Requip (Ropinirole Hydrochloride) - Summary

REQUIP SUMMARY

REQUIP (ropinirole) is an orally administered non-ergoline dopamine agonist.

Parkinson’s Disease

REQUIP is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

The effectiveness of REQUIP 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).

Restless Legs Syndrome

REQUIP is 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.

See all Requip indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Requip (Ropinirole)

Parkinson's Disease Quiz: Test Your Medical IQ
Source: MedicineNet Dementia Specialty [2017.09.19]
Title: Parkinson's Disease Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 8/23/2011 12:53:00 PM
Last Editorial Review: 9/19/2017 6:54:29 PM

Parkinson's Disease and Melanoma May Occur Together, Study Finds
Source: MedicineNet Melanoma Specialty [2017.07.10]
Title: Parkinson's Disease and Melanoma May Occur Together, Study Finds
Category: Health News
Created: 7/7/2017 12:00:00 AM
Last Editorial Review: 7/10/2017 12:00:00 AM

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

Parkinson's Disease
Source: MedicineNet amantadine Specialty [2016.08.09]
Title: Parkinson's Disease
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/9/2016 12:00:00 AM

Parkinson's Disease: Symptoms, Causes, Stages, Treatment
Source: MedicineNet rivastigmine Specialty [2016.06.01]
Title: Parkinson's Disease: Symptoms, Causes, Stages, Treatment
Category: Slideshows
Created: 8/16/2011 6:25:00 PM
Last Editorial Review: 6/1/2016 12:00:00 AM

more news >>

Published Studies Related to Requip (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 (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 (Ropinirole) Side Effects

Drug Ineffective (46),  Pathological Gambling (30),  Sudden Onset of Sleep (27),  Confusional State (25),  Fatigue (25),  Nausea (24),  Somnolence (22),  Insomnia (20),  Dyskinesia (17),  Fall (16), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Requip review by 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Restless leg syndrome
Dosage & duration:		0.5 mg taken at bedtime for the period of 2 years
Other conditions:		Sleeplessness
Other drugs taken:		None
		Reported Results
Benefits:		While standing, my legs were fine, but aching, cramping legs were keeping me from getting any sleep. My doctor suggested I try Requip, and its been the best thing I have done.
Side effects:		I have experienced no side effects, except sleeping at night. The warning says that it might make you drowsy, but that's also why they say to take it at night.
Comments:		I take Requip about 1-1/2 to 2 hours before bedtime. It permits relaxation of legs so I can sleep.

Requip review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		RLS
Dosage & duration:		1 mg/day taken 1 for the period of 1 yr
Other conditions:		none
Other drugs taken:		birth control
		Reported Results
Benefits:		my legs stay still so i can get to sleep and stay asleep
Side effects:		i feel nauseated about 1/2 hour after i take it
Comments:		I take 1 -1.5 mg per night about an hour before i go to bed. it stops the feeling of havingto move my legs and quiets them while i sleep so i can get sustained deep sleep.

Requip review by 63 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		RLS associated with sleep apnea
Dosage & duration:		3mg taken nightly for the period of 3 months
Other conditions:		diabetes
Other drugs taken:		Novalog
		Reported Results
Benefits:		None
Side effects:		Began with Requip pack and gradually increased dosage. Immediately felt more lethargic and irritable. On my third week at 3mg. I could not keep any food down in the mornings. My doctor said the sleepiness and irritability was not related to Requip. After 10 days of vomiting in the a.m I stopped the medication. Feel much better even though my doctor insists I need it.
Comments:		Gradually increased dosage. After last overnight sleep study doctor increased by dosage to 3 mg. That's when the severe nausea and then followed by vomiting.