TRIVASTAL RETARD 50 Piribedil 50mg Tablet 30's
RXDRUG-DR-X7970
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Features
Brand
Trivastal Retard 50
Full Details
Dosage Strength
50 mg
Drug Ingredients
- Piribedil
Drug Packaging
Tablet 30's
Generic Name
Piribedil
Dosage Form
Tablet
Registration Number
DR-X7970
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
This medicine is indicated in: the treatment of age-related minor neurological disorders, adjunctive treatment of lower limb arteritis (disease of the leg arteries that causes painful cramps on walking), visual disorders of circulatory origin, certain forms of Parkinson's disease.
Dosage/Direction for Use
1 tablet per day to be taken at the end of the main meal, increasing to 2 tablets daily in two doses in severe cases.
The dosage may be increased in Parkinson's disease. In monotherapy: 3 to 5 tablets in 3 to 5 divided doses per day. In combination with dopatherapy: 1-3 tablets in 1-3 divided doses per day.
These doses must be attained gradually: increase by 1 tablet every 3 days.
Discontinuation of treatment: Sudden discontinuation of dopamine agents may result in neuroleptic malignant syndrome. To avoid this risk, the dose of piribedil must be reduced gradually until complete discontinuation of treatment.
Impulse control disorders: To avoid the risk of impulse control disorders, prescription of the minimum effective dose is recommended. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Kidney or liver failure: Piribedil has not been studied in these groups of patients. It is recommended to treat these patients with caution.
Pediatric population: The safety and efficacy of piribedil in children under the age of 18 years have not been established. There is no available data. There is no justified use of piribedil in the pediatric population for this indication.
Method of administration: Oral route.
The tablets should be swallowed, without chewing, with half a glass of water at the end of the meal.
The dosage may be increased in Parkinson's disease. In monotherapy: 3 to 5 tablets in 3 to 5 divided doses per day. In combination with dopatherapy: 1-3 tablets in 1-3 divided doses per day.
These doses must be attained gradually: increase by 1 tablet every 3 days.
Discontinuation of treatment: Sudden discontinuation of dopamine agents may result in neuroleptic malignant syndrome. To avoid this risk, the dose of piribedil must be reduced gradually until complete discontinuation of treatment.
Impulse control disorders: To avoid the risk of impulse control disorders, prescription of the minimum effective dose is recommended. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Kidney or liver failure: Piribedil has not been studied in these groups of patients. It is recommended to treat these patients with caution.
Pediatric population: The safety and efficacy of piribedil in children under the age of 18 years have not been established. There is no available data. There is no justified use of piribedil in the pediatric population for this indication.
Method of administration: Oral route.
The tablets should be swallowed, without chewing, with half a glass of water at the end of the meal.
Overdosage
Given the emetic effect of piribedil at very high doses, overdosage is unlikely with the tablet form.
The signs of overdose are: blood pressure instability (arterial hypertension or hypotension), digestive symptoms (nausea, vomiting).
These symptoms disappear on discontinuation of administration and with symptomatic treatment.
The signs of overdose are: blood pressure instability (arterial hypertension or hypotension), digestive symptoms (nausea, vomiting).
These symptoms disappear on discontinuation of administration and with symptomatic treatment.
Administration
Should be taken with food: Take at the end of a main meal w/ ½ glass water. Swallow whole, do not chew/crush.
Contraindications
This medicine should not be used in the following cases: history of allergy to piribedil, myocardial infarction or other serious cardiovascular disease, in combination with antiemetic neuroleptics.
If in doubt, it is essential for the patient to ask the doctor or pharmacist for advice.
If in doubt, it is essential for the patient to ask the doctor or pharmacist for advice.
Special Precautions
Dyskinesia: In advanced stage Parkinson's disease, in conjunction with levodopa, dyskinesia may occur at the start of treatment with piribedil. In this case, the dose of piribedil should be reduced.
Orthostatic hypotension: Dopamine agonists are known to alter systemic blood pressure regulation resulting in postural orthostatic hypotension.
Monitoring of blood pressure is recommended, particularly at the start of treatment, given the risk of orthostatic hypotension associated with dopamine treatment.
Abnormal behaviour: Abnormal behaviour has been reported and may be associated with manifestations of confusion, agitation, aggression. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Sleep disorders: Piribedil has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with piribedil. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Given the age of the population treated, the risk of falls, whether related to hypotension, sudden sleep onset or delirium, must be taken into account.
Impulse control disorders: The onset of impulse control disorders must be regularly monitored in these patients. The patients and those close to them must be informed of the behavioural symptoms of impulse control disorders such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders, which may appear in patients treated with dopaminergic agonists including Piribedil (Trivastal Retard 50). A decrease of the doses or progressive discontinuation of the treatment must be envisaged if such symptoms appear.
Psychotic disorders: Dopamine agonists may cause or worsen psychotic disorders such as delusion, delirium, hallucinations.
Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Peripheral edema: Peripheral edema has been observed during the use of dopamine agonists. This should be taken into account when prescribing piribedil.
Neuroleptic malignant syndrome: Characteristic symptoms of neuroleptic malignant syndrome have been reported following sudden discontinuation of dopamine treatment.
Piribedil (Trivastal Retard 50) contains sucrose: Due to the presence of sucrose, this medicine is contraindicated in case of fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Effects on the ability to drive and operate machinery: Piribedil (Trivastal Retard 50) can induce drowsiness and sudden sleeping fits. In such cases, patient must not drive nor perform any activity for which an impairment in vigilance could expose the patient or others to a risk of serious accident or death until the disappearance of such effects.
Orthostatic hypotension: Dopamine agonists are known to alter systemic blood pressure regulation resulting in postural orthostatic hypotension.
Monitoring of blood pressure is recommended, particularly at the start of treatment, given the risk of orthostatic hypotension associated with dopamine treatment.
Abnormal behaviour: Abnormal behaviour has been reported and may be associated with manifestations of confusion, agitation, aggression. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Sleep disorders: Piribedil has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with piribedil. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.
Given the age of the population treated, the risk of falls, whether related to hypotension, sudden sleep onset or delirium, must be taken into account.
Impulse control disorders: The onset of impulse control disorders must be regularly monitored in these patients. The patients and those close to them must be informed of the behavioural symptoms of impulse control disorders such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders, which may appear in patients treated with dopaminergic agonists including Piribedil (Trivastal Retard 50). A decrease of the doses or progressive discontinuation of the treatment must be envisaged if such symptoms appear.
Psychotic disorders: Dopamine agonists may cause or worsen psychotic disorders such as delusion, delirium, hallucinations.
Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur.
Peripheral edema: Peripheral edema has been observed during the use of dopamine agonists. This should be taken into account when prescribing piribedil.
Neuroleptic malignant syndrome: Characteristic symptoms of neuroleptic malignant syndrome have been reported following sudden discontinuation of dopamine treatment.
Piribedil (Trivastal Retard 50) contains sucrose: Due to the presence of sucrose, this medicine is contraindicated in case of fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Effects on the ability to drive and operate machinery: Piribedil (Trivastal Retard 50) can induce drowsiness and sudden sleeping fits. In such cases, patient must not drive nor perform any activity for which an impairment in vigilance could expose the patient or others to a risk of serious accident or death until the disappearance of such effects.
Use In Pregnancy & Lactation
Pregnancy: The available data in mice show piribedil passes through the placental barrier, and is distributed in fetal organs.
In the absence of relevant data, the use of this drug during pregnancy and in women of childbearing age not using contraception is not recommended.
Lactation: In the absence of relevant data, the use of this drug during breastfeeding is not recommended.
Fertility: Studies conducted in animals have not shown any direct or indirect harmful effects on embryonic/fetal development, parturition or post-natal development.
In the absence of relevant data, the use of this drug during pregnancy and in women of childbearing age not using contraception is not recommended.
Lactation: In the absence of relevant data, the use of this drug during breastfeeding is not recommended.
Fertility: Studies conducted in animals have not shown any direct or indirect harmful effects on embryonic/fetal development, parturition or post-natal development.
Adverse Reactions
The following undesirable effects have been observed during treatment with piribedil and ranked under the following frequency: Very common (≥1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), not known (cannot be estimated from the available data).
The following signs may appear: Gastrointestinal disorders: Common: minor gastrointestinal disorders (nausea, vomiting, flatulence) which may disappear, particularly if the individual dose is adjusted (gastrointestinal symptoms can be greatly reduced by stepwise up titration: 50 mg increase every 2 weeks).
Psychiatric disorders: Common: psychic disorders such as confusion, hallucinations (visual, auditory, mixed) or agitation have been observed, which disappear when treatment is stopped.
Unknown frequency: aggression, psychotic disorders (delusion, delirium).
Impulse control disorders: Symptoms such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders may appear in patients treated with dopaminergic agonists including Piribedil (Trivastal Retard 50).
Nervous system disorders: Common: dizziness has been observed which disappears when treatment is stopped.
Unknown frequency: dyskinesia.
Piribedil is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiovascular disorders: Uncommon: hypotension, orthostatic hypotension, unstable blood pressure causing syncope or malaise.
General disorders and anomalies at the administration site: Unknown frequency: peripheral edema.
Risk of allergic reactions due to the presence of Cochineal red A (E124).
The following signs may appear: Gastrointestinal disorders: Common: minor gastrointestinal disorders (nausea, vomiting, flatulence) which may disappear, particularly if the individual dose is adjusted (gastrointestinal symptoms can be greatly reduced by stepwise up titration: 50 mg increase every 2 weeks).
Psychiatric disorders: Common: psychic disorders such as confusion, hallucinations (visual, auditory, mixed) or agitation have been observed, which disappear when treatment is stopped.
Unknown frequency: aggression, psychotic disorders (delusion, delirium).
Impulse control disorders: Symptoms such as: pathological gambling (compulsive gambling), hypersexuality, increased libido, compulsive spending or shopping, excessive consumption of food and compulsive food disorders may appear in patients treated with dopaminergic agonists including Piribedil (Trivastal Retard 50).
Nervous system disorders: Common: dizziness has been observed which disappears when treatment is stopped.
Unknown frequency: dyskinesia.
Piribedil is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Cardiovascular disorders: Uncommon: hypotension, orthostatic hypotension, unstable blood pressure causing syncope or malaise.
General disorders and anomalies at the administration site: Unknown frequency: peripheral edema.
Risk of allergic reactions due to the presence of Cochineal red A (E124).
Drug Interactions
Contraindicated combinations: Antiemetic neuroleptics: Reciprocal antagonism between the dopaminergic agent and the neuroleptic.
Use an anti-emetic without extrapyramidal effects.
Inadvisable combinations: Antipsychotic neuroleptics (except clozapine): Reciprocal antagonism between the dopaminergic agent and the neuroleptics.
The dopaminergic agent can provoke or aggravate psychotic disorders. If a neuroleptic treatment is required in parkinsonian patients treated with dopaminergic agents, the latter must be gradually reduced until withdrawal (the sudden withdrawal of dopaminergic agents can expose to a "neuroleptic malignant syndrome" risk).
Tetrabenazine: Reciprocal antagonism between the dopaminergic agent and tetrabenazine.
Alcohol consumption: Alcohol increases the sedative effect of piribedil.
Impaired vigilance may make driving vehicles and the use of machinery dangerous.
Combination to be taken into account: Other sedatives: Increase in central depression.
The impairment of alertness could make driving and using machines dangerous.
Use an anti-emetic without extrapyramidal effects.
Inadvisable combinations: Antipsychotic neuroleptics (except clozapine): Reciprocal antagonism between the dopaminergic agent and the neuroleptics.
The dopaminergic agent can provoke or aggravate psychotic disorders. If a neuroleptic treatment is required in parkinsonian patients treated with dopaminergic agents, the latter must be gradually reduced until withdrawal (the sudden withdrawal of dopaminergic agents can expose to a "neuroleptic malignant syndrome" risk).
Tetrabenazine: Reciprocal antagonism between the dopaminergic agent and tetrabenazine.
Alcohol consumption: Alcohol increases the sedative effect of piribedil.
Impaired vigilance may make driving vehicles and the use of machinery dangerous.
Combination to be taken into account: Other sedatives: Increase in central depression.
The impairment of alertness could make driving and using machines dangerous.
Storage
Store at temperature not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Piribedil is a dopaminergic agonist that stimulates dopamine receptors and the cerebral dopaminergic pathways.
In humans, the mechanism of action is demonstrated by the clinical pharmacology studies: stimulation of "dopaminergic" type cortical electrogenesis both while awake and during sleep, clinical activity on the different functions controlled by dopamine, with this activity being demonstrated via the use of behavioural or psychometric scales.
In addition, piribedil results in an increase in femoral blood flow (the existence of dopaminergic receptors in the femoral vascular bed explains the action of piribedil on peripheral circulation).
Pharmacokinetics: Absorption: Piribedil is absorbed rapidly.
Distribution: The maximum concentration is reached one hour after oral administration of piribedil. Plasma elimination is biphasic and is composed of a first phase characterized by a half-life of 1.7 hours and a second, slower phase characterized by a half-life of 6.9 hours.
Biotransformation: Metabolism of piribedil is intense, with two main metabolites (a hydroxylated derivative and a dihydroxylated derivative).
Elimination: Piribedil is excreted essentially in the urine: 68% of the piribedil absorbed is excreted by the renal route in the form of metabolites and 25% is excreted in bile.
Pharmacokinetic/pharmacodynamic correlations: The prolonged-release tablet containing 50 mg of piribedil allows in vivo gradual absorption and release of the active ingredient. The kinetic studies conducted in humans show extension of the therapeutic coverage which exceeds 24 hours. Urinary excretion is approximately 50% at the 24th hour and is total at the 48th hour.
In humans, the mechanism of action is demonstrated by the clinical pharmacology studies: stimulation of "dopaminergic" type cortical electrogenesis both while awake and during sleep, clinical activity on the different functions controlled by dopamine, with this activity being demonstrated via the use of behavioural or psychometric scales.
In addition, piribedil results in an increase in femoral blood flow (the existence of dopaminergic receptors in the femoral vascular bed explains the action of piribedil on peripheral circulation).
Pharmacokinetics: Absorption: Piribedil is absorbed rapidly.
Distribution: The maximum concentration is reached one hour after oral administration of piribedil. Plasma elimination is biphasic and is composed of a first phase characterized by a half-life of 1.7 hours and a second, slower phase characterized by a half-life of 6.9 hours.
Biotransformation: Metabolism of piribedil is intense, with two main metabolites (a hydroxylated derivative and a dihydroxylated derivative).
Elimination: Piribedil is excreted essentially in the urine: 68% of the piribedil absorbed is excreted by the renal route in the form of metabolites and 25% is excreted in bile.
Pharmacokinetic/pharmacodynamic correlations: The prolonged-release tablet containing 50 mg of piribedil allows in vivo gradual absorption and release of the active ingredient. The kinetic studies conducted in humans show extension of the therapeutic coverage which exceeds 24 hours. Urinary excretion is approximately 50% at the 24th hour and is total at the 48th hour.
MedsGo Class
Antiparkinsonian Drugs
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