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:

Avera McKennan Hospital

INN (שם בינלאומי):

ROPINIROLE HYDROCHLORIDE

הרכב:

ROPINIROLE 1 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE HYDROCHLORIDE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE
HYDROCHLORIDE TABLETS.
ROPINIROLE HYDROCHLORIDE TABLETS, USP, FILM COATED 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 hydrochloride 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 Hydrochloride Tablets can be taken with or without food
(2.1)
Retitration of ropinirole hydrochloride tablets 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