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Divulgaciones de contribuyentes
(Para obtener información adicional, consulte "Galantamina: información sobre el medicamento para el paciente" )
Para consultar las definiciones de abreviaturas, símbolos y grupos de edad utilizados en Lexicomp ( ver tabla )
Categoría farmacológica
Inhibidor de la acetilcolinesterasa (central)
Posología: Adulto
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enfermedad de Alzheimer
Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the
manufacturer’s labeling; however, single-dose galantamine pharmacokinetics were similar
to that observed in healthy subjects.
Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless
otherwise specified.
1% to 10%:
<1%:
Dermatologic: Hyperhidrosis
Postmarketing:
Otic: Tinnitus
Contraindications
Hypersensitivity to galantamine or any component of the formulation.
Warnings/Precautions
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental
abilities; patients must be cautioned about performing tasks that require mental
alertness (eg, operating machinery or driving).
• Vagotonic effects: Cholinesterase inhibitors may have vagotonic effects which may
cause bradycardia and/or heart block with or without a history of cardiac disease.
• Weight loss: Weight loss has been observed; monitor body weight.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with mild to moderate liver
impairment; not recommended in severe impairment. Dose adjustment recommended
in moderate impairment.
• Peptic ulcer disease: Use with caution in patients at risk of ulcer disease (eg, previous
history or NSAID use); may increase gastric acid secretion. Monitor for symptoms of
bleeding.
• Renal impairment: Use with caution in patients with moderate renal impairment; not
recommended in severe impairment (CrCl <9 mL/minute).
• Respiratory disease: Use with caution in patients with COPD and/or asthma.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
• Urinary tract obstruction: Use with caution in patients with bladder outlet obstruction;
cholinomimetics may cause or worsen outflow obstructions.
Special populations:
• Older adult: Limited safety data in patients ≥85 years of age. Use with caution
particularly in elderly patients with low body weight and/or serious comorbidities;
adjust dose with caution.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult
specific product labeling. [DSC] = Discontinued product
Pricing: US
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as
reference price only. A range is provided when more than one manufacturer's AWP price is
available and uses the low and high price reported by the manufacturers to determine the
range. The pricing data should be used for benchmarking purposes only, and as such should
not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or
considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly
disclaims all warranties of any kind or nature, whether express or implied, and assumes no
liability with respect to accuracy of price or price range data published in its solutions. In no
event shall Medi-Span be liable for special, indirect, incidental, or consequential damages
arising from use of price or price range data. Pricing data is updated monthly.
Generic: 4 mg
Administration: Adult
Oral: Administer solution or tablet with breakfast and dinner; administer ER capsule with
breakfast. If therapy is interrupted for ≥3 days, restart at the lowest dose and increase to
current dose. If using oral solution, mix dose with 3 to 4 ounces of any nonalcoholic
beverage; mix well and drink immediately.
Bariatric surgery: Capsule, extended release: Some institutions may have specific protocols
that conflict with these recommendations; refer to institutional protocols as appropriate.
No information available from manufacturer regarding safety of opening capsules.
Consider switching to IR tablets or oral solution.
Alzheimer disease, severe; Dementia with Lewy bodies and Parkinson disease dementia;
Vascular dementia, comorbid
International issues:
Reminyl [Canada and multiple international markets] may be confused with Amarel
brand name for glimepiride [France]; Amaryl brand name for glimepiride [US, Canada,
and multiple international markets]; Robinul brand name for glycopyrrolate [US and
multiple international markets].
Metabolism/Transport Effects
Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate
status based on clinically relevant drug interaction potential
Drug Interactions
(For additional information: Launch drug interactions program)
Note: Interacting drugs may not be individually listed below if they are part of a group
interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a
complete list of drug interactions by individual drug name and detailed management
recommendations, use the Lexicomp drug interactions program by clicking on the “Launch
drug interactions program” link above.
Amifampridine: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of
Amifampridine. Amifampridine side effects may also be increased. Amifampridine may
enhance the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase
inhibitor side effects may also be increased. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Galantamine. Risk C:
Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Galantamine. Risk C:
Monitor therapy
Breastfeeding Considerations
According to the manufacturer, the decision to breastfeed during therapy should consider
the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of
treatment to the mother.
Dietary Considerations
Administration with food is preferred, but not required; should be taken with breakfast and
dinner (tablet or solution) or with breakfast (capsule).
Monitoring Parameters
Mental status; body weight, symptoms of GI intolerance, symptoms of active or occult GI
bleeding
Mechanism of Action
Centrally-acting cholinesterase inhibitor (competitive and reversible). It elevates acetylcholine in
cerebral cortex by slowing the degradation of acetylcholine. Modulates nicotinic acetylcholine
receptor to increase acetylcholine from surviving presynaptic nerve terminals. May increase
glutamate and serotonin levels.
Distribution: 175 L
Bioavailability: ~90%
Time to peak: Immediate release: 1 hour (2.5 hours with food); extended release: 4.5-5
hours
Excretion: Urine (20%)
Altered kidney function: AUC increased 37% and 67% in moderate and severe renal function
impairment.
(AE) United Arab Emirates: Reminyl; (AR) Argentina: Intelec er | Reminyl; (AT) Austria: Galantamin
actavis | Galantamin easypharm | Galantamin krka | Galantamin Ratiopharm | Galantamin sandoz |
Nivalin | Reminyl; (AU) Australia: Apo galantamine | Galantamine an | Galantyl | Gamine | Reminyl;
(BE) Belgium: Galantamine apotex | Galantamine eg | Galantamine mylan | Galantamine Sandoz |
Galantamine teva | Reminyl; (BG) Bulgaria: Galantagamma | Nivalin; (BR) Brazil: Bromidrato de
galantamina | Clometine | Cogit | Coglive | Elatium | Gaudy | Regressa | Reminyl; (CH) Switzerland:
Galantamin helvepharm | Reminyl; (CL) Chile: Galanvitae | Reminyl; (CN) China: Galanthamine
hydrobromide | Hui min | Jin kang ling li | Qi er neng | Shi wei bao; (CO) Colombia: Antamin |
Reminyl; (CZ) Czech Republic: Apo Galant | Galantamin mylan | Galantamin Teva | Reminyl; (DE)
Germany: Galanaxiro | Galantagamma | Galantamin | Galantamin 1A pharma | Galantamin Aaa |
Galantamin actavis | Galantamin AL | Galantamin CT | Galantamin glenmark | Galantamin heumann
| Galantamin Hexal | Galantamin hormosan | Galantamin Neurax | Galantamin Ratiopharm |
Galantamine mylan | Galnora | Nivalin | Reminyl; (DO) Dominican Republic: Reminyl; (EC) Ecuador:
Reminyl er; (EE) Estonia: Galsya | Reminyl; (EG) Egypt: Famalzyl | Reminyl; (ES) Spain: Galantamina
Actavis | Galantamina amneal | Galantamina Apotex | Galantamina cinfa | Galantamina combix |
Galantamina Kern | Galantamina Mylan | Galantamina normon | Galantamina Ratiopharm |
Galantamina Sandoz | Galantamina stada | Galantamina Teva | Galantamina tevagen | Galnora |
Reminyl; (FI) Finland: Galantamin actavis | Galantamin krka | Galantamin mylan | Galantamin orion |
Galantamin Stada | Galantamine teva | Reminyl; (FR) France: Galantamine | Galantamine Arrow |
Galantamine Biogaran | Galantamine cristers | Galantamine eg | Galantamine krka | Galantamine
mylan | Galantamine Sandoz | Galantamine teva | Galantamine Zydus | Reminyl | Reminyl LP; (GB)
United Kingdom: Acumor | Consion XL | Elmino xl | Gaalin | Galantamine | Galantex | Galsya |
Galzemic | Gatalin | Gazylan | Luventa | Reminyl | Zeebral XL; (GR) Greece: Galantamine |
Galantamine /Pharmathen | Galanyl | Memo-Farmellas | Memoton Life | Micol raldex | Reminyl |
Zoroflog; (HK) Hong Kong: Reminyl; (ID) Indonesia: Reminyl; (IE) Ireland: Galsya | Reminyl; (IL) Israel:
Reminyl; (IN) India: Galamer | Galamer od; (IT) Italy: Galnora | Reminyl; (JO) Jordan: Reminyl; (JP)
Japan: Reminyl; (KR) Korea, Republic of: Galantamine | Galanyl Pr | Reminyl | Reminyl pr | Tamirin |
Tamirin sr; (KW) Kuwait: Reminyl; (LB) Lebanon: Reminyl; (LT) Lithuania: Galsya | Nivalin | Reminyl;
(LU) Luxembourg: Galantamine mylan | Reminyl; (LV) Latvia: Galsya | Nivalin; (MX) Mexico: Reminyl |
Reminyl er; (MY) Malaysia: Reminyl; (NL) Netherlands: Galantamine | Galantamine actavis |
Galantamine CF | Galantamine mylan | Galantamine Sandoz | Galantamine teva | Reminyl; (NO)
Norway: Galantamin krka | Reminyl; (NZ) New Zealand: Galantyl | Reminyl; (PE) Peru: Galanvitae sr |
Numencial | Reminyl; (PH) Philippines: Reminyl; (PK) Pakistan: Dementio | Dementio er | Reminyl; (PL)
Poland: Reminyl; (PR) Puerto Rico: Galantamine | Galantamine Hbr | Razadyne | Razadyne er; (PT)
Portugal: Galantamina | Galantamina Actavis | Galantamina Aurovitas | Galantamina ciclum |
Galantamina Generis | Galantamina Krka | Galantamina Labesfal | Galantamina Mylan |
Galantamina Ratiopharm | Galantamina Sandoz | Galantamina Teva | Galantamina Wynn |
Galantamina zentiva | Reminyl; (PY) Paraguay: Galantamina | Reminyl er; (RO) Romania: Galantamina
zentiva | Galsya | Reminyl; (RU) Russian Federation: Galantamin Teva | Galantamine | Galantamine
canon | Galnora sr | Nivalin | Reminyl; (SA) Saudi Arabia: Pms galantamine | Reminyl; (SE) Sweden:
Galantamin actavis | Galantamin krka | Galantamin mylan | Galantamin orion | Galantamin sandoz |
Galantamin Stada | Galantamin Teva | Indukolin | Reminyl; (SG) Singapore: Reminyl; (SI) Slovenia:
Galantamin Teva | Galsya | Gazylan | Reminyl; (SK) Slovakia: Galantamin mylan | Galantamin Teva |
Galsya | Reminyl; (TH) Thailand: Galantamine symgens | Reminyl; (TR) Turkey: Reminyl; (TW) Taiwan:
Reminyl; (UA) Ukraine: Reminyl; (UY) Uruguay: Galantamina normon | Galtamin | Reminyl; (VE)
Venezuela, Bolivarian Republic of: Proneurax; (ZA) South Africa: Remcept xl | Reminyl
REFERENCES
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