"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
DOSAGE AND ADMINISTRATION
The recommended starting dose of NAMENDA is 5 mg (2.5 mL) once daily. The dose should be increased in 5 mg increments to 10 mg/day (2.5 mL twice daily), 15 mg/day (2.5 mL and 5 mL as separate doses), and 20 mg/day (5 mL 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 (5 mL twice daily).
Dosing Titration Schedule
|Total daily dose||Strength per dose (mg)|
|Starting Dose||5 mg||5mg|
|Dose after week 1||10 mg||5 mg (first daily dose)
5 mg (second daily dose)
|Dose after week 2||15 mg||5 mg (first daily dose)
10 mg (second daily dose)
|Dose after week 3||20 mg||10 mg (first daily dose)
10 mg (second daily dose)
NAMENDA can be taken with or without food. If a patient misses a single dose of NAMENDA, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take NAMENDA for several days, dosing may need to be resumed at lower doses and retitrated as described above.
Do not mix NAMENDA oral solution with any other liquid. NAMENDA is administered with a dosing device that comes with the drug and consists of a syringe, syringe adaptor cap, tubing and other supplies a patient needs to administer the drug. The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient's mouth.
A target dose of 5 mg (2.5 mL) twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockcroft-Gault equation).
NAMENDA should be administered with caution to patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
NAMENDA 2 mg/mL oral solution: clear, alcohol-free, sugar-free, and peppermint flavored.
Storage And Handling
2 mg/mL Oral Solution
12 fl. oz. (360 mL) bottle NDC #0456-3202-12
Store NAMENDA oral solution at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured for: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC St. Louis, MO 63045. Manufactured by: Forest Laboratories Ireland Ltd. Revised August 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/25/2014
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