Truxal coated pills 50mg N50
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Description
Truxal pills are a neuroleptic, a derivative of thioxanthene. They have an antipsychotic, pronounced sedative and moderate anti-depressant effect.
Active ingredients
Chlorprothixen
Release form
Pills
Composition
The active substance is Chlorprothixene hydrochloride 25 mg / 50 mg. Excipients - corn starch 43.8 mg / 27.7 mg, lactose monohydrate 87.7 mg / 55.4 mg, copovidone 10 mg / 8.5 mg, glycerol 85% 4 mg / 3.4 mg, microcrystalline cellulose 20 mg / 17 mg, croscarmellose sodium 4 mg / 3.4 mg, talc 4 mg / 3.4 mg, magnesium stearate 1.5 mg / 1.28 mg. Shell - Opadry OY-S-9478 brown 4 mg / 3.4 mg (hypromellose, macrogol 400, black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171)).
Indications
Schizophrenia and other psychoses occurring with psychomotor agitation, agitation and anxiety. Abstinence syndrome in alcoholism and drug addiction. Depressive states, neurosis, psychosomatic disorders with anxiety, tension, anxiety, insomnia, sleep disorders. Epilepsy and oligophrenia, combined with mental disorders: agitation, agitation, mood lability and behavior disorders. Pain syndrome (in combination with analgesics). Hyperactivity, agitation, irritability, confusion, anxiety, disturbances of behavior and sleep in the elderly Disruptions in behavior and sleep in children.
Precautionary measures
With long-term therapy, especially in large doses, it is necessary to conduct careful monitoring, periodically assessing the condition of patients, in order to make a decision to reduce the maintenance dosage. With the concomitant treatment of diabetes mellitus, the administration of Truxal may require correction of the insulin dose. Due to the risk of malignant arrhythmias, Truxal should be used with caution in patients with a history of cardiovascular diseases and patients with cases of a prolonged QT interval in family history. Before starting treatment with Truxal, an ECG examination is necessary. When the QT interval is over 450 ms in men and 470 ms in women, Truxal should not be prescribed. During therapy, the need for an ECG study is assessed individually by the doctor based on the patient's condition.At prolongation of the QT interval, it is necessary to apply smaller doses of Truxal, at prolongation of the QT interval above 500 ms the therapy should be stopped. During treatment, it is recommended to conduct a periodic assessment of electrolyte balance. It was reported on the development of venous thromboembolism while taking neuroleptics. Due to the fact that patients under treatment with neuroleptics are often at risk of developing venous thromboembolism, before and during treatment with Truxalom it is necessary to determine the risk factors for the development of venous thromboembolism and to take precautions. Truxal is not registered for the treatment of behavioral disorders in elderly patients with dementia. During pregnancy, Truxal should be used only if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns whose mothers took antipsychotic drugs in the final stages of pregnancy or during childbirth may show signs of intoxication, such as lethargy, tremor, and excessive excitability. In addition, these newborns may have a low Apgar score. During treatment with Truxal, breastfeeding is allowed, if it is considered clinically necessary. However, it is recommended to monitor the condition of the newborn, especially in the first 4 weeks after birth. During the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed.
Use during pregnancy and lactation
Contraindicated for use during pregnancy and lactation.
Dosage and administration
Individual. For oral administration for adults, the daily dose varies from 10 mg to 600 mg, for children from 5 mg to 200 mg. The frequency of treatment and the duration of treatment are determined by indications.
Side effects
Most of the side effects depend on the dosage used. The incidence and severity of side effects are most pronounced at the beginning of treatment and decrease as therapy continues. Information about the frequency of side effects is presented on the basis of literature data and spontaneous reports. The frequency is indicated as: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10000 to < 1/1000), very rarely (<1/10000), or unknown (cannot be estimated based on existing data).On the part of the nervous system: very often - drowsiness, dizziness, often - dystonia, headache, infrequently - tardive dyskinesia, parkinsonism, convulsions, akathisia, very rarely - neuroleptic malignant syndrome. On the part of mental activity: often - insomnia, nervousness, agitation, decreased libido. Since the cardiovascular system: often - tachycardia, palpitations, infrequently - hypotension, hot flashes, rarely - prolongation of the QT interval on the electrocardiogram, very rarely - venous thromboembolism. On the part of the blood-forming organs: rarely - thrombocytopenia, neutropenia, leukopenia, agranulocytosis. On the part of the organs of vision: often - accommodation disturbance, blurred vision, rarely - movement of the eyeballs. On the part of the respiratory system: rarely - shortness of breath. From the digestive side. Systems: very often - dry mouth, increased. saliva., often - constipation, dyspepsia, nausea, infrequently - vomiting, diarrhea. for details, see the instructions.
Interaction with other drugs
Truxal can enhance the sedative effect of alcohol, the effects of barbiturates and other means of oppressive central nervous system. Truxal should not be prescribed together with guanethidine and similarly acting agents, since antipsychotics may enhance or weaken the effect of antihypertensive agents, the antihypertensive effect of guanethidine and similarly acting drugs decreases. The simultaneous use of neuroleptics and lithium increases the risk of neurotoxicity. Tricyclic antidepressants and antipsychotics mutually inhibit each other's metabolism. Truxal can reduce the effectiveness of levodopa and the action of adrenergic drugs and enhance the effect of anticholinergic drugs. Simultaneous use with metoclopramide and piperazine increases the risk of extrapyramidal disorders. The antihistamine effect of Chlorprothixene can suppress or eliminate the alcohol / disulfiram reaction.
special instructions
Contraindications - CNS depression, incl. with alcohol intoxication, barbiturates and other drugs that have a depressant effect on the central nervous system, pathological changes in the blood picture, myelodepression, pregnancy, lactation, hypersensitivity to chlorprotixen.