D DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.4 Pharmacokinetics in Special Populations 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology 14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
NAMENDA XR (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing 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.
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 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).
3 DOSAGE FORMS AND STRENGTHS
3.1 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.
3.2 Dosage Strengths Each 7 mg capsule contains 7 mg memantine HCl.
Each 14 mg capsule c |
