Mirapex is a drug intended for the treatment of parkinsonism.
The composition includes pramipexole monohydrate dichloride, which effectively fights motor disruptions and disorders in the body. The main element of the drug at the cellular level affects the area that is responsible for impaired motor coordination and the development of such a disease as Parkinson's.
When taken orally, the absorption of pramipexole from the gastrointestinal tract occurs quite quickly. Plasma Cmax is observed after approximately 120 minutes. The absolute bioavailability rate exceeds 90%. The degree of absorption of pramipexole does not depend on its reception during meals, but increases the time to reach plasma Cmax by about 60 minutes. Css is observed 48 hours after the start of Mirapex.
Clinical and pharmacological group
Anti-Parkinsonian drug - stimulator of dopaminergic transmission in the central nervous system.
Pharmacy sales terms
It is released on prescription.
How much is Mirapex? The average price in pharmacies is about 300 rubles.
Release form and composition
Mirapex is produced in the form of tablets containing:
- 0.125 mg, 0.25 mg, or 1 mg of pramipexole dihydrochloride monohydrate;
- Excipients: corn starch, mannitol, poividone, colloidal silicon dioxide, magnesium stearate.
Also, the drug is available in the form of long-acting tablets Mirapex PD, containing:
- 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of pramipexole monohydrate dihydrochloride;
- Auxiliary components: magnesium stearate, carbomer 941, hypromellose 2208, colloidal silicon dioxide, corn starch.
Mirapex, by stimulating dopamine receptors, reduces the lack of motor activity in Parkinson's disease.
The active ingredient of the drug, pramipexol, protects neurons from degradation, which develops in response to ischemia and taking Levodopa and methamphetamines. Mirapex is used to correct the condition of the patient with restless legs syndrome.
Studies have shown that people suffering from Parkinson's disease can take this drug for a long period of time - more than three years, since this drug does not lose its effectiveness.
Indications for use
Mirapex is used in restless legs syndrome and Parkinson’s disease. In the latter case, this drug can be prescribed both as an independent drug and in combination with Levodopa.
Mirapex is contraindicated in patients with personal hypersensitivity to pramipexole or other components of the tablets, as well as under the age of 18 years.
Careful use of the drug requires patients with low blood pressure and renal failure, as well as lactating and pregnant women.
Use during pregnancy and lactation
The effect of Mirapex on pregnant and lactating women has not been studied.
Studies on animals in order to ascertain the effect of pramipexole on their reproductive function did not show the 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 benefits 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 inhibition of secretion of prolactin, suggest its suppressive effect on lactation. For this reason, Mirapex should not be prescribed during breastfeeding.
Dosage and method of use
The instructions for use indicate that Mirapex tablets should be taken orally, regardless of the meal, washed down with water.
The daily dose should be evenly divided into 3 doses.
At the beginning of therapy, a daily dose of 0.375 mg is recommended, every 5-7 days it is gradually increased until the maximum therapeutic effect is achieved.
It is necessary to observe the following scheme for increasing the dose:
- I week: 0.375 mg per day, divided into 3 doses of 0.125 mg;
- Week 2: 0.75 mg per day, divided into 3 doses of 0.25 mg;
- Week III: 1.5 mg per day, divided into 3 doses of 0.5 mg.
If it is recommended to further increase the daily dose, 0.75 mg should be added every week until the maximum permissible value is reached - 4.5 mg per day.
For maintenance therapy, the individual daily dose varies within the limits of 0.375-4.5 mg. Regardless of the stage of the disease, the effectiveness of Mirapex was noted with a daily dose of 1.5 mg, while it is possible that in some cases, taking more than 1.5 mg of the drug per day may have an additional therapeutic effect, especially in the later stages of the disease, when the dose levodopa shown to reduce.
Termination of treatment with pramipexol is required to be carried out gradually over several days.
Patients using the drug as part of combination therapy with levodopa, during the maintenance course, as well as increasing the dose of pramipexole, need to reduce the dose of levodopa to avoid 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 QC is from 20 to 50 ml / min, then the reception begins with a daily dose of 0.25 mg divided by 2 times in 0.125 mg. With QC ≤ 20 ml / min, treatment begins with taking 0.125 mg once a day.
When kidney function deteriorates during maintenance therapy, the daily dose of pramipexole must be reduced by the same percentage that the CC decreases (for example, the CC is reduced by 30%, therefore, the daily dose of pramipexole must be reduced by 30%).
With QC from 20 to 50 ml / min, the daily dose can be divided into two doses, and if QC ≤ 20 ml / min, it can be taken at one time.
Patients with liver failure dose adjustment is not required.
During the use of Mirapex, the following side effects were recorded:
- On the part of the organ of vision: blurred vision, including blurred and reduced visual acuity. On the part of the respiratory system: shortness of breath.
- From the side of the central nervous system: amnesia, dizziness, dyskinesia, headache, hyperkinesia, drowsiness, sudden onset of drowsiness, loss of consciousness.
- Since the cardiovascular system: arterial hypotension.
- Mental disorders: behavioral disorders (reflex symptoms of impulse control disorders 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.
- On the part of the digestive tract: constipation, nausea, vomiting.
- On the part of the skin and subcutaneous tissue: itching, rashes and other allergic reactions.
- Common diseases: fatigue, peripheral edema.
- Infections and invasions: pneumonia.
- Research: weight loss, weight gain.
There are no cases of severe overdose. There are suspected symptoms of overdose: vomiting, nausea, hallucinations, hyperkinesia, lower blood pressure, agitation.
There is no specific antidote. Therapy to eliminate overdose involves a set of procedures: gastric lavage, symptomatic treatment, dynamic observation, the appointment of antipsychotics during excitation of the central nervous system.
The effect of hemodialysis in this case is not installed.
Before you start using the drug, read the specific instructions:
- It was reported that with a sharp cessation of therapy, a symptom complex resembling a neuroleptic malignant syndrome was observed.
- Hallucinations and confusion are among the most well-known adverse events in the treatment of dopamine agonists and levodopa. It should be noted that in the later stages of the disease, when Mirapex was combined with levodopa, hallucinations were observed more often than when using pramipexole alone at the early stage of the lesion. As a result, all patients should be warned about the possible development of hallucinations (mostly visual), which can adversely affect the ability to drive a car.
- Reports in the literature suggest that the treatment of restless legs syndrome with dopaminergic drugs may lead to its enhancement. This enhancement was an earlier onset of symptoms in the evening (or even in the afternoon), an increase in these symptoms and the spread of symptoms to other limbs. However, in a 26-week controlled clinical study specifically devoted to the study of this effect, there was no significant difference in the amplification of clinical symptoms between the pramipexole and placebo groups.
- 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.
- Patients and individuals who care for them should be aware that, in connection with treating patients with dopaminergic drugs, signs of abnormal behavior (symptoms of impulsive and compulsive actions), such as a tendency to overeating (hyperphagia), an obsessive desire to shop (pathological shopping), hypersexuality and pathological craving for gambling. In such cases, a decision should be made to reduce the dose / phase out the treatment.
- Care must be taken when a patient has a severe cardiovascular disease. In connection with the risk of orthostatic hypotension during dopaminergic therapy, it is recommended to monitor blood pressure, especially at the beginning of treatment.
- 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 medications that are used in Parkinson's disease, is not known.
- Patients should be informed about the possible sedative effect of Mirapex and the potentially dangerous episodes of sleep during daily activities (including driving) that can occur during any period of treatment. It is noted that in some cases, sleepiness is not preceded by a state of drowsiness. According to the available data, after a dose reduction or completion of therapy, no episodes of sleep were observed later.
- Due to the reasons given above, patients and individuals 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.
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 gained sufficient experience with Mirapex treatment to assess whether it affects negatively or not their mental and / or motor activity. If during treatment, patients experience increased drowsiness or episodes of falling asleep during daily activities (ie, during a conversation, eating, etc.), they should give up driving, working with equipment and consult a doctor.
When using the drug, you must consider the interaction with other drugs:
- When increasing the dose of pramipexole, a decrease in the dose of levodopa is recommended, while the dose of other anti-Parkinsonian drugs must be maintained at a constant level.
- 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.
- Selegiline and levodopa do not affect the pharmacokinetics of pramipexole. Paramipexol does not affect the total amount of absorption or elimination of levodopa.
- Because of possible cumulative effects, patients should be advised to exercise caution when taking other sedative drugs or ethanol in combination with Mirapex, as well as when taking drugs that increase the concentration of pramipexole in plasma (eg, cimetidine).
- 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 mainly metabolized, so interaction with pramipexol is unlikely.
- Concurrent use of pramipexole with antipsychotics should be avoided (for example, if antagonism is expected).
- 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, which is reflected in a decrease in the clearance of one or both drugs. In the case of simultaneous use of such drugs (including amantadine) and pramipexole, it is necessary to pay attention to such signs of excessive dopamine stimulation as dyskinesia, agitation or hallucinations. In such cases, it is necessary to reduce the dose.
Mirapex reviews on discussion forums for therapeutic drugs used for the treatment of Parkinson's disease, compared with reviews of other similar drugs, are more positive. Relatives of patients observe a lower frequency and severity of side effects of Mirapex, including drowsiness and hallucinations, as well as greater efficacy of this drug.
Among the negative aspects of such treatment can be noted a gradual decrease in the action of Mirapex, which leads to the need to search for its substitutes.
Analogues of Mirapex are represented by medicinal preparations similar to its main action:
- Role of CP;
- Requipo Modutab;
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 storage temperature is from 15 to 30 ºС.
Under these conditions, the shelf life of tablets is 3 years. Keep out of the reach of children!