ROPINIROLE HYDROCHLORIDE tablet film coated extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Mylan Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

ROPINIROLE HYDROCHLORIDE

रचना:

ROPINIROLE 2 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE EXTENDED-RELEASE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE
EXTENDED-RELEASE TABLETS.
ROPINIROLE EXTENDED-RELEASE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2.2, 2.3) 8/2014
Contraindications (4) 8/2014
Warnings and Precautions (5.5, 5.7) 8/2014
INDICATIONS AND USAGE
Ropinirole extended-release tablets are a, non-ergoline dopamine
agonist indicated for the treatment of Parkinson’s
disease. (1.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg and 12 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 Mylan Pharmaceuticals
Inc. at 1-877-446-3679 (1-877-4-INFO-
RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Ropinirole extended-release tablets are taken once daily, with or
without food; tablets must be swallowed whole and
must not be chewed, crushed, or divided. (2.1)
The recommended starting dose is 2 mg taken once daily for 1 to 2
weeks; the dose should be increased by 2 mg/day
at one week or longer intervals; the maximum dose is 24 mg/day (2.2,
14.2)
Renal Impairment: In patients with end-stage renal disease on
hemodialysis, the maximum recommended dose is 18
mg/day (2.2)
If ropinirole extended-release tablets must be discontinued, it should
be tapered gradually over a 7-day period;
retitration of ropinirole extended-release tablets may be warranted if
therapy is interrupted (2.1, 2.2)
Patients may be switched directly from immediate-release ropinirole to
ropini