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Fármacos: clorhidrato de amiodarona
¡ALERTA DE SEGURIDAD!
clorhidrato de amiodarona
am-ee-OH-dah-rohn
Nexterone, , Pacerone
Clase terapéutica: Antiarrítmicos
Clase farmacológica: derivados del benzofurano
Formularios disponibles
Inyección : 50 mg / mL; 150 mg / 100 ml; 360 mg / 200 ml; 450 mg / 9 ml; 450 mg / 200 ml; 750 mg / 500 ml;
900 mg / 18 ml; 900 mg / 500 ml; 1.000 mg / 500 ml
Comprimidos : 100 mg; 200 mg; 400 magnesio
Indicaciones y dosis
Advertencia de recuadro negro: La amiodarona está indicada para su uso solo en pacientes con fibrilación
ventricular recurrente potencialmente mortal o taquicardia ventricular hemodinámicamente inestable
recurrente que no responde a dosis adecuadas de otros antiarrítmicos o cuando no se pueden tolerar
medicamentos alternativos.
Prevención de arritmias ventriculares recurrentes potencialmente mortales, como fibrilación
ventricular o taquicardia ventricular hemodinámicamente inestable
Adultos: Administre una dosis de carga de 800 a 1.600 mg VO al día o dividida en dos dosis iguales al día
durante 1 a 3 semanas hasta que se produzca la primera respuesta terapéutica; luego 600 a 800 mg VO al
día durante 1 mes, seguido de una dosis de mantenimiento de 400 mg VO al día o, para pacientes con
intolerancia gastrointestinal grave, 200 mg VO dos veces al día. Determine la dosis de mantenimiento a
largo plazo de acuerdo con el efecto antiarrítmico.
O bien, administre una dosis de carga de 150 mg IV durante 10 minutos (15 mg / minuto); luego 360 mg
IV durante las próximas 6 horas (1 mg / minuto), seguido de 540 mg IV durante las próximas 18 horas (0,5
mg / minuto). Después de las primeras 24 horas, continúe con la infusión intravenosa de mantenimiento de
720 mg / 24 horas (0,5 mg / minuto).
La infusión de mantenimiento puede continuar con precaución durante 2 a 3 semanas. Para convertir a la
forma oral de IV (basado en una infusión de 720 mg / día): Si la infusión IV ha sido por menos de 1
semana, la dosis inicial es de 800 a 1,600 mg por vía oral al día; si la infusión intravenosa ha sido de 1 a 3
semanas, la dosis inicial es de 600 a 800 mg VO al día; si la infusión intravenosa ha durado más de 3
semanas, la dosis inicial es de 400 mg por vía oral al día.
Si ocurren episodios intercurrentes de fibrilación ventricular o taquicardia ventricular hemodinámicamente
inestable, se pueden administrar infusiones complementarias de 150 mg IV durante 10 minutos.
Administración
correos
Divida la dosis de carga oral en dos o tres dosis iguales y administre con las comidas para disminuir la
intolerancia gastrointestinal. Administre la dosis de mantenimiento una vez al día o divida en dos dosis con
las comidas para disminuir la intolerancia gastrointestinal.
IV
Administre el fármaco por vía intravenosa sólo si se dispone de ECG continuo y monitorización
electrofisiológica.
Mezcle la primera dosis de 150 mg en 100 ml de solución D W.
5
Si la infusión durará 2 horas o más, mezcle la solución en frascos de vidrio o poliolefina.
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Si la concentración es de 2 mg / ml o más, administre el medicamento a través de una vía central. Si es
posible, use una línea dedicada.
El fármaco puede ser un vesicante; Asegúrese de colocar correctamente la aguja o el catéter antes y
durante la infusión intravenosa y evite la extravasación.
Utilice un filtro en línea.
Monitoree continuamente el estado cardíaco del paciente. Si se produce hipotensión, reduzca la velocidad
de perfusión.
La amiodarona intravenosa filtra los plastificantes de los tubos intravenosos y se adsorbe en los tubos de
cloruro de polivinilo (PVC), lo que puede afectar negativamente el desarrollo del aparato reproductor
masculino en fetos, bebés y niños pequeños cuando se usa en concentraciones o velocidades de flujo fuera
de las recomendaciones.
Incompatibilidades: Aminofilina, ampicilina sódica-sulbactam sódica, bivalirudina, cefazolina sódica,
ceftazidima, digoxina, furosemida, heparina sódica, imipenem-cilastatina sódica, sulfato de magnesio,
micafungina, nitroprusiato sódico, NSS, piperacilina-tarato sódico, piperacilinaconctamida bicarbonato de
sodio, fosfatos de sodio, fosfatos de potasio.
Acción
Inhibe la estimulación adrenérgica y bloquea los canales de sodio y potasio, lo que prolonga la duración del
potencial de acción.
Ruta Comienzo Cima Duración
correos Variable 3 a 7 horas Variable
IV Desconocido Desconocido Variable
Vida media: oral, de 15 a 142 días; Rango medio de dosis única intravenosa, 9 a 36 días.
Reacciones adversas
SNC: fatiga, malestar, temblor, neuropatía periférica, ataxia, parestesia, insomnio, alteraciones del sueño, dolor
de cabeza, mareos.
CV: hypotension, asystole, atrial fibrillation, bradycardia, arrhythmias, HF, heart block, sinus arrest,
edema, flushing.
EENT: asymptomatic corneal microdeposits, visual disturbances, optic neuropathy or neuritis resulting in visual
impairment, abnormal smell.
GI: nausea, vomiting, abnormal taste, anorexia, constipation, abdominal pain, diarrhea.
Hematologic: coagulation abnormalities.
Hepatic: hepatic failure, hepatic dysfunction.
Metabolic: hypothyroidism, hyperthyroidism.
Respiratory: ARDS, severe pulmonary toxicity, pulmonary edema, eosinophilic pneumonitis.
Skin: photosensitivity, solar dermatitis, blue-gray skin.
Other: decreased libido.
Interactions
Drug-drug
Antiarrhythmics: May reduce hepatic or renal clearance of certain antiarrhythmics, especially flecainide,
procainamide, and quinidine. Use of amiodarone with other antiarrhythmics, especially mexiletine,
propafenone, disopyramide, and procainamide, may induce torsades de pointes. Avoid using together.
Azole antifungals, disopyramide, pimozide: May increase the risk of arrhythmias, including torsades de
pointes. Avoid using together.
Beta blockers, calcium channel blockers: May potentiate bradycardia, sinus arrest, and AV block; may increase
hypotensive effect. Use together cautiously.
Cimetidine: May increase amiodarone level. Use together cautiously.
Cyclosporine: May increase cyclosporine level, resulting in an increase in serum creatinine level and renal
toxicity. Monitor cyclosporine levels and renal function tests.
Dabigatran: May increase bleeding risk. Monitor patient closely.
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Digoxin: May increase digoxin level 70% to 100%. Monitor digoxin level closely, and reduce digoxin dosage
by half or stop drug completely when starting amiodarone therapy.
Fentanyl: May cause hypotension, bradycardia, and decreased cardiac output. Monitor patient closely.
Fluoroquinolones: May increase risk of arrhythmias, including torsades de pointes. Avoid using together.
HMG-CoA reductase inhibitors (lovastatin, simvastatin): May cause myopathy or rhabdomyolysis. Lovastatin
dosage shouldn’t exceed 40 mg daily. Simvastatin dosage shouldn’t exceed 20 mg daily. Lower the dosages of
other drugs in this class. Monitor patient carefully.
Loratadine, trazodone: May cause prolonged QT interval and torsades de pointes. Monitor closely.
Macrolide antibiotics (azithromycin, clarithromycin, erythromycin): May cause additive prolongation
of the QT interval. Use with caution.
Phenytoin: May decrease phenytoin metabolism and increase phenytoin level. May decrease amiodarone level.
Monitor phenytoin level and adjust dosages of drugs if needed.
Protease inhibitors (amprenavir, atazanavir, indinavir, lopinavir–ritonavir, nelfinavir, ritonavir,
saquinavir): May increase the risk of amiodarone toxicity. Use of ritonavir or nelfinavir with amiodarone is
contraindicated. Use other protease inhibitors cautiously.
Quinidine: May increase quinidine level, causing life-threatening cardiac arrhythmias. Avoid using together, or
monitor patient closely if use together can’t be avoided. Adjust quinidine dosage as needed.
Rifamycins: May decrease amiodarone level. Monitor patient closely.
Theophylline: May increase theophylline level and cause toxicity. Monitor theophylline level.
Warfarin: May increase anticoagulant response, with the potential for serious or fatal bleeding. Decrease
warfarin dosage 33% to 50% when starting amiodarone. Monitor patient closely.
St. John’s wort: May decrease amiodarone levels. Discourage use together.
Drug-food
Grapefruit juice: May inhibit CYP3A4 metabolism of drug in the intestinal mucosa, causing increased levels and
risk of toxicity. Discourage use together.
Drug-lifestyle
Sun exposure: May cause photosensitivity reaction. Advise patient to take precautions.
Effects on Lab Test Results
May increase alkaline phosphatase, ALT, AST, GGT, reverse T3, and T4 levels. May decrease T3 level.
May prolong PT and increase INR.
Contraindications & Cautions
Contraindicated in patients hypersensitive to drug or to iodine.
Contraindicated in those with cardiogenic shock, second- or third-degree AV block, severe SA node disease
resulting in bradycardia unless an artificial pacemaker is present, and in those for whom bradycardia has
caused syncope.
Use cautiously in patients receiving other antiarrhythmics. Upon starting amiodarone, attempt to gradually
discontinue prior antiarrhythmics.
Use cautiously in patients with pulmonary, hepatic, or thyroid disease.
Alert: Avoid use in patients with Wolff-Parkinson-White syndrome and preexcited atrial fibrillation or flutter.
Dialyzable drug: No.
Overdose Signs & Symptoms: AV block, bradycardia, hypotension, cardiogenic shock, hepatotoxicity.
Pregnancy-Lactation-Reproduction
Drug may cause fetal harm. Use during pregnancy only to treat life-threatening or refractory arrhythmias.
Drug appears in human milk. Contraindicated in breastfeeding women.
Nursing Considerations
Be aware of the high risk of adverse reactions.
Obtain baseline pulmonary, liver, and thyroid function test results and baseline chest X-ray.
Alert: Drug may cause hyperthyroidism or hypothyroidism. Hyperthyroidism can result in fatal
thyrotoxicosis or arrhythmia. If hyperthyroidism or hypothyroidism occurs, reduce dosage or discontinue
drug. Thyroid nodules and thyroid cancer have been reported. Use cautiously in patients with thyroid
disease. Monitor thyroid function during treatment, particularly in elderly patients and those with underlying
thyroid dysfunction.
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Black Box Warning: Give loading doses in a hospital setting and with continuous ECG monitoring because of
the slow onset of antiarrhythmic effect and the risk of life-threatening arrhythmias.
Black Box Warning: Drug may pose life-threatening management problems in patients at risk for sudden
death. Use only in patients with life-threatening, recurrent ventricular arrhythmias unresponsive to or
intolerant of other antiarrhythmics or alternative drugs.
Black Box Warning: Drug is highly toxic. Watch carefully for pulmonary toxicity. Risk increases in patients
receiving doses over 400 mg/day. Liver injury is also common and is usually mild but has been fatal in a
few cases.
Watch for evidence of pneumonitis, exertional dyspnea, nonproductive cough, and pleuritic chest pain.
Monitor pulmonary function tests and chest X-ray.
Correct electrolyte imbalances before start of therapy and throughout treatment.
Monitor LFTs and thyroid function test results and electrolyte levels, particularly potassium and magnesium.
Monitor PT and INR if patient takes warfarin and digoxin level if patient takes digoxin.
Instill methylcellulose ophthalmic solution during amiodarone therapy to minimize corneal microdeposits.
About 1 to 4 months after starting amiodarone, most patients develop corneal microdeposits, although 10%
or less have vision disturbances. Regular ophthalmic examinations are advised.
Reevaluate amiodarone therapy and promptly refer patient for ophthalmic examination if diagnosis of optic
neuropathy or optic neuritis is confirmed.
Monitor BP and HR and rhythm frequently. Perform continuous ECG monitoring when starting or changing
dosage. Notify prescriber of significant change in assessment results.
Alert: Patients may continue to be at risk for drug-related adverse reactions or drug interactions after
discontinuation of amiodarone.
Alert: May cause life-threatening or fatal reactions, including SJS and toxic epidermal necrolysis.
Discontinue drug immediately if such signs or symptoms as progressive rash with blisters or mucosal lesions
occur.
Safety and effectiveness in children haven’t been established. Life-threatening gasping syndrome may occur
in neonates given IV solutions containing benzyl alcohol.
During or after treatment with IV form, patient may be transferred to oral therapy.
Look alike-sound alike: Don’t confuse amiodarone with amiloride.
Patient Teaching
Advise patient to wear sunscreen or protective clothing to prevent sensitivity reaction to the sun. Monitor
patient for skin burning or tingling, followed by redness and blistering. Exposed skin may turn blue-gray.
Advise patient to keep follow-up appointments, including eye exams and blood tests.
Tell patient to report vision changes, weakness, “pins and needles” or numbness, poor coordination, weight
change, heat or cold intolerance, neck swelling, progressive rash, or mucosal lesions.
Dígale al paciente que tome el medicamento oral con comida si ocurren reacciones gastrointestinales.
Informe al paciente que los efectos adversos del fármaco son más frecuentes en dosis altas y se vuelven
más frecuentes con el tratamiento que dura más de 6 meses, pero generalmente son reversibles cuando se
suspende el fármaco. La resolución de las reacciones adversas puede tardar hasta 4 meses.
Dígale al paciente que no deje de tomar este medicamento sin consultar con el médico.
INSERT_FOLLETOS
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