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Namenda Indications, Dosage, Storage, Stability - Memantine

Namenda Indications, Dosage, Storage, Stability - Memantine

INDICATIONS AND USAGE

NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

DOSAGE AND ADMINISTRATION

The dosage of NAMENDA (memantine hydrochloride) shown to be effective in controlled clinical trials is 20 mg/day.

The recommended starting dose of NAMENDA is 5 mg once daily. The recommended target dose is 20 mg/day. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day). The minimum recommended interval between dose increases is one week.

NAMENDA can be taken with or without food.

Doses in Special Populations

Dose reduction in patients with moderate renal impairment should be considered. In patients with severe renal impairment the use of NAMENDA has not been systematically evaluated and is not recommended. (See Clinical Pharmacology-Pharmacokinetics)

HOW SUPPLIED

5 mg Tablet:

Bottle of 60 NDC #0456-3205-60

10 x 10 Unit Dose NDC #0456-3205-63

The capsule shaped film-coated tablets are tan, with the strength (5) debossed on one side and FL on the other.

10 mg Tablet:

Bottle of 60 NDC #0456-3210-60

10 x 10 Unit Dose NDC #0456-3210-63

The capsule shaped film-coated tablets are gray, with the strength (10) debossed on one side and FL on the other.

Titration Pak:

PVC/Aluminum Blister package containing 49 tablets. 28 x 5 mg and 21 x 10 mg tablets. NDC #0456-3200-14

The 5 mg capsule shaped film-coated tablets are tan, with the strength (5) debossed on one side and FL on the other.

The 10 mg capsule shaped film-coated tablets are gray, with the strength (10) debossed on one side and FL on the other.

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F)[see USP Controlled Room Temperature]

Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045 Licensed from Merz Pharmaceuticals GmbH, 10/03 © 2003 Forest Laboratories, Inc.

Revised Nov 05, 2003

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