Version July 2025
Dosage guidance:
Safety: Patients and caregivers of patients should be advised to ensure adequate fluid intake during treatment.
Alzheimer disease, mild to moderate:
IR 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.
ER 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.
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 (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: Immediate release: 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/day in 2 divided doses (Ref).
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: Immediate release: 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).
Missed dose: If therapy is interrupted for ≥3 days, restart at the lowest dose and increase to current dose.
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.
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
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
Refer to adult dosing; adjust dose with caution in patients with low body weight and/or serious comorbidities.
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
Hypersensitivity to galantamine or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other tertiary alkaloids.
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.
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]:
Generic: 4 mg, 8 mg, 12 mg
Yes
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.
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
Oral: Administer solution or tablet with breakfast and dinner; administer ER capsule with breakfast. Ensure adequate fluid intake during treatment. 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, mild to moderate: Treatment of mild to moderate dementia of Alzheimer disease
Alzheimer disease, severe; Dementia with Lewy bodies and Parkinson disease dementia; Vascular dementia, comorbid
Razadyne [DSC] may be confused with Rozerem
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].
Substrate of CYP2D6 (Minor), CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits Acetylcholinesterase;
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: Acetylcholinesterase Inhibitors may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Amifampridine: Acetylcholinesterase Inhibitors may increase therapeutic effects of Amifampridine. Amifampridine side effects may also be increased. Amifampridine may increase therapeutic effects of Acetylcholinesterase Inhibitors. Acetylcholinesterase inhibitor side effects may also be increased. Risk C: Monitor
Antipsychotic Agents: Benzgalantamine-Galantamine may increase neurotoxic (central) effects of Antipsychotic Agents. Risk C: Monitor
Benoxinate: Acetylcholinesterase Inhibitors may increase therapeutic effects of Benoxinate. Specifically, the effects of benoxinate may be prolonged. Risk C: Monitor
Beta-Blockers: Acetylcholinesterase Inhibitors may increase bradycardic effects of Beta-Blockers. Risk C: Monitor
Bradycardia-Causing Agents: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects 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 increase adverse/toxic effects of Chlorprothixene. Acetylcholinesterase Inhibitors may increase therapeutic effects of Chlorprothixene. Risk C: Monitor
Cholinergic Agonists: Acetylcholinesterase Inhibitors may increase adverse/toxic effects of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor
Corticosteroids (Systemic): May increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor
Dipyridamole: May decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Etrasimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid
Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects 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
Gepotidacin: May increase therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Ivabradine: Bradycardia-Causing Agents may increase bradycardic effects of Ivabradine. Risk C: Monitor
Lacosamide: Bradycardia-Causing Agents may increase AV-blocking effects of Lacosamide. Risk C: Monitor
Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid
Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may decrease neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor
Ozanimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor
Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects 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
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Siponimod: Bradycardia-Causing Agents may increase bradycardic effects 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 increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor
Adverse events have been observed in animal reproduction studies.
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.
Administration with food is preferred, but not required; should be taken with breakfast and dinner (tablet or solution) or with breakfast (capsule).
Mental status; body weight, symptoms of GI intolerance, symptoms of active or occult GI bleeding
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
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%)
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.
