Requip Labeling Updated with New Warnings, Dosing Information

The update includes new info on discontinuing the treatment for patients with restless legs syndrome
The update includes new info on discontinuing the treatment for patients with restless legs syndrome

The Food and Drug Administration (FDA) has approved labeling updates regarding dosage and warnings for Requip (ropinirole; GlaxoSmithKline) tablets.

Requip, an non-ergoline dopamine agonist, is indicated for the treatment of Parkinson's disease and moderate-to-severe primary restless legs syndrome (RLS).  

An update to the Dosage and Administration section states that when discontinuing Requip in patients with RLS, a gradual reduction of the daily dose is recommended. The full dosage titration schedule can be found in the prescribing information. 

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The Warnings and Precautions section includes an update on withdrawal-emergent hyperpyrexia and confusion. This symptom complex, resembling neuroleptic malignant syndrome, with no other clear etiology, has been reported in association with rapid dose reduction of, withdrawal of, or changes in, dopaminergic therapy. As a result, it is recommended that the dose be tapered at the end of treatment with Requip as a prophylactic measure. 

In addition, as augmentation and early-morning rebound have been observed with treatment for RLS, the dosage should be adjusted or discontinued if they occur. When discontinuing Requip in patients with RLS, a gradual reduction of the daily dose is recommended whenever possible.

Requip is available as 0.25mg, 0.5mg 1mg, 2mg, 3mg, 4mg, and 5mg strength tablets. 

For more information call (888) 825-5249 or visit Requip.com.

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