ROPINIROLE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Carilion Materials Management

INN (Διεθνής Όνομα):

ROPINIROLE HYDROCHLORIDE

Σύνθεση:

ROPINIROLE 1 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ropinirole Tablets USP are indicated for the treatment of Parkinson’s disease. Ropinirole Tablets USP are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Ropinirole Tablets USP are contraindicated in patients known to have hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. Ropinirole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Oral treatment of pregnant rats with ropinirole during organogenesis resulted in decreased fetal body weight, increased fetal death, and digital malformations at 24, 36, and 60 times, respectively, the maximum recommended human dose (MRHD) for Parkinson’s disease (24 mg/day) on a mg

Περίληψη προϊόντος:

Product: 68151-4073 NDC: 68151-4073-2 1 TABLET in a PACKAGE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ROPINIROLE- ROPINIROLE TABLET
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROPINIROLE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPINIROLE TABLETS
USP.
ROPINIROLE TABLETS USP, 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 USP 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
•
•
Parkinson’s Disease: (2)
•
•
Restless Legs Syndrome: (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
•
•
•
•
•
•
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 Roxane Laboratories,
Inc. at 1-800-962-8364 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Ropinirole Tablets USP 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 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 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 ons