GALANTAMINE HYDROBROMIDE solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

GALANTAMINE HYDROBROMIDE

Skład:

GALANTAMINE 4 mg in 1 mL

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. There are no adequate and well-controlled studies 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. Galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats, administration of galantamine (oral doses of 2 mg, 8 mg, 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. 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 mg, 12 mg, 28 mg, or 48 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. 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 mg, 8 mg, 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. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when galantamine is administered to a nursing woman. 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 6519 patients have investigated galantamine 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 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 mL to 59 mL/min, a dosage adjustment is recommended. The use of galantamine in patients with creatinine clearance less than 9 mL/min is not recommended [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] .

Podsumowanie produktu:

Galantamine Oral Solution, USP 4 mg/mL oral solution is supplied in a 100 mL bottle as a clear, colorless to pale yellow solution with a calibrated (in milliliters) syringe. The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 5 mL. NDC 0054-0137-49: Bottle of 100 mL Galantamine Oral Solution, USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DO NOT FREEZE. Keep this and all drugs out of the reach of children.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GALANTAMINE ORAL
SOLUTION.
GALANTAMINE ORAL SOLUTION
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine is a cholinesterase inhibitor indicated for the treatment
of mild to moderate dementia of the
Alzheimer’s type. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Oral Solution – 4 mg/mL (3)
CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients.
(4)
WARNINGS AND PRECAUTIONS
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•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥5%) were nausea, vomiting,
diarrhea, dizziness, headache, and
decreased appetite. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data may cause fetal harm. (8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2023
Galantamine Oral Solution: Recommended starting dosage is 4 mg (1 mL)
twice daily; increase dose
to initial maintenance dosage of 8 mg (2 mL) twice daily after a
minimum of 4 weeks. Based on
clinical benefit and tolerability, dosage may be increased to 12 mg (3
mL) twice daily after a minimum
of 4 weeks at 8 mg (2 mL) twice daily. (2.2)
Take with meals; ensure adequate fluid intake during treatment. (2.2)
Hepatic Impairment: should not exceed 16 mg (4 mL)/day for moderate
hepatic impairment; do not
use in patients with severe hepatic impairment. (2.3)
Renal Impairment: should not exceed 16 mg (4 mL)/day for creatinine
clearance 9 mL to 59 mL/min;
do not use in patients with creatinine clearance less than 9 mL/min.
(2.4)
Serious Skin Reactions: discontinue at first appearance of skin rash.
(5.1)
All patients sh