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| Tolerability |
| Demonstrated Safety Profile |
Adverse Event (AE) and Withdrawal Rate Profile
* AEs in >5% of patients treated with Requip and twice the rate for patients treated with placebo.
† Overall discontinuation rates due to AEs at 12 weeks in 4 clinical trials for RLS (TREAT RLS 1, TREAT RLS 2, TREAT RLS US, and RESET PLM). [18]
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Additional Important Safety Information
Rate of nausea with < 1 mg per day of Requip from 4% to 9% [18]
- Nausea was generally dose dependent and mild to moderate in intensity [18]
- Requip may be taken with food, which may help reduce the occurrence of nausea This has not been established in controlled clinical trials.
Requip is not a controlled substance.
- Requip is not a scheduled medication.
Dosing Considerations:
- Requip is metabolized by the liver
- Hepatically impaired patients may have higher plasma levels and lower clearance of the drug. Therefore, the drug should be titrated with caution in this population
- Dosage adjustment may be required if Requip is used with estrogen or CYP450 1A2 inhibitors, such as ciprofloxacin
- No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance 30 to 50 mL/min). Requip has not been studied in patients with severe renal impairment
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Important Safety Information
Requip has been associated with sedating effects, including somnolence, and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Requip should be discontinued if these events occur; it is unknown if dose reduction will eliminate episodes of somnolence. Prescribers should reassess patients for somnolence throughout treatment.
Syncope or symptomatic hypotension may occur, particularly during initial treatment or dose titration. Patients should be cautioned against rising rapidly after sitting or lying down. Because of possible additive effects, caution should be exercised with patients who have sleep disorders or are taking sedating medications, alcohol, CNS depressants, or medications that increase ropinirole plasma levels.
Patients and caregivers should be informed that impulse control symptoms, including compulsive behaviors such as pathological gambling and hypersexuality, have been reported in patients treated with dopaminergic agents, including ropinirole. These behaviors were reported principally in Parkinson's disease patients treated with dopaminergic agents, especially at higher doses.
For More Safety Information about Requip, click here.
Complete Prescribing Information for Requip® (ropinirole HCl) Tablets
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Tolerability
