Mirapex PD tablets 3 mg, 30 pcs. (Pramypeksol)

Release form

Sustained-release tablets.

Packing

Per pack 30 pcs.

Pharmacological action

Antiparkinsonian drug - dopamine receptor agonist. With high selectivity and specificity, it binds to dopamine receptors of the D2 subgroup, of which it has the most pronounced affinity for D3 receptors. It reduces the deficit of motor activity in Parkinson's disease by stimulating dopamine receptors in the striatum. Pramipexole inhibits dopamine synthesis, release and metabolism. In vitro pramipexole protects dopamine neurons from degeneration in response to ischemia or methamphetamine neurotoxicity.

Pramipexole in vitro protects neurons from the neurotoxicity of levodopa.

Reduces prolactin secretion (dose-dependent).

In clinical studies in healthy volunteers, in which an increase in the dose of Mirapex PD was carried out faster than it should (every 3 days), up to 4.5 mg / day, an increase in blood pressure and heart rate was observed. In studies on patients, this effect was not observed.

Indications

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

Contraindications

- children and adolescents under 18

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

Caution is advised to use the drug with renal failure, lowering blood pressure.

Use during pregnancy and lactation

It is possible if the expected effect of therapy exceeds the potential risk to the fetus (adequate and well-controlled studies on the use during pregnancy have not been carried out).

FDA category of effect on the fetus is C.

Breastfeeding should be discontinued during treatment (there is no evidence of penetration into human milk).

Special instructions

During treatment with pramipexole, episodes of sudden falling asleep against the background of daytime wakefulness were noted. Drowsiness usually develops when using Mirapex in doses of more than 1.5 mg / day. Episodes of sudden falling asleep against the background of daytime wakefulness arise against the background of already developed drowsiness. Factors that increase the risk of drowsiness include: the simultaneous administration of sedatives, sleep disorders, the simultaneous administration of drugs that increase the level of pramipexole in blood plasma (eg, cimetidine). Before prescribing Mirapex, the doctor must determine the presence of these risk factors. During therapy, it is necessary to monitor the patient's condition to identify a tendency to drowsiness. With the development of severe drowsiness in the daytime or the appearance of episodes of sudden falling asleep against the background of daytime wakefulness, which require active intervention, Mirapex should be discontinued. If it is necessary to continue therapy, the dose of the drug should be reduced and the patient should be advised to refrain from driving and other potentially dangerous activities.

During therapy with Mirapex, the incidence of arterial hypotension, as a rule, did not increase compared with placebo.

Elderly patients (65 years and older) require dose adjustment of Mirapex.

Since pramipexole is excreted by the kidneys, patients with kidney disease may require dose adjustment.

Influence on the ability to drive vehicles and operate machinery

The patient should refrain from driving and other potentially hazardous activities until the nature of the effect of the drug on the ability to concentrate and the speed of psychomotor reactions is established.

Use in pediatrics

Safety and effectiveness of the use of Mirapex in children have not been established.

Composition

1 tab.

pramipexole dihydrochloride monohydrate 3 mg

÷????hich corresponds to the content of pramipexole 0.26 mg

Excipients: hypromellose 2208 - 112.5 mg, corn starch - 119.375 mg, carbomer 941 - 15 mg, colloidal silicon dioxide - 1.5 mg - 1.5 mg, magnesium.

Dosage and administration of

Mirapex PD is taken orally. The initial dose at any stage of Parkinson's disease is 0.375 mg / day in 3 divided doses, if necessary, can be increased, but not more often than every 5-7 days according to the scheme: on the 1st day - by 0.375 mg / day, from the 2nd on the 7th - at 0.75 mg / day, the maintenance dose is 1.5-4.5 mg / day in 3 divided doses.

Side effects

From the central nervous system and peripheral nervous system: drowsiness, dyskinesia, hallucinations in some cases - insomnia. With a rapid reduction in the dose of pramipexole, and with a sharp withdrawal of the drug, a malignant antipsychotic syndrome was observed.

From the digestive system: nausea, constipation.

From the cardiovascular system: in some cases, at the beginning of treatment - arterial hypotension (especially with a gradual increase in dose over too short a time).

Other: in some cases, peripheral edema.

Drug interaction

With the simultaneous use of Mirapex and levodopa, dyskinesia may develop (in such cases, the dose of levodopa should be reduced).

There is no pharmacokinetic interaction between pramipexole and selegiline.

With simultaneous use with cimetidine, an increase in the concentration of pramipexole in blood plasma is noted. Other drugs that are secreted by the organic cation transport system in the kidneys can also increase plasma pramipexole concentrations.

Overdose

Symptoms: not established. There is no clinical experience with a significant overdose of Mirapex. One patient with a 10-year history of schizophrenia took 11 mg / d of pramipexole for 2 days, 2-3 times the recommended daily dose protocol. There were no undesirable effects due to dose increase. BP remained stable, although the heart rate increased to 100-120 beats / min.

Treatment: pramipexole antidote unknown. When symptoms of CNS stimulation occur, neuroleptics, either phenothiazine or butyrophenone derivatives, can be used, but the effectiveness of these drugs in eliminating the effects of Mirapex overdose has not been evaluated. In the treatment of overdose may require maintenance therapy, gastric lavage, the use of rehydration and detoxification of the body, ECG control.

Storage Conditions

The product should be stored in a dark place at 25 ° C (15 ° to 30 ° C).

Shelf life

3 years.

Deystvuyushtee substance

Pramipexole

Pharmacy terms Pharmacies

prescription

Dosage form

tablets

Possible product names

MIRAPEX PD 0, 003 N30 TABLE PROLONG

Mirapeks PD 3mg Tab. prolong. action X30

MIRAPEX PD TAB PROLONG.D 3MG No. 30

Mirapex PD tab. 3mg No. 30

MIRAPEX PD TAB. PROLONG. ACTION 3 MG No. 30



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