Trivastal Retard 50

Trivastal Retard 50 is 2-[4-(methylene-3,4-dioxybenzyl)-piperazin-1-yl] pyrimidine.

Oral

As monotherapy in Parkinson's disease

Adult: Monotherapy: 150-250 mg daily in divided doses. In combination with levodopa therapy: 80-140 mg daily.

Oral

Circulatory disorders

Adult: 50 mg daily or 100 mg daily in 2 divided doses for severe cases.

Parkinson's Disease: Monotherapy: 150-250 mg ie, 3-5 tabs as 3-5 to be divided doses into 3 to 5 administration daily.

Adjunct to L-dopa therapy: 1-3 tabs daily (approximately Trivastal Retard 50 50 mg per L-Dopa 250 mg). The therapeutic dosage must be reached gradually by increasing the dose by 1 tab every 3 days.

Hypersensitivity to Trivastal Retard 50 or to any of the excipients of Trivastal Retard 50.

Cardiovascular shock; acute phase of myocardial infarction.

In association with antiemetic neuroleptics; antipsychotic neuroleptics (excluding clozapine) (except in the case of parkinsonian patient).

Fructose intolerance, glucose or galactose malabsorption or sucrase-isomaltase deficiency (due to the presence of sucrose).

Contraindicated Associations: Antiemetic Neuroleptics: Reciprocal antagonism between dopaminergic agonist and neuroleptics. Use an antiemetic devoid of extrapyramidal effects.

Unadvisable Associations: Antipsychotic Neuroleptics (excluding Clozapine): Reciprocal antagonism between dopaminergic agonist and neuroleptics. The dopaminergic agonist can induce or aggravate psychotic disorders. If a neuroleptic treatment is required in patients with Parkinson's disease treated with dopaminergic agonists, the latter must be decreased progressively until full withdrawal (a sudden withdrawal of dopaminergics exposes to a risk of "malignant neuroleptic syndrome").

Tetrabenazine: Reciprocal antagonism between dopaminergic agonists and tetrabenazine.

Alcohol Consumption: Increase of Trivastal Retard 50 sedative effect by the alcohol. The modification of vigilance could make driving and using machines dangerous.

Associations to be Taken into Account: Other Sedatives: Increase in central depression. The modification of vigilance could make driving and using machines dangerous.

The following adverse reactions have been observed during treatment with Trivastal Retard 50 and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data).

The following symptoms may occur: 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: Psychiatric disorders eg, confusion, hallucinations or agitation have been observed, which may disappear when treatment is stopped. Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Trivastal Retard 50.

Nervous System Disorders: Common: Dizziness has been observed which disappears when treatment is stopped. Trivastal Retard 50 is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.

Vascular Disorders: Uncommon: Hypotension, orthostatic hypotension with syncope or malaise or unstable blood pressure. Due to the presence of Cochineal red, risk of alllergic reactions.