Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)
Janssen Pharmaceuticals, Inc.
galantamine hydrobromide
galantamine 8 mg
ORAL
PRESCRIPTION DRUG
RAZADYNE ER is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. RAZADYNE ER is 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 RAZADYNE ER or 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 doses of 2, 8, or 16 mg/kg/da
How Supplied RAZADYNE® ER (galantamine extended-release capsules) are supplied as follows: 8 mg white opaque, size 4 hard gelatin capsules with the inscription "GAL 8" – bottles of 30 (NDC 50458-387-30) 16 mg pink opaque, size 2 hard gelatin capsules with the inscription "GAL 16" – bottles of 30 (NDC 50458-388-30) 24 mg caramel opaque, size 1 hard gelatin capsules with the inscription "GAL 24" – bottles of 30 (NDC 50458-389-30) Storage and Handling RAZADYNE ER extended-release capsules 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.
New Drug Application
RAZADYNE- GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE RAZADYNE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED JANSSEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RAZADYNE ER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAZADYNE ER. RAZADYNE ER (GALANTAMINE EXTENDED-RELEASE CAPSULES), FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE RAZADYNE ER 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 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) 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 (2.2) 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) Conversion from galantamine tablets to RAZADYNE ER should occur at the same daily dosage with the last dose of galantamine tablets taken in evening and starting RAZADYNE ER once daily treatment the next morning. (2.5) 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 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) Cho Soma hati kamili