HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NAMENDA XR capsules safely and effectively. See full prescribing information for NAMENDA XR capsules.
NAMENDA XR ® (memantine hydrochloride) extended release capsules
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
NAMENDA XR contains memantine HCl, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1)
DOSAGE AND ADMINISTRATION
Initial Dose                   7 mg NAMENDA XR once daily (2.1)
Maintenance Dose      28 mg NAMENDA XR once daily (2.1)
A minimum of 1 week of treatment with the previous dose should be observed before increasing the dose. (2.1)
A target dose of 14 mg once daily is recommended in patients with severe renal impairment. (2.1)
DOSAGE FORMS AND STRENGTHS
NAMENDA XR is available as an extended-release capsule (3.1) in the following strengths: 7 mg, 14 mg, 21 mg, 28 mg (3.1, 3.2)
CONTRAINDICATIONS
NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. (4.1)
WARNINGS AND PRECAUTIONS
Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine. (5.1)
ADVERSE REACTIONS
The most commonly observed adverse reactions occurring at a frequency of at least 5% and greater than placebo with administration of NAMENDA XR 28 mg/day were headache, diarrhea and dizziness. Other less common and sometimes serious adverse events have been reported. (6)
To report SUSPECTED ADVERSE REACTIONS, Contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically eva luated and such use should be approached with caution. (7.1)
USE IN SPECIFIC POPULATIONS
Pediatric Use: The safety and effectiveness of NAMENDA XR in pediatric patients have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing 3 DOSAGE FORMS AND STRENGTHS
3.1 Dosage Form 3.2 Dosage Strengths 4 CONTRAINDICATIONS
4.1 Hypersensitivity 5 WARNINGS AND PRECAUTIONS
5.1 Genitourinary Conditions 5.2 Seizures 6 ADVERSE REACTIONS
6.1 Clinical Trial Data Sources 6.2 Adverse Reactions Leading to Discontinuation 6.3 Most Common Adverse Reactions 6.4 Vital Sign Changes 6.5 Laboratory Changes 6.6 ECG Changes 6.7 Other Adverse Reactions Observed During Clinical Trials of NAMENDA XR 6.8 Memantine Immediate Release Clinical Trial and Post Marketing Spontaneous Reports 7 DRUG INTERACTIONS
7.1 Use with other N-methyl-D-aspartate (NMDA) Antagonists 7.2 Effect of Memantine on the Metabolism of Other Drugs 7.3 Effect of Other Drugs on Memantine 7.4 Drugs Eliminated via Renal Mechanisms 7.5 Drugs That Make the Urine Alkaline 7.6 Drugs Highly Bound to Plasma Proteins 7.7 Use with Cholinesterase Inhibitors 8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 9 DRUG ABUSE AN