Thioridazine (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N05AC02 (Thioridazine)

Active Substance

Thioridazine (Rec.INN registered by WHO)

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 action; antihistaminic and antiemetic effects are weak. It has anticholinergic activity and causes a hypotensive effect. It is less potent than pericyazine.

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 hormones from the pituitary and hypothalamus. 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 attention, and 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

Open the list of ICD codes

ICD-10 code	Indication
F20	Schizophrenia
F21	Schizotypal disorder
F22	Chronic delusional disorders
F23	Acute and transient psychotic disorders
F25	Schizoaffective disorders
F29	Unspecified nonorganic psychosis
F31	Bipolar affective disorder
F32	Depressive episode
F33	Recurrent depressive disorder
F40	Phobic anxiety disorders (including agoraphobia, social phobias)
F41.0	Panic disorder [episodic paroxysmal anxiety]
F41.1	Generalized anxiety disorder
F41.2	Mixed anxiety and depressive disorder
F41.9	Anxiety disorder, unspecified
F91	Conduct disorders
G10	Huntington's chorea
R45.1	Restlessness and agitation

ICD-11 code	Indication
6A20.Z	Schizophrenia, unspecified episode
6A21.Z	Schizoaffective disorder, unspecified
6A22	Schizotypal disorder
6A23.Z	Acute and transient psychotic disorder, unspecified
6A24.Z	Delusional disorder, unspecified
6A2Z	Schizophrenia or other primary psychotic disorders, unspecified
6A60.Z	Bipolar type I disorder, unspecified
6A61.Z	Bipolar type II disorder, unspecified
6A6Z	Bipolar or similar disorder, unspecified
6A70.Z	Single episode depressive disorder, unspecified
6A71.Z	Recurrent depressive disorder, unspecified
6A73	Mixed depressive and anxiety disorder
6B00	Generalized anxiety disorder
6B01	Panic disorder
6B0Z	Anxiety or fear-related disorders, unspecified
6C91.Z	Dissocial behavioral disorder, unspecified
6C9Z	Disruptive behavior or dissocial disorders, unspecified
8A01.10	Huntington's chorea
MB24.F	Restlessness

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Individual. When taken orally, the daily dose for adults and children over 12 years of age is 20-800 mg/day, the frequency of administration is 2-4 times/day. The course of treatment with high doses should not exceed 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; 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; rarely – cholestatic jaundice.

From the cardiovascular system: postural hypotension (especially in elderly patients), cardiac arrhythmias. 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 nipples of the mammary glands, menstrual cycle disorders, inhibition of ejaculation.

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

From the respiratory system: nasal congestion.

Allergic reactions: skin rash, itching.

Contraindications

Acute depressive states, comatose states, pronounced depression of the central nervous system, severe diseases of the cardiovascular system, 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 stopping 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 consume alcohol during treatment.

Effect on the ability to drive vehicles and operate machinery

During treatment, one should refrain from potentially hazardous activities that require 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 increase in the 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 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 is increased, 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 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Thioridazine [Atoll LLC (Russia)]
Film-coated tablets, 10 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioridazine

Film-coated tablets, 10 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section: a core of white or almost white with a yellowish tint and a film coating.

	1 tab.
Thioridazine hydrochloride	10 mg

Excipients: lactose monohydrate (milk sugar) – 44.72 mg, microcrystalline cellulose – 15.2 mg, sodium carboxymethyl starch – 3.04 mg, povidone K25 – 2.28 mg, magnesium stearate – 0.76 mg.

Coating composition: hypromellose – 1.16 mg, macrogol 4000 – 0.34 mg, titanium dioxide – 0.5 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
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50 pcs. – contour cell packaging (10) – cardboard packs.
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30 pcs. – polypropylene jars (1) – cardboard packs.
50 pcs. – polypropylene jars (1) – cardboard packs.
60 pcs. – polypropylene jars (1) – cardboard packs.
100 pcs. – polypropylene jars (1) – cardboard packs.
25 pcs. – contour cell packaging (6) – cardboard pack.
30 pcs. – contour cell packaging (5) – cardboard pack.
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50 pcs. – contour cell packaging (4) – cardboard pack.
10 pcs. – contour cell packaging (1) – cardboard pack.
10 pcs. – contour cell packaging (6) – cardboard pack.
10 pcs. – contour cell packaging (10) – cardboard pack.
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10 pcs. – contour cell packaging (5) – cardboard pack.
100 pcs. – jar (1) – cardboard pack.
30 pcs. – contour cell packaging (2) – cardboard pack.
30 pcs. – contour cell packaging (6) – cardboard pack.
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25 pcs. – contour cell packaging (1) – cardboard pack.
10 pcs. – contour cell packaging (3) – cardboard pack.
50 pcs. – contour cell packaging (3) – cardboard pack.
25 pcs. – contour cell packaging (5) – cardboard pack.
20 pcs. – jar (1) – cardboard pack.
30 pcs. – contour cell packaging (10) – cardboard pack.
30 pcs. – contour cell packaging (3) – cardboard pack.
50 pcs. – contour cell packaging (6) – cardboard pack.
25 pcs. – contour cell packaging (10) – cardboard pack.

Thioridazine [Atoll LLC (Russia)]
Film-coated tablets, 25 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioridazine

Film-coated tablets, 25 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section: a core of white or almost white with a yellowish tint and a film coating.

	1 tab.
Thioridazine hydrochloride	25 mg

Excipients: lactose monohydrate (milk sugar) – 111.8 mg, microcrystalline cellulose – 38 mg, sodium carboxymethyl starch – 7.6 mg, povidone K25 – 5.7 mg, magnesium stearate – 1.9 mg.

Shell compositionhypromellose – 2.9 mg, macrogol 4000 – 0.85 mg, titanium dioxide – 1.25 mg.

Thioridazine [Atoll LLC (Russia)]
Film-coated tablets, 50 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioridazine

Film-coated tablets, 50 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 120, 125, 150, 180, 200, 250, 300, or 500 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section: a core of white or almost white with a yellowish tint and a film coating.

	1 tab.
Thioridazine hydrochloride	50 mg

Excipients : lactose monohydrate (milk sugar) – 223.6 mg, microcrystalline cellulose – 76 mg, sodium starch glycolate – 15.2 mg, povidone K25 – 11.4 mg, magnesium stearate – 3.8 mg.

Shell compositionhypromellose – 5.8 mg, macrogol 4000 – 1.7 mg, titanium dioxide – 2.5 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
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30 pcs. – polyethylene terephthalate bottles (1) – cardboard packs.
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30 pcs. – polypropylene bottles (1) – cardboard packs.
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50 pcs. – bottle (1) – cardboard pack.
100 pcs. – bottle (1) – cardboard pack.
25 pcs. – contour cell blister (3) – cardboard pack.
30 pcs. – contour cell blister (2) – cardboard pack.
30 pcs. – bottle (1) – cardboard pack.
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25 pcs. – contour cell blister (4) – cardboard pack.
10 pcs. – contour cell blister (5) – cardboard pack.
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10 pcs. – contour cell blister (6) – cardboard pack.
10 pcs. – contour cell blister (1) – cardboard pack.
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10 pcs. – bottle (1) – cardboard pack.
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25 pcs. – contour cell blister (1) – cardboard pack.
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30 pcs. – contour cell blister (4) – cardboard pack.
60 pcs. – bottle (1) – cardboard pack.
10 pcs. – contour cell blister (3) – cardboard pack.
25 pcs. – contour cell blister (6) – cardboard pack.
10 pcs. – contour cell blister (10) – cardboard pack.
50 pcs. – contour cell blister (10) – cardboard pack.
25 pcs. – contour cell blister (5) – cardboard pack.
50 pcs. – contour cell blister (3) – cardboard pack.
30 pcs. – contour cell blister (1) – cardboard pack.
30 pcs. – contour cell blister (10) – cardboard pack.

Medixlife (Author)

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