Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T)
Zydus Lifesciences Limited
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE 7 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Perskaitykite visą dokumentą