Active ingredient: chlorprothixene;
1 tablet contains 25 mg or 50 mg of chlorprothixene hydrochloride;
Excipients: corn starch lactose monohydrate, copolividone; glycerin (85%); cellulose microcrystalline sodium croscarmellose; talc magnesium stearate coating OPADRY OY-S-9478 brown
Hypersensitivity to the components of the preparation or the means of the thioxanthene group.
Circulatory collapse, depression of the central nervous system of any origin (for example, as a result of alcohol, barbiturate or opioid intoxication), coma.
Chlorprothixene may lead to prolongation of the QT interval. Persistent prolongation of the QT interval may increase the risk of malignant arrhythmias. Therefore, chlorprothixene is contraindicated in patients with a history of clinically significant cardiovascular disorders (eg, bradycardia < 50 beats/minute, recent acute myocardial infarction, decompensated heart failure, cardiac hypertrophy, arrhythmias if class IA and III antiarrhythmics are intended) and in patients with a history of ventricular arrhythmias or pyuretic tachycardia.
Chlorprothixene is contraindicated in patients with uncorrected hypokalemia and hypomagnesemia.
Chlorprothixene is contraindicated in patients with hereditary long QT syndrome or an established acquired long QT interval (QTc greater than 450 ms in men and 470 ms in women).
Co-administration with preparations that significantly prolong the QT interval.
The dosage should be selected individually. The initial dose should be low, then the dose should be increased relatively quickly until the optimal therapeutic effect is achieved.
Schizophrenia and other psychoses with psychomotor restlessness, agitation and anxiety disorder. The initial dose is 50-100 mg / day with a gradual increase until the optimal effect is achieved. The usual optimal dose is 300 mg per day, in some cases it can be increased to 1200 mg / day, if necessary.
The maintenance dose is usually 100-200 mg/day.
Due to the strong sedative effect, smaller doses should be taken during the day and higher doses in the evening.
pregnant
Clinical experience with pregnant women is limited. Chlorprothixene should not be administered during pregnancy unless the expected benefit to the patient outweighs the potential risk to the fetus.
Breastfeeding may be continued during treatment with chlorprothixene if clinically important, but monitoring of the infant is recommended, especially in the first four weeks after birth.
Cases of hyperprolactinemia, galactorrhea, amenorrhea, lack of ejaculation and erectile dysfunction have been reported. These conditions can have a negative impact on female and/or male sexual function and fertility. If clinically significant hyperprolactinemia, galactorrhea, amenorrhea, or sexual dysfunction occurs, dose reduction (if possible) or withdrawal should be considered. Effects after discontinuation of the preparation are reversible.
Children
Chlorprothixene is not recommended for use in children under 18 years of age because clinical studies of efficacy and safety in children and adolescents are insufficient.
Drivers
Truxal is a sedative. Truxal, like major mental illnesses, can impair attention and responsiveness, as well as affect behavior and psychomotor functions. Patients taking Truxal should not drive or operate dangerous machinery until they are aware of their personal reaction to the preparation.
Symptoms: drowsiness, coma, shock, extrapyramidal disorders, hyper- or hypothermia.
In severe cases, kidney damage.
With simultaneous overdose, along with agents that can affect cardiac activity, there have been cases of ECG changes, QT prolongation, torsades de pointes, cardiac arrest and ventricular arrhythmias.
Treatment: symptomatic and supportive therapy. After ingestion, gastric lavage should be carried out as soon as possible; activated charcoal can be used. Measures should be taken to support the respiratory and cardiovascular systems. Epinephrine should not be used, as a decrease in blood pressure may occur. Convulsions can be eliminated with diazepam, and extrapyramidal symptoms with biperiden.
For adults, doses of 2.5-4 g can be lethal, for children - about 4 mg / kg of body weight. Adults survived after 10 g, and a three-year-old child after 1000 mg.
From the side of the heart: often (≥ 1/100 to < 1/10) - tachycardia, palpitations.
From the nervous system: very often (≥ 1/10) - drowsiness, dizziness; often (≥ 1/100 to < 1/10) - dystonia, headaches.
Visual disturbances: often (≥ 1/100 to < 1/10) - disturbance of accommodation, vision.
From the gastrointestinal tract: very often (≥ 1/10) - dry mouth, saliva hypersecretion; often (≥ 1/100 to < 1/10) - constipation, dyspepsia, nausea.
From the skin and subcutaneous tissue: often (≥ 1/100 to < 1/10) - hyperhidrosis.
Musculoskeletal disorders: often (≥ 1/100 to < 1/10) - myalgia.
Metabolic disorders: often (≥ 1/100 to < 1/10) - increased appetite, weight gain.
Store at a temperature not exceeding 25°C, out of the reach of children.
Shelf life - 5 years.
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