ROPINIROLE tablet film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

American Health Packaging

INN (Rahvusvaheline Nimetus):

ROPINIROLE HYDROCHLORIDE

Koostis:

ROPINIROLE 0.25 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ROPINIROLE- ROPINIROLE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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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 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
Ropinirole tablets can be taken with or without food ( 2.1)
Retitration of ropinirole 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 (incidence with ropinirole at least 5%