Sonapax tablets p / o 10mg, No. 60

Schizophrenia, manic-depressive psychosis; neuroses accompanied by fear, anxiety, excitement, tension, depressed mood, sleep disturbances, obsessive states; psychotic disorders accompanied by hyperreactivity and agitation; severe behavioral disorders associated with psychotic disorders or neurological diseases, accompanied by aggressiveness, inability to concentrate for a long time; withdrawal symptoms (substance abuse, alcoholism); psychomotor agitation of various origins; moderate to severe depression in adults; Huntington's disease, tics; skin diseases that occur with severe and painful itching; in child psychiatry, it is used for behavioral disorders with increased psychomotor activity.

Inside. The dosage regimen is individual.
Adults
In acute psychosis, mania, schizophrenia and agitational depressions: on an outpatient basis - 150-400 mg per day; in the 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 usually achieved within 7 days, and the antipsychotic effect is noted after 10-14 days. The course of treatment is several weeks. Maintenance daily dose: 75-200 mg once at bedtime. When treating the elderly, usually low doses are used: 30-100 mg per day. The drug should be withdrawn gradually. With mild mental and emotional disorders - 30-75 mg per day, with moderate disorders - 50-200 mg per day. Start treatment with low doses, gradually increasing them to the optimal therapeutic dose. For psychosomatic disorders: 10-75 mg per day.To suppress severe itching, the dose of the drug is set individually and should not exceed 200 mg.
Children
from 4 to 7 years old - 10-20 mg per day. Frequency of admission - 2-3 times a day.
From 8 to 14 years old - 20-30 mg per day. Frequency rate of admission - 3 times a day.
From 15 to 18 years old - 30-50 mg per day. Frequency rate of admission - 3 times a day.

Active ingredient: thioridazine hydrochloride - 10 mg
Excipients: corn starch, colloidal silicon dioxide (aerosil), lactose, gelatin, stearic acid, talc, sucrose, gum arabic, dye - cochineal red.

Hypersensitivity, acute depressive states, coma of any etiology, craniocerebral trauma, progressive systemic diseases of the brain and spinal cord; severe cardiovascular failure, severe arterial hypotension, pheochromocytoma, porphyria, blood diseases (hypo- and aplastic processes). Pregnancy, lactation, children (up to 4 years).

Carefully
With alcoholism (predisposition to hepatotoxic reactions), pathological changes in the blood (impaired hematopoiesis), breast cancer (as a result of phenothiazine-induced prolactin secretion, the potential risk of disease progression and resistance to treatment with endocrine and cytotoxic drugs increases), angle-closure glaucoma, clinical prostatic hyperplasia manifestations, hepatic and / or renal failure, gastric ulcer and duodenal ulcer (during an exacerbation); diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease (extrapyramidal effects are enhanced); epilepsy; myxedema; chronic diseases accompanied by respiratory failure (especially in children);Reye's syndrome (increased risk of developing hepatotoxicity in children and adolescents); cachexia, vomiting (the antiemetic effect of phenothiazines can mask vomiting associated with an overdose of other drugs). Elderly age.

Trade (proprietary) name: Sonapax

International non-proprietary name:

Thioridazine

Chemical name: 10-2- (1-Methyl-2-piperidinyl) ethyl-2- (methylthio) 1 OH-phenothiazine (as hydrochloride or tartrate)

Dosage form:

dragee

Composition:

Active ingredient: thioridazine hydrochloride - 10 mg
Excipients: corn starch, colloidal silicon dioxide (aerosil), lactose, gelatin, stearic acid, talc, sucrose, gum arabic, dye - cochineal red.

Active ingredient: thioridazine hydrochloride - 25 mg.
Excipients: potato starch, sugar, gelatin, magnesium stearate, talc, gum arabic, dye - quinoline yellow.

Description
Sonapax 10 mg: round biconvex dragees of light pink color, uniform in color, without spots. Dragee on the break is white.
Sonapax 25 mg: round biconvex dragees of light yellow color, uniform in color, without spots. Dragee on the break is white.

Pharmacotherapeutic group:

antipsychotic (neuroleptic) agent.

ATX code: N05AC02

pharmachologic effect
Thioridazine is a piperidine derivative of phenothiazine that affects the central and peripheral nervous system. It has antipsychotic, tranquilizing, antidepressant, antipruritic and antiemetic effects. The mechanism of antipsychotic action is associated with the blockade of postsynaptic dopaminergic 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 zone of the cerebellum, peripheral - by the blockade of the vagus nerve in the gastrointestinal tract. Also has a sympatholytic and m-anticholinergic effect. In small doses, it has an anxiolytic effect, reduces feelings of tension and anxiety, in higher doses it exhibits antipsychotic (neuroleptic) properties.Antihistaminic and anticholinergic action is most pronounced among all drugs from the group of antipsychotics. In average therapeutic doses, it does not cause extrapyramidal disturbances and drowsiness. Has an alpha-adrenergic blocking effect and inhibits the release of hormones from the pituitary gland and hypothalamus. However, blockade of dopamine receptors increases the release of prolactin by the pituitary gland.

Pharmacokinetics
Absorption is high, the time of the onset of the maximum concentration (Cmax) in the blood plasma is 1-4 hours after ingestion. About 90% of the drug binds to plasma proteins. It is metabolized 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 higher T1 / 2, is less bound to proteins, the free concentration is higher than that of thioridazine. Excretion unchanged and in the form of metabolites - by the kidneys (35%), with bile. Excreted in breast milk.

Indications
Schizophrenia, manic-depressive psychosis; neuroses accompanied by fear, anxiety, excitement, tension, depressed mood, sleep disturbances, obsessive states; psychotic disorders accompanied by hyperreactivity and agitation; severe behavioral disorders associated with psychotic disorders or neurological diseases, accompanied by aggressiveness, inability to concentrate for a long time; withdrawal symptoms (substance abuse, alcoholism); psychomotor agitation of various origins; moderate to severe depression in adults; Huntington's disease, tics; skin diseases that occur with severe and painful itching; in child psychiatry, it is used for behavioral disorders with increased psychomotor activity.

Contraindications
Hypersensitivity, acute depressive states, coma of any etiology, craniocerebral trauma, progressive systemic diseases of the brain and spinal cord; severe cardiovascular failure, severe arterial hypotension, pheochromocytoma, porphyria, blood diseases (hypo- and aplastic processes). Pregnancy, lactation, children (up to 4 years).

Carefully
With alcoholism (predisposition to hepatotoxic reactions), pathological changes in the blood (impaired hematopoiesis), breast cancer (as a result of phenothiazine-induced prolactin secretion, the potential risk of disease progression and resistance to treatment with endocrine and cytotoxic drugs increases), angle-closure glaucoma, clinical prostatic hyperplasia manifestations, hepatic and / or renal failure, gastric ulcer and duodenal ulcer (during an exacerbation); diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease (extrapyramidal effects are enhanced); epilepsy; myxedema; chronic diseases accompanied by respiratory failure (especially in children);Reye's syndrome (increased risk of developing hepatotoxicity in children and adolescents); cachexia, vomiting (the antiemetic effect of phenothiazines can mask vomiting associated with an overdose of other drugs). Elderly age.

Dosing and Administration
Inside. The dosage regimen is individual.
Adults
In acute psychosis, mania, schizophrenia and agitational depressions: on an outpatient basis - 150-400 mg per day; in the 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 usually achieved within 7 days, and the antipsychotic effect is noted after 10-14 days. The course of treatment is several weeks. Maintenance daily dose: 75-200 mg once at bedtime. When treating the elderly, usually low doses are used: 30-100 mg per day. The drug should be withdrawn gradually. With mild mental and emotional disorders - 30-75 mg per day, with moderate disorders - 50-200 mg per day. Start treatment with low doses, gradually increasing them to the optimal therapeutic dose. For psychosomatic disorders: 10-75 mg per day.To suppress severe itching, the dose of the drug is set individually and should not exceed 200 mg.
Children
from 4 to 7 years old - 10-20 mg per day. Frequency of admission - 2-3 times a day.
From 8 to 14 years old - 20-30 mg per day. Frequency rate of admission - 3 times a day.
From 15 to 18 years old - 30-50 mg per day. Frequency rate of admission - 3 times a day.

Side effects From the side of the central nervous system: confusion, tardive dyskinesias, agitation, agitation, insomnia, extrapyramidal and dystonic disorders, parkinsonism, emotional disturbances, thermoregulatory disorders, a decrease in the seizure threshold, fainting.
From the gastrointestinal tract: hyposalivation, anorexia, increased appetite, dyspepsia, nausea, vomiting, diarrhea, paralytic ileus, weight gain, hypertrophy of the papillae of the tongue, rarely cholestatic hepatitis.
From the side of the cardiovascular system: hypotension, tachycardia.
From the hematopoietic system: in isolated cases - agranulocytosis, leukopenia, granulocytopenia, eosinophilia, thrombocytopenia, aplastic anemia, pancytopenia.
Allergic reactions: allergic skin reactions, erythema, rash, exfoliative dermatitis, angioedema, bronchospastic syndrome, nasal congestion, photophobia.
From the genitourinary system: decreased libido, impaired ejaculation, dysmenorrhea, hyperprolactinemia, gynecomastia, paradoxical ischuria, dysuria, priapism.
From the endocrine system: false positive pregnancy tests, weight gain.
From the senses: visual impairment, photophobia.
Others: melanosis of the skin (with prolonged use in high doses).

Overdose
Drowsiness, confusion, urinary retention, disorientation, coma, areflexia, hyperreflexia, dry mouth, nasal congestion, postural hypotension, depression of the respiratory center, convulsions, hypothermia. Treatment is symptomatic, aimed at reducing absorption and accelerating the elimination of the drug. Gastric lavage with activated charcoal solution, laxatives (eg magnesium sulfate). The introduction of isotonic solutions. Monitoring the function of the cardiovascular and respiratory systems. If necessary, artificial ventilation of the lungs, monitoring of the function of the cardiovascular system, and prevention of the development of metabolic acidosis are consistently carried out. There is no specific antidote.

Interaction with other medicinal products
Synergism of action with general anesthetics, opiates, barbiturates, ethanol, atropine. Enhances the hepatotoxic effect of antidiabetic drugs. With amphetamine - acts antagonistically. With levodopa - reduces the antiparkinsonian effect. Application with adrenaline - can lead to a sudden and pronounced decrease in blood pressure. With guanethidine, it 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 Sonapax can be weakened by anticonvulsants, cimetidine. Quinidine - potentiates the cardiodepressant effect. Ephedrine - contributes to a paradoxical decrease in blood pressure. Sympathomimetics - enhance 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 tachycardia. Antithyroid drugs increase the risk of agranulocytosis. Reduces the effect of appetite suppressants (with the exception of fenfluramine). Reduces the effectiveness of the emetic action of apomorphine, enhances its inhibitory effect on the central nervous system. Increases plasma concentration of prolactin and interferes with the action of bromocriptine. When used together with tricyclic antidepressants, maprotiline, MAO inhibitors, antihistamines, prolongation and enhancement of sedative and anticholinergic effects is possible. With thiazide diuretics - increased hyponatremia. With lithium preparations - a decrease in absorption in the gastrointestinal 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 perphenazine. When combined with beta-blockers, it enhances the hypotensive effect, increases the risk of developing irreversible retinopathy, arrhythmias and tardive dyskinesia.

Special instructions
During the period of treatment, it is necessary to monitor the morphological composition of the blood; refrain from using ethanol and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Influence on the ability to drive vehicles and maintain machinery in motion.
Sonapax weakens motor coordination and reduces the reaction, especially at the beginning of treatment, therefore, during the period of treatment with the drug, one should refrain from driving vehicles and servicing moving mechanisms.

Form of release
Dragee 10 mg 30 pieces and 25 mg pills 20 pieces are packed in blisters made of polyvinyl chloride film and aluminum foil.
2 blisters (10 mg pills) or 3 blisters (25 mg pills) are placed in a cardboard box with instructions for use.

Shelf life is
4 years.

Storage conditions
List B.
Store in a dry place, out of reach of children, at temperatures above 25 ? C. Do not use after the expiration date indicated on the package.

Terms of dispensing from pharmacies:

dispensed by prescription.