GALANTAMINE HYDROBROMIDE capsule extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

GALANTAMINE HYDROBROMIDE

Koostumus:

GALANTAMINE 8 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GALANTAMINE EXTENDED-RELEASE
CAPSULES.
GALANTAMINE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine extended-release capsules are a cholinesterase inhibitor
indicated for the treatment of mild to moderate
dementia of the Alzheimer’s type. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients.
(4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
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 and oral solution to galantamine
extended-release capsules should occur at the
same daily dosage with the last dose of galantamine tablets/oral
solution taken in the evening and starting galantamine
extended-release capsules once daily treatment the next morning. (2.1)
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