism of Cisapride. Risk X: Avoid combination

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine.

Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management:
Colchicine is contraindicated in patients with impaired renal or hepatic function who are also
receiving a p-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce
colchicine dose as directed. Risk D: Consider therapy modification

CycloSPORINE (Systemic): Azithromycin (Systemic) may increase the serum concentration of

CycloSPORINE (Systemic). Risk C: Monitor therapy

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the

active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose reductions may
be needed. Specific recommendations vary considerably according to US vs Canadian
labeling, specific P-gp inhibitor, renal function, and indication for dabigatran treatment. Refer
to full monograph or dabigatran labeling. Risk D: Consider therapy modification

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum

concentration of DOXOrubicin (Conventional). Management: Seek alternatives to P-
glycoprotein inhibitors in patients treated with doxorubicin whenever possible. One U.S.
manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Risk D: Consider
therapy modification
Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Edoxaban.
Management: See full monograph for details. Reduced doses are recommended for patients
receiving edoxaban for venous thromboembolism in combination with certain inhibitors.
Similar dose adjustment is not recommended for edoxaban use in atrial fibrillation. Risk D:
Consider therapy modification

Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus.

Management: Everolimus dose reductions are required for patients being treated for
subependymal giant cell astrocytoma or renal cell carcinoma. See prescribing information for
specific dose adjustment and monitoring recommendations. Risk D: Consider therapy
modification

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the
QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Risk X: Avoid combination

Hydroxychloroquine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination

Ivermectin (Systemic): Azithromycin (Systemic) may increase the serum concentration of

Ivermectin (Systemic). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and
Estriol. Risk C: Monitor therapy

Lovastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of

Lovastatin. Risk C: Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging

Agents. Risk X: Avoid combination

Mizolastine: Macrolide Antibiotics may increase the serum concentration of Mizolastine. Risk X:
Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate
Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use
should be accompanied by close monitoring for evidence of QT prolongation or other
alterations of cardiac rhythm. Risk D: Consider therapy modification

Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Naldemedine. Risk C: Monitor therapy

Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Naloxegol. Risk C: Monitor therapy

Nelfinavir: May increase the serum concentration of Azithromycin (Systemic). Risk C: Monitor
therapy

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

PAZOPanib. Risk X: Avoid combination

P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inhibitors may increase the serum

concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also
enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-
glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C:
Monitor therapy
Pimozide: Macrolide Antibiotics may enhance the QTc-prolonging effect of Pimozide. Macrolide
Antibiotics may decrease the metabolism of Pimozide. This mechanism may not apply to
azithromycin. Risk X: Avoid combination

Probucol: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Risk
X: Avoid combination

Promazine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Risk
X: Avoid combination

Prucalopride: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Prucalopride. Risk C: Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging
effect of Moderate Risk QTc-Prolonging Agents. Risk C: Monitor therapy

QuiNINE: Macrolide Antibiotics may increase the serum concentration of QuiNINE. Risk X: Avoid
combination

Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Ranolazine. Risk C: Monitor therapy

RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

RifAXIMin. Risk C: Monitor therapy

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Silodosin. Risk X: Avoid combination

Simvastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of

Simvastatin. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate.
Management: Consider using an alternative product for bowel cleansing prior to a
colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk
D: Consider therapy modification

Tacrolimus (Systemic): Azithromycin (Systemic) may increase the serum concentration of

Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Topical): Macrolide Antibiotics may increase the serum concentration of Tacrolimus
(Topical). Risk C: Monitor therapy

Terfenadine: Macrolide Antibiotics may enhance the QTc-prolonging effect of Terfenadine.

Macrolide Antibiotics may increase the serum concentration of Terfenadine. Risk X: Avoid
combination

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of

Topotecan. Risk X: Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live
attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid
vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial
agents. Use of this vaccine should be postponed until at least 3 days after cessation of
antibacterial agents. Risk D: Consider therapy modification
 Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax.
Management: Reduce the venetoclax dose by at least 50% in patients requiring these
combinations. Risk D: Consider therapy modification

VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration

of VinCRIStine (Liposomal). Risk X: Avoid combination

Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Risk
X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Macrolide Antibiotics may increase the serum concentration
of Vitamin K Antagonists. Risk C: Monitor therapy

Xipamide: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Risk
C: Monitor therapy

Food Interactions
Rate and extent of GI absorption may be altered depending upon the formulation. Azithromycin
suspension, not tablet form, has significantly increased absorption (46%) with food. Management:
Immediate release suspension and tablet may be taken without regard to food; extended release
suspension should be taken on an empty stomach (at least 1 hour before or 2 hours following a
meal).

Monitoring Parameters
Liver function tests, WBC with differential; number and type of stools/day for diarrhea; monitor
patients receiving azithromycin and drugs known to interact with erythromycin (ie, theophylline,
digoxin, anticoagulants, triazolam) since there are still very few studies examining drug-drug
interactions with azithromycin. When used as part of alternative treatment for gonococcal infection,
test-of-cure 7 days after dose (CDC, 2012).

Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific
product labeling. [DSC] = Discontinued product

Packet, Oral:

Zithromax: 1 g (3 ea, 10 ea) [cherry-banana flavor]

Generic: 1 g (3 ea, 10 ea)

Solution Reconstituted, Intravenous:

Zithromax: 500 mg (1 ea)

Generic: 500 mg (1 ea); 2.5 g (1 ea [DSC])

Solution Reconstituted, Intravenous [preservative free]:

Generic: 500 mg (1 ea)

Suspension Reconstituted, Oral:

Zithromax: 100 mg/5 mL (15 mL) [cherry-vanilla-banana flavor]

 Zithromax: 200 mg/5 mL (15 mL, 22.5 mL, 30 mL) [cherry flavor]

Zmax: 2 g (1 ea) [cherry-banana flavor]

Generic: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL, 30 mL)

Tablet, Oral:

Zithromax: 250 mg, 500 mg, 600 mg

Zithromax Tri-Pak: 500 mg

Zithromax Z-Pak: 250 mg

Generic: 250 mg, 500 mg, 600 mg

Tablet, Oral, as monohydrate:

Generic: 500 mg, 600 mg

Pricing: US
Pack (Azithromycin Oral)

1 g (3): $87.38

Pack (Zithromax Oral)

1 g (3): $404.02

Solution (reconstituted) (Azithromycin Intravenous)

500 mg (1): $7.20

Solution (reconstituted) (Zithromax Intravenous)

500 mg (1): $7.20

Suspension (reconstituted) (Azithromycin Oral)

100 mg/5 mL (15 mL): $34.88

200 mg/5 mL (22.5 mL): $34.88

Suspension (reconstituted) (Zithromax Oral)

100 mg/5 mL (15 mL): $159.40

200 mg/5 mL (22.5 mL): $159.40

Suspension (reconstituted) (Zmax Oral)

2 g (1): $160.21
 Tablets (Azithromycin Oral)

250 mg (6): $46.62

500 mg (30): $467.02

600 mg (30): $560.46

Tablets (Zithromax Oral)

250 mg (30): $1129.16

500 mg (30): $2258.28

600 mg (30): $2709.95

Tablets (Zithromax Tri-Pak Oral)

500 mg (3): $225.83

Tablets (Zithromax Z-Pak Oral)

250 mg (6): $225.82

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single
manufacturer of the brand and/or generic product, respectively. The pricing data should be used for
benchmarking purposes only, and as such should not be used to set or adjudicate any prices for
reimbursement or purchasing functions. Pricing data is updated monthly.

Generic Availability (US)

Yes

Mechanism of Action
Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal
subunit resulting in blockage of transpeptidation

Pharmacodynamics/Kinetics (Adult data unless noted)

Absorption: Oral: Rapid from the GI tract

Distribution: Extensive tissue; distributes well into skin, lungs, sputum, tonsils, and cervix;
penetration into CSF is poor; Vd: 31 to 33 L/kg

Protein binding (concentration dependent and dependent on alpha1-acid glycoprotein

concentrations): Oral, IV: 7% to 51%

Metabolism: Hepatic to inactive metabolites

Bioavailability: Oral: Tablet, immediate release oral suspension: 34% to 52%; extended release
oral suspension: 28% to 43%; variable effect with food (increased with immediate or delayed
release oral suspension, unchanged with tablet)

Half-life elimination: Terminal: Oral, IV:

 Infants and Children 4 months to 15 years: 54.5 hours

Adults: Immediate release: 68 to 72 hours; Extended release: 59 hours

Time to peak, serum: Oral: Immediate release: ~2 to 3 hours; Extended release: 3 to 5 hours

Excretion: Oral, IV: Biliary (major route 50%, unchanged); urine (6% to 14% unchanged)

Related Information
 Prevention of Infective Endocarditis
 Relative Infant Dose

Index Terms
Azithromycin Dihydrate; Azithromycin Monohydrate; Z-Pak; Zithromax TRI-PAK; Zithromax Z-PAK

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Last Updated 8/17/17

Azithromycin for bacterial infections

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Azithromycin for bacterial infections

This leaflet is about the use of azithromycin for the treatment of bacterial infections.

This leaflet has been written specifically for parents and carers about the
use of this medicine in children. The information may differ from that provided by the
manufacturer. Please read this leaflet carefully. Keep it somewhere safe so that you can read it
again.

If your child has ever had a reaction to any antibiotic, check with your doctor that your
child can have azithromycin before giving it.

Name of drug

Azithromycin
Brand name: Zithromax®

Why is it important for my child to take this medicine?

It is important that your child takes this medicine in the way that your doctor has told you to so
that it kills the bacteria and gets rid of the infection.

What is azithromycin available as?

 Tablets: 250 mg, 500 mg

 Capsules: 250 mg
 Liquid medicine (suspension): 200 mg in 5 mL; some may contain a small amount of
sugar

When should I give azithromycin?

Azithromycin is usually given once a day. This is usually in the morning.

Give the medicine at about the same time each day so that this becomes part of your child’s daily
routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of azithromycin (the dose) that is right for your child. The
dose will be shown on the medicine label.

It is important that you follow your doctor’s instructions about how much to give.

How should I give it?

Tablets and capsules should be swallowed with a glass of water, milk or juice.
Your child should not chew the tablet.
 Liquid medicine: Shake the bottle well and measure out the right amount using
a medicine spoon or oral syringe. You can get these from your pharmacist. Do not use a kitchen
teaspoon as it will not give the right amount.

It is important that you give your child the whole dose each time.

When should the medicine start working?

The medicine will start working straight away and your child should start to get better after taking
the medicine for 2 days. It is important that they take the whole course of medicine that has been
prescribed. Do not stop early.

What if my child is sick (vomits)?

 If your child is sick less than 30 minutes after having a dose of azithromycin, give them
the same dose again.
 If your child is sick more than 30 minutes after having a dose of azithromycin, you do
not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

Give the missed dose when you remember during the day, as long as this is at least 12 hours
before the next dose is due.

What if I give too much?

Azithromycin is normally a safe drug. It is unlikely to cause any problems if you give an extra
dose by mistake.

If you think you may have given your child too much azithromycin, contact your doctor or local
NHS services (111 in England and Scotland; 0845 46 47 in Wales). Have the medicine container
or packaging with you if you telephone for advice.

Are there any possible side-effects?

We use medicines to make our children better, but sometimes they have other effects that we
don’t want (side-effects).

Side-effects you must do something about

If your child is short of breath or is wheezing, or their face, lips or tongue start to swell, or they
develop a rash, they may be allergic to azithromycin. Take your child to hospital or call an
ambulance straight away.

Other side-effects you need to know about

  Your child may get diarrhoea or stomach pains and may feel sick (nausea) or be sick
(vomit) when they first start taking azithromycin. Giving the medicine with some food or
milk may help.
 Contact your doctor if your child has diarrhoea that goes on for more than 4 days or if it is
severe and watery, or contains blood.
 Your child may have a mild skin rash or itching.
 Your child may get headaches when taking azithromycin and they may feel sleepy or say
they have a funny taste in their mouth. These side effects usually go once they stop
taking the medicine.

There may, sometimes, be other side-effects that are not listed above. If you are concerned,
contact your doctor.

Important things to know about taking antibiotics [separate box]

 It is important that your child completes the course of antibiotic. This means that they
must take the medicine for the number of days that the doctor has told you to, or until all
the medicine has been taken. If you stop giving the antibiotic too soon, the troublesome
bacteria that are left will start to multiply again, and may cause another infection. There is
also a risk that these bacteria will be ‘resistant’ to (no longer be killed by) the first
antibiotic. This means that it might not work next time, and your child might need a
different antibiotic, which might not work as well or cause more side-effects.
 Children are sometimes sick (vomit) or get diarrhoea when taking antibiotics. Encourage
them to drink water to replace the fluid they have lost. If it is severe or your child is
drowsy, contact your doctor.
 Do not give your child any medicine to stop the diarrhoea unless your doctor has told you
to, as this can make things worse.
 Try to give the medicine at about the same times each day, to help you remember, and to
make sure that there is the right amount of medicine in your child’s body to kill the
bacteria.
 Only give this medicine to your child for their current infection.
 Never save medicine for future illnesses. Give old or unused antibiotics to your
pharmacist to dispose of.
 Only give the antibiotic to the child for whom it was prescribed. Never give it to anyone
else, even if their condition appears to be the same, as this could do harm.

If you think someone else may have taken the medicine by accident, contact your doctor for
advice.

Can other medicines be given at the same time as azithromycin?

 You can give your child medicines that contain paracetamol or ibuprofen, unless your
doctor has told you not to.
 Azithromycin should not be taken with some medicines that you get on prescription. Tell
your doctor and pharmacist about any other medicines that your child is taking before
giving azithromycin.
 Check with your doctor or pharmacist before giving any other medicines to your child.
This includes herbal or complementary medicines.

Is there anything else I need to know about this medicine?

 Azithromycin is a type of antibiotic called a macrolide. Your child should not have
azithromycin if they are allergic to any macrolide antibiotics (for example, erythromycin or
clithromycin).
  If your child has ever had an allergic reaction or other reaction to any medicine, tell your
doctor. If you have forgotten to tell your doctor, check with the doctor or pharmacist
before giving azithromycin to your child.

Where should I keep this medicine?

 Keep the medicine in a cupboard, away from heat and direct sunlight.
 You may need to keep liquid medicine in the fridge – check the instructions on the bottle.
Make sure that the medicine doesn’t freeze.
 Make sure that children cannot see or reach the medicine.
 Keep the medicine in the container it came in.

Who to contact for more information

Your doctor, pharmacist or nurse will be able to give you more information about azithromycin
and about other medicines used to treat bacterial infections.

You can also get useful information from:

 England - NHS 111

111
www.nhs.uk
 Scotland - NHS 24
111
www.nhs24.com
 Wales/Galw lechyd Cymru - NHS Direct
0845 4647
www.nhsdirect.wales.nhs.uk
 Northern Ireland - NI Direct
www.nidirect.gov.uk

Publication date:
28/05/2012
Copyright disclaimer:

Version 1.1, May 2012 (October 2014). © NPPG, RCPCH and WellChild 2011, all rights
reserved. Reviewed by: May 2015.

The primary source for the information in this leaflet is the British National Formulary for Children.
For details on any other sources used for this leaflet, please contact us through our
website, www.medicinesforchildren.org.uk.

We take great care to make sure that the information in this leaflet is correct and up-to-date.
However, medicines can be used in different ways for different patients. It is important that you
ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is
about the use of these medicines in the UK, and may not apply to other countries. The Royal
College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists
Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the
accuracy of information, omissions of information, or any actions that may be taken as a
consequence of reading this leaflet.