Galantamine CAPSULE, EXTENDED RELEASE
Refer to the “Also Known As” section to reference different products that include the same medication as Galantamine.
Brand Name: Galantamine
Generic Name: GALANTAMINE
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: CAPSULE, EXTENDED RELEASE
Packager: Actavis Pharma, Inc.
Data Current As Of: 2021-02-11
Indications & Usage
Galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
Galantamine extended-release capsules are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type (1)
use with anticholinergics
Galantamine has the potential to interfere with the activity of anticholinergic medications [see Clinical Pharmacology (12.3)].
use with cholinomimetics & other cholinesterase inhibitors
A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol [see Clinical Pharmacology (12.3)].
Non Clinical Toxicology
carcinogenesis, mutagenesis, impairment of fertility
In a 24-month oral carcinogenicity study in rats, an increase in endometrial adenocarcinomas was observed at 10 mg/kg/day (4 times the MRHD of 24 mg/day on a mg/m2 basis or 6 times on a plasma exposure [AUC] basis) and 30 mg/kg/day (12 times MRHD on a mg/m2 basis or 19 times on an AUC basis). No increase in neoplastic changes was observed in females at 2.5 mg/kg/day (equivalent to the MRHD on a mg/m2 basis or 2 times on an AUC basis) or in males up to the highest dose tested of 30 mg/kg/day (12 times the MRHD on a mg/m2 and AUC basis).
Galantamine was not carcinogenic in a 6-month carcinogenicity study in transgenic (P 53-deficient) mice at oral doses up to 20 mg/kg/day, or in a 24-month carcinogenicity study in mice at oral doses up to 10 mg/kg/day (equivalent to the MRHD on a plasma AUC basis).
Galantamine was negative in a battery of in vitro (bacterial reverse mutation, mouse lymphoma tk, and chromosomal aberration in mammalian cells) and in vivo (mouse micronucleus) genotoxicity assays.
Impairment of Fertility
No impairment of fertility was seen in rats given up to 16 mg/kg/day (7 times the MRHD on a mg/m2 basis) for 14 days prior to mating in females and for 60 days prior to mating in males.
Patient Counseling Information
Serious Skin Reactions
General Dosing Guidance
Instruct caregivers about the recommended dosage and administration of galantamine extended-release capsules. Galantamine extended-release capsules should be administered once daily in the morning, preferably with food. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage [see Dosage and Administration (2)].
Advise patients and caregivers to ensure adequate fluid intake during treatment [see Dosage and Administration (2)].
Advise patients and caregivers that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration.
Manufactured In India By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
Rev. B 8/2020