Sonapax (thioridazine hydrochloride) coated tablets 25 mg. №60

Description

Sonapax (thioridazine hydrochloride) coated tablets 25 mg. №60

Composition

active substance: thioridazine hydrochloride;

1 film-coated tablet contains: thioridazine hydrochloride 10 mg or 25 mg;

excipients:

film-coated tablets, 10 mg: corn starch, colloidal anhydrous silica, sucrose, lactose monohydrate, gelatin, stearic acid, talc, gum arabic (E 414), cochineal red A (E 124);

film-coated tablets, 25 mg: potato starch, sucrose, gelatin, gum arabic (E 414), magnesium stearate, sucrose, talc, quinoline yellow (E 104).

Dosage form

Coated tablets.

Basic physical and chemical properties:

• Sonapax 10 mg tablets are round, biconvex, film-coated, light pink tablets that are uniform in color. At the break white.
• Sonapax 25 mg tablets are round, biconvex, film-coated, light yellow tablets that are uniform in color. At the break white.

Pharmacotherapeutic group

Antipsychotics. Piperidine derivatives of phenothiazine.
ATX code N05A C02.

Pharmacological properties

It is an antipsychotic drug. The active substance blocks postsynaptic dopamine D2 receptors located in the mesolimbic zone. It also has a sedative (calming) effect, without causing lethargy, lethargy, emotional indifference. Shows a moderate antidepressant (thymoleptic) effect, weak antiemetic, antihistamine effect.

Indications

An antipsychotic neuroleptic, which is used for manic-depressive psychosis, schizophrenia, neuroses characterized by the presence of fears, phobias (obsessive states), feelings of excitement, anxiety, depressed mood, sleep disorders. Effective in the complex therapy of withdrawal symptoms (alcoholism and substance abuse), psychotic disorders that accompany agitation and hyperreactivity. Also prescribed for the treatment of pronounced changes in behavior that are the result of neurological or psychotic disorders, which are characterized by an inability to concentrate over a long period of time. It is effective in the treatment of behavioral disorders and psychomotor agitation, regardless of origin and age, nervous tics, moderate and severe depression, skin diseases accompanied by itching of neurological origin.
The main active component of the drug, thioridazine hydrochloride, is capable of exerting both peripheral and central effects on the functioning of the nervous system. It does not suppress motor activity, much less other antipsychotics are able to provoke extrapyramidal disorders. At the same time, it is able to have antidepressant, anti-autistic and some antipsychotic effects.

Contraindications

Contraindicated in acute depressive conditions, craniocerebral trauma, coma, severe forms of heart disorders, including arrhythmias, bradycardia, low blood pressure, porphyria, pheochromocytoma, some blood diseases that accompany hypo- or aplastic processes.

Application during pregnancy and lactation

There is no precise data on the safety of use in pregnant women or during lactation.

Method of administration and dosage

The recommended dosage is applied 2-4 times a day to ensure a dose-dependent effect. The effect ranges from mild sedation at 10 to 75 milligrams per day to highly pronounced neuroleptic, which appears at 100 to 130 mg per day. Begin treatment with a small dose, gradually increasing it. The optimal treatment effect is achieved after 2 weeks of therapy. After several weeks or months of treatment, an evening maintenance dosage is usually prescribed.
Only the attending physician specifies, adjusts the dose and determines the duration of treatment.
Manias, some psychoses, agitational depression, schizophrenia – from 50 to 200 mg per day for treatment at home and from 100 to 300 – in a hospital setting.
Psychosomatic disorders – 10-75 mg per day. Itching – no more than 200 mg. In child psychiatry, small dosages are used, at the age of 4-7 years – from 10 to 20 mg, up to 14 years – up to 30 mg, 15-18 years – up to 50 mg, which are taken in three doses.

Overdose

Exceeding the dosage entails the appearance of dry mouth, vomiting, urinary retention, paralysis of the intestine and, as a consequence, its obstruction. Psychosomatic disorders such as drowsiness or agitation, convulsions, speech disorders are noted. Possible disruption of the heart, there is tachycardia, apnea, pulmonary edema, coma. It is necessary to flush the stomach, causing vomiting, to carry out symptomatic treatment – artificial ventilation of the lungs, it is also necessary to control the work of the heart. The use of procainamide, disopyramide, quinidine is contraindicated.

Side effects

Possible agitation, excitement, parkinsonism, pressure drop, changes in appetite, weight gain, diarrhea, jaundice, photophobia, skin melanosis, allergic skin reactions, nasal congestion. Possibly false reaction to pregnancy tests.