MEMANTINE HYDROCHLORIDE capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Sun Pharmaceutical Industries, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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% and 15% to 20%,

Резиме производа:

7 mg capsule: Size #4 hard gelatin capsules, yellow colored cap and body with “031” imprinted in black ink on cap and body containing white to off white pellets. Bottles of 30’s with Child Resistant Cap…………....……...........................            NDC 47335-031-83 Bottles of 90’s with Child Resistant Cap.......................................................         NDC 47335-031-81 Bottles of 1000’s .................................................…….…...........................            NDC 47335-031-18 14 mg capsule: Size #4 hard gelatin capsules, yellow colored cap and dark green colored body with “032” imprinted in black ink on cap and body containing white to off white pellets. Bottles of 30's with Child Resistant Cap..................................…………..   NDC 47335-032-83 Bottles of 90's with Child Resistant Cap..................................………..…   NDC 47335-032-81 Bottles of 1000's ....................................................................….….........   NDC 47335-032-18 21 mg capsule: Size #3 hard gelatin capsules, white to off white colored cap and dark green colored body with “033” imprinted in black ink on cap and body containing white to off white pellets. Bottles of 30's with Child Resistant Cap.............................………………..            NDC 47335-033-83 Bottles of 90's with Child Resistant Cap………………...............................            NDC 47335-033-81 Bottles of 1000's ..............................................……….…...........................           NDC 47335-033-18 28 mg capsule: Size #2 hard gelatin capsules, dark green colored cap and body with “034” imprinted in black ink on cap and body containing white to off white pellets. Bottles of 30’s with Child Resistant Cap………………....................…..   NDC 47335-034-83 Bottles of 90’s with Child Resistant Cap………………......................…   NDC 47335-034-81 Bottles of 1000’s ..............................................……....................….….   NDC 47335-034-18 Store memantine hydrochloride extended-release capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep this and all medicines out of reach of children.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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, 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 are available as
extended-release capsule 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 REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT 1-800-818-4555
OR FDA A