GALANTAMINE- galantamine hydrobromide tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Apotex Corp.

Designació comuna internacional (DCI):

GALANTAMINE HYDROBROMIDE

Composición:

GALANTAMINE 4 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Galantamine tablets 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 hydrobromide 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

Resumen del producto:

Galantamine tablets, USP 4 mg are available for oral administration as white to off-white, round film-coated tablets, engraved "G4" on one side and "APO" on the other side. They are supplied as bottles of 30 (NDC 60505-2542-3), bottles of 60 (NDC 60505-2542-6), unit dose blisters of 100 (NDC 60505-2542-0) and bottles of 1,000 (NDC 60505-2542-8). Galantamine tablets, USP 8 mg are available for oral administration as pink round film-coated tablets, engraved "G8" on one side and "APO" on the other side. They are supplied as bottles of 30 (NDC 60505-2543-3), bottles of 60 (NDC 60505-2543-6), unit dose blisters of 100 (NDC 60505-2543-0) and bottles of 1,000 (NDC 60505-2543-8). Galantamine tablets, USP 12 mg are available for oral administration as orange, round film-coated tablets, engraved "G12" on one side and "APO" on the other side. They are supplied as bottles of 30 (NDC 60505-2544-3), bottles of 60 (NDC 60505-2544-6), unit dose blisters of 100 (NDC 60505-2544-0) and bottles of 1,000 (NDC 60505-2544-8). Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

GALANTAMINE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED
APOTEX CORP.
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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
RECENT MAJOR CHANGES
Warnings and Precautions (5.6)
INDICATIONS AND USAGE
Galantamine tablets are a cholinesterase inhibitor indicated for the
treatment of mild to moderate
dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
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 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 food; 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 r