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:

Dr. Reddys Laboratories 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. Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole extended-release tablets in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. In pregnant rabbits, ropinirole potentiated the teratogenic effects of L-dopa when these drugs were administered in combination [see Data] .   In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated populations is unknown.   Data Animal Data: Oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the 2 highest doses. These doses were also associated with maternal toxicity. The highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the MRHD for Parkinson’s disease (24 mg/day) on a body surface area (mg/m2 ) basis.   No effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the MRHD on a mg/m2  basis). In pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with L-dopa (250 mg/kg/day) than when L-dopa was administered alone. This drug combination was also associated with maternal toxicity.   Oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. The no-effect dose of 1 mg/kg/day is less than the MRHD on a mg/m2 basis. Risk Summary There are no data on the presence of ropinirole in human milk, the effects of ropinirole on the breastfed infant, or the effects of ropinirole on milk production. However, inhibition of lactation is expected because ropinirole inhibits secretion of prolactin in humans. Ropinirole or metabolites, or both, are present in rat milk.   The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropinirole extended-release tablets and any potential adverse effects on the breastfed infant from ropinirole or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole extended-release tablets is individually titrated to clinical therapeutic response and tolerability. Pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see Clinical Pharmacology (12.3) ]. In flexible-dose clinical trials of ropinirole extended-release, 387 patients were 65 years and older and 107 patients were 75 years and older. Among patients receiving ropinirole extended-release, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). In these trials, the incidence of overall adverse reactions increased with increasing age for both patients receiving ropinirole extended-release and placebo. In the fixed-dose clinical trials of ropinirole extended-release, 176 patients were 65 years and older and 73 were 75 and older. Among patients with advanced Parkinson’s disease receiving ropinirole extended-release, vomiting and nausea were more common in patients greater than 65 years (5% and 9%, respectively) compared with patients less than 65 (1% and 7%, respectively). No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). For patients with end-stage renal disease on hemodialysis, a reduced maximum dose is recommended [see Dosage and Administration (2.2), Clinical Pharmacology (12.3) ]. The use of ropinirole extended-release tablets in patients with severe renal impairment (creatinine clearance <30 mL/min) without regular dialysis has not been studied. The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. 

Product summary:

Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: Ropinirole extended-release tablets USP, 2 mg are pink colored, capsule shaped, biconvex, film-coated tablets debossed ‘R2’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30                                                               NDC 55111-659-30 Bottles of 90                                                               NDC 55111-659-90 Bottles of 500                                                             NDC 55111-659-05  Ropinirole extended-release tablets USP, 4 mg are light brown colored, capsule shaped, biconvex, film-coated tablets debossed ‘R4’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500.  Bottles of 30                                                               NDC 55111-661-30 Bottles of 90                                                               NDC 55111-661-90 Bottles of 500                                                             NDC 55111-661-05  Ropinirole extended-release tablets USP, 6 mg are white colored, capsule shaped, biconvex, film-coated tablets debossed ‘R6’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500.  Bottles of 30                                                               NDC 55111-727-30 Bottles of 90                                                               NDC 55111-727-90 Bottles of 500                                                             NDC 55111-727-05  Ropinirole extended-release tablets USP, 8 mg are brick red colored, capsule shaped, biconvex, film-coated tablets debossed ‘R8’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500.  Bottles of 30                                                               NDC 55111-662-30 Bottles of 90                                                               NDC 55111-662-90 Bottles of 500                                                             NDC 55111-662-05  Ropinirole extended-release tablets USP, 12 mg are light green colored, capsule shaped, biconvex, film-coated tablets debossed ‘R12’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500.    Bottles of 30                                                               NDC 55111-728-30 Bottles of 90                                                               NDC 55111-728-90 Bottles of 500                                                             NDC 55111-728-05 Storage Store at 20°C to 25°C (68°F 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
DR. REDDYS LABORATORIES 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
INDICATIONS AND USAGE
Ropinirole extended-release tablets are non-ergoline dopamine agonist
indicated for the treatment of
Parkinson’s disease. (1)
DOSAGE AND ADMINISTRATION
Ropinirole extended-release tablets are taken once daily, with or
without food; tablets must be
swallowed whole and 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
recommended dose of ropinirole
extended release tablets 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 approximately match the
total daily dose of immediate-release ropinirole. (2.3)
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
Sudden onset of sleep and somnolence may occur (5.1)
Syncope may occur (5.2)
Hypotension, including orthostatic hypotension may occur (5.3)
Elevation of blood pressure and changes in heart r