GALANTAMINE HYDROBROMIDE tablet film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)

Dostupné z:

Avera McKennan Hospital

INN (Medzinárodný Name):

galantamine hydrobromide

Zloženie:

galantamine 12 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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