NAMENDA XR- memantine hydrochloride capsule, extended release NAMENDA XR- memantine hydrochloride capsule, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Carilion Materials Management

INN (International namn):

MEMANTINE HYDROCHLORIDE

Sammansättning:

MEMANTINE HYDROCHLORIDE 14 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

NAMENDA XR (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Pregnancy Category B There are no adequate and well-controlled studies of memantine in pregnant women. NAMENDA XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 6 and 21 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). Slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginnin

Produktsammanfattning:

Product: 68151-5755 NDC: 68151-5755-8 1 CAPSULE, EXTENDED RELEASE in a CUP Product: 68151-5829 NDC: 68151-5829-8 1 CAPSULE, EXTENDED RELEASE in a BOTTLE

Bemyndigande status:

New Drug Application

Produktens egenskaper

NAMENDA XR- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
----------
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, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
NAMENDA XR is an NMDA receptor antagonist indicated for the treatment
of moderate to severe dementia of the
Alzheimer's type (1)
DOSAGE AND ADMINISTRATION
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 (2.1)
Patients with severe renal impairment: the recommended maintenance
dose of NAMENDA XR is 14 mg once daily
(2.3)
DOSAGE FORMS AND STRENGTHS
NAMENDA XR is available as an extended-release capsule in the
following strengths: 7 mg, 14 mg, 21 mg, 28 mg (3)
CONTRAINDICATIONS
NAMENDA XR is contraindicated in patients with known hypersensitivity
to memantine hydrochloride or to any excipients
used in the formulation (4)
WARNINGS AND PRECAUTIONS
Conditions that raise urine pH may decrease the urinary elimination of
memantine resulting in increased plasma levels of
memantine (5.1, 7.1)
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 (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-433-8871 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Switching from NAMENDA to NAMENDA XR Capsules
2.3 Dosing in Patients with Rena