Namenda Xr
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
NAMENDA XR (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
History
There is currently no drug history available for this drug.
Other Information
NAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:
The molecular formula is C12H21N•HCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water.
NAMENDA XR capsules are supplied for oral administration as 7, 14, 21 and 28 mg capsules (see How Supplied Section 16). Each capsule contains extended release beads with the labeled amount of memantine HCl and the following inactive ingredients: sugar spheres, polyvinylpyrrolidone, hypromellose, talc, polyethylene glycol, ethylcellulose, ammonium hydroxide, oleic acid, and medium chain triglycerides in hard gelatin capsules.
Sources
Namenda Xr Manufacturers
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Forest Laboratories, Inc.
![Namenda Xr (Memantine Hydrochloride) Capsule, Extended Release Namenda Xr (Memantine Hydrochloride) Kit [Forest Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Namenda Xr | Forest Laboratories, Inc.
2.1 Recommended DosingThe 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.
Special Populations:
Hepatic Impairment
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.
Renal ImpairmentNo 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).
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