MEMANTINE HYDROCHLORIDE capsule, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Golden State Medical Supply, Inc.

INN（国际名称）:

MEMANTINE HYDROCHLORIDE

组成:

MEMANTINE HYDROCHLORIDE 7 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride extended-release capsules are 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 to 4%

產品總結:

The 7 mg, capsule is available as a Size 4CS hard gelatin capsule with a yellow opaque cap and yellow opaque body, imprinted with “par” on the cap and “C346” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30.……..…NDC# 51407-054-30 The 14 mg, capsule is available as a Size 4CS hard gelatin capsule with a green opaque cap and yellow opaque body, imprinted with “par” on the cap and “C347” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30.………..NDC# 51407-055-30 Bottle of 90.………..NDC# 51407-055-90 The 21 mg, capsule is available as a Size 3CS hard gelatin capsule with a green opaque cap and white opaque body, imprinted with “par” on the cap and “C348” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30………...NDC# 51407-056-30 The 28 mg, capsule is available as a Size 2CS hard gelatin capsule with green opaque cap and green opaque body, imprinted with “par” on the cap and “C349” on the body in black ink, containing white to off-white spherical-shaped film-coated pellets. Bottle of 30………...NDC# 51407-057-30 Bottle of 90…….......NDC# 51407-057-90 Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature]

授权状态:

Abbreviated New Drug Application

产品特点

MEMANTINE HYDROCHLORIDE- MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. 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 are
N-methyl-D-aspartate (NMDA) receptor
antagonist indicated for the treatment of moderate to severe dementia
of the Alzheimer’s type (1) (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 are available as an
extended-release capsules in the
following strengths: 7 mg, 14 mg, 21 mg, 28 mg ( 3)
CONTRAINDICATIONS
Memantine hydrochloride extended-release capsules are 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 R