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Pronoran has anti-Parkinsonian effect.
The active substance piribedil is a dopaminergic receptor agonist. Penetrates into the bloodstream of the brain, where it binds to dopaminergic receptors in the brain, showing high affinity and selectivity for dopaminergic receptors of type D2 and D3. The mechanism of action of piribedil determines the basic clinical properties of the drug for the treatment of Parkinson's disease both in the initial and in the later stages of the disease with an impact on all the main motor symptoms. Piribedil, in addition to acting on dopaminergic receptors, exhibits antagonist activity of two main α-adrenergic receptors of the CNS (such as α2A and α2C). Synergistic action of piribedil as α antagonist2-receptors and dopaminergic receptor agonist of the brain have been demonstrated in various animal models with Parkinson's disease: long-term use of piribedil leads to less severe dyskinesia than the use of levodopa, with similar efficacy with respect to reversible akinesia associated with Parkinson's disease.
In pharmacodynamic studies in humans, cortical electrogenesis of the dopaminergic type was shown, both on awakening and during sleep, with clinical activity in relation to various functions controlled by dopamine, this activity was demonstrated using a behavioral or psychometric scale. In healthy volunteers, piribedil has been shown to improve attention and vigilance associated with cognitive tasks.
The effectiveness of Pronoran® as monotherapy or in combination with levodopa in the treatment of Parkinson's disease was studied in three double-blind, placebo-controlled clinical studies (2 studies compared with placebo and one compared with bromocriptine). The research involved 1103 patients of stage 1–3 on the scale of Hyun and Yar (Hoehn & jahr), 543 of which received Pronoran®.
It is shown that Pronoran® at a dosage of 150–300 mg / day, it is effective in acting on all motor symptoms with a 30% improvement according to a unified Parkinson's disease rating scale (UPDRS, Part III - motor) for more than 7 months with monotherapy and 12 months in combination with levodopa. Improvement of the second part of the scaleUPDRS - activity in everyday life - was evaluated in the same values.
In monotherapy, a statistically significant ratio of patients requiring emergency treatment with levodopa who received piribedil (16.6%) was less than in the group of patients who received placebo (40.2%).
The presence of dopaminergic receptors in the vessels of the lower extremities explains the vasodilating action of piribedil (increases blood flow in the vessels of the lower extremities).
Piribedil is rapidly and almost completely absorbed from the gastrointestinal tract and is rapidly distributed.
Cmax Piribedila in plasma is achieved 3–6 hours after oral administration of a controlled release dosage form. Plasma protein binding is medium (unbound fraction is 20–30%). Due to the low binding of piribedil with plasma proteins, the risk of drug interaction when used with other drugs is low.
Piribedil plasma elimination is biphasic in nature and consists of an initial phase and a second slower phase, resulting in maintaining a stable concentration of piribedil in blood plasma for more than 24 hours.
During the combined pharmacokinetic analysis, it was shown that T1/2 Piribedila after the on / in the introduction of an average of 12 hours and does not depend on the administered dose.
Piribedil is extensively metabolized in the liver and is excreted mainly in the urine: 75% of absorbed piribedil is excreted by the kidneys as metabolites.
- supportive symptomatic therapy for chronic cognitive impairment and neurosensory deficiency in the process of aging (attention, memory, etc.);
- Parkinson's disease: monotherapy (in forms mainly involving tremor) and in combination therapy with levodopa in both the initial and later stages of the disease, especially in forms involving tremor;
- as an auxiliary symptomatic therapy for intermittent claudication resulting from obliterating diseases of lower limb arteries (stage 2 according toLeriche andFontaine);
- treatment of the symptoms of ophthalmologic diseases of ischemic genesis (reduced visual acuity, narrowing of the visual field, reduced color contrast, etc.).
Active substance: piribedil 50 mg;
Excipients: magnesium stearate - 5 mg; Povidone - 20 mg; talc - 130 mg;
Shell: carmellose sodium — 0.71 mg; polysorbate 80 —0,3 mg; Ponso 4R crimson dye - 3.87 mg; Povidone - 6.31 mg; sodium bicarbonate — 0.15 mg; colloidal silicon dioxide — 0.27 mg; sucrose - 57.17 mg; talc - 50.37 mg; titanium dioxide - 0.78 mg; beeswax white - 0.07 mg
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Dosage and Administration
Inside after eating, without chewing, squeezed 1/2 cup of water.
By all indications, except Parkinson's disease - 50 mg (1 tablet) 1 time per day. In more severe cases, 50 mg 2 times a day.
Parkinson's disease: monotherapy - from 150 to 250 mg (3 to 5 tablets) per day, it is recommended to divide into 3 doses; if necessary, taking the drug in a dose of 250 mg is recommended to take 2 tablets of 50 mg in the morning and afternoon, and 1 tablet in the evening; in combination with levodopa preparations - 150 mg (3 tablets) per day, it is recommended to be divided into 3 doses.
When selecting the dose in case of its increase, it is recommended to titrate the dose, gradually increasing it by 1 tablet (50 mg) every 2 weeks.
From the digestive tract: minor gastrointestinal symptoms (nausea, vomiting, flatulence), these adverse reactions are reversible in the selection of the appropriate individual dose. Selection of the dose by gradually increasing the dosage (50 mg every 2 weeks until the recommended dose is reached) leads to a significant reduction in the manifestation of these side effects.
From the side of the central nervous system: mental disorders, such as confusion, hallucinations, agitation or dizziness, which disappear when the drug is withdrawn, may occur.
Reception of piribedil is accompanied by drowsiness and in extremely rare cases may be accompanied by severe sleepiness in the daytime, up to a sudden sleep.
From the CCC: hypotension, orthostatic hypotension with loss of consciousness or malaise, or blood pressure lability.
Allergic reactions: the risk of allergic reactions to the dye crimson, which is part of the drug.
Carefully: Due to the fact that the preparation contains sucrose, patients with intolerance to fructose, glucose or galactose, as well as to patients with a deficiency of sucroisomaltase (a rare metabolic disorder), the drug is not recommended.
In connection with the mutual antagonism between dopaminergic anti-parkinsonian drugs and antipsychotics, the simultaneous appointment with antipsychotics (with the exception of clozapine) is contraindicated.
1. Patients with extrapyramidal syndrome caused by taking antipsychotics should be prescribed anticholinergic drug therapy and dopaminergic antiparkinsonian drugs should not be prescribed (due to the blocking of dopaminergic receptors by neuroleptics).
2. Dopaminergic anti-parkinsonic drugs can cause or exacerbate psychotic disorders. If the prescription of neuroleptics to patients with Parkinson's disease who are receiving treatment with dopaminergic anti-parkinsonian drugs is required, the dose of the latter should be gradually reduced until the final withdrawal (the sudden cancellation of dopaminergic drugs is associated with the risk of developing neuroleptic malignant syndrome).
3. Antiemetic neuroleptics (antiemetic drugs should not be used that do not cause extrapyramidal symptoms).
Due to the mutual antagonism between dopaminergic anti-parkinsonian drugs and tetrabenazine, simultaneous administration of these drugs is not recommended.
Do not use piribedila with alcohol.
Caution must be exercised in the appointment of piribedil with other drugs that have a sedative effect.
In some patients (especially in patients with Parkinson's disease), while receiving piribedil, a state of severe drowsiness sometimes occurs, sometimes even falling asleep suddenly. This phenomenon is extremely rare, but nevertheless, patients driving a car and / or working on equipment that requires a high degree of attention should be warned about this. If such reactions occur, it is necessary to consider reducing the dose of piribedil or discontinuing therapy with this drug.
Given the age of the population receiving PIribedil therapy, the risk of falls, which can be caused by sudden sleep, hypotension, or confusion, should be considered.
Patients and their caregivers should be warned about the possible symptoms of behavior disorder (gambling addiction, increased libido and hypersexuality, obsessive desire to shop and compulsive overeating) while taking the drug. If you experience these symptoms, you should consider reducing the dose or phasing out drug therapy.
The dye crimson, which is part of the drug, in some patients increases the risk of an allergic reaction.
Impact on the ability to drive vehicles and mechanisms. Patients who had episodes of severe drowsiness and / or sudden sleep during piribedil therapy should refrain from driving vehicles and equipment requiring a high degree of attention until these reactions disappear.
Symptoms: vomiting, which is due to the effect on the chemoreceptor trigger zone, the lability of AD (increased or decreased), impaired gastrointestinal function (nausea, vomiting).
Treatment: drug withdrawal, symptomatic therapy.
- Brand name: Pronoran
- Active ingredient: Piribedil
- Dosage form: Pills
- Manufacturer: Servier
- Country of Origin: France
Studies and clinical trials of Piribedil (Click to expand)
- A randomized, double-blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease
- Synthèse du méthanesulfonate de (pyrimidyl-2)-1-(méthylène)-(dioxy-3, 4-benzyl)-4-pipérazinium (Piribedil) marqué au 14C
- Repeated administration of piribedil induces less dyskinesia than L-dopa in MPTP-treated common marmosets: A behavioural and biochemical investigation
- Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: A 6-month, randomized, placebo-controlled study
- Piribedil for restless legs syndrome: A pilot study
- End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients: A pharmacokinetic/pharmacodynamic, randomized, double-blind study
- The Parkinson–Control study: A 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease
- Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study
- Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo-controlled, randomized, double-blind, cross-over study
- DA agonists - Non-Ergot derivaties: Piribedil
- An appraisal of the antiparkinsonian activity of piribedil in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-treated common marmosets
- Chemically modified carbon paste electrode for the potentiometric flow injection analysis of piribedil in pharmaceutical preparation and urine
- Determination of piribedil in biological materials by gas—liquid chromatography—mass fragmentography
- Poly(vinyl chloride) ion-selective electrodes for Piribedil determination
- Electroanalytical characteristics of piribedil and its differential pulse and square wave voltammetric determination in pharmaceuticals and human serum
- Piribedil and bromocriptine in Parkinson's disease: a single-blind crossover study
- Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers
- Piribedil-induced sleep attacks in Parkinson's disease
- Parkinsonism by haloperidol and piribedil
- Yawning elicited by systemic and intrastriatal injection of piribedil and apomorphine in the rat
- l-Dopa and piribedil alter different components of attentional behavior dependent on dose
- Effects of apomorphine and piribedil on pentylenetetrazol-induced seizures in mice
- Piribedil in Parkinson's syndrome: A clinical study
- Parkinson's disease: pathological mechanisms and actions of piribedil