Section 05 · Monograph
Galantamine
Reviewed Nov 2026FDA label
Razadyne ERAChE inhibitor + nicotinic modulator
- Forms
- ER cap: 8, 16, 24mg
- Dose
- Start 8mg/day, titrate q4wk to 16-24mg/day
- MOA
- Inhibits AChE, allosteric nicotinic modulation
Indications
- Treatment of mild to moderate dementia of the Alzheimer's typeFDA-labeled
Off-Label Uses
- Vascular dementia / mixed dementiaOff-label
- Dementia with Lewy bodiesOff-label
Mechanism of Action
- Dual mechanism: reversible, competitive inhibitor of acetylcholinesterase (AChE)
- Also acts as an allosterically potentiating ligand at nicotinic acetylcholine receptors, enhancing endogenous nicotinic cholinergic neurotransmission independent of AChE inhibition
- Naturally derived alkaloid (originally isolated from snowdrop and daffodil bulbs); minimal effect on butyrylcholinesterase relative to rivastigmine
Full Dosing
Adult / usual
- Extended-release capsule (Razadyne ER): initiate 8 mg once daily in the morning, preferably with food
- After ≥4 weeks, increase to 16 mg once daily based on tolerability
- After a further ≥4 weeks, may increase to a maximum of 24 mg once daily
- Immediate-release tablet/solution: initiate 4 mg twice daily, titrate to 8 mg BID then up to 12 mg BID at ≥4-week intervals
- Ensure adequate fluid intake during dose escalation
- If therapy is interrupted for several days or more, restart at the lowest dose and re-titrate
Renal
- Moderate hepatic or renal impairment (CrCl 9-59 mL/min): dose should generally not exceed 16 mg/day
Contraindications
- Known hypersensitivity to galantamine hydrobromide or any formulation excipients
- Severe hepatic impairment (Child-Pugh C)
- Severe renal impairment (creatinine clearance less than 9 mL/min)
Drug Interactions
- CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine) and CYP3A4 inhibitors (ketoconazole, erythromycin) increase galantamine exposure
- Anticholinergic drugs may antagonize galantamine's cholinergic activity
- Other cholinesterase inhibitors or cholinergic agonists: additive cholinergic toxicity
- Succinylcholine and similar agents: risk of exaggerated muscle relaxation during anesthesia
- NSAIDs: increased risk of GI bleeding
- Beta-blockers and other negative chronotropic agents: additive bradycardia risk
Adverse Effects
- Nausea (most common, dose-related), vomiting, diarrhea
- Decreased appetite and weight loss
- Dizziness and headache
- Syncope, bradycardia, and AV block
- Skin reactions including rare severe cutaneous reactions
- Rare seizures
Monitoring Parameters
- Weight and nutritional status at baseline and periodically
- Heart rate and signs of syncope; baseline ECG in patients with cardiac conduction disease
- GI tolerability with each titration step
- Baseline hepatic and renal function to guide dosing limits
- Skin for rash or hypersensitivity reactions
- Hydration status, particularly during vomiting/diarrhea episodes
Pregnancy & Lactation
- No adequate, well-controlled studies in pregnant women
- Animal reproduction studies showed developmental toxicity at maternally toxic dose levels
- Alzheimer's disease predominantly affects postmenopausal women, limiting pregnancy exposure data
- Unknown whether excreted in human milk; use during breastfeeding not recommended without weighing risk/benefit