Mirapex

Mirapex is a drug intended for the treatment of parkinsonism.

The composition of the drug includes pramipexole monohydrate dichloride, which effectively fights with motor disruptions and disorders in the body. The main element of the drug at the cellular level affects the area that is responsible for violations of coordination of movements and the development of such an ailment as parkinson.

When taken orally, absorption of pramipexole from the digestive tract occurs rather quickly. Plasma Cmax is observed after approximately 120 minutes. The absolute bioavailability index exceeds 90%. The degree of absorption of pramipexole does not depend on its intake during meals, but increases the time to reach the plasma Cmax by about 60 minutes. Css is noted 48 hours after the start of taking Mirapox.

Clinical and pharmacological group

The antiparkinsonian drug is a stimulant of dopaminergic transmission in the central nervous system.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much does Mirapex cost? The average price in pharmacies is at the level of300 rubles.

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Form of issue and composition

It is produced by Mirapex in the form of tablets containing:

• , 25 mg, 5 mg or 1 mg pramipexole dihydrochloride monohydrate;
• Excipients: corn starch, mannitol, povidone, silicon dioxide colloid, magnesium stearate.

Also the preparation is issued in the form of tablets of the prolonged action of Mirapex PD containing:

• , 75 mg 5 mg mg, 3 mg or, mg of pramipexole dihydrochloride monohydrate;
• Auxiliary components: magnesium stearate, carbomer 941, hypromellose 2208, silicon dioxide colloid, corn starch.

Pharmacological effect

MIAPEX, due to stimulation of dopamine receptors, reduces the deficiency of motor activity in Parkinson's disease.

The active component of the drug, pramipexole, protects neurons from degradation, which develops in response to ischemia and the intake of levodopa and methamphetamines. Mirapex is used to correct a patient's condition in the "restless legs" syndrome.

Studies have shown that people with Parkinson's disease can take this medicine over a long period of time - more than three years, since this drug of its effectiveness is not loses.

Indications for use

Mirapex is used in the syndrome of "restless legs" and Parkinson's disease. With the last disease, this drug can be prescribed both as an independent medicine, and in combination with Levodopa.

Contraindications

Mirapex is contraindicated in patients with personal hypersensitivity to pramipexole or other pill components, as well as under the age of 18 years.

A careful prescription of the drug is required for patients with reduced blood pressure and renal insufficiency, as well as lactating and pregnant women.

Use in pregnancy and lactation

The effect of Mirapex on pregnant and lactating women has not been investigated.

Investigations carried out on animals to determine the effect of pramipexole on their reproductive function did not show a teratogenic effect of the drug, but revealed some embryotoxicity. In this regard, the appointment of Mirapex during pregnancy is allowed only in cases of a clear excess of the benefit of such treatment in comparison with the possible risk to the fetus.

The isolation of pramipexole with the milk of a nursing mother has not been studied. Since one of the effects of pramipexole is the inhibition of prolactin secretion, it is suggested that it suppresses lactation. For this reason, Mirapex should not be prescribed during breastfeeding.

Dosage and route of administration

The instructions for use indicate that the Mirapex tablets should be taken orally, regardless of food intake, washed down with water.

The daily dose should be evenly divided into 3 divided doses.

At the beginning of therapy, a daily dose of 75 mg is recommended, every 5-7 days it is gradually increased to achieve maximum therapeutic effect.

The following dose increase regimen should be observed:

• I week 75 mg per day, divided into 3 divided doses, 25 mg;
• II week 5 mg per day, divided into 3 divided doses, 5 mg;
• III week mg per day, divided into 3 divided doses, mg.

If a further increase in the daily dose is recommended, each week should be added at, 5 mg until the maximum allowable value is reached, in mg per day.

For maintenance therapy, the individual daily dose varies within the limits of 75 mg. Regardless of the stage of the disease, the effectiveness of MIAPEX was observed at a daily dose, mg, with the possibility that in some cases, the intake of more than, mg of the drug per day may have an additional therapeutic effect, especially at later stages of the disease, when the dose of levodopa is shown to reduce.

Termination of treatment with pramipexole is required to be carried out gradually, for several days.

Patients using the drug as part of complex therapy with levodopa during the supportive course, and with an increase in the dose of pramipexole, the dose of levodopa should be reduced to avoid an increased dopaminergic stimulation.

Initial therapy in patients with renal insufficiency with CC ≥ 50 ml / min does not require a reduction in the daily dose. If the SC is from 20 to 50 ml / min, then the reception starts with a daily dose, 5 mg divided by 2 times, 25 mg. With QC ≤ 20 ml / min, treatment is started with admission, 25 mg once a day.

When kidney function worsens during maintenance therapy, the daily dose of pramipexole should be reduced by the same the percentage to which the QC is reduced (for example, CC is less by 30%, therefore, by 30%, the daily dose pramipexole).

With SC from 20 to 50 ml / min, the daily dose can be divided into two doses, and if KK ≤ 20 ml / min - take it at a time.

Patients with hepatic insufficiency do not need a dose adjustment.

Side effects

During the application of Mirapex, these side effects were documented:

1. From the side of the organ of vision: visual impairment, including blurred vision and reduced visual acuity. From the respiratory system: shortness of breath.
2. From the side of the central nervous system: amnesia, dizziness, dyskinesia, headache, hyperkinesia, drowsiness, sudden onset of sleepiness, loss of consciousness.
3. From the side of the cardiovascular system: arterial hypotension.
4. Mental disorders: behavioral disorders (reflex symptoms of impulse control disorder and compulsive behavior), in particular overeating, painful craving for shopping, hypersexuality and pathological craving for gambling; sleep disturbance, confusion, mania, hallucinations, hyperphagia, insomnia, libido disorders (increase or decrease), paranoia, anxiety.
5. From the gastrointestinal tract: constipation, nausea, vomiting.
6. From the skin and subcutaneous tissue: itching, rashes and other allergic reactions.
7. Common diseases: fatigue, peripheral edema.
8. Infections and invasions: pneumonia.
9. Research: decrease in body weight, increase in body weight.

Overdose

There are no reports of severe overdose. There are presumed symptoms of an overdose: vomiting, nausea, hallucinations, hyperkinesia, lowering blood pressure, agitation.

There is no specific antidote. Therapy to eliminate overdose provides a set of procedures: gastric lavage, symptomatic treatment, dynamic observation, the appointment of neuroleptics when CNS is excited.

The effect of hemodialysis in this case is not established.

special instructions

Before you start using the drug, read the special instructions:

1. It was reported that with a sharp discontinuation of therapy, there was a symptom complex resembling a malignant neuroleptic syndrome.
2. Hallucinations and confusion of consciousness are among the most known undesirable phenomena in the therapy of dopamine agonists and levodopa. It should be noted that in the late stages of the disease with the combination of Mirapox and levodopa hallucinations were observed more often than with the use of one pramipexole at an early stage of the lesion. As a result, all patients should be warned about the possible development of hallucinations (mainly visual), which can negatively affect the ability to drive a car.
3. The reports in the literature indicate that the treatment of restless legs syndrome with dopaminergic drugs may lead to its amplification. This reinforcement was an earlier onset of symptoms in the evening (or even in the afternoon), an increase in this symptom and the spread of symptoms to other extremities. However, in a 26-week controlled clinical trial specifically dedicated to the study of this effect, there was no significant difference in the increase in clinical symptoms between pramipexole and placebo.
4. In patients with psychotic disorders, the appointment of dopamine agonists in combination with pramipexole is only possible after a preliminary assessment of the possible risk-benefit. Simultaneous administration of pramipexole with antipsychotic drugs should be avoided.
5. It is recommended to check eyesight at regular intervals or immediately after prescribing the drug in the presence of such disorders.
6. Patients and those who care about them should be aware that, in connection with the treatment of patients with dopaminergic drugs, there may be signs of abnormal behavior (symptoms impulsive and compulsive actions), such as a tendency to overeating (hyperphagia), obsessive desire to shop (pathological shopping), hypersexuality and pathological craving for gambling games. In such cases, a decision should be made to reduce the dose / gradually stop treatment.
7. Care should be taken when a patient has a serious cardiovascular disease. In connection with the risk of developing orthostatic hypotension during therapy with dopaminergic drugs, it is recommended to monitor blood pressure, especially at the beginning of treatment.
8. Epidemiological studies have shown that patients with Parkinson's disease have a high risk (2 to about 6 times higher) of melanoma than the general population. Whether this increased risk is a consequence of Parkinson's disease, or is associated with other factors, such as taking medications that are used in Parkinson's disease, is not known.
9. Patients should be informed of the possible sedative effect of Mirapecx and potentially dangerous episodes falling asleep during daily activities (including motor transport management), which can be observed in any period treatment. It is noted that in some cases, sleep is not preceded by a state of drowsiness. According to available data, after a decrease in dose or completion of therapy, episodes of falling asleep were not observed later.
10. Due to the reasons given above, patients and persons who care for them should be informed that in The period of taking pramipexole or other dopaminergic drugs should be carefully treated for possible development melanoma.

When applying the drug, it is possible to develop sedative effects, including drowsiness and falling asleep during daily activities. Since drowsiness is a frequent undesirable phenomenon with potentially serious consequences, patients should not drive the car or work with other complex mechanisms until they have acquired sufficient experience of treatment with Mirapex to assess whether it affects negatively or not on their mental and / or motor activity. If during treatment patients experience increased drowsiness or episodes of falling asleep during their daily activities (ie during a conversation, eating, etc.), they must give up driving, working with machinery and turn to the doctor.

Drug Interactions

When using the drug, it is necessary to take into account the interaction with other drugs:

1. With an increase in the dose of pramipexole, a reduction in the dose of levodopa is recommended, while the dose of other antiparkinsonian drugs should be maintained at a constant level.
2. Pramipexole is bound to an insignificant degree (& 0; 0%) by binding to plasma proteins and subjected to biotransformation. Therefore, interactions with other drugs that affect binding to plasma proteins, or excretion due to biotransformation are unlikely.
3. Selegiline and levodopa do not affect the pharmacokinetics of pramipexole. Paramipexole does not affect the overall absorption or elimination of levodopa.
4. Because of possible cumulative effects, patients should be cautioned when taking other sedative medications or ethanol in combination with the preparation Mirapex, as well as with the simultaneous administration of drugs that increase the concentration of pramipexole in plasma (for example, cimetidine).
5. Interaction with anticholinergic drugs and amantadine has not been studied. However, interaction with amantadine is possible, because drugs have a similar elimination mechanism. Anticholinergic drugs are generally metabolized, so interaction with pramipexole is unlikely.
6. It is necessary to avoid simultaneous administration of pramipexole with antipsychotic drugs (for example, if antagonism is expected).
7. Drugs that inhibit the active secretion of cationic drugs through the renal tubules (eg, cimetidine), or which are themselves excreted by active secretion through the renal tubules, can interact with pramipexole, which is manifested in a decrease in the clearance of one or both of the medicinal means. In the case of simultaneous use of such drugs (including amantadine) and pramipexole, you must pay attention to such signs of excessive dopamine stimulation, like dyskinesia, agitation or hallucinations. In such cases, it is necessary to reduce the dose.

Reviews

Reviews about Mirapecs at forums dedicated to discussing therapeutic drugs used to treat illness Parkinson's, in comparison with reviews of other similar drugs, are more positive character. Relatives of patients observe a lower incidence and severity of MIAPEX side effects, including drowsiness and hallucinations, as well as greater efficacy of this drug.

Among the negative aspects of this treatment, we can note a gradual decrease in the effect of Mirapec, which leads to the need to search for its substitutes.

Analogues

Analogues of Mirapecx are presented by medical preparations similar to it with their main action:

• Aberghin;
• Parlodel;
• Bromocriptine;
• Rolprin SR;
• Pronoran;
• Bromergon;
• Rekvip Modabit;
• Newpro;
• Decrying.

Before using analogues, consult your doctor.

Storage conditions and shelf life

According to the manufacturer's recommendations, it should be stored in a dry place, protected from moisture and sunlight. The optimum temperature regime of storage is from 15 to 30 ºС.

If these conditions are met, the shelf life of the tablets is 3 years. Keep away from children!

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