Pramipexole
Teva
1492 Items
2019-09-19
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Clinical Pharmacology
Pramipexole-Teva - dopaminergic, anti-Parkinsonian.
Pharmacodynamics
Pramipexole is a dopamine receptor agonist, with high selectivity and specificity binds to dopamine D2receptors, has a pronounced affinity for dopamine D3-receptors.
Reduces the lack of motor activity in Parkinson's disease by stimulating dopamine receptors in the striatum.
Pramipexol inhibits the synthesis, release and metabolism of dopamine, protects dopaminergic neurons from degeneration arising in response to ischemia or methamphetamine neurotoxicity.
In clinical studies, the efficacy of pramipexol treatment in the late stages of Parkinson's disease was shown, during which there was a significant decrease in the number of motor disorders and a much later development of complications compared with levodopa monotherapy.
Pharmacokinetics
Suction.After ingestion, pramipexol is quickly and completely absorbed, reaching Cmax approximately 1–3 h in plasma. The absolute bioavailability of pramipexol exceeds 90%. The rate of absorption decreases with food intake, however, food intake does not affect the total amount of absorption. Pramipexole is characterized by linear kinetics and relatively small concentration variability between individual patients.
Distribution.Vd makes 400 l. Plasma protein binding is less than 20%.
Metabolism and excretion.Slightly metabolized in the body. About 90% of the dose is excreted by the kidneys (80% - unchanged) and less than 2% - with feces. The total clearance of pramipexole is about 500 ml / min, renal clearance is about 400 ml / min.
The value of the final T1/2 is 8 hours in young healthy volunteers and about 12 hours in older people.
Indications
Symptomatic treatment of Parkinson's disease as monotherapy or in combination with levodopa drugs at an advanced stage of the disease, when the effects of levodopa weaken or become intermittent and fluctuations of the therapeutic effect (on-off) occur.
Composition
Excipients: mannitol; MCC; carboxymethyl starch sodium; Povidone K25; colloidal silicon dioxide; magnesium stearate; sodium fumarate
Pramipexole is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Pramipexole-Teva | Teva | Israel | pills |
| Mirapex PD | Boehringer Ingelheim | Austria | pills |
| Mirapex | Boehringer Ingelheim | Austria | pills |
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Dosage and Administration
Pramipexole is taken orally. The initial dose at any stage of Parkinson's disease - 0.375 mg / day in 3 doses, if necessary, may increase, 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 - 0.75 mg / day; maintenance dose - 1.5-4.5 mg / day in 3 divided doses.
Adverse reactions
From the side of the central nervous system and peripheral nervous system: drowsiness, dyskinesias, hallucinations; in some cases - insomnia. With a rapid decrease in the dose of pramipexole, as well as with a sharp withdrawal of the drug, a neuroleptic malignant syndrome was observed.
From the digestive system: nausea, constipation.
Since the cardiovascular system: in some cases, at the beginning of treatment - arterial hypotension (especially with a gradual increase in dose for too short a time).
Other: in some cases, peripheral edema.
Contraindications
With care: renal failure, lowering blood pressure.
Drug interactions
With the simultaneous use of Pramipexole and levodopa may develop dyskinesia (in such cases, the dose of levodopa should be reduced).
There is no pharmacokinetic interaction between pramipexol and selegiline.
With simultaneous use with cimetidine, an increase in plasma concentration of pramipexole is noted. Other drugs that are secreted by the organic cation transport system in the kidney can also contribute to an increase in plasma concentration of pramipexole.
Pregnancy and Lactation
The effect on 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 show teratogenicity in rats and rabbits, but at doses toxic to pregnant females, it was embryotoxic in rats.
During pregnancy, the drug should be prescribed only if the potential benefit to the mother outweighs the potential risk to the fetus.
Removal of the drug in breast milk has not been studied. Since pramipexol inhibits prolactin secretion, it can be assumed that it also suppresses lactation. Therefore, the drug should not be taken during lactation.
Special instructions
During treatment with pramipexol, episodes of sudden falling asleep were noted against the background of daytime wakefulness. Drowsiness usually develops with the use of Pramipexole in doses of more than 1.5 mg / day. Episodes of sudden sleep on the background of daytime wakefulness occur on the background of the already developed sleepiness. Factors that increase the risk of drowsiness include: simultaneous use of sedatives, sleep disorders, simultaneous use of drugs that increase the level of pramipexole in the blood plasma (for example, cimetidine). Before prescribing Pramipexole, the physician should determine the presence of the indicated risk factors. During therapy, it is necessary to monitor the patient's condition in order to identify the propensity for drowsiness. With the development of severe daytime sleepiness or the appearance of episodes of sudden sleep on the background of daytime wakefulness, which require active intervention, Pramipexole should be canceled. If necessary, continue therapy should reduce the dose of the drug and recommend that the patient refrain from driving and other potentially dangerous activities.
During the treatment with Pramipexole, the incidence of arterial hypotension, as a rule, did not increase compared with placebo.
Elderly patients (65 years and older) require dose adjustment of Pramipexole.
Since pramipexol is excreted by the kidneys, patients with kidney disease may need a dose adjustment.
Influence on ability to drive motor transport and control mechanisms
The patient should refrain from driving and other potentially hazardous activities until the nature of the drug's effect on the ability to concentrate and the speed of psychomotor reactions is established.
Use in Pediatrics
Safety and effectiveness of Pramipexole in children has not been established.
Overdosage
Symptoms: not installed. Clinical experience with a significant overdose of Pramipexole is absent.One patient with a 10-year history of schizophrenia took 11 mg / day of pramipexole for 2 days; this is 2-3 times more than the daily dose recommended by the protocol. No adverse effects were noted due to an increase in dose. Blood pressure remained stable, although the heart rate increased to 100-120 beats / min.
Treatment: antidote pramipexole is unknown. If symptoms of CNS stimulation appear, neuroleptics can be used - derivatives of phenothiazine or butyrophenone, however, the effectiveness of these drugs in eliminating the effects of Pramipexole overdose has not been evaluated. In the treatment of overdose may require maintenance therapy, gastric lavage, the use of means for rehydration and detoxification of the body, ECG monitoring.
- Brand name: Mirapex
- Active ingredient: Pramipexole
- Dosage form: pills
- Manufacturer: Teva
- Country of Origin: Israel
Studies and clinical trials of Pramipexole (Click to expand)
- Comparison of pramipexole, fluoxetine, and placebo in patients with major depression
- Modafinil treatment of pramipexole-associated somnolence
- A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications
- Development and validation of a sensitive LC-MS/MS method with electrospray ionization for quantitation of pramipexole in human plasma: application to a clinical pharmacokinetic study
- Development and validation of GC/MS method for determination of pramipexole in rat plasma
- Quantification of pramipexole in human plasma by liquid chromatography tandem mass spectrometry using tamsulosin as internal standard
- Pramipexole in treatment-resistant depression: An extended follow-up
- Pramipexole modulates the neural network of reward anticipation
- Inhibition by R(+) or S(–) pramipexole of caspase activation and cell death induced by methylpyridinium ion or beta amyloid peptide in SH-SY5Y neuroblastoma
- Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole
- Tinnitus control by dopamine agonist pramipexole in presbycusis patients: A randomized, placebo-controlled, double-blind study
- Double-blind, single-dose, cross-over study of the effects of pramipexole, pergolide, and placebo on rest tremor and UPDRS part III in Parkinson's disease
- Randomized, double-blind study of pramipexole with placebo and bromocriptine in advanced Parkinson's disease
- Randomized, double-blind, 3-month parallel study of the effects of pramipexole, pergolide, and placebo on parkinsonian tremor
- Modafinil and pramipexole-associated somnolence
- Pramipexole-treated Parkinson's disease during pregnancy
- Long-term efficacy and safety of pramipexole in advanced Parkinson's disease: Results from a European multicenter trial
- Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome
- Increase in body weight after pramipexole treatment in Parkinson's disease
- Efficacy of pramipexole in restless legs syndrome: A six-week, multicenter, randomized, double-blind study (effect-RLS study)
- Impact of pramipexole on the onset of levodopa-related dyskinesias
- An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease
- Pramipexole and gender identity disorder: Expanding the phenotype of hypersexuality in Parkinson's disease
- Pramipexole combined with levodopa improves motor function but reduces dyskinesia in MPTP-treated common marmosets
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