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Galantamine: Drug information

Galantamine: Drug information
(For additional information see "Galantamine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Razadyne ER [DSC];
  • Razadyne [DSC]
Brand Names: Canada
  • APO-Galantamine;
  • Auro-Galantamine ER;
  • Mar-Galantamine ER [DSC];
  • MYLAN-Galantamine ER;
  • PAT-Galantamine ER;
  • PMS-Galantamine ER
Pharmacologic Category
  • Acetylcholinesterase Inhibitor (Central)
Dosing: Adult
Alzheimer disease

Alzheimer disease, mild to moderate:

Immediate-release tablet or solution: Oral: Initial: 4 mg twice daily for 4 weeks; if tolerated, increase to 8 mg twice daily for ≥4 weeks; if tolerated, increase to 12 mg twice daily. Range: 16 to 24 mg daily in 2 divided doses.

Extended-release capsule: Oral: Initial: 8 mg once daily for 4 weeks; if tolerated, increase to 16 mg once daily for ≥4 weeks; if tolerated, increase to 24 mg once daily. Range: 16 to 24 mg once daily.

Note: If therapy is interrupted for ≥3 days, restart at the lowest dose and increase to current dose.

Alzheimer disease, severe (off-label use): Oral: Immediate-release tablet: Initial: 4 mg twice daily for 4 weeks; if tolerated, increase to 8 mg twice daily for ≥4 weeks; if tolerated, increase to 12 mg twice daily. May decrease to 8 mg twice daily if the target dose is not tolerated. Range: 16 to 24 mg daily in 2 divided doses (Ref).

Dementia with Lewy bodies and Parkinson disease dementia

Dementia with Lewy bodies and Parkinson disease dementia (off-label use): Note: In patients with mild or moderate dementia with Lewy bodies, consider galantamine therapy only in patients who do not tolerate donepezil and rivastigmine (Ref).

Oral: American Psychiatric Association recommends dosing and titration similar to those for patients with Alzheimer disease (Ref).

Vascular dementia, comorbid

Vascular dementia, comorbid (off-label use): Note: For use in patients with suspected comorbid Alzheimer disease, Parkinson disease dementia, or dementia with Lewy bodies (Ref).

Oral: Initial: 4 mg twice daily for 4 weeks; increase to 8 mg twice daily for 4 weeks; if tolerated, increase to 12 mg twice daily. Range: 16 to 24 mg/day in 2 divided doses (Ref).

Conversion from immediate release to extended release formulation: Patients may be switched from the immediate-release formulation to the extended-release formulation by taking the last immediate-release dose in the evening and beginning the extended-release dose the following morning; the same total daily dose should be used.

Conversion to galantamine from other cholinesterase inhibitors: Patients experiencing poor tolerability with donepezil or rivastigmine should wait until side effects subside or allow a 7-day washout period prior to beginning galantamine. Patients not experiencing side effects with donepezil or rivastigmine may begin galantamine therapy the day immediately following discontinuation of previous therapy (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Moderate impairment (CrCl 9 to 59 mL/minute): Maximum dose: 16 mg/day.

Severe impairment (CrCl <9 mL/minute): Use is not recommended

Dosing: Hepatic Impairment: Adult

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.

Moderate impairment (Child-Pugh class B): Maximum dose: 16 mg/day

Severe impairment (Child-Pugh class C): Use is not recommended

Dosing: Older Adult

Refer to adult dosing; adjust dose with caution in patients with low body weight and/or serious comorbidities.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Nausea (21%), vomiting (11%)

1% to 10%:

Cardiovascular: Bradycardia (1%), syncope (1%)

Endocrine & metabolic: Weight loss (5%)

Gastrointestinal: Abdominal distress (2%), abdominal pain (4%), decreased appetite (7%), diarrhea (7%), dyspepsia (2%)

Nervous system: Depression (4%), dizziness (8%), drowsiness (2%), falling (4%), fatigue (4%), headache (7%), lethargy (1%), malaise (1%)

Neuromuscular & skeletal: Muscle spasm (1%), tremor (2%)

Miscellaneous: Laceration (1%)

<1%:

Cardiovascular: First degree atrioventricular block, flushing, hypotension, palpitations, sinus bradycardia, supraventricular extrasystole

Dermatologic: Hyperhidrosis

Endocrine & metabolic: Dehydration

Gastrointestinal: Dysgeusia, retching

Nervous system: Hypersomnia, myasthenia, paresthesia

Ophthalmic: Blurred vision

Frequency not defined: Gastrointestinal: Anorexia

Postmarketing:

Cardiovascular: Complete atrioventricular block, hypertension

Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme, skin rash, Stevens-Johnson syndrome

Hepatic: Hepatitis, increased liver enzymes

Hypersensitivity: Hypersensitivity reaction

Nervous system: Drug-induced extrapyramidal reaction, hallucination, seizure

Otic: Tinnitus

Contraindications

Hypersensitivity to galantamine or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other tertiary alkaloids.

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).

• Extrapyramidal effects: May exacerbate extrapyramidal symptoms due to an increase in cholinergic tone.

• Skin reactions: Skin reactions including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis and erythema multiforme have been reported. Treatment discontinuation may be necessary if skin reaction occurs; if rash is suspected to be drug related, do not resume galantamine and consider alternative therapy.

• 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:

• Cardiac conduction abnormalities: Use with caution in patients with sick-sinus syndrome, bradycardia, or conduction abnormalities.

• 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

Capsule Extended Release 24 Hour, Oral, as hydrobromide [strength expressed as base]:

Razadyne ER: 8 mg [DSC], 16 mg [DSC], 24 mg [DSC]

Generic: 8 mg, 16 mg, 24 mg

Solution, Oral, as hydrobromide:

Generic: 4 mg/mL (100 mL)

Tablet, Oral, as hydrobromide [strength expressed as base]:

Razadyne: 4 mg [DSC], 8 mg [DSC]

Razadyne: 12 mg [DSC] [contains fd&c yellow #6(sunset yellow)alumin lake]

Generic: 4 mg, 8 mg, 12 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsule ER 24 Hour Therapy Pack (Galantamine Hydrobromide ER Oral)

8 mg (per each): $6.36

16 mg (per each): $6.36

24 mg (per each): $6.36

Solution (Galantamine Hydrobromide Oral)

4 mg/mL (per mL): $3.75

Tablets (Galantamine Hydrobromide Oral)

4 mg (per each): $3.18

8 mg (per each): $3.18

12 mg (per each): $3.18

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral, as hydrobromide [strength expressed as base]:

PAT-Galantamine ER: 8 mg, 16 mg, 24 mg

Generic: 8 mg, 16 mg, 24 mg

Tablet, Oral, as hydrobromide [strength expressed as base]:

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.

Use: Labeled Indications

Alzheimer disease, mild to moderate: Treatment of mild to moderate dementia of Alzheimer disease

Use: Off-Label: Adult

Alzheimer disease, severe; Dementia with Lewy bodies and Parkinson disease dementia; Vascular dementia, comorbid

Medication Safety Issues
Sound-alike/look-alike issues:

Razadyne [DSC] may be confused with Rozerem

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

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

Anticholinergic Agents: Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Antipsychotic Agents: Galantamine may enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

Benoxinate: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Benoxinate. Specifically, the effects of benoxinate may be prolonged. Risk C: Monitor therapy

Beta-Blockers: Acetylcholinesterase Inhibitors may enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Chlorprothixene: Acetylcholinesterase Inhibitors may enhance the adverse/toxic effect of Chlorprothixene. Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Chlorprothixene. Risk C: Monitor therapy

Cholinergic Agonists: Acetylcholinesterase Inhibitors may enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. 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

Dipyridamole: May diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Succinylcholine: Acetylcholinesterase Inhibitors may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if galantamine is present in breast milk.

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.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: 175 L

Protein binding: 18%

Metabolism: Hepatic metabolism primarily via CYP2D6 to O-desmethyl-galantamine and 3A4 to galantamine-N-oxide; the activity of galantamine metabolites is not considered to be clinically relevant (Farlow 2003; Scott 2000)

Bioavailability: ~90%

Half-life elimination: ~7 hours

Time to peak: Immediate release: 1 hour (2.5 hours with food); extended release: 4.5-5 hours

Excretion: Urine (20%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: AUC increased 37% and 67% in moderate and severe renal function impairment.

Hepatic function impairment: Cl decreased about 25% in moderate (Child-Pugh score 7 to 9) hepatic function impairment.

Older adult: Concentrations are about 30% to 40% higher.

Sex: Cl is about 20% lower in women than in men.

CYP2D6 poor metabolizers: There is an approximate 35% increase in AUC of unchanged drug and 25% decrease in median Cl.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Reminyl;
  • (AR) Argentina: Intelec er | Reminyl | Reminyl er;
  • (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: Alzynamin | Bromidrato de galantamina | Clometine | Cogit | Coglive | Elatium | Gaudy | Regressa | Reminyl | Reminyl er;
  • (CH) Switzerland: Galantamin helvepharm | Galantamin SR zentiva | Reminyl;
  • (CL) Chile: Galanvitae | Reminyl er;
  • (CN) China: Galanthamine hydrobromide | Hui min | Jin kang ling li | Qi er neng | Shi wei bao | Yi you li ning;
  • (CO) Colombia: Antamin | Reminyl | Reminyl er;
  • (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 | Reminyl er;
  • (EC) Ecuador: Reminyl er;
  • (EE) Estonia: Galantamin 1A pharma | 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 | Reminyl er;
  • (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;
  • (QA) Qatar: Reminyl;
  • (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 abacus medicine | 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;
  • (VN) Viet Nam: Newgala;
  • (ZA) South Africa: Remcept xl | Reminyl
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