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Generic Requip Ropinirole 0.25/0.5/1/2mg

Use caution when performing tasks requiring mental alertness such as driving or using machinery. Limit alcohol use because it may intensify the drowsiness and dizziness effects of this drug. Although the effects of Requip during pregnancy have not been adequately studied in humans, birth defects have occurred in animals. If you are pregnant or plan to become pregnant, inform your doctor immediately. Requip may inhibit production of breast milk. Most of these cases occurred more than 4 weeks after initiation of therapy with Requip, and were usually associated with a recent increase in dose. Of 208 patients being treated with both L-dopa and Requip in placebo-controlled advanced Parkinson's disease trials, there were reports of syncope in 6 (2.9%) compared to 2 of 120 (1.7%) of placebo/L-dopa patients.

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Ropinirole Precautions

Requip may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate preexisting dyskinesia in patients treated with L-dopa for Parkinson's disease. No dosage adjustment is needed in patients with mild to moderate renal impairment (creatinine clearance of 30 to 50 mL/min). Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. Whether the observed increased risk was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, was unclear. Requip is one of the dopamine agonists used to treat Parkinson's disease.

Requip Adverse Reactions

The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. Some epidemiologic studies have shown that patients with Parkinson's disease have a higher risk (perhaps 2- to 4-fold higher) of developing melanoma than the general population. During the premarketing development of Requip, patients received Requip either without L-dopa (early Parkinson's disease studies) or as concomitant therapy with L-dopa (advanced Parkinson's disease studies). Approximately 24% of 157 patients treated with Requip who participated in the double-blind, placebo-controlled early Parkinson's disease (without L-dopa) trials discontinued treatment due to adverse events compared to 13% of 147 patients who received placebo.

Requip Drug Interactions

A small number of reports have been received of possible fibrotic complications, including pleural effusion, pleural fibrosis, interstitial lung disease, and cardiac valvulopathy, in the development program and postmarketing experience for Requip. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied.

Requip Overdosage

The most commonly observed adverse events (greater than 5%) in the double-blind, placebo-controlled early Parkinson's disease trials associated with the use of Requip (n = 157) not seen at an equivalent frequency among the placebo-treated patients (n = 147) were, in order of decreasing incidence: nausea, dizziness, somnolence, headache, vomiting, syncope, fatigue, dyspepsia, viral infection, constipation, pain, increased sweating, asthenia, dependent/leg edema, orthostatic symptoms, abdominal pain, pharyngitis, confusion, hallucinations, urinary tract infections, and abnormal vision. The adverse events most commonly causing discontinuation of treatment by patients treated with Requip were: nausea (6.4%), dizziness (3.8%), aggravated Parkinson's disease (1.3%), hallucinations (1.3%), somnolence (1.3%), vomiting (1.3%), and headache (1.3%).

Table 4 lists treatment-emergent adverse events that occurred in greater than 2% of patients with RLS treated with Requip participating in the 12-week double-blind, placebo-controlled studies and were numerically more common in the group treated with Requip. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. These categories are used in the listing below.

The frequencies presented represent the proportion of the 1,599 individuals exposed to Requip who experienced events of the type cited on at least 1 occasion while receiving Requip. Infrequent: Cardiac failure, bradycardia, tachycardia, supraventricular tachycardia, angina pectoris, bundle branch block, cardiac arrest, cardiomegaly, aneurysm, mitral insufficiency. Frequent: Neuralgia. Infrequent: Involuntary muscle contractions, hypertonia, dysphonia, abnormal coordination, extrapyramidal disorder, migraine, choreoathetosis, coma, stupor, aphasia, convulsions, hypotonia, peripheral neuropathy, paralysis.