Mirapex 0,25 mg 30 tablets — Made in Germany — Free Delivery
(Mirapex )
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Description Mirapex 0,25 mg 30 tablets — Made in Germany — Free Delivery
Product description
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 during the course of the disease until the advanced stages, when the effect of levodopa is reduced or becomes unstable and there is a fluctuation in the therapeutic effect (on-off phenomenon);
- symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, doses not exceeding 0.75 mg.
Compound
The active substance is pramipexole (one tablet contains pramipexole dihydrochloride monohydrate 0.25 mg, which corresponds to 0.18 mg pramipexole).
Excipients: mannitol (E 421), corn starch, anhydrous colloidal silicon dioxide, povidone, magnesium stearate.
Contraindications
Hypersensitivity to pramipexole or to any other component of the preparation.
Mode of application
All dosing information refers to pramipexole as pramipexole dihydrochloride.
Parkinson's disease
The daily dose is used in 3 divided doses.
initial treatment. As shown below, the dose of the preparation should be increased gradually, from an initial 0.375 mg per day every 5-7 days. If patients do not experience intolerable side effects, the dose should be titrated until the maximum therapeutic effect is achieved.
The scheme for increasing the dose of 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 it is necessary to further increase the dose, the daily dose should be increased by 0.75 mg weekly to a maximum of 4.5 mg per day. However, it should be noted that the incidence of drowsiness increases with doses of 1.5 mg per day.
supportive 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 effect of treatment was observed starting with a daily dose of 1.5 mg. Further dose adjustments should be made based on clinical response and the occurrence of adverse reactions.
In clinical studies, about 5% of patients took doses of less than 1.5 mg. In advanced Parkinson's disease, a dose higher than 1.5 mg per day may be useful in patients for whom a reduction in the dose of levodopa is planned in combination therapy with levodopa. It is recommended to reduce the dose of levodopa in case of increasing the dose of Mirapex® and during maintenance therapy, depending on the response of individual patients.
Termination of treatment. Sudden discontinuation of dopaminergic therapy may lead to the development of neuroleptic malignant syndrome. The dose of pramipexole should be reduced according to the 0.75 mg regimen to a daily dose of 0.75 mg. Thereafter, the dose should be reduced to 0.375 mg per day.
restless leg syndrome
The recommended initial dose of Mirapex® is 0.125 mg once a day 2-3 hours before bedtime. For patients who require additional symptomatic relief, the dose may be increased every 4 to 7 days up to a maximum of 0.75 mg per day.
The scheme for increasing the dose of Mirapex®:
- the first stage of titration: a single daily evening dose - 0.125 mg;
- the second stage of titration (if necessary): a single daily evening dose - 0.25 mg;
- the third stage of titration (if necessary): a single daily evening dose - 0.50 mg;
- the fourth stage of titration (if necessary): a single daily evening dose - 0.75 mg.
It is necessary to evaluate the patient's response to treatment after 3 months and reconsider the need to continue therapy. If treatment is interrupted for more than a few days, restart at the dose indicated above.
Termination 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 trial, relapse of restless legs syndrome symptoms (increased severity of symptoms from baseline) was observed in 10% of patients (14 of 135 patients) after sudden discontinuation of pramipexole. This effect was observed for all doses.
Method of use - tablets must be taken orally with water, with or without food.
Application features
pregnant
The effect on pregnancy and lactation in humans has not been studied. "Mirapex®" can be used by pregnant women only if the potential benefit outweighs the potential risk to the fetus.
Since Mirapex® treatment suppresses prolactin secretion, a decrease in lactation is possible. Excretion of Mirapex® into breast milk has not been studied in women. This preparation is not recommended for 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 justification for the use of Mirapex® in children with Parkinson's disease.
Restless legs syndrome. The use of Mirapex® is not recommended for children (under the age of 18 years) due to insufficient data on safety and efficacy.
Tourette 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 disease.
Drivers
"Mirapex®" may have a significant effect on the ability to drive vehicles or work with mechanisms. You may experience hallucinations or drowsiness.
Patients with drowsiness and / or episodes of a sudden attack of drowsiness should refrain from driving and potentially hazardous activities when impaired attention increases the risk of serious injury or death when using Mirapex®.
Overdose
There is no clinical experience of significant overdose. Expected side effects associated with 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. In case of signs of excitation of the central nervous system, antipsychotics can be prescribed. Treatment of overdose patients may require general supportive measures along with gastric lavage, fluid administration, activated charcoal, and electrocardiogram monitoring.
Side effects
Most adverse reactions are usually observed at the beginning of therapy, a significant proportion of them disappear even if therapy is continued.
In patients with Parkinson's disease treated with pramipexole compared with placebo, nausea, dyskinesia, arterial hypotension, dizziness, drowsiness, insomnia, constipation, hallucinations, headache and fatigue were common (≥ 5%) adverse reactions.
The incidence of drowsiness increased with doses of 1.5 mg per day. The most common adverse reaction when taken in combination with levodopa was dyskinesia. Hypotension may occur early in treatment, especially if pramipexole is titrated too rapidly.
In patients with restless leg syndrome treated with pramipexole, nausea, headache, dizziness, and fatigue were common (≥ 5%) adverse reactions. Nausea and fatigue were more frequently observed in women (20.8% and 10.5%, respectively) compared with men (6.7% and 7.3%, respectively) during treatment with Mirapex®.
Storage conditions
Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life - 3 years.
Tags: Mirapex
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