ROPINIROLE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.  Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or 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 extended-release tablets 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/m2  basis. The combined oral administration of ropinirole at 8 t

Product summary:

Each capsule shaped, film coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:  2 mg: pink tablets debossed with 'L191' NDC 46708-262-30    bottle of 30 tablets NDC 46708-262-90    bottle of 90 tablets NDC 46708-262-31    bottle of 100 tablets NDC 46708-262-71    bottle of 500 tablets NDC 46708-262-91    bottle of 1000 tablets NDC 46708-262-10    carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with 'L193' NDC 46708-263-30    bottle of 30 tablets NDC 46708-263-90    bottle of 90 tablets NDC 46708-263-31    bottle of 100 tablets NDC 46708-263-71    bottle of 500 tablets NDC 46708-263-91    bottle of 1000 tablets NDC 46708-263-10    carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with 'L321' NDC 46708-264-30    bottle of 30 tablets NDC 46708-264-90    bottle of 90 tablets NDC 46708-264-31    bottle of 100 tablets NDC 46708-264-71    bottle of 500 tablets NDC 46708-264-91    bottle of 1000 tablets NDC 46708-264-10    carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with 'L194' NDC 46708-265-30    bottle of 30 tablets NDC 46708-265-90    bottle of 90 tablets NDC 46708-265-31    bottle of 100 tablets NDC 46708-265-71    bottle of 500 tablets NDC 46708-265-91    bottle of 1000 tablets NDC 46708-265-10    carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with 'L195' NDC 46708-266-30    bottle of 30 tablets NDC 46708-266-90    bottle of 90 tablets NDC 46708-266-31    bottle of 100 tablets NDC 46708-266-71    bottle of 500 tablets NDC 46708-266-91    bottle of 1000 tablets NDC 46708-266-10    carton of 100 (10X10) unit dose tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE - ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE
ALEMBIC PHARMACEUTICALS LIMITED
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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 non-ergoline dopamine agonist
indicated for the treatment of
Parkinson’s disease (1.1) (1)
DOSAGE AND ADMINISTRATION
•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 1 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 ropinirole extended-release
tablets; the initial switching dose of ropinirole extended-release
tablets should most closely match the
total daily dose of immediate-release ropinirole. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 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)
•Syncope may