GALANTAMINE capsule extended release
Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Tabia za bidhaa
(SPC)
13-05-2018
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Viambatanisho vya kazi:
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)
Inapatikana kutoka:
Teva Pharmaceuticals USA, Inc.
INN (Jina la Kimataifa):
GALANTAMINE HYDROBROMIDE
Tungo:
GALANTAMINE 8 mg
Dawa ya aina:
PRESCRIPTION DRUG
Idhini hali ya:
Abbreviated New Drug Application
Tabia za bidhaa
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 DRUG.SAFETY@TEVAPHARM.COM; 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
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