Drug Catalog - Product Detail
Memantine HCl Cap ER 24HR 28 MG 90 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43975-0266-09 | ANI PHARMACEUTICALS | 90 | 28MG | CAPSULE |
Generic Name
Substance Name
Product Type
Route
Application Number
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 USP occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: colloidal silicon dioxide, ethylcellulose, hydroxypropyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, sugar spheres and talc, in hard gelatin capsules (containing gelatin, titanium dioxide and red iron oxide) imprinted with black ink containing black iron oxide, potassium hydroxide (14 mg and 28 mg), propylene glycol, and shellac. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Memantine hydrochloride extended-release capsules 7 mg, are flesh opaque cap and body, hard gelatin capsules, printed “7MG” on the cap and “A242” on the body and are supplied as: Bottles of 30 NDC 43975-242-03 Memantine hydrochloride extended-release capsules 14 mg, are flesh opaque cap and white opaque body, hard gelatin capsules, printed “14MG” on the cap and “A264” on the body and are supplied as: Bottles of 30 NDC 43975-264-03 Bottles of 90 NDC 43975-264-09 Memantine hydrochloride extended-release capsules 21 mg, are pink opaque cap and body, hard gelatin capsules, printed “21MG” on the cap and “A243” on the body. Bottles of 30 NDC 43975-243-03 Bottles of 90 NDC 43975-243-09 Memantine hydrochloride extended-release capsules 28 mg, are pink opaque cap and white opaque body, hard gelatin capsules, printed “28MG” on cap and “A266” on the body and are supplied as: Bottles of 30 NDC 43975-266-03 Bottles of 90 NDC 43975-266-09 Store memantine hydrochloride extended-release capsules 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]. Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
1 INDICATIONS AND USAGE Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride extended-release capsules are a 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 extended-release capsules is 7 mg once daily; the dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily; the minimum recommended interval between dose increases is one week. ( 2.1 ) • Patients with severe renal impairment: the recommended maintenance dose of memantine hydrochloride extended-release capsules is 14 mg once daily. ( 2.3 ) 2.1 Recommended Dosing The dosage of memantine hydrochloride extended-release capsules shown to be effective in a controlled clinical trial is 28 mg once daily. The recommended starting dose of memantine hydrochloride extended-release capsules is 7 mg once daily. The dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily. The minimum recommended interval between dose increases is one week. The dose should only be increased if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily. Memantine hydrochloride extended-release capsules can be taken with or without food. Memantine hydrochloride extended-release capsules can be taken intact or may be opened, sprinkled on applesauce, and thereby swallowed. The entire contents of each memantine hydrochloride extended-release capsule should be consumed; the dose should not be divided. Except when opened and sprinkled on applesauce, as described above, memantine hydrochloride extended-release capsules should be swallowed whole. Memantine hydrochloride extended-release capsules should not be divided, chewed, or crushed. If a patient misses a single dose of memantine hydrochloride extended-release capsules, 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 extended-release capsules for several days, dosing may need to be resumed at lower doses and retitrated as described above. 2.2 Switching from Memantine Hydrochloride Tablets to Memantine Hydrochloride Extended-Release Capsules Patients treated with memantine hydrochloride tablets may be switched to memantine hydrochloride extended-release capsules as follows: It is recommended that a patient who is on a regimen of 10 mg twice daily of memantine hydrochloride tablets be switched to memantine hydrochloride extended-release capsules 28 mg once daily capsules the day following the last dose of 10 mg memantine hydrochloride tablets. There is no study addressing the comparative efficacy of these 2 regimens. In a patient with severe renal impairment, it is recommended that a patient who is on a regimen of 5 mg twice daily of memantine hydrochloride tablets be switched to memantine hydrochloride extended-release capsules 14 mg once daily capsules the day following the last dose of 5 mg memantine hydrochloride tablets. 2.3 Dosing in Patients with Renal Impairment In patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min, based on the Cockcroft-Gault equation), the recommended maintenance dose (and maximum recommended dose) is 14 mg/day [see Clinical Pharmacology (12.3) ] .