Drug Catalog - Product Detail
MEMANTINE HCL TB 10MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0597-05 | DR.REDDY'S LABORATORIES, INC. | 500 | 10MG | TABLET |
PACKAGE FILES
Generic Name
MEMANTINE
Substance Name
MEMANTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090048
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, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets 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: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Memantine hydrochloride tablets USP, 5 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘596’ on other side. They are supplied in bottles of 30, 60, 100, 500, unit dose package of 10 (1 x 10) and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-596-30 Bottles of 60 NDC 55111-596-60 Bottles of 100 NDC 55111-596-01 Bottles of 500 NDC 55111-596-05 Unit dose package of 10 (1 x 10) NDC 55111- 596-79 Unit dose package of 100 (10 x 10) NDC 55111-596-78 Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side. They are supplied in bottles of 30, 60, 100, 500, unit dose package of 10 (1 x 10) and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-597-30 Bottles of 60 NDC 55111-597-60 Bottles of 100 NDC 55111-597-01 Bottles of 500 NDC 55111-597-05 Unit dose package of 10 (1 x 10) NDC 55111- 597-79 Unit dose package of 100 (10 x 10) NDC 55111-597-78 Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]
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 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, 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 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 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 )