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Namenda (Memantine Hydrochloride) - Indications and Dosage

 
 



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.

Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.

Doses in Special Populations

A target dose of 5 mg BID is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockroft-Gault equation):

For males: CLcr = [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

For females: CLcr = 0.85 · [140-age (years)]· Weight (kg)/[72 · serum creatinine (mg/dL)]

HOW SUPPLIED

5 mg Tablet:

Bottle of 60NDC #0456-3205-60
10 x 10 Unit DoseNDC #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 60NDC #0456-3210-60
10 x 10 Unit DoseNDC #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.

Oral Solution:

The dosage recommendations for oral solution are the same as those for tablets. The oral solution is clear, alcohol-free, sugar-free, and peppermint flavored.

2 mg/mL Oral Solution (10 mg = 5 mL)

12 fl. oz. (360 mL) bottle NDC #0456-3202-12

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
Rev. 04/07
© 2007 Forest Laboratories, Inc.

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