GALANTAMINE HYDROBROMIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Patriot Pharmaceuticals, LLC

INN (International Name):

galantamine hydrobromide

Composition:

galantamine 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GALANTAMINE ER is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. GALANTAMINE ER is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of GALANTAMINE ER or galantamine tablets in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats, administration of galantamine (oral doses of 2, 8, or 16

Product summary:

How Supplied GALANTAMINE ER (galantamine extended-release capsules) are supplied as follows: 8 mg white opaque, size 4 hard gelatin capsules with the inscription "GAL 8" – bottles of 30 (NDC 10147-0891-3) 16 mg pink opaque, size 2 hard gelatin capsules with the inscription "GAL 16" – bottles of 30 (NDC 10147-0892-3) 24 mg caramel opaque, size 1 hard gelatin capsules with the inscription "GAL 24" – bottles of 30 (NDC 10147-0893-3) Storage and Handling GALANTAMINE ER extended-release capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE CAPSULE,
EXTENDED RELEASE
PATRIOT PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE ER SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GALANTAMINE ER.
GALANTAMINE ER (GALANTAMINE EXTENDED-RELEASE CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
GALANTAMINE ER is a cholinesterase inhibitor indicated for the
treatment of mild to moderate dementia of
the Alzheimer's type ( 1)
DOSAGE AND ADMINISTRATION
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)
Take with food; ensure adequate fluid intake during treatment ( 2.1)
Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in
patients with severe hepatic impairment ( 2.2)
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. ( 2.3)
Conversion from galantamine tablets to GALANTAMINE ER should occur at
the same daily dosage with
the last dose of galantamine tablets taken in evening and starting
GALANTAMINE ER once daily
treatment the next morning. ( 2.5)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 8 mg, 16 mg, 24 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide or any excipients (
4)
WARNINGS AND PRECAUTIONS
Serious skin reactions: discontinue at first appearance of skin rash (
5.1)
All patients should be considered at risk for adverse effects on
cardiac conduction, including
bradycardia and AV block, due to vagotonic effects on sinoatrial and
atrioventricular nodes ( 5.3)
Active or occult gastrointestinal bleeding: monitor, especially those
with an increased risk for developing
ulcers ( 5.4)
Cholinomimetic