Thioril
Thioril: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Thioril
ATX code: N05AC02
Active ingredient: thioridazine (thioridazine)
Manufacturer: Torrent Pharmaceuticals (India)
Description and photo update: 2018-21-11
Prices in pharmacies: from 127 rubles.
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Thioril is an antipsychotic drug (neuroleptic).
Release form and composition
The dosage form of Thioril is film-coated tablets: round, biconvex, from light pink to pink with a grayish brown tint and darker splashes (10 tablets in a blister, in a cardboard box of 3, 6 or 10 blisters).
Composition of 1 film-coated tablet:
- active substance: thioridazine hydrochloride - 25 mg;
- auxiliary components: starch, calcium hydrogen phosphate, talc, K-30 povidone, magnesium stearate;
- film casing: TRC casing-A [hypromellose, talc, pigment mixture-A (talc, macrogol-6000, titanium dioxide), colloidal silicon dioxide], varnish based on dyes sunset yellow, indigo carmine, crimson.
Pharmacological properties
Pharmacodynamics
Thioridazine - the active ingredient of Thioril, is a piperidine derivative of phenothiazine. It has antipsychotic, tranquilizing, antidepressant, antipruritic, alpha-adrenergic blocking and m-anticholinergic effects. In small doses, the substance reduces the feeling of anxiety and tension, has an anxiolytic effect, in large doses it exhibits neuroleptic properties. When taken in moderate therapeutic doses, it does not cause drowsiness and extrapyramidal disturbances. In addition, thioridazine has mild antiemetic and moderate antihypertensive effects. The central antiemetic effect of the drug is explained by the inhibition or blockade of dopamine O2 receptors in the chemoreceptor trigger zone of the cerebellum, peripheral - by the blockade of the vagus nerve in the gastrointestinal tract (GIT).
The antipsychotic (neuroleptic) effect of Thioril is explained by the blockade of postsynaptic dopaminergic receptors in the mesolimbic structures of the brain. Thioridazine inhibits the release of hormones from the hypothalamus and the pituitary gland (however, the release of prolactin by the pituitary gland increases due to blockade of dopamine receptors), has an alpha-adrenergic blocking effect.
Pharmacokinetics
Thioridazine is highly absorbable. After taking Thioril inside, its maximum concentration is reached within 1-4 hours. The connection with plasma proteins is 90%. Metabolism occurs in the liver with the formation of active metabolites - mesoridazine and sulforidazine. Mesoridazine has a greater activity than thioridazine, its connection with plasma proteins is lower, and the half-life is longer. Also, his free concentration is higher.
The elimination period of thioridazine is 6–40 hours. It is excreted by the kidneys (35%) and with bile. It is excreted in breast milk of lactating women.
Indications for use
- schizophrenia;
- psychotic disorders with hyperactivity and psychomotor agitation;
- behavioral disorders due to mental and neurological diseases;
- moderate depressive disorders;
- neurosis, accompanied by anxiety, agitation, fear and tension.
Contraindications
Absolute:
- severe depressive conditions;
- coma;
- severe depression of the central nervous system (CNS);
- a history of blood diseases;
- severe cardiovascular disease (for example, uncompensated chronic heart failure, arterial hypotension);
- traumatic brain injury;
- systemic diseases of the brain and spinal cord (progressive);
- liver failure;
- age up to 3 years;
- hypersensitivity to any component of Thioril, as well as other phenothiazine derivatives.
Relative:
- alcoholism (due to the risk of hepatotoxic reactions);
- blood pathology (violation of hematopoiesis);
- breast cancer (due to the potential risk of disease progression, as well as an increase in resistance to therapy with endocrine and cytostatic drugs as a result of phenothiazine-induced prolactin secretion);
- angle-closure glaucoma;
- hyperplasia of the prostate gland with clinical manifestations;
- renal / hepatic impairment;
- exacerbation of gastric ulcer and duodenal ulcer;
- conditions that increase the risk of thromboembolism;
- Parkinson's disease (due to increased extrapyramidal effects);
- epilepsy;
- myxedema;
- chronic diseases, accompanied by respiratory failure (especially in children);
- Reye's syndrome (due to the increased risk of hepatotoxicity in children and adolescents);
- cachexia;
- vomiting (the antiemetic effect of Thioril can mask vomiting caused by an overdose of other drugs);
- elderly age.
Instructions for the use of Thioril: method and dosage
It is recommended to carry out therapy with Thioril in the minimum effective dose, determined individually for each patient, depending on the severity of the symptoms of the disease and their genesis. The total daily dose of Thioril is 200-800 mg, divided into 2-4 doses.
Usually the initial dose of Thioril for adults and children over 12 years of age is 50-100 mg 3 times a day, then it is adjusted. The maximum dose is 800 mg / day. After control of symptoms is achieved, it is gradually reduced to a minimum maintenance.
For children 3–12 years old, the recommended starting dose of Thioril is 0.5–3 mg / kg / day, divided into several doses. Then it is gradually increased until a therapeutic effect is achieved. The maximum daily dose is 3 mg / kg.
Side effects
- CNS: drowsiness, confusion, akathisia, anxiety, headache, neuroleptic malignant syndrome, convulsions, extrapyramidal disorders and tardive dyskinesias (with prolonged use);
- digestive system: dry mouth, nausea, vomiting, constipation, hypertrophy of the papillae of the tongue, paralytic ileus, cholestatic hepatitis;
- cardiovascular system: postural hypotension (especially in elderly patients), cardiac arrhythmias, tachycardia, with prolonged use, it is possible to lengthen the QT interval, smooth the T wave, the appearance of a U wave on the ECG;
- hematopoietic system: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, granulocytopenia, eosinophilia, pancytopenia;
- endocrine system: hyperprolactinemia, menstrual irregularities, ejaculation disorders, decreased libido;
- metabolism: melanosis (with prolonged use of high doses of Thioril);
- respiratory system: nasal congestion;
- allergic reactions: rash, itching, angioedema, exfoliative dermatitis;
- organ of vision: photophobia, visual impairment, pigmentary retinopathy (when using high doses of the drug);
- other: incontinence or urinary retention, weight gain.
Overdose
Thioril overdose symptoms: drowsiness, confusion, urinary retention, depression of the respiratory center, disorientation, arterial hypotension, areflexia or hyperreflexia, arrhythmia, convulsions, coma, collapse.
As a treatment, gastric lavage, the intake of activated charcoal, and symptomatic therapy are indicated. With arterial hypotension, the introduction of plasma substitutes is recommended.
special instructions
When taking Thioril, the morphological composition of the blood should be monitored. Alcohol intake should be excluded.
Influence on the ability to drive vehicles and complex mechanisms
During therapy with Thioril, one should refrain from driving vehicles and engaging in other potentially hazardous activities that require speed of psychomotor reactions.
Application during pregnancy and lactation
There is no reliable data on the safety and efficacy of Thioril during pregnancy, and therefore its use is possible only when the expected benefit to the mother outweighs the possible risk to the fetus.
If it is necessary to use Thioril during lactation, breastfeeding should be discontinued.
Pediatric use
According to the instructions, Thioril is not prescribed for children under 3 years old.
With impaired renal function
Patients with kidney disease need a lower starting dose of Thioril.
For violations of liver function
Patients with liver disease need regular monitoring of liver function. In case of liver failure, Thioril is contraindicated.
Use in the elderly
For elderly patients, a lower initial dose of Thioril is recommended, followed by an increase.
Drug interactions
- general anesthetics, opiates, barbiturates, ethanol, atropine: synergistic action;
- hypoglycemic drugs: hepatotoxicity increases;
- levodopa: antiparkinsonian action decreases;
- adrenaline: the risk of a sudden, pronounced decrease in blood pressure (BP);
- guanethidine: its antihypertensive effect decreases;
- antihypertensive drugs (except for guanethidine): their effect increases, the risk of orthostatic hypotension increases;
- anticoagulants and oral hypoglycemic drugs: their effect decreases;
- anticonvulsants, cimetidine: the effect of Thioril decreases;
- quinidine: potentiates the cardiodepressant effect of thioridazine;
- ephedrine: risk of paradoxical decrease in blood pressure;
- sympathomimetics: arrhythmogenic effect increases;
- probucol, cisapride, astemizole, disopyramide, erythromycin, pimozide, procainamide, quinidine: risk of prolongation of the QT interval and the development of ventricular arrhythmias;
- antithyroid drugs: the risk of developing agranulocytosis increases;
- drugs to reduce appetite (except for fenfluramine): their effect decreases;
- apomorphine: its emetic effect decreases, the inhibitory effect on the central nervous system increases;
- bromocriptine: Thioril interferes with its action by increasing the plasma prolactin concentration;
- tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, antihistamines: risk of prolongation and enhancement of sedative and anticholinergic effects;
- thiazide diuretics: risk of increased hyponatremia;
- lithium preparations: their absorption decreases, the rate of excretion of lithium ions by the kidneys increases, the severity of extrapyramidal disorders increases (the antiemetic effect of thioridazine can hide the early symptoms of lithium intoxication);
- beta-blockers: their hypotensive effect increases, the risk of developing irreversible retinopathy, arrhythmia and tardive dyskinesia increases.
Analogs
Thioril's analogs are: Thiodazin, Sonapax, Thioridazin, Ridazin, Tison, Melleril.
Terms and conditions of storage
Store in a dry place, away from light, at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Thioril
Reviews of Thioril show its effectiveness. Patients report relief from anxiety and improved sleep. Among the side effects, an increase in heart rate, a decrease in blood pressure are noted.
The price of Thioril in pharmacies
Approximate price for Thioril (25 mg tablets, 100 pcs. In a package) - 140 rubles.
Thioril: prices in online pharmacies
Drug name Price Pharmacy |
Thioril 25 mg film-coated tablets 100 pcs. 127 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!