Drug Catalog - Product Detail
MEMANTINE HCL 5MG TB 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 72606-0514-02 | CELLTRION USA | 60 | 5MG | TABLET |
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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 is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified 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, triacetin, FD&C Yellow #6 and FD&C Blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets). structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg Tablets : Orange, film-coated, capsule shaped tablets debossed with ‘W121’ on one side and other side plain. Bottle of 30 tablets with child-resistant closure, NDC 72606-514-01 Bottle of 60 tablets with child-resistant closure, NDC 72606-514-02 Bottle of 500 tablets, NDC 72606-514-04 12 x 24 Unit dose NDC 72606-514-05 10 mg Tablets : Grey, film-coated, capsules shaped tablets debossed with ‘W122’ on one side and other side plain. Bottle of 30 tablets with child-resistant closure, NDC 72606-515-01 Bottle of 60 tablets with child-resistant closure, NDC 72606-515-02 Bottle of 500 tablets, NDC 72606-515-04 12 x 24 Unit dose NDC 72606-515-05 Titration Pack : The 5 mg capsule shaped, film-coated tablets are orange in color, with ‘W121’ debossed on one side and other side plain. The 10 mg capsule shaped, film coated tablets are grey in color, with ‘W122’ debossed on one side and other side plain. PVC/Aluminum Blister Package containing 49 tablets. 28 x 5 mg tablets and 21 x 10 mg tablets NDC 72606-516-01 Store memantine hydrochloride tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride 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 AND ADMINISTRATION The recommended starting dose of memantine hydrochloride tablets, USP 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, USP can be taken with or without food. If a patient misses a single dose of memantine hydrochloride tablets, USP, 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, USP 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 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 )