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15-May-2020 19:19

Some have reported these events more than 1 year after initiation of treatment.

In controlled clinical trials, somnolence was commonly reported in patients receiving Ropinirole tablets and was more frequent in Parkinson's disease (up to 40% Ropinirole tablets, 6% placebo) than in Restless Legs Syndrome (12% Ropinirole tablets, 6% placebo) .

Patients treated with Ropinirole tablets have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents.

In controlled clinical trials in patients with Parkinson's disease, syncope was observed more frequently in patients receiving Ropinirole tablets than in patients receiving placebo (early Parkinson's disease without levodopa [L-dopa]: Ropinirole tablets 12%, placebo 1%; advanced Parkinson's disease: Ropinirole tablets 3%, placebo 2%).

Syncope was reported in 1% of patients treated with Ropinirole tablets for RLS in 12-week, placebo-controlled clinical trials compared with 0.2% of patients treated with placebo .

Most cases occurred more than 4 weeks after initiation of therapy with Ropinirole tablets, and were usually associated with a recent increase in dose.

The frequency of administration should be reduced from three times daily to twice daily for 4 days.

For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of Ropinirole tablets, USP.

In controlled clinical trials in patients with Parkinson's disease, syncope was observed more frequently in patients receiving Ropinirole tablets than in patients receiving placebo (early Parkinson's disease without levodopa [L-dopa]: Ropinirole tablets 12%, placebo 1%; advanced Parkinson's disease: Ropinirole tablets 3%, placebo 2%).Syncope was reported in 1% of patients treated with Ropinirole tablets for RLS in 12-week, placebo-controlled clinical trials compared with 0.2% of patients treated with placebo .Most cases occurred more than 4 weeks after initiation of therapy with Ropinirole tablets, and were usually associated with a recent increase in dose.The frequency of administration should be reduced from three times daily to twice daily for 4 days.For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of Ropinirole tablets, USP.The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime.