Thioril (Thioril)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThioridazineThioridazine
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    • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet contains: the current substance: thioridazine hydrochloride 25.00 mg; Excipients: calcium hydrophosphate 20.00 mg, starch 30.50 mg, povidone K-30 1.50 mg, magnesium stearate 1.00 mg, talc 2.00 mg. Composition of the film shell: TRC shell-A (hypromellose 38%, talcum powder 36.2%, pigment mixture-A 20%, silicon colloidal dioxide 5.8%; composition pigment mixture-A: talc 5.258%. titanium dioxide 9,028%, macrogol-6000 5,714%) - 1.88 mg, a dye based on a dye solar sunset yellow 0,06 mg, lacquer based on indigo carmine dye 0,03 mg, varnish based on the dye crimson (Ponso 4R) 0.03 mg.

    Description:
    Round biconvex tablets from light pink to pink with a grayish-brownish tinge. Blotches of a darker color are allowed.

    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.C.02   Thioridazine

    Pharmacodynamics:
    Thioridazine is a piperidine derivative of phenothiazine.Has antipsychotic, tranquilizing, antidepressant, antipruritic, as well as alpha-adreno-and m-cholinoblocking action. In small doses has an anxiolytic effect; reduces the feeling of tension and anxiety, at higher doses exhibits antipsychotic (neuroleptic) properties. In average therapeutic doses does not cause extrapyramidal disorders and drowsiness. Has a weak antiemetic effect, moderate - hypotensive.
    The mechanism of antipsychotic action is associated with the blockade of postsynaptic dopaminergic 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, blockade of dopamine receptors increases the prolapse of the pituitary gland. The central antiemetic effect is due to oppression or blockade of dopamine O-receptors in the chemoreceptor trigger zone of the cerebellum, peripheral to the blockade of the vagus nerve in the digestive tract

    Pharmacokinetics:
    Absorption is high, the time to reach the maximum concentration (C max) in blood plasma is 1-4 hours after ingestion.About 90% of the drug binds to plasma proteins. Metabolised in the liver with the formation of active metabolites (mesoridazine and sulforidazine). The half-life (T1 / 2) is 6-40 hours. Mesoridazine is pharmacologically more active than the starting material, has a longer half-life, is less associated with proteins, a free concentration is higher than that of thioridazine. Excretion in unchanged form and in the form of metabolites - kidneys (35%), with bile. Excreted in breast milk.

    Indications:
    Schizophrenia, psychotic disorders, accompanied by hyperactivity and psychomotor agitation; behavioral disorders related to mental disorders and / or neurological diseases; mild depressive disorders; neuroses accompanied by anxiety, agitation, tension, fear.

    Contraindications:
    Expressed depressive conditions, coma, marked depression of the central nervous system, blood diseases in the anamnesis, children under 3 years old, severe cardiovascular diseases (uncompensated CHF, arterial hypotension), craniocerebral trauma, progressive systemic diseases of the brain and spinal cord, liver failure , hypersensitivity to thioridazine and other phenothiazine derivatives.

    Carefully:
    Alcoholism (predisposition to hepatotoxic reactions), pathological changes in blood (hemopoiesis), breast cancer (as a result of phenothiazine-induced prolactin secretion, the potential risk of disease progression and resistance to endocrine and cytotoxic drugs increases), closed-angle glaucoma, prostatic hyperplasia with clinical manifestations, hepatic and / or renal insufficiency, gastric ulcer and duodenal ulcer (during an exacerbation), becoming ill niyah associated with an increased risk of thromboembolic complications, disease Parkinson's (amplified
    extrapyramidal effects), epilepsy, myxedema, chronic diseases,
    (especially in children), Reye's syndrome (increased risk of developing hepatotoxicity in children and adolescents), cachexia, vomiting (antiemetic effect of phenothiazines may mask vomiting associated with overdose of other drugs) in elderly patients.

    Pregnancy and lactation:In pregnancy, the use of Tioril is possible only if the expected benefit to the mother exceeds the potential risk to the fetus.Adequate and well-controlled safety studies of the drug during pregnancy have not been conducted. If it is necessary to administer Thioril during lactation, breastfeeding should be discontinued.
    Dosing and Administration:
    The dose is selected individually, taking into account the genesis of the symptoms and the degree of their severity. For each patient, it is recommended to determine the minimum effective dose.
    Usually the initial dose of Thioril for adults and children over 12 years is 50 - 100 mg 3 times a day. The dose, if necessary, is gradually increased to a maximum of 800 mg per day and, when the control of symptoms is reached, gradually reduce to a minimal maintenance dose. The total daily dose is 200 to 800 mg divided into 2-4 doses.
    For children aged 3 to 12 years, the recommended dose of the drug is from 0.5 mg / kg / day to 3 mg / kg / day, divided into several receptions. The dose is gradually increased until the optimal therapeutic effect is obtained or until the maximum dose of 3 mg / kg / day is reached.
    For use in children, it is advisable to use other dosage forms of thioridazine, which allow to accurately dose the drug.

    Side effects:
    From the side of the central nervous system: there may be drowsiness, confusion, anxiety, akathisia, headache; in isolated cases - malignant neuroleptic syndrome; convulsions, tk. thioridazine can reduce the threshold of convulsive readiness. With prolonged use, extrapyramidal disorders are possible. In very rare cases with prolonged use, late dyskinesias are possible.
    From the digestive system: dry mouth, constipation, nausea, vomiting, hypertrophy of the papillae of the tongue, rarely - paralytic ileus, cholestatic hepatitis.
    From the cardiovascular system: postural hypotension is possible (especially in elderly patients), cardiac arrhythmias, tachycardia. In high doses, like other phenothiazines, especially with concomitant hypokalemia, can cause a change in the ECG - prolongation of the QT interval, smoothing of the T wave, the appearance of the U wave.
    On the part of the hematopoiesis system: in isolated cases - leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, granulocytopenia, eosinophilia, pancytopenia.
    On the part of the endocrine system, hyperprolactinaemia, menstrual irregularities, ejaculation disorders, decreased libido are possible.
    From the side of metabolism: with prolonged use in high doses, it is possible to develop melanosis.
    On the part of the respiratory system: nasal congestion.
    Allergic reactions: possible skin rash, itching, angioedema,
    exfoliative dermatitis.
    From the side of the organ of vision: photophobia, impaired vision; in high doses more often than other phenothiazines, thioridazine causes pigment retinopathy.
    Other: urinary incontinence or retention; rarely - an increase in body weight.
    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 the appointment of activated charcoal. Treatment is symptomatic, with arterial hypotension shown the introduction of plasma substitutes.

    Interaction:
    Synergism of action with common anesthetics, opiates, barbiturates, ethanol, atropine. Enhances the hepatotoxic effect of hypoglycemic drugs. With amphetamine - effective antagonistically. FROM levodopa - reduces
    antiparkinsonian action. Use with adrenaline - can lead to a sudden and pronounced decrease in blood pressure. With guanethidine reduces the antihypertensive effect of the latter, but enhances the effect of other antihypertensive drugs, which increases the risk of significant orthostatic hypotension. Reduces the effect of anticoagulants and oral hypoglycemic agents. The action of thioridazine can weaken anticonvulsant drugs, cimetidine. Quinidine when combined, potentiates cardio-depressant action. Ephedrine - contributes to a paradoxical decrease in blood pressure. Sympathomimetics - intensify the arrhythmogenic effect. Probucol, astemizole, cisapride, disopyramide, erythromycin, pimozide, procainamide and quinidine contribute to an additional lengthening of the QT interval, which increases the risk of developing ventricular arrhythmia with simultaneous use with thioridazine. Antithyroid drugs - increase the risk of agranulocytosis. Thioridazine reduces the effect of funds that reduce appetite (with the exception of fenfluramine). Reduces the effectiveness of the emetic action of apomorphine, enhances its inhibitory effect on the central nervous system.Increases the concentration in the plasma of prolactin and prevents the action of bromocriptine. When combined with tricyclic antidepressants, maprotiline, MAO inhibitors, antihistamine drugs, lengthening and strengthening of sedative and anticholinergic effects is possible. With thiazide diuretics - increased hyponatremia. With lithium preparations - a decrease in absorption in the digestive tract, an increase in the rate of excretion of lithium ions by the kidneys, an increase in the severity of extrapyramidal disorders. Early signs of lithium intoxication (nausea and vomiting) may be masked by the antiemetic effect of thioridazine. When combined with beta-blockers thioridazine enhances the hypotensive effect, increases the risk of developing irreversible retinopathy, arrhythmia and tardive dyskinesia.

    Special instructions:
    During the treatment period, it is necessary to monitor the morphological composition of the blood, to refrain from drinking alcohol.
    Patients with liver disease require regular monitoring of liver function. Elderly patients, patients with malnutrition or with kidney or liver disease, it is recommended to prescribe a low initial dose with a gradual increase.

    Effect on the ability to drive transp.cf. and fur:
    During the treatment period, one should refrain from potentially dangerous activities requiring increased attention and rapid psychomotor reactions.

    Form release / dosage:

    Film coated tablets 25 mg.


    Packaging:

    10 tablets in a blister of PVC film and aluminum foil. 3, 6 or 10 blisters with instructions for use in cardboard pack.

    Sample not for sale: 10 tablets per blister from PVC film and aluminum foil. 1. blister with instructions for use in cardboard tutu.

    Storage conditions:
    Store at a temperature of no higher than 30 ° C in a dry, dark place. Keep out of the reach of children.

    Shelf life:
    3 years from the date of production.
    Do not use after the time specified on the package

    Terms of leave from pharmacies:On prescription
    Registration number:П N014762 / 01
    Date of registration:11.12.2008
    The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India
    Information update date: & nbsp10.09.2015
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