GALANTAMINE HYDROBROMIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

GALANTAMINE HYDROBROMIDE

Composition:

GALANTAMINE 8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules 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 (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unkn

Product summary:

How Supplied Galantamine hydrobromide extended-release capsules are supplied as follows: 8 mg (Size 2 white opaque/white opaque capsules imprinted ‘835’ with black ink on cap and body filled with white color capsule shaped uncoated tablet plain on both sides) Bottles of 30 with child-resistant cap.....................................................NDC 47335-835-83 Bottles of 100 with child-resistant cap...................................................NDC 47335-835-88 Bottles of 100.................................................NDC 47335-835-08 Bottles of 1000...............................................NDC 47335-835-18 16 mg (Size 2 pink opaque/pink opaque capsules imprinted ‘836’ with black ink on cap and body filled with pink color capsule shaped uncoated tablet plain on both sides) Bottles of 30 with child-resistant cap.....................................................NDC 47335-836-83 Bottles of 100 with child-resistant cap...................................................NDC 47335-836-88 Bottles of 100.................................................NDC 47335-836-08 Bottles of 1000...............................................NDC 47335-836-18 24 mg (Size 2 caramel opaque/caramel opaque capsules imprinted ‘837’ with black ink on cap and body filled with caramel color capsule shaped uncoated tablet plain on both sides) Bottles of 30 with child-resistant cap.....................................................NDC 47335-837-83 Bottles of 100 with child-resistant cap...................................................NDC 47335-837-88 Bottles of 100.................................................NDC 47335-837-08 Bottles of 1000...............................................NDC 47335-837-18 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense with a child resistant closure in a well-closed container. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GALANTAMINE HYDROBROMIDE - GALANTAMINE HYDROBROMIDE CAPSULE,
EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE
HYDROBROMIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES.
GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Galantamine hydrobromide 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 is 8 mg/day in morning; increase to
initial maintenance dose of 16
mg/day after a minimum of 4 weeks. Based on clinical benefit and
tolerability, dosage may be
increased to 24 mg/day after a minimum of 4 weeks at 16 mg/day. (2.1)
Take with food; 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)
Conversion from galantamine tablets to galantamine hydrobromide
extended-release capsules should
occur at the same daily dosage with the last dose of galantamine
tablets taken in evening and starting
galantamine hydrobromide extended-release capsules once daily
treatment the next morning. (2.5)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 8 mg, 16 mg, 24 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
atrioventricula