Drug Catalog - Product Detail
MEMANTINE HCL 10MG TAB 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 33342-0298-15 | MACLEODS PHARMACEUTICALS | 500 | 10MG | TABLET |
PACKAGE FILES
Generic Name
MEMANTINE HYDROCHLORIDE
Substance Name
MEMANTINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202840
Description
11 DESCRIPTION Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 USP is 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/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets). figure1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Memantine hydrochloride tablet USP, 5 mg: Peach color, capsule shape, film-coated tablet, debossed with “CL27” on one side and plain on the other side. Bottle of 60 NDC # 33342-297-09 Bottle of 500 NDC # 33342-297-15 Carton of 100 (10 x 10 unit dose) NDC # 33342-297-12 Memantine hydrochloride tablet USP, 10 mg: Gray color, capsule shape, film-coated tablet, debossed with “CL28” on one side and plain on the other side. Bottle of 60 NDC # 33342-298-09 Bottle of 500 NDC # 33342-298-15 Carton of 100 (10 x 10 unit dose) NDC # 33342-298-12 Store memantine hydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Prevent from light and moisture.Preserve in tight containers.
Indications & Usage
1 INDICATIONS & USAGE Memantine hydrochloride USP is 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 & 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 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 – 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 )