Composition
Composition of 1 film-coated tablet: Active ingredient: thioridazine hydrochloride-25 mg; auxiliary components: starch, calcium hydrophosphate, talc, povidone K-30, magnesium stearate; film coating: TRC shell-A [hypromellose, talc, pigment mixture-A (talc, macrogol-6000, titanium dioxide), colloidal silicon dioxide], varnish based on dyes sunny sunset yellow, indigo carmine, crimson.
Pharmacological action
Thioridazine-the Active ingredient of Thioryl, is a piperidine derivative of phenothiazine. It has antipsychotic, tranquilizing, antidepressant, antipruritic, alpha-adrenoblocking and m-holinoblocking effects.
In small doses, the substance reduces the feeling of anxiety and tension, has an anxiolytic effect, in large doses-shows neuroleptic properties. When taken in medium therapeutic doses, it does not cause drowsiness and extrapyramidal disorders. 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 Og 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 suppresses the release of hormones of the hypothalamus and pituitary gland (however, the release of prolactin by the pituitary gland increases due to the blockade of dopamine receptors), has an alpha-adrenoblocking effect.
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.
Contraindications
Severe depressive states, comatose states, severe CNS depression, a history of blood diseases, children under 2 years of age, severe diseases of the cardiovascular system, liver failure, hypersensitivity to thioridazine and other phenothiazine derivatives.
Side effects
From the central nervous system:  drowsiness, confusion, restlessness, akathisia, headache, visual disturbances are possible; in isolated cases – neuroleptic malignant syndrome; convulsions, since Thioril can reduce the threshold of convulsive readiness. With prolonged use, extrapyramidal disorders are possible. In high doses, it causes retinopathy pigmentosa more often than other phenothiazines. In very rare cases, tardive dyskinesia is possible with prolonged use. From the digestive system:  possible dry mouth, constipation, nausea, vomiting, hypertrophy of the papillae of the tongue, rarely-paralytic ileus, cholestatic hepatitis. From the cardiovascular system:  postural hypotension (especially in elderly patients), cardiac arrhythmias, and tachycardia are possible. In high doses, like other phenothiazines, especially with concomitant hypokalemia, it can cause ECG changes – prolongation of the QT interval, smoothing of the T wave, the 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 disorders, ejaculation disorders, decreased libido are possible. From the side of metabolism:  with prolonged use in high doses, melanosis may develop. Respiratory system disorders:  nasal congestion. Allergic reactions:  possible skin rash, pruritus, angioedema, exfoliative dermatitis. Other services:  incontinence or urinary retention is possible; rarely-weight gain, photophobia, visual impairment.
Interaction
With the simultaneous use of Thioril with other drugs that have a depressing effect on the central nervous system, as well as ethanol and ethanol – containing drugs, it is possible to increase central nervous system depression; with levodopa, it is possible to reduce the antiparkinsonian effect; with lithium preparations, it is possible to have a neurotoxic effect. Thioril may reduce the concentration of phenobarbital in plasma, reduce the effect of anticoagulants and oral antidiabetic agents. The undesirable anticholinergic effect of Thioril may be enhanced when used concomitantly with anticholinergic drugs.
How to take, course of use and dosage
Tioril is taken orally. The dosage regimen is selected individually, taking into account the genesis of symptoms and their severity. The daily dose for adults and children over 12 years of age is 20-600 mg, the frequency of use is 2-3 times a day. The maximum dose is 800 mg / day. The course of high-dose treatment is continued for no more than 4 weeks in a hospital setting. Children aged 2 to 5 years — 1 mg / kg / day. Children over 5 years of age are usually prescribed 75 mg / day, the frequency of use is 2-4 times a day.
Overdose
Symptoms: Â increased drowsiness, confusion, urinary retention, respiratory depression, hypotension, disorientation, areflexia, hyperreflexia, convulsions, arrhythmia. In severe cases, coma, collapse. Treatment: Â gastric lavage, followed by the appointment of activated charcoal. Treatment is symptomatic, with arterial hypotension, the introduction of plasma substitutes is indicated.
Special instructions
Use with caution in patients with cardiac arrhythmias, heart diseases, severe respiratory diseases, renal failure, Parkinson’s disease, angle-closure glaucoma, prostatic hypertrophy, myasthenia gravis, epilepsy, pheochromocytoma.
Avoid drinking alcohol during the treatment period. Patients with liver diseases require regular monitoring of liver function. Elderly patients, emaciated or suffering from kidney or liver diseases are recommended to be prescribed a low initial dose with a gradual increase.
Influence on the ability to drive motor vehicles and manage mechanisms:
During the treatment period, you should refrain from potentially dangerous activities that require increased attention and rapid psychomotor reactions.
Storage conditions
Store at temperatures below 30°C in a place protected from light and moisture and keep out of the reach of children.
Shelf life
3 years
Active ingredient
Thioridazine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as directed by your doctor
Indications
Manic-Depressive Psychosis, Insomnia, Mental disorders, Depression, Schizophrenia
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