Dyskinesia and movement disorders such as Huntington’s disease, early dyskinesia, late dyskinesia. Psychomotor disorders in the elderly. Psychomotor disorders in chronic alcoholism.
active substance: tiapride hydrochloride;
1 tablet contains 111.1 mg of tiapride hydrochloride, which corresponds to 100 mg of tiapride;
Excipients: mannitol (E 421), microcrystalline cellulose, magnesium stearate, povidone, colloidal anhydrous silica.
Main physical and chemical properties: white tablets, round, with beveled edges and a cross-shaped fracture line on both sides.
Tiapride belongs to the ortho-methoxy substituted benzamides (orthopramides), a group of substances with a central action.
Tiapride is characterized by a high affinity for central dopaminergic receptors, especially if they are pre-sensitized to dopamine. Tiapride acts antidopaminergically, mainly on dopamine D2-receptors, due to which the antidyskinetic effect of the drug is achieved.
Unlike traditional antipsychotics, tiapride has a minor cataleptic effect. Due to these properties, tiapride is suitable for the treatment of movement disorders of central origin.
Pharmacological and clinical studies have shown that tiapride has antiemetic properties.
Dyskinesia and movement disorders such as Huntington’s disease, early dyskinesia, tardive dyskinesia.
Psychomotor disorders in the elderly.
Psychomotor disorders in chronic alcoholism.
Hypersensitivity to the active substance or to any other component of the drug; prolactin-dependent tumor (eg, pituitary prolactinoma), epithelial breast cancer; pheochromocytoma. Concomitant use of levodopa or other dopaminergic drugs. Existing central nervous system (CNS) depression or coma, bone marrow depression.
Method of application and dosage
The tablets should be taken without chewing, drinking plenty of fluids, preferably with a meal.
The dose of the drug should be set individually. The daily dose should be divided into 3 doses.
Dyskinesias and movement disorders
- Early dyskinesia: 150-400 mg / day.
- Late dyskinesia: 300-800 mg / day.
- Huntington’s disease: 300-1200 mg / day.
Psychomotor disorders in the elderly – 200-400 mg / day.
Psychomotor disorders in chronic alcoholism – 300-400 mg / day.
Impaired liver or kidney function. For patients with severe renal insufficiency, the dose should be reduced depending on creatinine clearance, namely
The ratio of creatinine clearance to the recommended dose
50-80 ml / min-75% of the standard daily dose
10-50 ml / min-50% of the standard daily dose
less than 10 ml / min-25% of the standard daily dose
No dose adjustment is required in patients with hepatic impairment.
The duration of treatment depends on the clinical symptoms. At creatinine clearance less
10 ml / min is recommended 1/4 of the standard dose (the tablet has the ability to divide).
As experience with tiapride in this age group is still insufficient, the drug should not be used in children.
Symptoms. Experience with tiapride overdose is limited. Drowsiness and sedation, coma, hypotension and extrapyramidal symptoms may occur. Gastric lavage and symptomatic treatment are recommended.
In case of acute overdose, the possibility of concomitant use of other drugs should be considered. Due to the fact that tiapride is very poorly dialyzed, hemodialysis to remove this substance is ineffective.
Treatment. The specific antidote is unknown. Therefore, symptomatic intensive care and careful continuous monitoring of cardiac function (risk of QT prolongation with subsequent ventricular arrhythmia) until complete disappearance of overdose symptoms and careful monitoring of respiratory function are required.
With severe extrapyramidal symptoms, anticholinergics should be prescribed.
Side effects are classified by their severity and frequency:
- From the nervous system:
common: dizziness, vertigo, headache, parkinsonism and parkinson-like symptoms, such as tremor, hypokinesia, increased salivation;
rare: akathisia, dystonia (spasms, crooked neck, ocular crisis, trismus);
very rare: acute dyskinesia. As with all antipsychotics, long-term dyskinesia (characterized by rhythmic involuntary movements, especially of the tongue and / or face) may develop after long-term treatment with tiapride, requiring close patient supervision. This was reported after treatment with the drug for more than 3 months. In such cases, treatment with anticholinergic, antiparkinsonian drugs is not indicated, because they either have no effect at all, or may even worsen the patient’s condition.
Development of neuroleptic malignant syndrome ̶ potentially life-threatening complication that may occur as a result of treatment with antipsychotics.
All these symptoms can be completely eliminated by using antiparkinsonian drugs.
- Mental disorders:
common: fatigue, drowsiness, insomnia, sedative effect, anxiety, apathy.
- From the endocrine system:
rare: tiapride causes hyperprolactinaemia, which is reversible upon discontinuation of treatment. The following side effects may occur: galactorrhea, amenorrhea, breast enlargement, breast tenderness, frigidity in women, as well as gynecomastia and impotence in men.
- General disorders and disorders:
General: asthenia / fatigue, nasal congestion, dry mouth, constipation, jaundice, minor hepatic impairment, photosensitivity reactions, miosis, blurred vision, dilated pupils, tachycardia, ECG changes, arrhythmia, delirium, catatonic-like conditions, nocturnal conditions, , depression, convulsions, difficulty urinating, ejaculation inhibition, priapism, hypo / hyperthermia, hypercholesterolemia, hypersensitivity reactions, including urticaria, exfoliative dermatitis, erythema, contact sensitivity. Prolonged therapy can cause pigment deposits in the skin, eyes; there may be clouding of the cornea and lenses. Hematological disorders, including hemolytic anemia, aplastic anemia, thrombocytopenic purpura, eosinophilia, agranulocytosis, leukopenia.
Uncommon: weight gain, in isolated cases of allergies.
In addition, orthostatic hypotension has been reported. There have been reports of sudden death (possible causes include cardiac arrhythmias, asphyxia).
Tiapride may cause QT prolongation; increases the risk of severe ventricular arrhythmias, such as ventricular fibrillation.
Neonatal disorders: neonatal withdrawal syndrome.
Store in the original package at a temperature not exceeding 25 oC out of reach of children.