Active Ingredient: Rotigotine
Rotigotine is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Transdermal, 1 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 2 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 3 milligrams rotigotine, daily, over the duration of 22 weeks. The maximum allowed total dose is 3 milligrams rotigotine daily.
A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the dose may be increased in weekly increments of 1 mg/24 h to a maximum dose of 3 mg/24 h. The need for treatment continuation should be reconsidered every 6 months.
Rotigotine should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of rotigotine. Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Rotigotine should not be placed on skin that is red, irritated or damaged.
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