GALANTAMINE HYDROBROMIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (MRHD) of 24 mg/day on a body surface area (mg/m2 ) basis. When galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the MRHD on a mg/m2 basis. In a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. The no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the MRHD on a mg/m2 basis. Risk Summary There are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production.   The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition. The safety and effectiveness in pediatric patients have not been established. Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions (6.1) and Clinical Studies (14)] . The mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. In patients with moderate hepatic impairment, a dosage adjustment is recommended. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . In patients with a creatinine clearance of 9 to 59 mL/min, a dosage adjustment is recommended. The use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 mL/min is not recommended [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] .

Product summary:

How Supplied Galantamine hydrobromide extended-release capsules are available as follows: 16 mg (Size 2 pink opaque/pink opaque capsules imprinted ‘836’ with black ink on cap and body filled with pink color capsule shaped uncoated tablet plain on both sides) Bottles of 30 with child-resistant cap.....................................................NDC 63629-2365-1 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense with a child resistant closure in a well-closed container. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE CAPSULE,
EXTENDED RELEASE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE
HYDROBROMIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES.
GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 8/2021
INDICATIONS AND USAGE
Galantamine hydrobromide is a cholinesterase inhibitor indicated for
the treatment of mild to moderate
dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
Galantamine hydrobromide extended-release capsules: recommended
starting dosage is 8 mg/day in
morning; increase to initial maintenance dose of 16 mg/day after a
minimum of 4 weeks. Based on
clinical benefit and tolerability, dosage may be increased to 24
mg/day after a minimum of 4 weeks at
16 mg/day.(2.1)
Conversion from galantamine hydrobromide tablets to galantamine
hydrobromide extended-release
capsules should occur at the same daily dosage with the last dose of
galantamine hydrobromide
tablets taken in evening and starting galantamine hydrobromide
extended-release capsules once daily
treatment the next morning. (2.1)
Take with food; ensure adequate fluid intake during treatment (2.1)
Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in
patients with severe hepatic impairment (2.3)
Renal impairment: should not exceed 16 mg/day for creatinine clearance
9 to 59 mL/min; do not use in
patients with creatinine clearance less than 9 mL/min. (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules – 8 mg, 16 mg, 24 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients
(4)
WARNINGS AND PRECAUTIONS
Serious skin reactions: discontinue at first appearance of skin rash
(5.1)
All patients should be considered at risk for adverse ef