Tiaprilan (tiapride hydrochloride) tablets 100 mg. №20

Description

Tiaprilan (tiapride hydrochloride) tablets 100 mg. №20

Composition

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.

Dosage form

Tablets.

Main physical and chemical properties: white tablets, round, with beveled edges and a cross-shaped break line on both sides.

Pharmacotherapeutic group

Antipsychotics.
ATX code N05A L03.

Pharmacological properties

Tiaprilan 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.

Indication:

• dyskinesia and movement disorders such as Huntington’s disease, early dyskinesia, tardive dyskinesia;
• psychomotor disorders in the elderly;
• psychomotor disorders in chronic alcoholism.

Contraindication

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 Tiaprilan 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.

Children

As experience with tiapride in this age group is still insufficient, the drug should not be used in children.

Overdose

• 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

Side effects are classified by their severity and frequency:

• From the nervous system: dizziness, vertigo, headache, parkinsonism and parkinson-like symptoms, such as tremor, hypokinesia, increased salivation;
• Mental disorders: fatigue, drowsiness, insomnia, sedative effect, anxiety, apathy.
• From the endocrine system: tiapride causes hyperprolactinaemia, which is reversible upon discontinuation of treatment.
• General disorders and disorders: 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.