MIRAPEX PD PILLS 3 MG

Indications and usage

- symptomatic treatment of idiopathic Parkinson's disease (the drug can be used for monotherapy or in combination with levodopa).

Tablets of prolonged action should be taken 1 time / day, approximately at the same time of day. pills are swallowed whole with water, pills should not be chewed, crushed or crushed. pills can be taken regardless of the meal.

If the time of the next intake of the drug was missed, then if no more than 12 hours have passed since the usual time of intake, the drug should be taken in a daily dose. If more than 12 hours have passed, then the drug should not be taken, the next intake should take place the next day at the usual time.

Patients who are already taking Mirapex pills, you can transfer the pill to prolonged action Mirapex® PD during the day, in the same dose.

Initial therapy:

As presented below, the dose should be gradually increased from the starting dose of 0.375 mg / day and then increased every 5-7 days. To prevent unwanted side effects, the dose should be selected before reaching the maximum therapeutic effect.

If a further dose increase is necessary, the daily dose is increased by 0.75 mg at weekly intervals to a maximum dose of 4.5 mg / day.

Supportive treatment:

The therapeutic dose should be in the range from 0.375 mg to a maximum dose of 4.5 mg / day. In the main studies conducted in the initial and advanced stages of the disease, during the dose increase, the effectiveness of treatment was observed starting from a daily dose of 1.5 mg. This does not exclude the fact that in individual patients a daily dose above 1.5 mg may lead to an additional therapeutic effect.

This applies in part to patients with advanced disease who have been shown to reduce the dose of levodopa.

Treatment termination:

The dose of the drug should be reduced by 0.75 mg / day, until the daily dose reaches 0.75 mg. After that, the dose should be reduced to 0.375 mg / day.

Combined levodopa treatment

With simultaneous therapy with levodopa, it is recommended as the dose is increased, as well as during maintenance therapy with pramipexol, to reduce the dose of levodopa. This is necessary to prevent excessive dopaminergic stimulation.

Use in renal failure

Removal of pramipexole from the body depends on the function of the kidneys.

With initial therapy in patients with QA above 50 ml / min, a decrease in the daily dose or frequency of administration is not required.

In patients with CC from 30 to 50 ml / min, treatment should begin with a dose of 0.375 mg of the drug every other day. After one week of therapy, before increasing the daily dose, precautions should be taken and the therapeutic response and tolerance carefully assessed.If a further dose increase is necessary, the daily dose should be increased by 0.375 mg of pramipexole at weekly intervals to a maximum dose of 2.25 mg of pramipexole / day.

Data on treatment with sustained-release pills for patients with QA below 30 ml / min are not available. The appropriateness of using pills with regular release should be examined.

If kidney function has decreased during maintenance treatment, follow the recommendations presented above.

Use in liver failure

There is no need to reduce the dose in patients with liver failure.

Application of children and teenagers

The safety and efficacy of the drug in children and adolescents under the age of 18 years has not been established.

Adverse reactions

When using the drug, the following side effects are listed: abnormal behavior (symptoms of impulsive and compulsive actions), such as the tendency to overeat (hyperphagia), obsessive desire to shop (pathological shopping), hypersexuality and pathological gambling; abnormal dreams, amnesia, heart failure, confusion, constipation, delirium, dizziness, dyskinesia, shortness of breath, weakness, hallucinations, headache, hiccups, hyperkinesia, hyperphagia, decrease in blood pressure, the violation of the secretion of antidiuretic hormone, insomnia, libido, hysteria, insomnia, impaired secretion of antidiuretic hormone, insomnia, libido, hysteria, insomnia, impaired secretion of antidiuretic hormone, insomnia, libido, loss of blood pressure, insomnia, insomnia, antidiuretic hormone peripheral edema; pneumonia; itching, rash, and other hypersensitivity reactions; anxiety,drowsiness, sudden sleep, fainting, blurred vision (including diplopia, reduced visual acuity and clarity of perception), vomiting, changes in body weight, including loss of appetite.

The frequency of cases of lowering blood pressure during treatment with Mirapex® PD is no greater than with placebo. However, hypotension may occur in some patients at the beginning of treatment, especially if the dosage of the drug is increased too quickly. With drug treatment Mirapex® PD may be associated with a libido disorder (increase or decrease).

Patients taking pramipexole pills reported sudden falling asleep during daytime activities, including driving, which sometimes resulted in traffic accidents. At the same time, some of them did not report any warning signs, such as drowsiness, often observed in patients taking pramipexole pills in doses above 1.5 mg / day, which, according to modern knowledge of sleep physiology, always lead to a sudden sleep. A clear connection with the duration of treatment was not detected. At the same time, some patients also took other drugs with potentially sedative properties. In most cases where such information was available, there were no such episodes after dose reduction or discontinuation of treatment. Parkinson's patients treated with dopamine agonist therapy, including Mirapex® PD, especially in large doses, reported pathological gambling, increased libido and hypersexuality, which usually occurred after lowering the dose or stopping treatment.

During clinical studies and post-marketing follow-up, heart failure was reported in patients taking pramipexol. The causal relationship between treatment with pramipexol and heart failure has not been proven.

Inside the system-organ classes, the following categories are used by the frequency of occurrence of side effects: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000); not installed.

- children's and teenage age up to 18 years;

- hypersensitivity to pramipexol or to any component of the drug.

WITH caution should use the drug for renal failure, lower blood pressure.

The possibility of using the drug during pregnancy and lactation in humans has not been studied.

The possible effects of pramipexole on reproductive function were investigated in animal experiments. Pramipexol does not exhibit teratogenicity in rats and rabbits, but at doses toxic to pregnant females, it was embryotoxic in rats.

In pregnancy, the drug should be prescribed only if the potential benefit to the mother exceeds the potential risk to the fetus.

Removal of the drug in breast milk has not been studied.The concentration of the drug in rat milk was higher than in plasma. Since pramipexol inhibits prolactin secretion, it can be assumed that it also suppresses lactation. Therefore, the drug should not be taken during lactation.

The effects on fertility in humans have not been studied. The results of studies conducted on animals do not indicate the presence of direct or indirect signs of adverse effects on fertility in males.

Application for violations of the liver

There is no need to reduce the dose in patients with liver failure.

With caution in renal failure.

Use in children

Contraindicated in children under 18 years.

When prescribing the drug Mirapex® PD in patients with renal insufficiency, dose reduction is recommended.

Hallucinations and confusion are known side effects in the treatment of dopamine agonists and levodopa.

Hallucinations are more often observed during treatment with Mirapex.® PD in combination with levodopa in patients with advanced stage of Parkinson's disease than with monotherapy in patients with Parkinson's disease at an early stage of the disease. Patients should be informed that hallucinations may develop (mainly visual). Patients should be warned that hallucinations that affect their ability to drive can occur.

Patients and individuals who care for them should be aware that in connection with treating patients with dopaminergic agents, signs of abnormal behavior (symptoms of impulsive and compulsive actions), such as a tendency to overeating, an obsessive desire to shop (pathological shopping), may occur, hypersexuality and pathological gambling. In such cases, a decision should be considered to reduce the dose / phase out the treatment.

In patients with psychotic disorders, the administration of dopamine agonists in combination with pramipexol is possible only after a preliminary assessment of the possible risk-benefit. Simultaneous use of pramipexole with antipsychotic drugs should be avoided.

It is recommended to check the vision at regular intervals or immediately after the appointment of the drug in the presence of such violations.

Care must be taken when a patient has a severe cardiovascular disease. In connection with the risk of orthostatic hypotension, dopaminergic therapy is recommended to control blood pressure, especially at the beginning of treatment.

Patients should be warned about the possible sedative effect of the drug, including drowsiness and sudden sleep during daytime activities. Patients should be explained that in case of increased drowsiness or episodes of sudden sleep during daily activities (for example, during a conversation, eating, etc.) that can happen at any time during treatment,they should not drive or engage in potentially hazardous activities and should consult a doctor.

Epidemiological studies have shown that patients with Parkinson's disease have a high risk (from 2 to about 6 times higher) of developing melanoma than in the general population. Whether this increased risk is a consequence of Parkinson's disease, or is associated with other factors, such as the medication used for Parkinson's disease, is not known.

Due to the reasons given above, patients and people who care about them should be informed that while taking pramipexole or other dopaminergic drugs, one should be attentive to the possible development of melanoma.

There are reports that with the sudden cessation of therapy with dopaminergic drugs, symptoms of the neuroleptic malignant syndrome may be observed.

Influence on ability to drive motor transport and control mechanisms

Patients should be informed about the possibility of hallucinations (mostly visual) that may affect the ability to drive a car.

When using the drug may develop sedative effects, including drowsiness and falling asleep during daily activities. Since drowsiness is a frequent adverse event with potentially serious consequences, patients should not drive a car or work with other complex mechanisms until they have enough experience with Mirapex® PD, to assess whether it affects negatively or not on their mental and / or physical activity. Patients should be advised that if, during treatment, they experience increased drowsiness or episodes of falling asleep during daily activities (ie, during a conversation, eating, etc.), then they should give up driving, working with equipment, and consult a doctor.

Cases of overdose are not described.

Estimated symptoms characteristic of the pharmacodynamic profile of dopamine receptor agonists: nausea, vomiting, hyperkinesia, hallucinations, agitation and reduction of blood pressure.

Treatment: there is no established antidote; for an overdose, gastric lavage, symptomatic therapy, and dynamic observation are recommended. The effectiveness of hemodialysis has not been established. When signs of excitation of the central nervous system may appoint neuroleptics.

Pramipexol to a small extent (<20%) binds to plasma proteins and undergoes biotransformation. Therefore, interactions with other drugs that affect binding to plasma proteins, or excretion due to biotransformation are unlikely.

Drugs that inhibit the active secretion of cationic drugs through the renal tubules (for example, cimetidine), or that are themselves excreted through active secretion through the renal tubules, can interact with pramipexol, resulting in reduced clearance of one or both drugs. In the case of simultaneous use of such drugs (includingamantadine) and pramipexole should pay attention to such signs of excessive dopamine stimulation as dyskinesia, agitation or hallucinations. In such cases, it is necessary to reduce the dose.

Selegiline and levodopa do not affect the pharmacokinetics of pramipexole. Pramipexol does not affect the total absorption or elimination of levodopa. Interaction with anticholinergic drugs and amantadine has not been studied. However, interaction with amantadine is possible, since drugs have a similar elimination mechanism. Anticholinergic drugs are mainly excreted by the metabolic pathway, therefore interaction with pramipexol is unlikely.

When increasing the dose of the drug in patients with Parkinson's disease, a decrease in the dose of levodopa is recommended, while the dose of other anti-Parkinsonian drugs must be maintained at a constant level.

Due to possible cumulative effects, patients should be advised to exercise caution when taking other sedative medicines or alcohol in combination with Mirapex.® PD, as well as the simultaneous administration of drugs that increase the concentration of pramipexole in plasma (eg, cimetidine).

The drug is available on prescription.

The drug should be stored in a dry place inaccessible to children at a temperature not higher than 25 ° C.