"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 recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week, and only 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.
Switching from NAMENDA Tablets to NAMENDA XR Capsules
Patients treated with NAMENDA tablets 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 tablets be switched to NAMENDA XR 28 mg once daily capsules the day following the last dose of a 10 mg NAMENDA tablet. 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 tablets be switched to NAMENDA XR 14 mg once daily capsules the day following the last dose of a 5 mg NAMENDA tablet.
No dosage adjustment is recommended in patients with mild or moderate hepatic impairment. NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
No dosage adjustment is recommended in patients with mild or moderate renal impairment.
A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min, based on the Cockroft-Gault equation).
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 #4 size capsule, with “FLI 7 mg” black imprint.
The 14 mg capsules are a yellow cap and dark green opaque body #4 size 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 #4 size capsule, with “FLI 21 mg” black imprint on the white to off-white cap.
The 28 mg capsules are a dark green opaque #3 size capsule, with “FLI 28 mg” white imprint.
- Each 7 mg capsule contains 7 mg memantine HCl.
- Each 14 mg capsule contains 14 mg memantine HCl.
- Each 21 mg capsule contains 21 mg memantine HCl.
- Each 28 mg capsule contains 28 mg memantine HCl.
For a full list of excipients, see DESCRIPTION.
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# 0456-3428-9010 x 10
Unit Dose: NDC# 0456-3428-63
Titration Pack: 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, Inc. St. Louis, MO 63045. Manufactured by: Forest Laboratories Ireland Ltd
Last reviewed on RxList: 7/21/2014
This monograph has been modified to include the generic and brand name in many instances.
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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