Galantamine
Regulatory sources consulted
- AEMPS CIMA Ficha Técnica: 77289
- https://cima.aemps.es/cima/dochtml/ft/77289/FT_77289.html
- CredibleMeds.org
- Flockhart Table (Indiana University)
- Clinical Pharmacology Knowledge
- AEMPS CIMA · nº registro 77289 ↗
- RxNorm rxcui 4637 ↗
Approved indications
- Symptomatic treatment of mild to moderately severe Alzheimer's type dementia.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Severe hepatic impairment (Child-Pugh score > 9).
- Severe renal impairment (creatinine clearance < 30 ml/min).
Clinical warnings
- Major warning · Serious skin reactions: Stevens-Johnson syndrome (SJS) and acute generalized exanthematous pustulosis (AGEP) have been reported. Treatment should be discontinued at the first appearance of a skin rash. — EMA SPC
- Cardiovascular effects: Due to its pharmacological action, it can cause bradycardia and atrioventricular block. Use with caution in patients with sick sinus syndrome or supraventricular conduction disorders. — EMA SPC
Drug interactions
- HighKetoconazoleJ02AB02
Mechanism: Potent inhibition of CYP3A4, a major metabolic pathway for galantamine, increasing its AUC by 30-40%.
Recommendation: In patients initiating treatment with potent inhibitors of CYP3A4 (e.g., ketoconazole) or CYP2D6 (e.g., paroxetine), consider reducing the galantamine maintenance dose. Monitor for cholinergic adverse effects.
EMA SPC
Adverse events
Common (≥1%)
nausea · vomiting · dizziness · headache · bradycardia
Rare but serious
severe cutaneous adverse reactions (SCARs: SJS/AGEP) · complete atrioventricular block · hepatitis · seizures
Pregnancy and lactation
Pregnancy: There are no adequate clinical data. It should not be used during pregnancy unless clearly necessary. Lactation: It is unknown whether it is excreted in human milk. Women taking galantamine should not breast-feed.