ROPINIROLE HYDROCHLORIDE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Wockhardt USA LLC.

INN (Alþjóðlegt nafn):

ROPINIROLE HYDROCHLORIDE

Samsetning:

ROPINIROLE 0.25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Ropinirole tablets, USP  are indicated for the treatment of Parkinson's disease. Ropinirole tablets, USP are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole 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 tablets 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 L-dopa when these drugs

Vörulýsing:

Each irregular hexagonal shaped, film-coated Ropinirole Tablets, USP are available containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole. 0.25 mg: white tablets debossed with "W" on one side and "154" on the other side. They are available as follows: NDC 64679-154-01                bottles of 30 tablets NDC 64679-154-02                bottle of 100 tablets NDC 64679-154-03                bottle of 500 tablets NDC 64679-154-04                unit dose package of 100 tablets 0.5 mg: yellow tablets debossed with "W" on one side and "155" on the other side. They are available as follows: NDC 64679-155-01                bottles of 30 tablets NDC 64679-155-02                bottle of 100 tablets NDC 64679-155-03                bottle of 500 tablets NDC 64679-155-04                unit dose package of 100 tablets 1 mg: green tablets debossed with "W" on one side and "171" on the other side. They are available as follows: NDC 64679-171-01                bottles of 30 tablets NDC 64679-171-02                bottle of 100 tablets NDC 64679-171-03                bottle of 500 tablets NDC 64679-171-04                unit dose package of 100 tablets 2 mg: pale yellowish pink tablets, debossed with "W" on one side and "172" on the other side. They are available as follows: NDC 64679-172-01                bottles of 30 tablets NDC 64679-172-02                bottle of 100 tablets NDC 64679-172-03                bottle of 500 tablets NDC 64679-172-04                unit dose package of 100 tablets 3 mg: purple tablets, debossed with "W" on one side and "174" on the other side. They are available as follows: NDC 64679-174-01                bottles of 30 tablets NDC 64679-174-02                bottle of 100 tablets NDC 64679-174-03                bottle of 500 tablets NDC 64679-174-04                unit dose package of 100 tablets 4 mg: brown tablets debossed with "W" on one side and "175" on the other side. They are available as follows: NDC 64679-175-01                bottles of 30 tablets NDC 64679-175-02                bottle of 100 tablets NDC 64679-175-03                bottle of 500 tablets NDC 64679-175-04                unit dose package of 100 tablets 5 mg: blue tablets debossed with "W" on one side and "177" on the other side. They are available as follows: NDC 64679-177-01                bottles of 30 tablets NDC 64679-177-02                bottle of 100 tablets NDC 64679-177-03                bottle of 500 tablets NDC 64679-177-04                unit dose package of 100 tablets Storage Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
WOCKHARDT USA LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE TABLETS.
ROPINIROLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 9/2016
Warnings and Precautions (5.7, 5.9) 9/2016
INDICATIONS AND USAGE
Ropinirole tablets, USP is a non-ergoline dopamine agonist indicated
for the treatment of Parkinson's disease (PD) and
moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2)
DOSAGE AND ADMINISTRATION
Ropinirole tablets, USP can be taken with or without food. (2.1)
Retitration of ropinirole tablets, USP may be warranted if therapy is
interrupted. (2.1)
Parkinson's Disease:
The recommended starting dose is 0.25 mg taken three times daily;
titrate to a maximum daily dose of 24 mg. (2.2)
Renal Impairment: The maximum recommended dose is 18 mg/day in
patients with end-stage renal disease on
hemodialysis. (2.2)
Restless Legs Syndrome:
The recommended starting dose is 0.25 mg once daily, 1 to 3 hours
before bedtime, titrate to a maximum
recommended dose of 4 mg daily. (2.3)
Renal Impairment: The maximum recommended dose is 3 mg/day in patients
with end-stage renal disease on
hemodialysis. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg (3)
CONTRAINDICATIONS
History of hypersensitivity/allergic reaction (including urticaria,
angioedema, rash, pruritus) to ropinirole or to any of the
excipients. (4)
WARNINGS AND PRECAUTIONS
Sudden onset of sleep and somnolence may occur (5.1)
Syncope may occur (5.2)
Hypotension, including orthostatic hypotension may occur (5.3)
May cause hallucinations and psychotic-like behaviors (5.4)
May cause or exacerbate dyskinesia (5.5)
May cause problems with impulse control or compulsive behaviors (5.6)
ADVERSE REACTIONS
Most common adverse reactions (inciden