ROPINIROLE HYDROCHLORIDE tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)

Доступно од:

Zydus Lifesciences Limited

INN (Међународно име):

ROPINIROLE HYDROCHLORIDE

Састав:

ROPINIROLE 0.25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Ropinirole hydrochloride tablets are indicated for the treatment of Parkinson's disease. Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole hydrochloride tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (MRHD) for Parkinson's disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. In pregnant rabbits, ropinirole potentiated the teratogenic effects of

Резиме производа:

Ropinirole Hydrochloride Tablets equivalent to 0.25 mg of ropinirole are white-colored, round-shaped, film-coated tablets debossed with "ZF22" on one side and plain on other side and are supplied as follows: NDC 65841-712-01 in bottle of 100 tablets NDC 65841-712-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 0.5 mg of ropinirole are yellow-colored, round-shaped, film-coated tablets, debossed with "ZF23" on one side and plain on the other side and are supplied as follows: NDC 65841-713-01 in bottle of 100 tablets NDC 65841-713-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 1 mg of ropinirole are green-colored, round-shaped, film-coated tablets, debossed with "ZF24" on one side and plain on the other side and are supplied as follows: NDC 65841-714-01 in bottle of 100 tablets NDC 65841-714-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 2 mg of ropinirole are pink-colored, round-shaped, film-coated tablets, debossed with "ZF25" on one side and plain on the other side and are supplied as follows: NDC 65841-715-01 in bottle of 100 tablets NDC 65841-715-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 3 mg of ropinirole are purple-colored, round-shaped, film-coated tablets, debossed with "ZF42" on one side and plain on the other side and are supplied as follows: NDC 65841-716-01 in bottle of 100 tablets NDC 65841-716-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 4 mg of ropinirole are brown-colored, round-shaped, film-coated tablets, debossed with "ZF43" on one side and plain on the other side and are supplied as follows: NDC 65841-717-01 in bottle of 100 tablets NDC 65841-717-10 in bottle of 1000 tablets Ropinirole Hydrochloride Tablets equivalent to 5 mg of ropinirole are blue-colored, round-shaped, film-coated tablets, debossed with "ZF26" on one side and plain on the other side and are supplied as follows: NDC 65841-718-01 in bottle of 100 tablets NDC 65841-718-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use. Dispense in a tight, light-resistant container.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED
ZYDUS LIFESCIENCES LIMITED
----------
ROPINIROLE TABELTS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-712-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 0.25 mg
100 tablets
NDC 65841-713-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 0.5 mg
100 tablets
NDC 65841-714-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 1 mg
100 tablets
NDC 65841-715-01in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 2 mg
100 tablets
NDC 65841-716-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 3 mg
100 tablets
NDC 65841-717-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 4 mg
100 tablets
NDC 65841-718-01 in bottle of 100 tablets
Ropinirole Hydrochloride Tablets, 5 mg
100 tablets
ROPINIROLE HYDROCHLORIDE
ropinirole hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-712
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE -
UNII:030PYR8953)
ROPINIROLE
0.25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
Z F22
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-712-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/23/2009
2
NDC:65841-712-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
09/23/2009
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090411
09/23/2009
ROPINIROLE HYDROC