MIRAPEX ® tablets are used for the following indications:
Treatment of signs and symptoms of idiopathic Parkinson's disease in adults, as monotherapy (without levodopa) or in combination with levodopa throughout the course of the disease until the late stages, when the effect of levodopa is reduced or becomes unstable and there is suspicion of a therapeutic effect (the "on-off" phenomenon); symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, doses not exceeding 0.75 mg.
Composition
The active substance is pramipexole (one tablet contains 1 mg of pramipexole dihydrochloride monohydrate, which corresponds to 0.7 mg of pramipexole).
Excipients: mannitol (E 421), corn starch, colloidal anhydrous silicon dioxide, povidone, magnesium stearate.
Contraindication
Hypersensitivity to pramipexole or any other component of the drug.
Method of application
All dosage information refers to pramipexole as pramipexole dihydrochloride.
Parkinson's disease
The daily dose is administered in 3 equal doses.
Initial treatment. As shown below, the dose of the drug should be increased gradually, starting with 0.375 mg per day every 5-7 days. If patients do not experience intolerable side effects, the dose should be titrated to achieve maximum therapeutic effect.
Scheme of increasing the dose of the drug "MIRAPEX®":
1st week - 3x0.125 mg (total daily dose - 0.375 mg); 2nd week - 3x0.25 mg (total daily dose - 0.75 mg); 3rd week - 3x0.5 mg (total daily dose - 1.5 mg).
If further dose increases are necessary, the daily dose should be increased by 0.75 mg weekly to a maximum of 4.5 mg/day. However, it should be noted that the incidence of drowsiness increases with doses of 1.5 mg/day.
Maintenance therapy. The individual dose ranges from 0.375 mg to a maximum of 4.5 mg per day. When increasing the dose during the main studies, the treatment effect was observed starting from a daily dose of 1.5 mg. Further dose adjustment should be made based on clinical response and taking into account the occurrence of adverse reactions.
In clinical trials, approximately 5% of patients received doses less than 1.5 mg. In progressive Parkinson's disease, a dose higher than 1.5 mg per day may be beneficial in patients for whom a reduction in the levodopa dose is planned in combination therapy with levodopa. It is recommended to reduce the levodopa dose when increasing the dose of MIRAPEX ® and during maintenance therapy, depending on the response of individual patients.
Discontinuation of treatment. Abrupt discontinuation of dopaminergic therapy may lead to the development of neuroleptic malignant syndrome. The dose of pramipexole should be reduced by 0.75 mg to a daily dose of 0.75 mg. After this, the dose should be reduced to 0.375 mg per day.
Restless legs syndrome
The recommended starting dose of MIRAPEX ® is 0.125 mg once daily 2-3 hours before bedtime. For patients requiring additional symptom relief, the dose may be increased every 4-7 days to a maximum of 0.75 mg per day.
Scheme of increasing the dose of the drug "MIRAPEX®":
first titration stage: single daily evening dose - 0.125 mg; second titration stage (if necessary): single daily evening dose - 0.25 mg; third titration stage (if necessary): single daily evening dose - 0.50 mg; fourth titration stage (if necessary): single daily evening dose - 0.75 mg.
The patient's response to treatment should be assessed after 3 months and the need for continued therapy should be reconsidered. If treatment is interrupted for more than a few days, it should be restarted at the dose indicated above.
Discontinuation of treatment. Since the daily dose for the treatment of restless legs syndrome does not exceed 0.75 mg, MIRAPEX ® can be discontinued without a gradual dose reduction. In a 26-week placebo-controlled clinical study, recurrence of restless legs syndrome symptoms (increased severity of symptoms compared to baseline) was observed in 10% of patients (14 out of 135 patients) after abrupt discontinuation of pramipexole. This effect was observed for all doses.
Method of use - tablets should be taken orally with water, with or without food.
Application features
Pregnant women
The effect on pregnancy and lactation in humans has not been studied. MIRAPEX ® should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus.
Since treatment with MIRAPEX ® inhibits prolactin secretion, a decrease in lactation is possible. The excretion of MIRAPEX ® into breast milk has not been studied in women. This medicine is not recommended for use in women who are breastfeeding. If the use of MIRAPEX ® cannot be avoided, breastfeeding should be discontinued.
Children
Parkinson's disease. The safety and efficacy of MIRAPEX ® in children (under 18 years of age) have not been established. There is no evidence to support the use of MIRAPEX ® in children with Parkinson's disease.
Restless legs syndrome. The use of MIRAPEX ® is not recommended in children (under 18 years of age) due to insufficient data on safety and efficacy.
Tourette's syndrome. MIRAPEX ® should not be used in children (under 18 years of age) with Tourette's syndrome due to the negative benefit/risk ratio for this condition.
MIRAPEX ® may have a significant effect on the ability to drive or operate machinery. Hallucinations or drowsiness may occur.
Patients with drowsiness and/or episodes of sudden onset of drowsiness should refrain from driving and potentially hazardous activities where impaired attention increases the risk of serious or fatal injury when using the drug "MIRAPEX®".
Overdose
There is no clinical experience of significant overdose. Expected adverse effects related to the pharmacodynamic profile of a dopamine agonist include nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension. An antidote for dopamine agonist overdose has not been established. Neuroleptics may be administered if signs of central nervous system excitation occur. Treatment of patients with overdose may require general supportive measures including gastric lavage, fluid administration, administration of activated charcoal and monitoring of the electrocardiogram.
Side effects
Most adverse reactions are usually observed at the beginning of therapy, a significant part of them disappear even if therapy continues.
In patients with Parkinson's disease, the most common adverse reactions (≥ 5%) observed with pramipexole compared to placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucinations, headache and fatigue. The incidence of somnolence was increased at doses of 1.5 mg/day. The most common adverse reaction when taken in combination with levodopa was dyskinesia. Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too rapidly.
In patients with restless legs syndrome treated with pramipexole, common adverse reactions (≥ 5%) were nausea, headache, dizziness and fatigue. Nausea and fatigue were more frequently observed in women (20.8% and 10.5%, respectively) compared to men (6.7% and 7.3%, respectively) when treated with MIRAPEX ®.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
