MEMANTINE HYDROCHLORIDE capsule, extended release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Zydus Lifesciences Limited

INN (국제 이름):

MEMANTINE HYDROCHLORIDE

구성:

MEMANTINE HYDROCHLORIDE 7 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Memantine hydrochloride extended-release capsules, 7 mg are white to off-white pellets filled in size '4' hard gelatin capsules with white opaque cap imprinted with '546' in black ink and white opaque body and are supplied as follows: NDC 70771-1321-3 in bottle of 30 capsules NDC 70771-1321-9 in bottle of 90 capsules NDC 70771-1321-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 14 mg are white to off-white pellets filled in size '4' hard gelatin capsules with light blue opaque cap imprinted with '547' in black ink and green opaque body and are supplied as follows: NDC 70771-1322-3 in bottle of 30 capsules NDC70771-1322-9 in bottle of 90 capsules NDC 70771-1322-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 21 mg are white to off-white pellets filled in size '4' hard gelatin capsules with white opaque cap imprinted with '548' in black ink and green opaque body and are supplied as follows: NDC 70771-1323-3 in bottle of 30 capsules NDC 70771-1323-9 in bottle of 90 capsules NDC 70771-1323-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Memantine hydrochloride extended-release capsules, 28 mg are white to off-white pellets filled in size '3' hard gelatin capsules with light green opaque cap imprinted with '549' in black ink and light green opaque body and are supplied as follows: NDC 70771-1324-3 in bottle of 30 capsules NDC 70771-1324-9 in bottle of 90 capsules NDC 70771-1324-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tightly closed container.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MEMANTINE HYDROCHLORIDE - MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Memantine Hydrochloride Extended-release Capsules, 7 mg
NDC 70771-1321-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 14 mg
70771-1322-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 21 mg
NDC 70771-1323-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 28 mg
NDC 70771-1324-3
30 Counts
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1321
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE -
UNII:W8O17SJF3T)
MEMANTINE
HYDROCHLORIDE
7 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
AMMONIA (UNII: 5138Q19F1X)
ALCOHOL (UNII: 3K9958V90M)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE) , WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
14mm
FLAVOR
IMPRINT CODE
546
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1321-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
04/08/2018
2
NDC:70771-
1321-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
04/08/2018
3
NDC:70771-
1321-4
10 in 1 CARTON
04/08/2018
3
NDC:70771-
1321-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING