Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Zydus Lifesciences Limited
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 0.25 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Læs hele dokumentet