Active Ingredient: Pramipexole
Pramipexole is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
0.09 - 0.54 mg
From 0.09 To 0.54 mg once every day
The recommended starting dose of pramipexole is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days to a maximum of 0.54 mg of base (0.75 mg of salt) per day (as shown in the table below).
Patient’s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered. If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Dose schedule of pramipexole:
| Titration | Step Once Daily Evening Dose (mg of base) | Once Daily Evening Dose (mg of salt) |
|---|---|---|
| 1 | 0.088 | 0.125 |
| 2* | 0.18 | 0.25 |
| 3* | 0.35 | 0.50 |
| 4* | 0.54 | 0.75 |
* if needed
Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) pramipexole can be discontinued without tapering off. In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment. This effect was found to be similar across all doses.
It should be taken once daily 2-3 hours before bedtime.
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