PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)

Disponible desde:

Zydus Lifesciences Limited

Designación común internacional (DCI):

PRAMIPEXOLE DIHYDROCHLORIDE

Composición:

PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

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