Active Ingredient: Pramipexole
Pramipexole is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
0.26 - 3.3 mg
From 0.26 To 3.3 mg once every day
0.26 mg
The daily dose is administered in equally divided doses 3 times a day.
Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect.
Ascending dose schedule of pramipexole:
| Week | Dose (mg of base) | Total Daily Dose (mg of base) | Dose (mg of salt) <>_.Total Daily Dose (mg of salt) | |
|---|---|---|---|---|
| 1 | 3 × 0.088 | 0.264 | 3 × 0.125 | 0.375 |
| 2 | 3 × 0.18 | 0.54 | 3 × 0.25 | 0.75 |
| 3 | 3 × 0.35 | 1.1 | 3 × 0.5 | 1.50 |
If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day. However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg (of salt) per day.
The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day. During dose escalation in pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt). Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions. In clinical trials approximately 5% of patients were treated at doses below 1.1 mg of base (1.5 mg of salt). In advanced Parkinson’s disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended. It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with pramipexole, depending on reactions in individual patients.
Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome. Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt). Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day.
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