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Requip XL

"June 14, 2011 -- The FDA has issued an alert about medication errors involving patients who were mistakenly given the antipsychotic risperidone, (brand name Risperdal) instead of ropinirole (Requip), which is used to treat Parkinson's disease and"...

Requip XL

Requip XL

SIDE EFFECTS

The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

During the premarketing development of REQUIP XL (ropinirole extended release tablets) , patients with advanced Parkinson's disease received REQUIP XL (ropinirole extended release tablets) or placebo as adjunctive therapy in 1 clinical trial. In a second trial, patients with early Parkinson's disease were treated with REQUIP XL (ropinirole extended release tablets) or the immediate-release formulation of REQUIP without L-dopa.

Advanced Parkinson's Disease (With L-dopa)

The most commonly observed adverse reactions ( ≥ 5% and numerically greater than placebo) in the 24-week, double-blind, placebo-controlled trial for the treatment of advanced Parkinson's disease during treatment with REQUIP XL (ropinirole extended release tablets) were, in order of decreasing incidence: dyskinesia, nausea, dizziness, hallucination, somnolence, abdominal pain/discomfort, and orthostatic hypotension.

Approximately 6% of 202 patients treated with REQUIP XL (ropinirole extended release tablets) discontinued treatment due to adverse event(s) compared with 5% of 191 patients who received placebo. The adverse event most commonly causing discontinuation of treatment with REQUIP XL (ropinirole extended release tablets) was hallucination (2%).

Table 2 lists adverse reactions that occurred with a frequency of at least 2% (and were numerically greater than placebo) in patients with advanced Parkinson's disease treated with REQUIP XL (ropinirole extended release tablets) who participated in the 26-week, double-blind, placebo-controlled study. In this study, either REQUIP XL (ropinirole extended release tablets) or placebo was used as an adjunct to L -dopa. Adverse reactions were generally mild or moderate in intensity.

Table 2. Treatment-Emergent Adverse Reaction Incidence in a Double-Blind, Placebo-Controlled Trial in Advanced Stage Parkinson's Disease (With L-dopa) (Events ≥ 2% of Patients Treated with REQUIP XL (ropinirole extended release tablets) and > % with Placebo)

Body System/Adverse Reaction REQUIP XL (ropinirole extended release tablets)
(n = 202)
%
Placebo
(n = 191)
%
Ear and labyrinth disorders
  Vertigo 4 2
Gastrointestinal disorders
  Nausea 11 4
  Constipation 4 2
  Abdominal pain/discomfort 6 3
  Diarrhea 3 2
  Dry mouth 2 < 1
General disorders
  Edema peripheral 4 1
Injury, poisoning, and procedural complication
  Fall* 2 1
Musculoskeletal and connective tissue disorders
  Back pain 3 2
Nervous system disorders
  Dyskinesia* 13 3
  Dizziness 8 3
  Somnolence 7 4
Psychiatric disorders
  Hallucination 8 2
  Anxiety 2 1
Vascular disorders
  Orthostatic hypotension 5 1
  Hypotension 2 0
  Hypertension* 3 2
*Dose-related.

Although this study was not designed for optimally characterizing dose-related adverse reactions, there was a suggestion (based upon comparison of incidence of adverse reactions across dose ranges for REQUIP XL (ropinirole extended release tablets) and placebo) that the incidence for dyskinesia, hypertension, and fall was dose-related to REQUIP XL (ropinirole extended release tablets) .

The incidence for many adverse reactions with REQUIP XL (ropinirole extended release tablets) treatment was increased relative to placebo (i.e., REQUIP XL (ropinirole extended release tablets) % Placebo % = treatment difference ≥ 2%) in either the titration or maintenance phases of the study. During the titration phase, an increased incidence (shown in descending order of % treatment difference) was observed for dyskinesia, nausea, abdominal pain/ discomfort, orthostatic hypotension, dizziness, vertigo, hypertension, peripheral edema, and dry mouth. During the maintenance phase, an increased incidence was observed for dyskinesia, nausea, dizziness, hallucination, somnolence, fall, hypertension, abnorma dreams, constipation, chest pain, bronchitis, and nasopharyngitis. Some adverse reactions developing in the titration phase persisted ( ≥ 7 days) into the maintenance phase. These “persistent” adverse reactions included dyskinesia, hallucination, orthostatic hypotension, and dry mouth.

The incidence of adverse reactions was not clearly different between women and men.

Early Parkinson's Disease (Without L -dopa)

The most commonly observed adverse reactions ( > 5%) in the 36-week early Parkinson's disease trial during treatment with REQUIP XL (ropinirole extended release tablets) were, in order of decreasing incidence: nausea (19%), somnolence (11%), abdominal pain/discomfort (7%), dizziness (6%), headache (6%), and constipation (5%). The type of adverse reactions and the frequency (i.e. incidence) with which they occurred were generally similar over the whole treatment period in this study of early Parkinson's disease patients who were initially treated with REQUIP XL (ropinirole extended release tablets) or the immediate-release formulation of REQUIP and subsequently crossed over to treatment with the other formulation.

During the titration phase, an increased incidence with REQUIP XL (ropinirole extended release tablets) compared with the immediate-release formulation of REQUIP (i.e., REQUIP XL (ropinirole extended release tablets) % - REQUIP IR % = treatment difference > 2%), shown in descending order of % treatment difference, was observed for: constipation, hallucination, vertigo, abdominal pain/discomfort, nausea, vomiting, fall, headache, diarrhea, pyrexia, and flatulence. During the maintenance phase, an increased incidence was observed for fall, myalgia, and sleep disorder. Several adverse reactions developing in the titration phase persisted ( > 7 days) into the maintenance phase. These “persistent” adverse reactions included: constipation, hallucination, muscle spasms, flatulence, insomnia, sleep disorder, abdominal pain/discomfort, cough, and nasopharyngitis.

Adverse Reactions Observed During the Clinical Development of the Immediate-Release Formulation of REQUIP for Parkinson's Disease (Advanced and Early)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

In patients with advanced Parkinson's disease who were treated with the immediate-release formulation of REQUIP, the most common adverse reactions ( ≥ 5% treatment difference from placebo; presented in order of decreasing treatment difference frequency) were dyskinesia (21%), somnolence (12%), nausea (12%), dizziness (10%), confusion (7%), hallucinations (6%), headache (5%), and increased sweating (5%). In patients with early Parkinson's disease who were treated with the immediate-release formulation of REQUIP, the most common adverse reactions ( > 5% treatment difference from placebo; presented in order of decreasing treatment difference frequency) were nausea (38%), somnolence (34%), dizziness (18%), syncope (11%), viral infection (8%), fatigue (7%), leg edema (6%), asthenia (5%), and dyspepsia (5%).

Read the Requip XL (ropinirole extended release tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

P450 Interaction

In vitrometabolism studies showed that CYP1A2 is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with ropinirole, adjustment of the dose of ropinirole may be required.

Coadministration of ciprofloxacin, an inhibitor of CYP1A2, with immediate-release ropinirole increased the AUC of ropinirole by 84% on average and Cmax by 60% [see CLINICAL PHARMACOLOGY].

Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking. In one study in patients with Restless Legs Syndrome, cigarette smokers had an approximate 30% lower Cmax and a 38% lower AUC than did nonsmokers, when those parameters were normalized for dose.

There is no evidence of interaction between ropinirole and other CYP1A2 substrates (e.g., theophylline).

Ropinirole and its circulating metabolites do not inhibit or induce P450 enzymes therefore ropinirole is unlikely to affect the pharmacokinetics of other drugs by a P450 mechanism [see CLINICAL PHARMACOLOGY].

L-dopa

Coadministration of carbidopa + L-dopa (SINEMET ) with immediate-release ropinirole had no effect on the steady-state pharmacokinetics of ropinirole. Oral administration of immediate-release ropinirole increased mean steady-state Cmax of L-dopa by 20%, but its AUC was unaffected [see CLINICAL PHARMACOLOGY].

Estrogens

Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy [HRT]) reduced the oral clearance of ropinirole by approximately 35%. Dosage adjustment is not needed for initiating REQUIP XL (ropinirole extended release tablets) in patients on estrogen therapy because patients are individually titrated with REQUIP XL (ropinirole extended release tablets) to tolerance or adequate effect. If estrogen therapy is stopped or started during treatment with REQUIP XL (ropinirole extended release tablets) , then adjustment of the dose of REQUIP XL may be required.

Dopamine Antagonists

Since ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may diminish the effectiveness of REQUIP XL (ropinirole extended release tablets) . Patients with a history or presence of major psychotic disorders should be treated with dopamine agonists only if the potential benefits outweigh the risks.

Drug Abuse And Dependence

Controlled Use

Ropinirole is not a controlled substance.

Dependence

Animal studies and human clinical trials with ropinirole did not reveal any potential for drug-seeking behavior or physical dependence.

Read the Requip XL Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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