GALANTAMINE- galantamine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

GALANTAMINE HYDROBROMIDE

Composition:

GALANTAMINE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Galantamine Tablets, USP are available containing galantamine hydrobromide, USP equivalent to 4 mg, 8 mg, or 12 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 0378-2721-91 bottles of 60 tablets 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 0378-2722-91 bottles of 60 tablets The 12 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and G23 on the other side. They are available as follows: NDC 0378-2723-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GALANTAMINE- GALANTAMINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity to galantamine hydrobromide 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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2017
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)
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 an