NAMENDA XR memantine hydrochloride capsule extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T)

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

MEMANTINE HYDROCHLORIDE

Sudėtis:

MEMANTINE HYDROCHLORIDE 28 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

New Drug Application

Prekės savybės

NAMENDA XR - MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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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 evaluated
and such use should be approached with caution. (7.1)
USE IN SPECIFIC POPULATIONS
Pediatric Use: The saf