国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)
Major Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine tablets 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 tablets 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 d
How Supplied Galantamine Tablets USP are supplied as follows: 4 mg white color film coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side. Available: Cartons of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7104-04 Storage and Handling Galantamine Tablets USP should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
Abbreviated New Drug Application
GALANTAMINE- GALANTAMINE TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GALANTAMINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GALANTAMINE TABLETS GALANTAMINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Galantamine Tables are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS Known hypersensitivity to galantamine hydrobromide or any excipients ( 4) WARNINGS AND PRECAUTIONS • • • • Galantamine tablets: Recommended starting dosage is 4 mg twice daily; increase to initial maintenance dosage of 8 mg twice daily after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 12 mg twice daily after a minimum of 4 weeks at 8 mg twice daily. ( 2.2) Take with meals; ensure adequate fluid intake during treatment ( 2.2) 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) Tablets – 4 mg, 8 mg, 12 mg ( 3) Serious skin reactions: discontinue at first appearance of skin rash ( 5.1) All patients should be considered at risk for adverse effects on cardiac conduction, including bradycardia and AV block, due to vagotonic effects on sinoatrial and atrioventricular nodes ( 5.3) Active or occult gastrointestinal bleeding: monitor, especially those with an increased risk for developing ulcers ( 5.4) Cholinomimetics may cause bladder outflow obstruction ( 5.5) • • ADVERSE REACTIONS THE MOST COMMON ADVERSE REACTIONS (≥ 5%) WERE NAUSEA, VOMITING, DIARRHEA, DIZZINESS, HEADACHE, DECREASED APPETITE, AND WEIGHT DECREASED ( 6.1) TO 阅读完整的文件