GALANTAMINE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Slate Run Pharmaceuticals, LLC

INN (International Name):

GALANTAMINE HYDROBROMIDE

Sammensætning:

GALANTAMINE 4 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 ga

Produkt oversigt:

How Supplied Galantamine Tablets USP are supplied as follows: 4 mg white color film coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side. Bottle of 60 (NDC 70436-004-06) 8 mg purple color film coated, round, biconvex tablet, debossed “YB” on one side and “112” on the other side. Bottle of 60 (NDC 70436-005-06) 12 mg peach color film coated, round, biconvex tablet, debossed “YB” on one side and “113” on the other side. Bottle of 60 (NDC 70436-006-06) Storage and Handling Galantamine Tablets USP 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

GALANTAMINE- GALANTAMINE TABLET, FILM COATED
SLATE RUN PHARMACEUTICALS, LLC
----------
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) 8/2021
INDICATIONS AND USAGE
Galantamine Tables 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 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
T