GALANTAMINE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

McKesson Corporation dba SKY Packaging

INN (Tên quốc tế):

GALANTAMINE HYDROBROMIDE

Thành phần:

GALANTAMINE 8 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Teratogenic Effects Pregnancy Category C: 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 hydrobromide 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, 8, 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

Tóm tắt sản phẩm:

Product: 63739-708 NDC: 63739-708-33 10 TABLET, FILM COATED in a BLISTER PACK / 3 in a BOX, UNIT-DOSE Product: 63739-999 NDC: 63739-999-33 10 TABLET, FILM COATED in a BLISTER PACK / 3 in a BOX, UNIT-DOSE

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

GALANTAMINE - GALANTAMINE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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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 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, vomiti