Drug Catalog - Product Detail
MEMANTINE HCL TB 5MG 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0229-07 | LUPIN PHARMACEUTICALS | 60 | 5MG | TABLET |
PACKAGE FILES
Generic Name
MEMANTINE HYDROCHLORIDE
Substance Name
MEMANTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090051
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 are available for oral administration as capsule-shaped, biconvex, film-coated tablets, containing memantine hydrochloride 5 mg and 10 mg. The tablets also contain the following inactive ingredients: croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6/Sunset Yellow FCF Aluminium Lake and FD&C Blue No. 2/Indigo Carmine Aluminium Lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol and iron oxide black (10 mg tablets). Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg Tablets : Tan coloured, capsule shaped, biconvex, film-coated tablets, debossed with 'LU on one side and 'W01' on the other side. Bottle of 60 NDC #68180-229-07 10 x 10 Unit Dose NDC #68180-229-13 10 mg Tablets : Grey coloured, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'W02' on the other side. Bottle of 60 NDC #68180-230-07 10 x 10 Unit Dose NDC #68180-230-13 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight containers.
Indications & Usage
1 INDICATIONS AND USAGE 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 ) Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 ) The recommended starting dose of memantine hydrochloride tablet is 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 tablet 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 Cockcroft-Gault equation). Hepatic Impairment Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY ( 12.3 )] .