GALANTAMINE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals USA Inc.

INN (Nama Antarabangsa):

GALANTAMINE HYDROBROMIDE

Komposisi:

GALANTAMINE 4 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Galantamine Tablets, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine tablets are 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 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% to 4% and 15% to 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,

Ringkasan produk:

Galantamine Tablets USP, 4 mg (equivalent to 5.126 mg galantamine hydrobromide) are light-pink, round , biconvex, film-coated tablets debossed with '77' on one side and 'Z' on the other side and are supplied as follows: NDC 68382-177-14 in bottle of 60 tablets NDC 68382-177-01 in bottle of 100 tablets NDC 68382-177-10 in bottle of 1,000 tablets NDC 68382-177-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Galantamine Tablets USP, 8 mg (equivalent to 10.252 mg of galantamine hydrobromide) are off-white, round, biconvex, film-coated tablets debossed with '78' on one side and 'Z' on the other side and are supplied as follows: NDC 68382-178-14 in bottle of 60 tablets NDC 68382-178-01 in bottle of 100 tablets NDC 68382-178-10 in bottle of 1,000 tablets NDC 68382-178-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Galantamine Tablets USP, 12 mg (equivalent to 15.378 mg of galantamine hydrobromide) are off-white, round, biconvex, film-coated tablets debossed with '79' on one side and 'Z' on the other side and are supplied as follows: NDC 68382-179-14 in bottle of 60 tablets NDC 68382-179-01 in bottle of 100 tablets NDC 68382-179-10 in bottle of 1,000 tablets NDC 68382-179-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

GALANTAMINE - GALANTAMINE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GALANTAMINE TABLETS.
GALANTAMINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine is a cholinesterase inhibitor indicated for the treatment
of mild to moderate dementia of the
Alzheimer's type (1).
DOSAGE AND ADMINISTRATION
Galantaminetablets: 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
Tablets – 4 mg, 8 mg, 12 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)
Cholinomimetics may cause bladder outflow obstruction (5.5)
Monitor for respiratory adverse events in patients with a history of
severe asthma or obstructive
pulmonary disease (5.7)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) were nausea, vomiting,
diarrhea, dizz