ROPINIROLE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Bryant Ranch Prepack

Designació comuna internacional (DCI):

ROPINIROLE HYDROCHLORIDE

Composición:

ROPINIROLE 0.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ropinirole tablets are indicated for the treatment of Parkinson’s disease. Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole 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 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 L-dopa when these drugs were administered in combin

Resumen del producto:

Product: 63629-6315 NDC: 63629-6315-1 30 TABLET, FILM COATED in a BOTTLE

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
BRYANT RANCH PREPACK
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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
Warnings and Precautions (5.7, 5.9) 9/2016
INDICATIONS AND USAGE
Ropinirole tablets are 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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Parkinson’s Disease:
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•
Restless Legs Syndrome:
•
•
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
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence with ropinirole at least 5%
greater than placebo) in the respective indications
we re :
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT 1-888-721-
Dosage and Administration (2.3) 9/2016
Ropinirole tablets can be taken with or without food (2.1)
Retitration of ropinirole may be warranted if therapy is interrupted
(2.1)
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)
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 hypo