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Requip XL (Ropinirole Hydrochloride) - Summary

 
 



REQUIP XL SUMMARY

REQUIP (ropinirole) and REQUIP XL (ropinirole extended release) is an orally administered non-ergoline dopamine agonist.

REQUIP XL (ropinirole extended-release tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
See all Requip XL indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Requip XL (Ropinirole)

Medical News Today: Scientists offer new view on origins of Parkinson's disease
Source: Featured Health News from Medical News Today [2016.06.24]
A new study suggests stress on the endoplasmic reticulum of cells triggers neurodegeneration in Parkinson's disease and not just failure of mitochondria.

Scientists offer new view on origins of Parkinson's disease
Source: Biology / Biochemistry News From Medical News Today [2016.06.24]
A new study suggests stress on the endoplasmic reticulum of cells triggers neurodegeneration in Parkinson's disease and not just failure of mitochondria.

Parkinson's Disease on the Rise?
Source: Medscape NeurologyHeadlines [2016.06.23]
A new study has found a significant increase in the incidence of Parkinson's over the course of 3 decades, more than doubling in men since 1976.
Medscape Medical News

Parkinson's Disease: Prevalence Seen as Rising (CME/CE)
Source: MedPage Today Neurology [2016.06.22]
(MedPage Today) -- Biggest spike seen in men 70 years of age and up

20th International Congress of Parkinson's Disease and Movement Disorders
Source: Medscape NeurologyHeadlines [2016.06.21]
Read clinically focused news coverage of key developments from MDS 2016.
Medscape Neurology

more news >>

Published Studies Related to Requip XL (Ropinirole)

Rotigotine vs ropinirole in advanced stage Parkinson's disease: a double-blind study. [2014]
(PD) patients on concomitant levodopa therapy... CONCLUSIONS: Rotigotine was well tolerated at doses up to 16 mg/24 h and showed

[Efficacy and safety of ropinirole in the treatment of Parkinson's disease: a multi-center, randomized, double-blind and bromocriptine-controlled trial]. [Article in Chinese] [2013]
Parkinson's disease... CONCLUSIONS: Ropinirole is both effective and safe in the treatment of Chinese

The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study. [2013]
Parkinson's disease (PD) not optimally controlled with L-dopa... CONCLUSIONS: This study demonstrated for the first time in Chinese subjects that

PREPARED: Comparison of prolonged and immediate release ropinirole in advanced Parkinson's disease. [2011.06]
BACKGROUND: PREPARED was a randomized, parallel-group, double-blind, multicenter study to evaluate the efficacy of adjunctive ropinirole prolonged release (PR) versus immediate release (IR) in patients with advanced Parkinson's disease (PD)... CONCLUSIONS: Adjunctive PR provided a significantly greater improvement in symptom control in terms of the odds of achieving >/= 20% maintained reduction in time spent "off" compared with IR. Interpretation may be confounded by the higher doses of PR versus IR that were achieved, in combination with lower doses of L-dopa by the study end. Despite dosing differences, the PR titration regimen was generally well tolerated, with an AE profile similar to that of IR. Copyright (c) 2011 Movement Disorder Society.

Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. [2011.06]
Comorbid depressive symptoms in restless legs syndrome (RLS) remain a treatment challenge, as some antidepressants aggravate RLS symptoms...

more studies >>

Clinical Trials Related to Requip XL (Ropinirole)

REQUIP RLS Post Marketing Surveillance [Completed]

Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets [Completed]
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel. The pre-dose (0. 00 hours) blood sample was collected before dosing and post-dose samples were collected at 2. 00, 3. 00, 4. 00, 5. 00, 5. 50, 6. 00, 6. 50, 7. 00, 7. 50, 8. 00, 8. 50, 9. 00, 9. 50, 10. 00, 10. 50, 11. 00, 12. 00, 14. 00, 16. 00, 20. 00, 24. 00 and 30. 00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i. e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.

Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions [Completed]
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel. The pre-dose (0. 00 hours) blood sample was collected before dosing and post-dose samples were collected at 2. 00, 3. 00, 4. 00, 5. 00, 5. 50, 6. 00, 6. 50, 7. 00, 7. 50, 8. 00, 8. 50, 9. 00, 9. 50, 10. 00, 10. 50, 11. 00, 12. 00, 14. 00, 16. 00, 20. 00, 24. 00 and 30. 00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i. e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.

Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions [Completed]
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel after consuming the whole standardized high fat non-veg breakfast. The pre-dose (0. 00 hours) blood sample was collected before dosing and post-dose samples were collected at 2. 00, 3. 00, 4. 00, 5. 00, 6. 00, 7. 00, 7. 50, 8. 00, 8. 50, 9. 00, 9. 50, 10. 00, 10. 50, 11. 00, 11. 50, 12. 00, 12. 50, 13. 00, 14. 00, 16. 00, 20. 00, 24. 00 and 30. 00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i. e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.

Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528 [Completed]
This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528. Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous. Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

more trials >>

Reports of Suspected Requip XL (Ropinirole) Side Effects

Medication Residue (8)Somnolence (7)Drug Ineffective (6)OFF Label USE (6)Drug Administration Error (5)Hallucination (5)Nausea (5)Hallucination, Visual (5)Insomnia (5)Malaise (4)more >>


Page last updated: 2016-06-24

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