ประเทศ: สหรัฐอเมริกา
ภาษา: อังกฤษ
แหล่งที่มา: NLM (National Library of Medicine)
galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)
Avera McKennan Hospital
galantamine hydrobromide
galantamine 12 mg
PRESCRIPTION DRUG
New Drug Application
GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GALANTAMINE HBR ER AND GALANTAMINE HBR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GALANTAMINE HBR ER AND GALANTAMINE HBR. GALANTAMINE HBR (GALANTAMINE HYDROBROMIDE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2001 RECENT MAJOR CHANGES Warnings and Precautions, Serious Skin Reactions (5.1) 02/2015 INDICATIONS AND USAGE GALANTAMINE HBr ER and GALANTAMINE HBr is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type (1) DOSAGE AND ADMINISTRATION GALANTAMINE HBr ER: 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 HBr tablets to GALANTAMINE HBr ER should occur at the same daily dosage with the last dose of GALANTAMINE HBr tablets taken in evening and starting GALANTAMINE HBr ER once daily treatment the next morning. (2.1) GALANTAMINE HBr 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) DOSAGE FORMS AND STRENGTHS Extended-release capsules – 8 mg, 16 mg, 24 mg (3) Tablets – 4 mg, 8 mg, 12 mg (3) CONTRAINDICAT อ่านเอกสารฉบับเต็ม