Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)
Zydus Lifesciences Limited
PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg
ORAL
PRESCRIPTION DRUG
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. None. Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest
Pramipexole dihydrochloride extended-release tablets, 0.375 mg are white to off-white, oval, tablets with buff to light brown speckles, debossed with "474" on one side and plain on the other side and are supplied as follows: NDC 70771-1328-3 in bottle of 30 tablets NDC 70771-1328-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pramipexole dihydrochloride extended-release tablets, 0.75 mg are white to off-white, oval, tablets with buff to light brown speckles, debossed with "475" on one side and plain on the other side and are supplied as follows: NDC 70771-1329-3 in bottle of 30 tablets NDC 70771-1329-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pramipexole dihydrochloride extended-release tablets, 1.5 mg are white to off-white, oval, tablets with buff to light brown speckles, debossed with "476" on one side and plain on the other side and are supplied as follows: NDC 70771-1330-3 in bottle of 30 tablets NDC 70771-1330-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pramipexole dihydrochloride extended-release tablets, 2.25 mg are white to off white, oval, tablets, with buff to light brown speckles debossed with '874' on one side and plain on other side and are supplied as follows: NDC 70771-1331-3 in bottle of 30 tablets Pramipexole dihydrochloride extended-release tablets, 3 mg are white to off-white, oval, tablets with buff to light brown speckles, debossed with "477" on one side and plain on the other side and are supplied as follows: NDC 70771-1332-3 in bottle of 30 tablets NDC 70771-1332-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pramipexole dihydrochloride extended-release tablets, 3.75 mg are white to off white, oval, tablets, with buff to light brown speckles debossed with '875' on one side and plain on other side and are supplied as follows: NDC 70771-1333-3 in bottle of 30 tablets NDC 70771-1333-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pramipexole dihydrochloride extended-release tablets, 4.5 mg are white to off-white, oval, tablets with buff to light brown speckles, debossed with "478" on one side and plain on the other side and are supplied as follows: NDC 70771-1334-3 in bottle of 30 tablets NDC 70771-1334-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.
Abbreviated New Drug Application
PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE ZYDUS LIFESCIENCES LIMITED ---------- PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1328-3 Pramipexole Dihydrochloride Extended-release Tablets, 0.375 mg R only 30 tablets NDC 70771-1329-3 Pramipexole Dihydrochloride Extended-release Tablets, 0.75 mg R only 30 tablets x x NDC 70771-1330-3 Pramipexole Dihydrochloride Extended-release Tablets, 1.5 mg R only 30 tablets NDC 70771-1331-3 Pramipexole Dihydrochloride Extended-release Tablets, 2.25 mg x R only 30 tablets NDC 70771-1332-3 Pramipexole Dihydrochloride Extended-release Tablets, 3 mg R only 30 tablets x x NDC 70771-1333-3 Pramipexole Dihydrochloride Extended-release Tablets, 3.75 mg R only 30 tablets NDC 70771-1334-3 Pramipexole Dihydrochloride Extended-release Tablets, 4.5 mg R only 30 tablets x x PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride tablet, extended release PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1328 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH STARCH, CORN (UNII: O8232NY3SJ) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE TO OFF-WHITE) , BROWN (Buff to light brown speckles) SCORE no score SHAPE OVAL (oval) SIZE 11mm FLAVOR IMPRINT CODE 474 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1328-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2018 2 NDC:70771- 1328-4 10 in 1 CARTON 04/24/2018 2 NDC:70771- 1328-2 1 Läs hela dokumentet