HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

GALANTAMINE HYDROBROMIDE

Composition:

GALANTAMINE 8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine 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 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% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats,

Product summary:

How Supplied Galantamine extended-release capsules, USP contain white to off-white matrix tablets. 8 mg white opaque cap and body, size 1 hard gelatin capsules with inscription “WPI 3496” 16 mg pink opaque cap and white opaque body, size 1 hard gelatin capsules with the inscription “WPI 3497” 24 mg pink opaque cap and body, size 1 hard gelatin capsules with the inscription “WPI 3498” The capsules are supplied as follows: 8 mg capsules – bottles of 30 NDC 0591-3496-30 16 mg capsules – bottles of 30 NDC 0591-3497-30 24 mg capsules – bottles of 30 NDC 0591-3498-30 Storage and Handling Galantamine Extended-release Capsules, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GALANTAMINE- GALANTAMINE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GALANTAMINE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
GALANTAMINE EXTENDED-RELEASE CAPSULES.
GALANTAMINE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 8/2021
INDICATIONS AND USAGE
Galantamine extended-release capsules are a cholinesterase inhibitor
indicated for the treatment of mild
to moderate dementia of the Alzheimer’s type (1)
DOSAGE AND ADMINISTRATION
Galantamine extended-release capsules: 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).
Conversion from galantamine tablets to galantamine extended-release
capsules should occur at the
same daily dosage with the last dose of galantamine tablets taken in
evening and starting galantamine
extended-release capsules once daily treatment the next morning (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 (2.3).
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
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
atrio