Sonapax

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sonapax: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Drug interactions
10. Analogs
11. Terms and conditions of storage
12. Terms of dispensing from pharmacies
13. Reviews
14. Price in pharmacies

Latin name: Sonapax

ATX code: N05AC02

Active ingredient: Thioridazine (Thioridazine)

Manufacturer: PHARMACEUTICAL WORKS JELFA, SA, Poland

Description and photo update: 2019-12-08

Prices in pharmacies: from 233 rubles.

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Sonapax is a drug with a neuroleptic effect.

Release form and composition

The dosage form of Sonapax is coated tablets (dragees): round, biconvex, the color at the break is white, the color of the shell is light pink (10 mg each) or light yellow (25 mg), uniform color (10/25 mg: 30/20 tablets in blisters, in a cardboard box 2/3 of the package).

Composition of 1 tablet:

active substance: thioridazine hydrochloride - 10 or 25 mg;
additional components (10/25 mg): corn starch - 8/0 mg; potato starch - 0 / 46.5 mg; colloidal silicon dioxide - 1.5 / 0 mg; lactose monohydrate - 26.4 / 0 mg; gelatin - 0.1 / 0.5 mg; stearic acid - 1/0 mg; talc - 3/6 mg; sucrose - 0/60 mg; magnesium stearate - 0/2 mg;
shell (10/25 mg): sucrose - 35.799 / 85.668 mg; acacia gum - 0.5 / 3.4 mg; talc - 13.7 / 30.8 mg; crimson dye (Ponso 4R) - 0.001 / 0 mg; quinoline yellow dye - 0.132 / 0 mg.

Pharmacological properties

Pharmacodynamics

Thioridazine belongs to the group of piperidine derivatives of phenothiazine and directly affects the central and peripheral nervous system. It has antiemetic, antipruritic, antidepressant, tranquilizing and antipsychotic effects.

The cause of the antipsychotic effect is the blockade of postsynaptic dopamine receptors located in the mesolimbic structures of the brain. The central antiemetic effect is caused by blockade or inhibition of the functioning of dopamine D2 receptors located in the chemoreceptor trigger zone of the brain stem. The peripheral antiemetic effect is due to the blockade of the vagus nerve in the gastrointestinal tract.

Also, thioridazine is characterized by a-adrenergic blocking and m-anticholinergic action. Of all antipsychotics, the substance is able to most effectively block Hi-histamine and m-cholinergic receptors. In small quantities, it has an anxiolytic effect, reduces feelings of anxiety and tension. When taking higher doses of Sonapax, its neuroleptic (antipsychotic) properties are manifested. Also, thioridazine stimulates the production of prolactin by the pituitary gland and lengthens the QTc interval (the degree of severity depends on the dose), which can provoke severe ventricular arrhythmias with a possible fatal outcome, including "pirouette" tachycardia.

Pharmacokinetics

The degree of absorption of thioridazine in the gastrointestinal tract is quite high. The maximum concentration of the substance in the blood plasma is observed 1–4 hours after ingestion. Thioridazine binds to plasma proteins by about 90% and is metabolized in the liver, forming active metabolites sulforidazine and mesoridazine. The half-life is 6-40 hours. Mesoridazine has greater pharmacological activity than the parent compound, has a longer half-life, is less bound to plasma proteins, and the free fraction is higher than that of thioridazine.

The active component of Sonapax is excreted unchanged and in the form of metabolites through the kidneys (approximately 35%) and intestines. Thioridazine also passes into breast milk.

Indications for use

schizophrenia (as a second-line drug in case of ineffectiveness / contraindications to the use of other drugs);
psychotic disorders, proceeding with agitation and hyperreactivity;
withdrawal symptoms (alcoholism, substance abuse);
severe behavior disorders associated with the inability to concentrate attention for a long time and with aggressiveness;
neuroses, which are accompanied by such disorders as psychomotor agitation, sleep disturbances, fear, anxiety, psycho-emotional stress, obsessive states, depressive disorders;
psychomotor agitation of various etiologies;
behavioral disorders accompanied by increased psychomotor activity (child psychiatry).

Contraindications

Absolute:

severe depressive conditions;
congenital low activity of the isoenzyme CYP2D6;
pronounced depression of the central nervous system;
long QT syndrome;
coma;
burdened history of blood diseases and arrhythmias;
liver failure;
lactose or fructose intolerance, lactase or isomaltase / sucrase deficiency, glucose-galactose malabsorption;
combined use with drugs that prolong the QT interval;
age up to 4 years;
period of breastfeeding;
hypersensitivity to drug components and other phenothiazine derivatives.

Relative contraindications - diseases / conditions in which Sonapax tablets are prescribed with caution:

alcoholism (predisposition to the development of hepatotoxic reactions);
mammary cancer;
pathological changes in the blood picture (disorders of the hematopoietic system);
hyperplasia of the prostate gland, proceeding with clinical manifestations;
angle-closure glaucoma;
exacerbation of gastric ulcer and duodenal ulcer;
renal failure;
Parkinson's disease (due to increased extrapyramidal effects);
cachexia, vomiting (due to the likelihood of masking vomiting, which is associated with an overdose of other drugs);
diseases occurring with an increased risk of thromboembolic complications;
chronic diseases that are accompanied by breathing disorders (especially in children);
myxedema;
Reye's syndrome (due to an increased likelihood of hepatotoxicity in children / adolescents);
epilepsy.

Due to the prolongation of the QT interval, the likelihood of severe toxic effects must be considered.

For pregnant women, Sonapax is prescribed only after assessing the benefit / risk ratio (the safety profile for this category of patients has not been studied).

Instructions for the use of Sonapax: method and dosage

Sonapax tablets are taken orally.

The doctor determines the regimen for taking the drug individually, based on the severity of the condition.

The recommended dosage regimen of Sonapax:

schizophrenia: adults - from 50-100 mg (at the beginning of treatment) 3 times a day, with a gradual increase, if necessary, to a maximum dose of 800 mg / day; after achieving the effect, the dose is reduced to the lowest maintenance dose; the average daily dose is 200-800 mg in 2-4 doses; children - 0.5 mg / kg in several doses; if necessary, it is possible to increase to a maximum of 3 mg / kg;
psychomotor excitement of various origins; psychotic disorders that proceed with agitation and hyperreactivity; severe behavior disorders associated with the inability to concentrate attention for a long time and aggressiveness: outpatient - 150-400 mg per day, inpatient - 250-800 mg per day; therapy should be started with the use of low doses - 25–75 mg per day, gradually increasing to the optimal therapeutic one, which is achieved within a week; the development of the antipsychotic effect is noted 10–14 days after the start of treatment; the duration of the course is usually several weeks; maintenance dose - 75-200 mg per day before bedtime, once.

In elderly patients, the dose of Sonapax is usually reduced to 30–100 mg per day.

It is necessary to cancel the drug gradually.

Scheme of using Sonapax for other indications (daily dose):

neuroses with mild emotional / cognitive impairment: 30–75 mg, if ineffective, the dose is gradually increased to 50–200 mg;
withdrawal symptoms: from 10–75 to 150–400 mg (depending on the severity of the condition);
neuroses with a somatic component: 10–75 mg; treatment should be started with low doses, gradually increasing them to the optimal therapeutic;
behavioral disorders in children, accompanied by increased psychomotor activity: 4–7 years old - 2–3 times a day, 10–20 mg; 8-14 years old - 3 times a day, 20-30 mg; 15-18 years old - 3 times a day, 30-50 mg.

Side effects

hematopoietic system: eosinophilia, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, granulocytopenia, thrombocytopenia;
central nervous system: confusion, extrapyramidal and dystonic disorders, neuroleptic malignant syndrome, tardive dyskinesia, agitation, insomnia, agitation, parkinsonism, thermoregulatory disturbances, emotional disturbances, fainting, lowering of the convulsive threshold;
cardiovascular system: lowering blood pressure, tachycardia, ECG changes, including dose-dependent prolongation of the QT interval, tachycardia pirouette;
digestive system: nausea, vomiting, increased appetite, hyposalivation, anorexia, hypertrophy of the papillae of the tongue, dyspepsia, diarrhea, paralytic intestinal obstruction, cholestatic hepatitis;
endocrine system: weight gain, false positive pregnancy tests;
genitourinary system: hyperprolactinemia, gynecomastia, dysmenorrhea, decreased libido, paradoxical ischuria, impaired ejaculation, priapism, dysuria;
sense organs: photophobia, visual impairment;
allergic reactions: bronchospastic syndrome, nasal congestion, allergic skin reactions, rash, erythema, photophobia, exfoliative dermatitis, angioedema;
other reactions: melanosis of the skin (with a long course with high doses).

Overdose

Symptoms of a Sonapax overdose are manifested as follows:

from the urinary system: uremia, oliguria;
on the part of the cardiovascular system: suppression of myocardial function, arrhythmias, tachycardia of the "pirouette" type, ventricular tachycardia, sinus tachycardia, lowering blood pressure, ventricular fibrillation, shock, AV block, changes in the electrocardiogram, bradycardia, T wave changes and non-specific ST segment, prolongation of PR and QT intervals;
from the digestive system: intestinal obstruction, constipation, decreased gastrointestinal motility;
from the nervous system: blurred consciousness, areflexia, extrapyramidal disorders, agitation, convulsions, hyperthermia, hypothermia, sedation, coma;
from the autonomic nervous system: blurred visual perception, mydriasis, urinary retention, miosis, nasal congestion, dry skin and oral mucosa;
from the respiratory system: apnea, depression of the respiratory center, pulmonary edema.

If the concentration of thioridazine in blood plasma exceeds 10 mg / l, it begins to exhibit toxic properties. At a concentration of 20–80 mg / l, the patient's death occurs.

First aid measures for Sonapax overdose are to ensure airway patency and conduct pulmonary ventilation and adequate oxygenation. It is necessary to immediately begin long-term monitoring of cardiovascular activity, which consists in a regular electrocardiogram.

Overdose treatment consists in the normalization of acid-base balance and elimination of electrolyte disturbances, as well as the introduction of lidocaine (caution should be exercised because of the high risk of seizures), isoproterenol, phenytoin, up to defibrillation and implantation of artificial pacemakers. Due to the possible additional lengthening of the QT interval, it is recommended to stop taking quinidine, procainamide and disopyramide. To correct low blood pressure, vasopressors and infusion solutions are allowed. With a consistently low blood pressure, the use of metaraminol, norepinephrine or phenylephrine is indicated. Since phenothiazine derivatives have alpha-adrenergic blocking properties, it is unacceptable to use non-selective alpha- and beta-adrenergic agonists (dopamine,epinephrine) due to the increased risk of paradoxical vasodilation.

To remove a dose of Sonapax that was not absorbed in the body, it is necessary to flush the stomach and then take activated charcoal. Induction of vomiting is undesirable due to the likely development of dystopia and the potential aspiration of vomit.

Extrapyramidal disorders in an acute condition are stopped with trihexyphenidil or diphenhydramine.

During convulsive seizures, it is recommended to refuse the administration of barbiturates, which can aggravate the depression of the respiratory center.

Since thioridazine is largely bound to plasma proteins and has a high _Vd, hemodialysis, hemoperfusion, forced diuresis and changes in urine pH probably do not affect the rate of excretion of the substance from the body.

special instructions

During the period of application of Sonapax, it is necessary to control the morphological composition of the blood.

Ethanol should not be used during thioridazine therapy.

According to the instructions, Sonapax weakens motor coordination and lowers the speed of psychomotor reactions, especially at the beginning of therapy, therefore, it is recommended to refuse to drive vehicles and maintain moving mechanisms during the period of drug use.

Drug interactions

With the combined use of Sonapax with certain drugs / substances, the following effects may develop:

anticoagulants: a decrease in their action;
general anesthetics, narcotic analgesics, barbiturates, ethanol, atropine: synergism of action;
amphetamine: antagonistic action;
hypoglycemic agents: increased hepatotoxic effect;
levodopa: decrease in antiparkinsonian action;
epinephrine: a sudden and pronounced drop in blood pressure;
guanethidine: a decrease in its antihypertensive effect, but an increase in the effects of other antihypertensive drugs (the likelihood of significant orthostatic hypotension increases);
cimetidine, drugs with an anticonvulsant effect: weakening the effect of Sonapax;
quinidine: potentiation of the cardiodepressant action;
sympathomimetics: increased arrhythmogenic action;
ephedrine: a paradoxical decrease in blood pressure;
procainamide, probucol, astemizole, disopyramide, cisapride, pimozide, erythromycin, and quinidine: additional lengthening of the QT interval (the likelihood of ventricular tachycardia increases);
antithyroid drugs: an increase in the likelihood of agranulocytosis;
apomorphine: a decrease in the emetic effect, an increase in the inhibitory effect on the central nervous system;
drugs that reduce appetite (except for fenfluramine): a decrease in their effectiveness;
bromocriptine: interfering with its action;
prolactin: an increase in its plasma concentration;
tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, histamine H ₁ receptor blockers: prolongation / enhancement of m-anticholinergic and sedative effects;
thiazide diuretics: increased hyponatremia;
beta-blockers: increased antihypertensive action, increased likelihood of irreversible retinopathy, tardive dyskinesia and arrhythmias;
lithium preparations: increased severity of extrapyramidal disorders, a decrease in their absorption in the gastrointestinal tract, an increase in the rate of excretion of lithium ions by the kidneys (early symptoms of lithium intoxication in the form of nausea and vomiting can be masked by the antiemetic effect of Sonapax);
fluvoxamine, propranolol, pindolol: an increase in the plasma concentration of thioridazine (the likelihood of arrhythmias increases);
drugs that prolong the QT interval (cisapride), inhibitors of the isoenzyme CYP2D6 (paroxetine, fluoxetine): an increase in the likelihood of developing arrhythmias, including pirouette tachycardia.

Analogs

The analogues of Sonapax are: Thiodazin, Seroquel, Neuleptil, Thioril, Rispolept.

Terms and conditions of storage

Store in a dry place out of reach of children at temperatures up to 25 ° C.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sonapax

According to reviews, Sonapax is a mild antipsychotic of weak action, which is well tolerated and rarely provokes adverse reactions. However, some patients claim that prolonged use can lead to impotence.

Doctors consider the drug to be effective, but some of them note that there are more modern analogues, and besides, sometimes Sonapax has an adverse effect on the work of the heart.

Since Sonapax is harmless for children and they tolerate it well, the drug is often prescribed to hyperactive pediatric patients with attention deficit disorder. Reviews of its use in this case differ significantly. Some parents say that the drug helped, others complain of increased activity or, conversely, the child's unusual lethargy after taking it.

Price for Sonapax in pharmacies

The approximate price for Sonapax tablets with a dosage of 10 mg is 284–328 rubles, and with a dosage of 25 mg - 443–485 rubles (60 pcs per pack).

Sonapax: prices in online pharmacies

Drug name

Price

Pharmacy

Sonapax 10 mg film-coated tablets 60 pcs.

233 r

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Sonapax tablets p.p. 10mg 60 pcs.

243 r

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Sonapax 25 mg film-coated tablets 60 pcs.

RUB 250

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Sonapax tablets p.p. 25mg 60 pcs.

RUB 400

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!