"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 XR (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
DOSAGE AND ADMINISTRATION
The dosage of NAMENDA XR shown to be effective in a controlled clinical trial is 28 mg once daily.
The recommended starting dose of NAMENDA XR 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.
NAMENDA XR can be taken with or without food. NAMENDA XR capsules can be taken intact or may be opened, sprinkled on applesauce, and thereby swallowed. The entire contents of each NAMENDA XR capsule should be consumed; the dose should not be divided.
Except when opened and sprinkled on applesauce, as described above, NAMENDA XR should be swallowed whole. NAMENDA XR capsules should not be divided, chewed, or crushed.
If a patient misses a single dose of NAMENDA XR, 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 XR for several days, dosing may need to be resumed at lower doses and retitrated as described above.
Switching From NAMENDA To NAMENDA XR Capsules
Patients treated with NAMENDA may be switched to NAMENDA XR capsules as follows:
It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA be switched to NAMENDA XR 28 mg once daily capsules the day following the last dose of 10 mg NAMENDA. 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 NAMENDA be switched to NAMENDA XR 14 mg once daily capsules the day following the last dose of 5 mg NAMENDA.
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].
Dosage Forms And Strengths
Each capsule contains 7 mg, 14 mg, 21 mg, or 28 mg of memantine HCl.
- The 7 mg capsules are a yellow opaque capsule, with “FLI 7 mg” black imprint.
- The 14 mg capsules are a yellow cap and dark green opaque body capsule, with “FLI 14 mg” black imprint on the yellow cap.
- The 21 mg capsules are a white to off-white cap and dark green opaque body capsule, with “FLI 21 mg” black imprint on the white to off-white cap.
- The 28 mg capsules are a dark green opaque capsule, with “FLI 28 mg” white imprint.
Storage And Handling
7 mg Capsule
Yellow opaque capsule, with “FLI 7 mg” black imprint.
Bottle of 30: NDC# 0456-3407-33
14 mg Capsule
Yellow cap and dark green opaque capsule with “FLI 14 mg” black imprint on the yellow cap.
Bottle of 30: NDC# 0456-3414-33
Bottle of 90: NDC# 0456-3414-90
10 x 10 Unit Dose: NDC# 0456-3414-63
21 mg Capsule
White to off-white cap and dark green opaque capsule, with “FLI 21 mg” black imprint on the white to off-white cap.
Bottle of 30: NDC# 0456-3421-33
28 mg Capsule
Dark green opaque capsule, with “FLI 28 mg” white imprint.
Bottle of 30: NDC# 0456-3428-33
Bottle of 90: NDC# 0456-3428-90
10 x 10 Unit Dose: NDC# 0456-3428-63
NDC# 0456-3400-29 Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg)
Store 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: 9/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/14/2014
Additional Namenda XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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