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Namenda XR

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Namenda XR

Namenda XR

INDICATIONS

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

Recommended Dosing

The dosage of NAMENDA XR (memantine hydrochloride extended release capsules) shown to be effective in a controlled clinical trial is 28 mg once daily.

The recommended starting dose of NAMENDA XR (memantine hydrochloride extended release capsules) 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 (memantine hydrochloride extended release capsules) can be taken with or without food. NAMENDA XR (memantine hydrochloride extended release capsules) capsules can be taken intact or may be opened, sprinkled on applesauce, and thereby swallowed. The entire contents of each NAMENDA XR (memantine hydrochloride extended release capsules) capsule should be consumed; the dose should not be divided.

Except when opened and sprinkled on applesauce, as described above, NAMENDA XR (memantine hydrochloride extended release capsules) should be swallowed whole. NAMENDA XR (memantine hydrochloride extended release capsules) capsules should not be divided, chewed, or crushed.

Switching from NAMENDA Tablets to NAMENDA XR (memantine hydrochloride extended release capsules) Capsules

Patients treated with NAMENDA tablets may be switched to NAMENDA XR (memantine hydrochloride extended release capsules) 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 (memantine hydrochloride extended release capsules) 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 (memantine hydrochloride extended release capsules) 14 mg once daily capsules the day following the last dose of a 5 mg NAMENDA tablet.

Special Populations

Hepatic Impairment

No dosage adjustment is recommended in patients with mild or moderate hepatic impairment. NAMENDA XR (memantine hydrochloride extended release capsules) should be administered with caution to patients with severe hepatic impairment.

Renal 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).

HOW SUPPLIED

Dosage Forms And Strengths

Dosage Form

Capsule

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.

Dosage Strengths
  • 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.

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# 0456-3407-63

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

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)

Storage

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. Manufactured by: Forest Laboratories Ireland Ltd. Licensed from Merz Pharmaceuticals GmbH. Issued [06.2010]

Last reviewed on RxList: 7/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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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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