RVP

Drug Catalog - Product Detail

MEMANTINE HCL 10MG TB 60

NDC Mfr Size Str Form
29300-0172-16 UNICHEM PHARMACEUTICALS 60 10MG TABLET
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Generic Name
MEMANTINE HYDROCHLORIDE
Substance Name
MEMANTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA200022
Description
11 DESCRIPTION Memantine hydrochloride, USP 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 HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets, USP are available for oral administration as round-shaped, film-coated tablets containing 5 mg of memantine hydrochloride and as capsule-shaped, film-coated tablets containing 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, povidone, crospovidone and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coating: hypromellose, titanium dioxide and polyethylene glycol 4000. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Memantine hydrochloride tablets, USP are supplied as: 5 mg Tablet: Off white, round-shaped, biconvex, film-coated tablets with '171' debossed on one side and 'U' on the other side. Bottle of 60 NDC 29300-171-16 Bottle of 500 NDC 29300-171-05 10 mg Tablet: Off white, capsule-shaped, biconvex, film-coated tablets with '172' debossed on one side and 'U' on the other side. Bottle of 60 NDC 29300-172-16 Bottle of 500 NDC 29300-172-05 Store memantine hydrochloride tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride tablets are an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 ) Memantine hydrochloride tablets are 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 tablets for several days, dosing may need to be resumed at lower doses and retitrated as described above. Special Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 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 )] .