Sonapaks - instructions for use, analogs, reviews and release forms (tablets and pills 10 mg and 25 mg) of the drug for the treatment of schizophrenia and neuroses in adults, children and pregnancy. Interaction with alcohol

In this article, you can read the instructions for using the drug Sonapax. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Sonapax in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Sonapaksa in the presence of existing structural analogues. Use for the treatment of schizophrenia and neuroses in adults, children, as well as during pregnancy and lactation.Interaction of the drug with alcohol.

Sonapax - antipsychotic drug (antipsychotic). Thioridazine (the active substance of the preparation Sonapaks) 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 caused by oppression or blockade of dopamine D2 receptors in the chemoreceptor trigger zone of the brainstem, peripheral by the blockade of the vagus nerve in the digestive tract. Also has alpha-adrenoblocking and m-holinoblocking action. The blockade of histamine H1 receptors 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.

Sonapaks dose-dependently lengthens the interval of QTc, which can lead to severe life-threatening ventricular arrhythmias, including tachycardia such as pirouette.

Composition

Thioridazine hydrochloride + excipients.

Pharmacokinetics

Absorption is high. About 90% of thioridazine binds to plasma proteins. Metabolised in the liver with the formation of active metabolites (mesoridazine and sulforidazine). Mesoridazine is pharmacologically more active than the parent substance, 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 drug of the second line of therapy in patients who are contraindicated with other drugs, or there is no curative 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 disorders, obsessive states, depressive disorders;
• abstinence syndrome (substance abuse, alcoholism);
• in children's psychiatry apply in behavior disorders with increased psychomotor activity.

Forms of release

Tablets coated with 10 mg and 25 mg.

Dragee 10 mg and 25 mg.

Instructions for use and dosage

Inside. The dosage regimen is chosen individually taking into account the severity of the disease.

In schizophrenia, adults are prescribed in an initial dose of 50-100 mg 3 times a day with a gradual increase if necessary to a maximum dose of 800 mg per day. Once the effect is achieved, the dose can be reduced to a minimum maintenance dose. The total daily dose ranges from 200-800 mg per day in 2-4 doses. Children are prescribed at an initial dose of 500 mcg / kg per day in several doses. If necessary, increase the dose; the maximum daily dose is 3 mg / kg per day.

Psychotic disorders, accompanied by hyperreactivity and excitement; severe behavioral disorders associated with aggressiveness,inability to prolong the 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.

For elderly patients, the drug is usually prescribed in a low dose: 30-100 mg per day.

The drug should be withdrawn gradually.

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 a low dose, gradually increasing it to the optimal therapeutic dose.

With abstinence syndrome, depending on the severity of the condition - from 10-75 mg per day to 150-400 mg per day.

When behavior disorders with increased psychomotor activity in children aged 4-7 years - 10-20 mg per day, the frequency of reception - 2-3 times a day; at the age of 8-14 years - 20-30 mg per day, the frequency of reception - 3 times a day; at the age of 15-18 years - 30-50 mg per day,the frequency of reception is 3 times a day.

Side effect

• confusion of consciousness;
• late dyskinesias;
• excitation;
• insomnia;
• extrapyramidal and dystonic disorders;
• Parkinsonism;
• emotional disorders;
• thermoregulation disorders;
• decreased convulsive threshold;
• fainting;
• hyposalivation;
• anorexia;
• increased appetite;
• dyspepsia;
• nausea, vomiting;
• diarrhea;
• paralytic intestinal obstruction;
• a decrease in blood pressure;
• tachycardia;
• change ECG, incl. dose-dependent lengthening of the QT interval;
• tachycardia of the "pirouette" type;
• agranulocytosis, leukopenia, granulocytopenia, eosinophilia, thrombocytopenia, aplastic anemia, pancytopenia;
• skin allergic reactions;
• erythema;
• rash;
• exfoliative dermatitis;
• angioedema;
• nasal congestion;
• photosensitization;
• decreased libido;
• violation of ejaculation;
• dysmenorrhea;
• hyperprolactinemia;
• gynecomastia;
• dysuria;
• priapism;
• false positive pregnancy tests;
• increase in body weight;
• visual impairment;
• photophobia.

Contraindications

• pronounced depressive conditions;
• comatose conditions;
• marked depression of the central nervous system;
• history of blood diseases;
• syndrome of prolonged QT interval;
• simultaneous reception with drugs that extend the QT interval;
• an arrhythmia in the anamnesis;
• liver failure;
• hypersensitivity to thioridazine and other phenothiazine derivatives;
• congenital low activity of the isoenzyme CYP2D6;
• children under 4 years;
• deficiency of lactase or sucrose / isomaltase, intolerance to fructose or lactose, glucose-galactose malabsorption.

Application in 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.

Use in children

Contraindicated in children under 4 years.

special instructions

During the treatment it is necessary to monitor the morphological composition of the blood.

During treatment, patients should refrain from drinking alcohol.

Impact on the ability to drive vehicles and manage mechanisms

The drug weakens motor coordination and reduces the speed of psychomotor reactions, especially at the beginning of treatment, so patients should abstain from driving and servicing moving vehicles during the drug treatment period.

Drug Interactions

Synaptic action of Sonapax with general anesthetics, narcotic analgesics, barbiturates, ethanol (alcohol), atropine.

Sonapaks enhances the hepatotoxic effect of hypoglycemic agents.

With amphetamine, thioridazine acts antagonistically.

With levodopa - reduces antiparkinsonian action.

Use with epinephrine can lead to a sudden and pronounced decrease in blood pressure.

With the simultaneous use of ephedrine, a paradoxical decrease in blood pressure is possible.

Thioridazine reduces the antihypertensive effect of guanethidine, but enhances the effect of other antihypertensive agents, which increases the risk of significant orthostatic hypotension.

Thioridazine reduces the effect of anticoagulants.

The action of thioridazine can weaken anticonvulsants, cimetidine.

Quinidine potentiates cardiodepressant action of thioridazine.

Sympathomimetics increase the arrhythmogenic effect of thioridazine.

Probucol, astemizole, cisapride, disopyramide, erythromycin, pimozide, procainamide and quinidine contribute to an additional prolongation of the QT interval, which, when combined with thioridazine, increases the risk of developing ventricular tachycardia.

With simultaneous use with thioridazine, antithyroid drugs increase the risk of developing agranulocytosis.

Sonapaks reduces the effect of funds that reduce appetite (with the exception of fenfluramine).

Thioridazine reduces the effectiveness of the emetic action of apomorphine, enhances its inhibitory effect on the central nervous system.

Thioridazine increases the concentration in the plasma of prolactin and prevents the action of bromocriptine.

When used simultaneously with tricyclic antidepressants, maprotiline, MAO inhibitors, histamine H1 receptor blockers, lengthening and strengthening of sedative and m-cholinoblocking effects is possible.

With simultaneous use with thiazide diuretics, hyponatremia increases.

With simultaneous use with lithium preparations, absorption from the digestive tract decreases, the rate of elimination of lithium ions by the kidneys increases,the severity of extrapyramidal disorders increases, early signs of lithium intoxication (nausea and vomiting) may be masked by the antiemetic effect of thioridazine.

In combination with beta-blockers, thioridazine helps to increase the hypotensive effect, increases the risk of developing irreversible retinopathy, arrhythmia and tardive dyskinesia.

The interaction of Sonapax with drugs extending the QT interval (cisapride), and inhibitors of the isoenzyme CYP2D6 (fluoxetine, paroxetine), can contribute to the occurrence of arrhythmias, including. tachycardia of the "pirouette" type.

In the interaction of thioridazine with fluvoxamine, propranolol, pindolol, an increase in thioridazine in the blood plasma is possible, which increases the risk of arrhythmias.

Analogues of the drug Sonapaks

Structural analogs for the active substance:

• Melleril;
• Thiodasin;
• Thioridazine;
• Thioril;
• Tyson.

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