Namenda XR

NAMENDA XR- memantine hydrochloride capsule, extended release
NAMENDA XR- memantine hydrochloride
Allergan, Inc.

1 INDICATIONS AND USAGE

NAMENDA XR® is 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 dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily. The minimum recommended interval between dose increases is one week. The dose should only be increased 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.

If a patient misses a single dose of NAMENDA XR, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take NAMENDA XR for several days, dosing may need to be resumed at lower doses and retitrated as described above.

2.2 Switching from NAMENDA to NAMENDA XR Capsules

Patients treated with NAMENDA 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 be switched to NAMENDA XR 28 mg once daily capsules the day following the last dose of 10 mg NAMENDA. 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 be switched to NAMENDA XR 14 mg once daily capsules the day following the last dose of 5 mg NAMENDA.

2.3 Dosing in Patients with Renal Impairment

In patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min, based on the Cockcroft-Gault equation), the recommended maintenance dose (and maximum recommended dose) is 14 mg/day [see Clinical Pharmacology ( 12.3)].

3 DOSAGE FORMS AND STRENGTHS

Each capsule contains 7 mg, 14 mg, 21 mg, or 28 mg of memantine hydrochloride.

  • The 7 mg capsules are a yellow opaque capsule, with “FLI 7 mg” black imprint.
  • The 14 mg capsules are a yellow cap and dark green opaque body 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 capsule, with “FLI 21 mg” black imprint on the white to off-white cap.
  • The 28 mg capsules are a dark green opaque capsule, with “FLI 28 mg” white imprint.

4 CONTRAINDICATIONS

NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

5 WARNINGS AND PRECAUTIONS

5.1 Genitourinary Conditions

Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1)].

6 ADVERSE REACTIONS

6.1 Clinical Trial s Experience

NAMENDA XR was evaluated in a double-blind placebo-controlled trial in which a total of 676 patients with moderate to severe dementia of the Alzheimer’s type (341 patients on NAMENDA XR 28 mg/day and 335 patients on placebo) were treated for up to 24 weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions Leading to Discontinuation

In the placebo-controlled clinical trial of NAMENDA XR, the proportion of patients in the NAMENDA XR group and the placebo group who discontinued treatment due to adverse reactions was 10% and 6%, respectively. The most common adverse reaction that led to treatment discontinuation in the NAMENDA XR group was dizziness, at a rate of 1.5%.

Most Common Adverse Reactions

The most commonly observed adverse reactions seen in patients administered NAMENDA XR in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a frequency higher than placebo, were headache, diarrhea and dizziness.

Table 1 lists adverse reactions that were observed at an incidence of ≥ 2% in the NAMENDA XR group and occurred at a rate greater than placebo.

Table 1: Adverse Reactions Observed with a Frequency of ≥ 2% in the NAMENDA XR Group and at a Rate Greater than Placebo
Adverse R eaction Placebo (n=335) % NAMENDA XR 28 mg (n=341) %
Gastrointestinal Disorders
Diarrhea 4 5
Constipation 1 3
Abdominal pain 1 2
Vomiting 1 2
Infections and I nfestations
Influenza 3 4
Investigations
Weight, increased 1 3
Musculoskeletal and C onnective T issue D isorders
Back pain 1 3
Nervous S ystem D isorders
Headache 5 6
Dizziness 1 5
Somnolence 1 3
Psychiatric D isorders
Anxiety 3 4
Depression 1 3
Aggression 1 2
Renal and U rinary D isorders
Urinary incontinence 1 2
Vascular D isorders
Hypertension 2 4
Hypotension 1 2

Seizure

Memantine has not been systematically evaluated in patients with a seizure disorder. In clinical trials of memantine, seizures occurred in 0.3% of patients treated with memantine and 0.6% of patients treated with placebo.

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