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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)

Autoimmunity may have role in Parkinson's disease
Source: Immune System / Vaccines News From Medical News Today [2017.06.21]
Scientists discover that fragments of the alpha-synuclein protein that clogs up dopamine cells in Parkinson's disease trigger an autoimmune response.

Statins may raise the risk of Parkinson's disease
Source: Cardiovascular / Cardiology News From Medical News Today [2017.06.15]
New research suggests that rather than protecting against Parkinson's disease, it is possible that the use of statins may increase its risk.

Research provides new insights into the cause of urinary dysfunction in Parkinson's disease
Source: Urology / Nephrology News From Medical News Today [2017.06.12]
A new study from the University of Hertfordshire, published in the journal PLOS ONE, has found that urinary dysfunction and incontinence observed among Parkinson's disease sufferers may start at the...

Infection with seasonal flu may increase risk of developing Parkinson's disease
Source: Flu / Cold / SARS News From Medical News Today [2017.06.01]
Most cases of Parkinson's have no known cause, and researchers continue to debate and study possible factors that may contribute to the disease.

Hepatitis Infection May Raise Risk for Parkinson's Disease
Source: MedicineNet Tremor Specialty [2017.03.31]
Title: Hepatitis Infection May Raise Risk for Parkinson's Disease
Category: Health News
Created: 3/30/2017 12:00:00 AM
Last Editorial Review: 3/31/2017 12:00:00 AM

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...

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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: 2017-06-21

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