REQUIP- ropinirole tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

GlaxoSmithKline LLC

INN (Միջազգային անվանումը):

ROPINIROLE HYDROCHLORIDE

Կազմը:

ROPINIROLE 0.25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

REQUIP is indicated for the treatment of Parkinson’s disease. REQUIP is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). REQUIP is 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 REQUIP 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 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 were administered in combination [see Data] . In the U.S. general population, the estimated ba

Ապրանքի ամփոփագիր:

Each pentagonal film-coated TILTAB tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: Storage Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

REQUIP- ROPINIROLE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REQUIP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR REQUIP.
REQUIP (ROPINIROLE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
REQUIP 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
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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
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
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REQUIP Tablets can be taken with or without food. (2.1)
Retitration of REQUIP 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)
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)
Mos