Sonapaks® (Sonapax)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThioridazineThioridazine
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    VALEANT, LLC     Russia
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    • Dosage form: & nbspcoated tablets
    Composition:
    Tablets, coated with a coating of 10 mg Composition of the core tablets:
    Active substance: thioridazine hydrochloride 10 mg
    Auxiliary substances: corn starch - 8.0 mg, silicon dioxide colloid - 1.5 mg, lactose monohydrate - 26.4 mg, gelatin - 0.1 mg, stearic acid - 1.0 mg, talc - 3.0 mg.
    The composition of the shell: sucrose - 35,799 mg, acacia gum - 0.50 mg, talc - 13.70 mg, dye crimson [Ponso 4R] - 0.001 mg.
    Tablets coated with 25 mg
    Composition of the core of the tablets: /
    Active ingredient: thioridazine hydrochloride 25 mg
    Auxiliary substances: potato starch - 46.5 mg, sucrose - 60.0 mg, gelatin - 0.5 mg, magnesium stearate - 2.0 mg, talc - 6.0 mg.
    Sheath composition: sucrose - 85,668, acacia gum - 3,40 mg, talc - 30,80, dye quinoline yellow - 0,132 mg.

    Description:
    Tablets 10 mg: round biconvex tablets of light pink color, homogeneous in color. At the break, white.
    Tablets 25 mg: round biconvex tablets of light yellow color, homogeneous in color.At the break, white.

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

    N.05.A.C.02   Thioridazine

    Pharmacodynamics:
    Thioridazine is a piperidine derivative of phenothiazine, which affects the central and peripheral nervous system. Has antipsychotic, tranquilizing, antidepressant, antipruritic and antiemetic effect. The mechanism of antipsychotic action is due to the blockade of postsynaptic dopamine receptors in the mesolimbic structures of the brain. The central antiemetic effect is due to the inhibition or blockade of dopamine D2 receptors in the chemoreceptor trigger region of the brainstem, and peripheral to the blockade of the vagus nerve in the gastrointestinal tract (GI tract). It also has a-adrenoblocking and m-cholinoblocking action. The blockade of Hi-histamine and m-cholinergic receptors is most pronounced among all neuroleptics. In small doses, it has an anxiolytic effect, reduces feelings of tension and anxiety, and exhibits antipsychotic (neuroleptic) properties in higher doses. Increases the pituitary gland prolactin. ,
    Thioridazine dose-dependent extends the QTc interval, which can lead to severe life-threatening ventricular arrhythmias, including "pirouette" tachycardia.

    Pharmacokinetics:
    Absorption is high, the time to reach the maximum concentration (TCmax) in blood plasma is 1-4 hours after ingestion. About 90% of thioridazine 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 parent substance, has a larger T1 / 2, binds less to plasma proteins, the free fraction is higher than that of thioridazine. It is excreted unchanged in the form of metabolites - kidneys (35%), intestines. Excreted in breast milk.

    Indications:
    Schizophrenia (as a 'second-line drug' in patients who are contraindicated with other drugs, or have no therapeutic effect when taking other medicines).
    Psychotic disorders, accompanied by hyperreactivity and excitement; severe behavioral disorders associated with aggressiveness, inability to prolonged concentration of attention; psychomotor agitation of various genesis.Neuroses accompanied by fear, anxiety, psychomotor agitation, psychoemotional stress, sleep disturbance, obsessive states, depressive disorders; abstinence syndrome (substance abuse, alcoholism).
    In children's psychiatry apply for behavioral disorders with increased psychomotor activity.

    Contraindications:
    Depressive states, coma, marked depression of the central nervous system, history of blood disease, children under 4 years old, QT prolonged interval syndrome, concomitant use with drugs prolonging the QT interval, arrhythmias in the anamnesis; hepatic insufficiency, hypersensitivity to thioridazine and other phenothiazine derivatives, congenital low activity of the isoenzyme CYP2D6. Deficiency of lactase or sugarase / isomaltase, intolerance to fructose or lactose, glucose-galactose malabsorption.

    Carefully:
    Alcoholism (predisposition to hepatotoxicity), pathological changes in the blood picture (hemodyscrasia) carcinoma - breast (resulting phenothiazine derivatives induced increases prolactin secretion potential riskprogression of the disease and resistance to treatment with endocrine and cytotoxic drugs), closed-angle glaucoma, prostatic hyperplasia with clinical manifestations, renal failure, stomach and duodenal ulcer (during exacerbation); diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease (extrapyramidal effects are intensified); epilepsy; myxedema; chronic diseases accompanied by respiratory failure (especially in children); Reye syndrome (increased risk of hepatotoxicity in children and adolescents); cachexia, vomiting (antiemetic effect of phenothiazine derivatives may mask vomiting associated with overdose of other drugs). Consider the risk of severe toxic effects due to prolongation of the QT interval.

    Pregnancy and lactation:
    In pregnancy, the use of the drug is only possible if the expected benefit to the mother exceeds the potential risk to the fetus. Adequate and well-controlled studies of drug safety during pregnancy have not been conducted.If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:
    Inside. The dosage regimen is chosen individually taking into account the severity of the disease.
    When schizophrenia adults start with 50-100 mg 3 times a day with a gradual increase to a maximum of 800 mg / day (if necessary). Once the effect is achieved, the dose can be reduced to a minimum maintenance dose. The total daily dose varies between 200-800 mg / day in 2-4 doses. Children start with 0.5 mg / kg / day in several doses. If necessary, increase the dose (the maximum daily dose is 3 mg / kg / day).
    Psychotic disorders, accompanied by hyperreactivity and excitement; severe behavioral disorders associated with aggressiveness, inability to prolonged concentration of attention; psychomotor agitation of various genesis: in outpatient settings - 150-400 mg per day; in a hospital - 250-800 mg per day. Treatment usually begins with low doses, 25-75 mg per day, gradually increasing to the optimal therapeutic dose, which is achieved within 7 days, and the antipsychotic effect is observed after 10-14 days.The course of treatment is several weeks. Supportive daily dose: 75-200 mg once before bedtime.
    At treatment of persons of advanced age usually apply low doses: 30-100 mg per day. The drug should be withdrawn gradually.
    Neuroses, withdrawal syndrome (substance abuse, alcoholism)
    With neuroses with mild cognitive and emotional disorders - 30-75 mg per day, with ineffectiveness, the dose is gradually increased to 50-200 mg per day. With neuroses with a somatic component - 10-75 mg per day. Begin treatment with low doses, gradually increasing them to the optimal therapeutic dose. With abstinence syndrome, depending on the severity of the condition from 10-75 mg / day to 150-400 mg / day. In case of behavior disorders with increased psychomotor activity in children:
    4-7 years of 10-20 mg per day. Multiplicity of reception - 2-3 times a day.
    8-14 years of 20-30 mg per day. Multiplicity of admission - 3 times a day.
    15-18 years for 30-50 mg per day. Multiplicity of admission - 3 times a day.

    Side effects:
    From the side of CNC:
    Confusion of consciousness, late dyskinesias, agitation, agitation, insomnia, extrapyramidal and dystonic disorders, parkinsonism, emotional disorders, thermoregulatory disorders, decreased convulsive threshold, syncope, malignant neuroleptic syndrome.
    From the gastrointestinal tract:
    Hyposalivation, anorexia, increased appetite, dyspepsia, nausea, vomiting, diarrhea, paralytic intestinal obstruction, hypertrophy papillas of the tongue,
    cholestatic hepatitis.
    From the side of the cardiovascular system:
    Reduced blood pressure, tachycardia, ECG changes, including dose-dependent lengthening of the QT interval, pirouette tachycardia.
    On the part of the hematopoiesis system:
    Agranulocytosis, leukopenia, granulocytopenia, eosinophilia, thrombocytopenia, aplastic anemia, pancytopenia.
    Allergic paakia
    Skin allergic reactions, erythema, rash, exfoliative dermatitis, angioedema, bronchospastic syndrome, nasal congestion, photophobia. From the genitourinary system:
    Decreased libido, impaired ejaculation, dysmenorrhea, hyperprolactinaemia, gynecomastia, paradoxical ishuria, dysuria, priapism.
    From the endocrine system: false positive pregnancy tests, weight gain.
    From the sense organs:
    Visual impairment, photophobia.
    Other:
    Melanosis of the skin (with prolonged use in high doses).

    Overdose:
    Symptoms:
    From the cardiovascular system: arrhythmias, lowering blood pressure (BP), shock, changes in ECG, lengthening of QT and PR intervals, nonspecific changes in ST segment and T wave, bradycardia, sinus angina,
    atrioventricular blockade, ventricular tachycardia, ventricular fibrillation, "pirouette" tachycardia, oppression of myocardial function.
    From the side of the central nervous system: sedative effect, extrapyramidal disorders, confusion, agitation, hypothermia, hyperthermia, convulsions, areflexia, coma.
    On the part of the autonomic nervous system: mydriasis, miosis, dry skin and, oral mucosa, nasal congestion, urinary retention, blurred vision.
    On the part of the respiratory system: respiratory depression, apnea, pulmonary edema.
    From the digestive system: decreased motility, constipation, intestinal
    obstruction.
    From the urinary system: oliguria, uremia.
    Toxicity begins to manifest with a concentration of thioridazine in the plasma of more than 10 mg / l, at a concentration of 20-80 mg / l, death occurs.
    Treatment:
    It is necessary to provide airway patency and establish adequate oxygenation and pulmonary ventilation. Immediately begin a long-term monitoring of cardiovascular activity (ECG).Treatment consists of correction of electrolyte disturbances and acid-base balance, the introduction of lidocaine (caution is recommended due to an increased risk of seizures), phenytoin, isoproterenol, up to the installation of artificial pacemakers and defibrillation. In view of the possible additional prolongation of the QT interval, the use of disopyramide, procainamide and quinidine should be avoided.
    Correction of a lowered blood pressure may require the introduction of infusion solutions and vasopressors. With a persistently low blood pressure, the administration of phenylephrine, norepinephrine or metamyramine is indicated. a-adrenoblocking properties of phenothiazine derivatives do not allow the use of nonselective a- and p-adrenomimetics (epinephrine, dopamine) - the risk of paradoxical vasodilation.
    To remove unabsorbed dose of the drug, it is recommended to wash the stomach using activated charcoal. Induction of vomiting is less preferable because of the risk of dystonia and potential aspiration of vomit.
    Acute extrapyramidal disorders are treated with diphenhydramine or trihexyphenidyl.
    When arresting seizures, barbiturates should be avoided (risk of aggravation of respiratory depression).
    Due to the high volume of distribution and strong binding to plasma proteins, forced diuresis, hemoperfusion, hemodialysis and pH change in urine, most likely, do not affect the excretion of phenothiazine derivatives from the body.

    Interaction:
    Synergism of action with general anesthetics, narcotic analgesics, barbiturates, ethanol, atropine.
    Enhances the hepatotoxic effect of hypoglycemic agents.
    With amphetamine - it acts antagonistically.
    With levodopa - reduces antiparkinsonian action.
    Use with epinephrine - 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.
    The action of thioridazine can weaken anticonvulsant drugs, cimetidine. Quinidine - Potentiates cardiodepressive 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 elongation of the QT interval, which increases the risk of developing ventricular tachycardia.
    Antithyroid drugs increase the risk of agranulocytosis.
    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. While the use of tricyclic antidepressants, maprotiline, MAO inhibitors, blockers of histamine Hi-receptor may elongation and increased sedation and m-anticholinergic effects.
    With thiazide diuretics - increased hyponatremia.
    With drugs lithium - reduced absorption in the gastrointestinal tract, increasing the rate of excretion by the kidneys of lithium ions, increased severity of extrapyramidal disorders, early signs of lithium toxicity (nausea and vomiting) can be masked antiemetic effect thioridazine.
    In combination with beta-blockers enhances the hypotensive effect, it increases the risk of irreversible retinopathy, arrhythmias and tardive dyskinesia. Interaction with drugs extending the QT interval (cisapride) and inhibitors of the isoenzyme CYP2D6 (fluoxetine, paroxetine), can contribute to the occurrence of arrhythmias, including pirouette tachycardia.
    When interacting with fluvoxamine. propranolol. pindolol, the content of thioridazine in the blood plasma may increase, which increases the risk of arrhythmias.

    Special instructions:
    During the treatment it is necessary to monitor the morphological composition of the blood; refrain from using ethanol.

    Effect on the ability to drive transp. cf. and fur:
    The drug weakens motor coordination and reduces the speed of psychomotor reactions, especially at the beginning of treatment, so during drug treatment should refrain from the management of vehicles and maintenance of moving mechanisms.

    Form release / dosage:coated tablets 10 mg, 25 mg
    Packaging:
    For 30 tablets coated with a coating (10 mg) or 20 tablets coated with a coating (25 mg) in blisters A1 / PVC.
    For 2 blisters (10 mg) or 3 blisters (25 mg), together with the instructions for use are placed in a cardboard box.
    Storage conditions:.Store in a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    4 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015031 / 01
    Date of registration:28.05.2009
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.09.2015
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