Drug Catalog - Product Detail
GALANTAMINE HBR ER 8MG 30CT CAPS
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47335-0835-83 | SUN PHARMACEUTICALS | 30 | 8MG | CAPSULE |
PACKAGE FILES
Generic Name
GALANTAMINE HYDROBROMIDE
Substance Name
GALANTAMINE HYDROBROMIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090178
Description
11 DESCRIPTION Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4a S ,6 R ,8a S )- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6 H -benzofuro [3a,3,2- ef ][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C 17 H 21 NO 3 •HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is: Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. galantamine-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
Indications & Usage
1 INDICATIONS AND USAGE Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )
Dosage and Administration
2 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) 2.1 Recommended Dosage and Administration Administer galantamine hydrobromide extended-release capsules once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. The recommended starting dosage of galantamine hydrobromide extended-release capsules is 8 mg/day. Increase to the initial maintenance dosage of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day may be attempted after a minimum of 4 weeks at 16 mg/day. Increase dosage based upon assessment of clinical benefit and tolerability of the previous dosage. The dosage of galantamine hydrobromide extended-release capsules shown to be effective in a controlled clinical trial is 16 to 24 mg/day. 2.2 Dosage in Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9), the dosage should generally not exceed 16 mg/day. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment (Child-Pugh score of 10 to 15) is not recommended [see Clinical Pharmacology (12.3)]. 2.3 Dosage in Patients with Renal Impairment In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of galantamine hydrobromide extended-release capsules is not recommended [see Clinical Pharmacology (12.3)]. 2.4 Treatment Interruption If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose. The abrupt withdrawal of galantamine hydrobromide extended-release capsules in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug. 2.5 Switching to Galantamine Hydrobromide Extended-release Capsules from Galantamine Tablets Patients currently being treated with galantamine tablets can convert to galantamine hydrobromide extended-release capsules by taking their last dose of galantamine tablets in the evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. Converting from galantamine tablets to galantamine hydrobromide extended-release capsules should occur at the same total daily dosage.