Drug Catalog - Product Detail
MEMANTINE HCL TAB 10MG 60CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47335-0322-86 | SUN PHARMACEUTICALS | 60 | 10MG | TABLET |
PACKAGE FILES
Generic Name
MEMANTINE HYDROCHLORIDE
Substance Name
MEMANTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090058
Description
11 DESCRIPTION Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride tablets, USP are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, talc, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide red, yellow iron oxide, and FD&C yellow #6 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol, talc and black iron oxide (10 mg tablets). spl-memantine-chemical-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg Tablets: Orange, capsule-shaped, film-coated tablets, debossed with "321" on one side and plain on the other side. Bottles of 60’s with Child Resistant Cap ………… NDC 47335-321-86 Bottles of 100’s with Child Resistant Cap ……….. NDC 47335-321-88 Bottles of 100’s with Non Child Resistant Cap ….. NDC 47335-321-08 Bottles of 1000’s with Non Child Resistant Cap .... NDC 47335-321-18 10 mg Tablets: Gray, capsule-shaped, film-coated tablets, debossed with "322" on one side and plain on the other side. Bottles of 30’s with Child Resistant Cap ………… NDC 47335-322-83 Bottles of 60’s with Child Resistant Cap ………… NDC 47335-322-86 Bottles of 100’s with Child Resistant Cap ……….. NDC 47335-322-88 Bottles of 100’s with Non Child Resistant Cap ….. NDC 47335-322-08 Bottles of 500’s with Non Child Resistant Cap ….. NDC 47335-322-13 Bottles of 1000’s with Non Child Resistant Cap .... NDC 47335-322-18 Store memantine hydrochloride tablets, USP 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 in a tightly closed container as described in the USP.
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride tablets are 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day. Memantine hydrochloride tablets can be taken with or without food. If a patient misses a single dose of memantine hydrochloride tablets, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride tablets for several days, dosing may need to be resumed at lower doses and retitrated as described above. Specific Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 to 29 mL/min based on the Cockroft-Gault equation). Hepatic Impairment Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology ( 12.3 )]. May be taken with or without food ( 2 ) Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg twice daily. A minimum of 1 week of treatment with the previous dose should be observed before increasing the dose. ( 2 ) Severe renal impairment: recommended dose is 5 mg twice daily. ( 2 )