United States - English - NLM (National Library of Medicine)

trigen laboratories, llc - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - 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 maximum recommended human dose (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 popul

United States - English - NLM (National Library of Medicine)

wockhardt limited - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - ropinirole extended-release tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson’s disease. none. pregnancy category c. there are no adequate and well-controlled studies using ropinirole in pregnant women. ropinirole extended-release tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.   in animal reproduction studies, ropinirole has been shown to have adverse effects on embryo-fetal development, including teratogenic effects. 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 the mrhd, respectively. the combined administration of ropinirole at 8 times the mrhd and a clinically relevant dose of l-dopa to pregnant rabbits during organogenesis produced a greater incidence and severity of fetal malformations (primarily digit defects) than were seen in the offspring of rabbits treated with l-d

United States - English - NLM (National Library of Medicine)

wockhardt usa llc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - 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 maximum recommended human dose (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 populat

United States - English - NLM (National Library of Medicine)

solco healthcare us, llc - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole tablets are indicated for the treatment of parkinson's disease. ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole 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]

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole tablets are indicated for the treatment of parkinson’s disease. ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole 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 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 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 extended-release ropinirole for parkinson’s disease, 387 patients were 65 years and older and 107 patients were 75 years and older. among patients receiving extended-release ropinirole, 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 extended-release ropinirole and placebo. in the fixed-dose clinical trials of extended-release ropinirole, 176 patients were 65 years and older and 73 were 75 and older. among patients with advanced parkinson’s disease receiving extended-release ropinirole, 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, 2.3), clinical pharmacology (12.3)]. the use of ropinirole 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.

United States - English - NLM (National Library of Medicine)

wockhardt usa llc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - 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 are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole 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 maximum recommended human dose (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

United States - English - NLM (National Library of Medicine)

wockhardt limited - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson's disease. the effectiveness of ropinirole tablet was demonstrated in randomized, controlled trials in patients with early parkinson's disease who were not receiving concomitant l-dopa therapy as well as in patients with advanced disease on concomitant l-dopa (see clinical pharmacology: clinical trials). ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). key diagnostic criteria for rls are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. difficulty falling asleep may frequently be associated with moderate-to-severe rls. rop

United States - English - NLM (National Library of Medicine)

rebel distributors corp - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.5 mg - ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson’s disease. the effectiveness of ropinirole hydrochloride tablets were demonstrated in randomized, controlled trials in patients with early parkinson’s disease who were not receiving concomitant l-dopa therapy as well as in patients with advanced disease on concomitant l-dopa (see clinical pharmacology: clinical trials). ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). key diagnostic criteria for rls are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. difficulty falling asleep may frequently be

United States - English - NLM (National Library of Medicine)

dispensing solutions, inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 2 mg - ropinirole tablets usp are indicated for the treatment of the signs and symptoms of idiopathic parkinson’s disease. the effectiveness of ropinirole hydrochloride was demonstrated in randomized, controlled trials in patients with early parkinson’s disease who were not receiving concomitant l-dopa therapy as well as in patients with advanced disease on concomitant l-dopa (see clinical pharmacology: clinical trials). ropinirole tablets usp are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). key diagnostic criteria for rls are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. difficulty falling asleep may frequently be associated with moderate-to-

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - ropinirole hydrochloride 0.285mg equivalent to to 0.25 mg ropinirole - film coated tablet - 0.25 mg - active: ropinirole hydrochloride 0.285mg equivalent to to 0.25 mg ropinirole excipient: citric acid hyprolose hypromellose lactose macrogol 8000 magnesium stearate titanium dioxide - ropinirole is indicated for the treatment of parkinson's disease. ropinirole is effective as early therapy in patients requiring dopaminergic therapy. in a comparative study, ropinirole was superior to bromocriptine. when these two drugs were administered concomitantly with selegiline there was no difference between them. ropinirole delays the need for initiation of l-dopa therapy. as adjunctive treatment of l-dopa, ropinirole enhances the efficacy of l-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic l-dopa therapy and permits reduction in daily l-dopa dose.