GALANTAMINE- galantamine tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

West-Ward Pharmaceuticals Corp.

INN (Διεθνής Όνομα):

GALANTAMINE HYDROBROMIDE

Σύνθεση:

GALANTAMINE 4 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. 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 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, 8 mg, 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. The no-effect dose fo

Περίληψη προϊόντος:

Galantamine Tablets USP 4 mg tablet is supplied as a round, light green film coated, biconvex tablet, debossed with product identification "54” over “177" on one side and plain on the other side. NDC 0054-0090-21: Bottle of 60 Tablets 8 mg tablet is supplied as a round, light green film coated, biconvex tablet, debossed with product identification "54” over “731" on one side and plain on the other side. NDC 0054-0091-21: Bottle of 60 Tablets 12 mg tablet is supplied as a round, light green film coated, biconvex tablet, debossed with product identification "54” over “421" on one side and plain on the other side. NDC 0054-0092-21: Bottle of 60 Tablets Galantamine should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all drugs out of the reach of children.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GALANTAMINE- GALANTAMINE TABLET
WEST-WARD PHARMACEUTICALS 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
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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity to galantamine or any excipients. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥5%) were nausea, vomiting,
diarrhea, dizziness, headache and decreased appetite.
(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward
Pharmaceuticals Corp. at 1-800-962-8364 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
Warnings and Precautions, Serious Skin Reactions (5.1) 02/2015
Tablets: Recommended starting dosage is 4 mg twice daily; increase
dose 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 galantamine 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 to 59 mL/min; do not use in patients
with creatinine clearance less than 9 mL/min. (2.4)
Tablets – 4 mg, 8 mg and 12 mg (3)
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 vagot