GALANTAMINE capsule extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)

Boleh didapati daripada:

Teva Pharmaceuticals USA, Inc.

INN (Nama Antarabangsa):

GALANTAMINE HYDROBROMIDE

Komposisi:

GALANTAMINE 8 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

GALANTAMINE- GALANTAMINE CAPSULE, EXTENDED RELEASE
GALANTAMINE- GALANTAMINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE EXTENDED-RELEASE
CAPSULES AND GALANTAMINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
GALANTAMINE EXTENDED-RELEASE CAPSULES AND GALANTAMINE TABLETS.
GALANTAMINE EXTENDED-RELEASE CAPSULES, FOR ORAL USE GALANTAMINE
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine extended-release capsules and galantamine tablets are
cholinesterase inhibitors indicated for the treatment of
mild to moderate dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients
(4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) were nausea, vomiting,
diarrhea, dizziness, headache, and decreased appetite
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Galantamine extended-release capsules: 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 tablets to galantamine extended-release
capsules should occur at the same daily
dosage with the last dose of galantamine tablets taken in evening and
starting galantamine extended-release capsules
once daily treatment the next morning. (2.1)
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