GALANTAMINE HYDROBROMIDE 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:

Yabao Pharmaceutical Co., Ltd. Beijing

INN (International Name):

galantamine hydrobromide

Composition:

galantamine 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Galantamine Hydrobromide Tablets, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine hydrobromide tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or 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 hydrobromide 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, 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 ske

Product summary:

Galantamine hydrobromide tablets, USP are supplied as follows: 4 mg white color coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side: bottles of 60 NDC 51990-111-04, bottles of 100 NDC 51990-111-02, bottles of 1000 NDC 51990-111-03. 8 mg purple color coated, round, biconvex tablet, debossed “YB” on one side and “112” on the other side: bottles of 60 NDC 51990-112-04, bottles of 100 NDC 51990-112-02, bottles of 1000 NDC 51990-112-03. 12 mg peach color coated, round, biconvex tablet, debossed “YB” on one side and “113” on the other side: bottles of 60 NDC 51990-113-04, bottles of 100 NDC 51990-113-02, bottles of 1000 NDC 51990-113-03. Galantamine hydrobromide tablets, USP should be stored at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

GALANTAMINE HYDROBROMIDE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED
YABAO PHARMACEUTICAL CO., LTD. BEIJING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE
HYDROBROMIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
GALANTAMINE HYDROBROMIDE TABLETS, USP.
GALANTAMINE HYDROBROMIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine hydrobromide tablets, USP is a cholinesterase inhibitor
indicated for the treatment of mild to moderate
dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
Recommended starting dosage for galantamine hydrobromide tablets 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. (2.1)
Take with meals; ensure adequate fluid intake during treatment (2.1)
Hepatic impairment: should not exceed 16 mg/day for moderate hepatic
impairment; do not use in patients with severe
hepatic impairment (2.2)
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 (2.3)
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 pulmo