Country: United States
Language: English
Source: NLM (National Library of Medicine)
galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)
Yabao Pharmaceutical Co., Ltd. Beijing
galantamine hydrobromide
galantamine 4 mg
ORAL
PRESCRIPTION DRUG
Galantamine Hydrobromide Tablets, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine hydrobromide tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or any excipients used in the formulation. Pregnancy Category C: 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 hydrobromide tablets 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, 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 ske
Galantamine hydrobromide tablets, USP are supplied as follows: 4 mg white color coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side: bottles of 60 NDC 51990-111-04, bottles of 100 NDC 51990-111-02, bottles of 1000 NDC 51990-111-03. 8 mg purple color coated, round, biconvex tablet, debossed “YB” on one side and “112” on the other side: bottles of 60 NDC 51990-112-04, bottles of 100 NDC 51990-112-02, bottles of 1000 NDC 51990-112-03. 12 mg peach color coated, round, biconvex tablet, debossed “YB” on one side and “113” on the other side: bottles of 60 NDC 51990-113-04, bottles of 100 NDC 51990-113-02, bottles of 1000 NDC 51990-113-03. Galantamine hydrobromide tablets, USP should be stored at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
New Drug Application
GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED YABAO PHARMACEUTICAL CO., LTD. BEIJING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GALANTAMINE HYDROBROMIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GALANTAMINE HYDROBROMIDE TABLETS, USP. GALANTAMINE HYDROBROMIDE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Galantamine hydrobromide tablets, USP is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type (1) DOSAGE AND ADMINISTRATION Recommended starting dosage for galantamine hydrobromide tablets 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. (2.1) Take with meals; 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 (2.2) 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 (2.3) DOSAGE FORMS AND STRENGTHS Tablets – 4 mg, 8 mg, 12 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 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) Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmo Read the complete document