Thioril (Tablets) Instructions for Use

Marketing Authorization Holder

Torrent Pharmaceuticals, Ltd. (India)

Contact Information

Torrent Pharmaceuticals Ltd. (India)

ATC Code

N05AC02 (Thioridazine)

Active Substance

Thioridazine (Rec.INN registered by WHO)

Dosage Form

Thioril

Film-coated tablets, 25 mg: 10, 30, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light pink to pink with a grayish-brownish tint, round, biconvex; inclusions of a darker color are allowed.

Excipients: calcium hydrogen phosphate, starch, povidone K30, magnesium stearate, talc.

Film coating composition TRC coating-A (hypromellose, talc, pigment mixture-A, colloidal silicon dioxide).
Pigment mixture-A composition talc, titanium dioxide, macrogol 6000, sunset yellow FCF aluminum lake, indigo carmine aluminum lake, ponceau 4R aluminum lake.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Psycholeptics. Antipsychotic agents. Piperazine derivatives of phenothiazine

Pharmacological Action

An antipsychotic agent (neuroleptic), a piperidine derivative of phenothiazine. It has antipsychotic, moderate sedative effects (without pronounced inhibition).

When used in small doses, it has an anxiolytic effect, reduces feelings of tension and anxiety, and has moderate antidepressant activity.

Antiemetic and extrapyramidal effects are weakly expressed.

Pharmacokinetics

Absorption

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Time to reach C_max in blood plasma is 1-4 hours.

Metabolism

Metabolized in the liver.

Elimination

T_1/2 is 6-40 hours. Excreted by the kidneys, with bile.

Indications

• Schizophrenia;
• Psychotic disorders accompanied by hyperactivity and psychomotor agitation;
• Behavioral disorders associated with psychotic disorders and/or neurological diseases;
• Moderate depressive disorders;
• Neuroses accompanied by anxiety, agitation, tension, fear.

ICD codes

Dosage Regimen

The dose is set individually, taking into account the origin of the symptoms and their severity.

For adults and children over 12 years, the dose is 20-600 mg/day, frequency of administration is 2-4 times/day. The maximum dose is 800 mg per day. The course of treatment with high doses should not exceed 4 weeks.

For children aged 2 to 5 years – 1 mg/kg/day. For children over 5 years, 75 mg/day is usually prescribed, frequency of administration is 2-4 times/day.

Adverse Reactions

From the nervous system: drowsiness, confusion, anxiety, akathisia, headache, visual disturbances are possible; in isolated cases – neuroleptic malignant syndrome, seizures (since Thioril may lower the seizure threshold); with long-term use, extrapyramidal disorders, tardive dyskinesia are possible.

From the organ of vision: in high doses, more often than other phenothiazines, it causes pigmentary retinopathy.

From the digestive system: dry mouth, constipation, nausea, vomiting, hypertrophy of the tongue papillae are possible; rarely – paralytic ileus, cholestatic hepatitis.

From the cardiovascular system: postural hypotension (especially in elderly patients), cardiac arrhythmias, tachycardia are possible; in high doses (like other phenothiazines), especially with concomitant hypokalemia, it can cause ECG changes – prolongation of the QT interval, flattening of the T wave, appearance of the U wave.

From the hematopoietic system: in isolated cases – leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, granulocytopenia, eosinophilia, pancytopenia.

From the endocrine system: hyperprolactinemia, menstrual cycle disorders, ejaculation disorders, decreased libido are possible.

From metabolism: with long-term use in high doses, the development of melanosis is possible.

From the respiratory system: nasal congestion.

Allergic reactions: skin rash, itching, angioedema, exfoliative dermatitis are possible.

Other: urinary incontinence or retention are possible; rarely – weight gain, photophobia, visual impairment.

Contraindications

• Severe depressive states;
• Comatose states;
• Severe CNS depression;
• History of blood diseases;
• Children under 2 years of age;
• Severe cardiovascular diseases;
• Hepatic insufficiency;
• Hypersensitivity to thioridazine and other phenothiazine derivatives.

Use in Pregnancy and Lactation

There have been no adequate and strictly controlled studies of the safety of the drug during pregnancy.

During pregnancy, Thioril can be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to prescribe Thioril during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency. Patients with liver diseases require regular monitoring of liver function.

Use in Renal Impairment

It is recommended to prescribe the drug to patients suffering from kidney diseases at a low initial dose with a gradual increase.

Pediatric Use

The drug is contraindicated in children under 2 years of age.

For children over 12 years, the dose is 20-600 mg/day, frequency of administration is 2-4 times/day. The maximum dose is 800 mg per day. The course of treatment with high doses should not exceed 4 weeks.

For children aged 2 to 5 years – 1 mg/kg/day. For children over 5 years, 75 mg/day is usually prescribed, frequency of administration is 2-4 times/day.

Special Precautions

Use with caution in patients with cardiac arrhythmias, heart diseases, severe respiratory diseases, renal failure, Parkinson’s disease, closed-angle glaucoma, prostatic hypertrophy, myasthenia gravis, epilepsy, pheochromocytoma.

Patients with liver diseases require regular monitoring of liver function.

It is recommended to prescribe the drug to elderly, debilitated patients or those suffering from kidney or liver diseases at a low initial dose with a gradual increase.

Avoid alcohol consumption during treatment.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Overdose

Symptoms: increased drowsiness, confusion, urinary retention, respiratory center depression, arterial hypotension, disorientation, areflexia, hyperreflexia, convulsions, arrhythmia. In severe cases – coma, collapse.

Treatment: gastric lavage followed by administration of activated charcoal. Treatment is symptomatic; for arterial hypotension, administration of plasma substitutes is indicated.

Drug Interactions

With simultaneous use of Thioril with other drugs that have a depressant effect on the CNS, as well as with ethanol and ethanol-containing drugs, an increase in CNS depression is possible; with levodopa – a decrease in the antiparkinsonian effect; with lithium preparations – a neurotoxic effect is possible.

Thioril may lower plasma concentrations of phenobarbital and reduce the effect of anticoagulants and oral antidiabetic agents.

The undesirable anticholinergic effect of Thioril may be enhanced with simultaneous use of anticholinergic drugs.

Storage Conditions

The drug should be stored out of the reach of children, protected from light and moisture, at a temperature below 30°C (86°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.