ROPINIROLE HYDROCHLORIDE tablet film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Bryant Ranch Prepack

INN (שם בינלאומי):

ROPINIROLE HYDROCHLORIDE

הרכב:

ROPINIROLE 1 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ROPINIROLE HYDROCHLORIDE- 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
Dosage and Administration (2.2, 2.3) 8/2014
Warnings and Precautions (5.4, 5.6, 5.9) 8/2014
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) (1)
DOSAGE AND ADMINISTRATION
· Ropinirole tablets can be taken with or without food (2.1) (2)
· Retitration of ropinirole tablets may be warranted if therapy is
interrupted (2.1) (2)
Parkinson’s Disease: (2)
· The recommended starting dose is 0.25 mg taken three times daily;
titrate to a maximum daily dose of 24 mg (2.2)
(2)
· Renal Impairment: The maximum recommended dose is 18 mg/day in
patients with end-stage renal disease on
hemodialysis (2.2) (2)
Restless Legs Syndrome: (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) (2)
· Renal Impairment: The maximum recommended dose is 3 mg/day in
patients with end-stage renal disease on
hemodialysis (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg (3) (3)
CONTRAINDICATIONS
History of hypersensitivity/allergic reaction (including urticaria,
angioedema, rash, pruritus) to ropinirole or to any of the
excipients (4) (4)
WARNINGS AND PRECAUTIONS
· Sudden onset of sleep and somnolence may occur (5.1) (5)
· Syncope may occur (5.2) (5)
· Hypotension, including orthostatic hypotension may occur (5.3) (5)
· May cause hallucinations and psychotic-like behaviors (5.4) (5)
· May cause or exacerbate dyskinesia (5.5) (5)
· May cause problems with impulse control or com