MEMANTINE HYDROCHLORIDE capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Xiamen LP Pharmaceutical Co., Ltd.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation . Risk  Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women.  Adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules  [see  Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and

Produkt oppsummering:

7 mg Capsule Opaque light green cap and opaque white body capsule, with “LPM” black imprint on the cap and “7 mg” black imprint on the body. Bottle of 30:       NDC# 71034-007-30 14  mg  Capsule Opaque blue cap and opaque white body capsule, with “LPM” black imprint on the cap and “14 mg” black imprint on the body. Bottle of 30:       NDC# 71034-008-30 28  mg  Capsule Opaque rich yellow cap and opaque white body capsule, with “LPM” black imprint on the cap and “28 mg” black imprint on the body. Bottle of 30:       NDC# 71034-009-30 Store memantine hydrochloride extended-release capsules at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
XIAMEN LP PHARMACEUTICAL CO., LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMANTINE
HYDROCHLORIDE EXTENDED RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR MEMANTINE HYDROCHLORIDE EXTENDED RELEASE CAPSULES.
MEMANTINE HYDROCHLORIDE EXTENDED RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules is a
N-methyl-D-aspartate (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 memantine hydrochloride
extended-release capsules 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 memantine
hydrochloride extended-release capsules is 14 mg once daily. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Memantine hydrochloride extended-release capsules is available as an
extended-release capsule in the
following strengths: 7 mg, 14 mg, 28 mg ( 3)
CONTRAINDICATIONS
Memantine hydrochloride extended-release capsules 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 memantine hydrochloride
extended-release capsules 28 mg/day were
headache, diarrhea and dizziness. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT XIAMEN LP
PHARMACEUTICAL CO., LTD. AT
1