GALANTAMINE- galantamine tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Mylan Institutional Inc.

INN（国際名）:

GALANTAMINE HYDROBROMIDE

構図:

GALANTAMINE 4 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. There are no adequate and well-controlled studies 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. Galantamine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats, administration of galantamine (oral doses of 2 mg/kg/day, 8 mg/kg/day, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. Th

製品概要:

Galantamine Tablets, USP are available containing galantamine hydrobromide, USP equivalent to 4 mg or 8 mg of galantamine, respectively. The 4 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and G21 on the other side. They are available as follows: NDC 51079-852-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). The 8 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and G22 on the other side. They are available as follows: NDC 51079-853-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

認証ステータス:

Abbreviated New Drug Application

製品の特徴

GALANTAMINE- GALANTAMINE TABLET, FILM COATED
MYLAN INSTITUTIONAL 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 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 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 mL/min 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, and 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%) w