Sonapax^® (Tablets) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

N05AC02 (Thioridazine)

Active Substance

Thioridazine (Rec.INN registered by WHO)

Dosage Forms

	Sonapax®	Film-coated tablets, 10 mg: 60 pcs.
		Film-coated tablets, 25 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light pink in color, uniform in coloration, round, biconvex; the core is white on the cross-section.

Excipients: corn starch – 8 mg, colloidal silicon dioxide – 1.5 mg, lactose monohydrate – 26.4 mg, gelatin – 0.1 mg, stearic acid – 1 mg, talc – 3 mg.

Shell composition sucrose – 35.799 mg, acacia gum – 0.5 mg, talc – 13.7 mg, Ponceau 4R dye – 0.001 mg.

30 pcs. – blisters (2) – cardboard packs.

Film-coated tablets light yellow in color, uniform in coloration, round, biconvex; the core is white on the cross-section.

Excipients: potato starch – 46.5 mg, sucrose – 60 mg, gelatin – 0.5 mg, magnesium stearate – 2 mg, talc – 6 mg.

Shell composition sucrose – 85.668 mg, acacia gum – 3.4 mg, talc – 30.8 mg, Quinoline Yellow dye – 0.132 mg.

20 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Antipsychotic agent (neuroleptic)

Pharmacological Action

Antipsychotic agent (neuroleptic), a piperidine derivative of phenothiazine. It has antipsychotic, moderate sedative (without pronounced inhibition), and also antidyskinetic effects; antihistaminic and antiemetic effects are weakly expressed. It possesses anticholinergic activity and causes a hypotensive effect. It is inferior in intensity of action to periciazine.

The mechanism of antipsychotic action is associated with the blockade of postsynaptic dopamine receptors in the mesolimbic structures of the brain. It also has an alpha-adrenergic blocking effect and suppresses the release of pituitary and hypothalamic hormones. However, the blockade of dopamine receptors increases the release of prolactin by the pituitary gland.

The central antiemetic effect is due to the inhibition or blockade of dopamine D₂ receptors in the chemoreceptor trigger zone of the cerebellum, the peripheral effect is due to the blockade of the vagus nerve in the gastrointestinal tract.

Pharmacokinetics

Clinical data on the pharmacokinetics of thioridazine are limited.

Phenothiazines have high binding to plasma proteins. They are excreted mainly by the kidneys and partially with bile.

Indications

Schizophrenia, psychotic disorders accompanied by hyperactivity and agitation; severe behavioral disorders associated with psychotic disorders or neurological diseases, accompanied by aggressiveness, inability to maintain prolonged concentration, reduced tolerance to frustration. Moderate and severe depression in adults; neuroses accompanied by anxiety, agitation, depressed mood, tension, sleep disorders, fears; Huntington’s disease.

ICD codes

Dosage Regimen

Individual. When taken orally, the daily dose for adults and children over 12 years of age is 20-800 mg/day, frequency of administration – 2-4 times/day. The course of treatment with high doses is continued for no more than 5 weeks.

For children 1-5 years old – 1 mg/kg/day; over 5 years old – 75-100 mg/day, in severe cases – 300 mg/day; frequency of administration – 2-4 times/day.

Maximum daily dose for adults and children over 12 years of age is 800 mg.

Adverse Reactions

From the central nervous system drowsiness, confusion, anxiety, excessive motor excitability, headaches, postural hypotension (especially in elderly patients), visual disturbances are possible; in isolated cases – neuroleptic malignant syndrome. With long-term use, extrapyramidal disorders are possible. In high doses, it causes pigmentary retinopathy more often than other phenothiazines.

From the digestive system dry mouth, nausea, vomiting, diarrhea are possible; rarely – cholestatic jaundice.

From the cardiovascular system postural hypotension (especially in elderly patients), cardiac arrhythmias 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.

From the endocrine system swelling of the mammary gland nipples, menstrual cycle disorders, inhibition of ejaculation are possible.

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

From the respiratory system nasal congestion.

Allergic reactions skin rash, itching are possible.

Contraindications

Acute depressive states, comatose states, pronounced depression of the central nervous system, severe cardiovascular diseases, history of blood diseases, children under 1 year of age, hypersensitivity to thioridazine.

Use in Pregnancy and Lactation

During pregnancy, the use of thioridazine is possible only for strict indications. Adequate and well-controlled studies of the safety of thioridazine during pregnancy have not been conducted. It should be borne in mind that newborns whose mothers received Thioridazine at the end of pregnancy may experience symptoms of intoxication: excessive drowsiness, tremor, hyperactivity. If it is necessary to use thioridazine during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Patients with liver diseases require regular monitoring of liver function.

Use in Renal Impairment

Use with caution in patients with renal failure.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

Use with caution in patients with cardiac arrhythmias, heart diseases, severe respiratory diseases, renal failure, Parkinson’s disease, history of angle-closure glaucoma, prostatic hypertrophy, myasthenia gravis, epilepsy, pheochromocytoma, hypersensitivity to other phenothiazines.

Patients with liver diseases require regular monitoring of liver function.

Do not allow alcohol consumption during the treatment period.

Effect on the ability to drive vehicles and operate machinery

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

Drug Interactions

With simultaneous use with drugs that have a depressant effect on the central nervous system, with ethanol, ethanol-containing drugs, an increase in the depressant effect on the central nervous system is possible.

With simultaneous use, the effect of anticonvulsants and cimetidine is reduced.

With simultaneous use of agents with anticholinergic action, an increase in anticholinergic action is possible.

With simultaneous use with sympathomimetics, the arrhythmogenic effect is enhanced.

With simultaneous use, the effect of antihypertensive drugs is enhanced, and the risk of developing orthostatic hypotension increases.

With simultaneous use, the effectiveness of appetite suppressants (except for fenfluramine) is reduced.

With simultaneous use with antithyroid agents, there is a risk of developing agranulocytosis; with anticoagulants – the effectiveness of anticoagulants is reduced; with beta-blockers – an increase in the hypotensive effect, an increased risk of developing irreversible retinopathy, arrhythmia, and tardive dyskinesia is possible.

With simultaneous use with hypoglycemic agents, a slight decrease in their effectiveness is possible; with amphetamine – antagonistic interaction is manifested; with apomorphine – the emetic effect of apomorphine is reduced, its depressant effect on the central nervous system is enhanced.

With simultaneous use, Thioridazine increases the concentration of prolactin in the blood plasma and reduces the effect of bromocriptine.

With simultaneous use, a decrease in the effects of guanethidine and clonidine is possible; a decrease in the antiparkinsonian effect of levodopa.

With simultaneous use of probucol, astemizole, cisapride, disopyramide, erythromycin, pimozide, procainamide, prolongation of the QT interval and an increased risk of developing ventricular tachycardia are possible.

With simultaneous use with lithium salts, the absorption of lithium from the gastrointestinal tract is reduced, the rate of excretion of lithium ions by the kidneys increases, and extrapyramidal disorders are enhanced. Early signs of lithium intoxication (nausea and vomiting) may be masked by the antiemetic effect of thioridazine.

With simultaneous use of thiazide diuretics, an increase in hyponatremia is possible.

With simultaneous use with trazodone, an increase in the concentration of trazodone in the blood plasma is possible; with phenobarbital – a decrease in the concentration of phenobarbital in the blood plasma is possible.

With simultaneous use with quinidine, the cardiodepressant effect is potentiated. Prolongation of the QT interval and an increased risk of developing ventricular tachycardia are possible.

With simultaneous use with epinephrine, a sharp and pronounced decrease in blood pressure is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.