International generic name

Chlorpromazine

Drug form and composition

Solution for injection. One ampoule of 2 ml (2.5%) contains 50 mg Chlorpromazine hydrochloride (25 mg per ml). One ampoule of 5 ml (0.5% or 1%) contains 25 mg (5 mg per ml) or 50 mg (10 mg per ml) Chlorpromazine hydrochloride.

Indications

Neurosis, manifesting with emotion; tetanus - as a part of the combined therapy. In mental disorders - schizophrenia; chronic paranoid conditions; maniacal phase of cyclophrenia; alcohol psychosis; chorea minor. In nausea and vomiting of different causes; in serious singultus; in the treatment of acute porphyria. In surgery and anesthesiology: for preparation of the patient for narcosis; in postoperative and traumatic shock.

Dosage and administration

The preparation is administered parenterally - intramuscularly and intravenously. In order to reduce the irritation effect of the medicine, intramuscularly are injected low concentration solutions (0.5%). In intravenous application, because of the acid reaction of the solution, it should be previously diluted in 10-20 ml glucose or saline and injected slowly. Adults: in mental disorders - 25-50 mg single dose, as the same dose may be repeated after 1 hour; in cases of vomiting and serious singultus - intramuscularly in single dose 25 mg, as the same dose may be injected repeatedly each 3-4 hours; as an anxiolytic - intramuscularly in dose 12.5-25 mg. Maximal dose should not exceed 1 g/24h. Only in rare cases the dose may reach 2 g, but for a short time.

Contraindications

Severe liver diseases; hypersensitivity to Chlorazin; epilepsy; severe renal failure; Parkinson’s disease; coma and acute injuries of the brain; cardiovascular diseases; respiratory tract disorders; hypotension; stomach and duodenal ulcer; hyperprolactinemia; pregnancy and nursing.

Special warnings and precautions

In patients with chronic pulmonary diseases (pulmonary emphysema, asthma) Chlorazin should be administered with care. The preparation should be administered with care in children, as they are predisposed to development of neuromuscular and extrapyramidal reactions. Particularly high risk exists in children with dehydration and acute infectious diseases (i. e. varicella and small pox). In elderly patients the preparation should be used with particular care, as they usually require lower dose. The patients with mental syndromes should be treated with 1/3 to 1/2 of the usual dose. The treatment with Chlorazin may cause leucopenia and thrombopenia, which increases the risk of microbial infections, retardation of the wound recovery, and gum bleeding. In patients with history for convultions the preparation should be used with care, as it may provoke such a symptom.

Drug interactions

Chlorazin potentiates effects of the medicines, depressing the central nervous system - anesthetics, barbiturates, narcotic analgetics, alcohol; reduces the effect of the oral anticoagulant drugs, sulphonylurea antidiabetic preparations, levodopa, guanethidine, insulin, and metformin. In concomitant administration with propranolol the plasma level of both medicines is elevated. Chlorazin reduces the anticonvulsive effect of the phenobarbital and other antiepileptic drugs, diminishing the convulsion threshold. Diuretics and antihypertensive medicines may worsen the orthostatic hypotension, caused by Chlorazin.

Adverse reactions

Parkinson's syndrome and dyskinesia; xerostomia; dystonia - more frequent in children; gastrointestinal disorders; accommodation disorders; urine retention; mechanic jaundice; photosensitization; menstruation disorders; galactorrhoea; gynecomastia; glaucoma.

Pharmacological mechanisms

Chlorazin is phenothiazine neuroleptic, possessing dopaminergic, adrenolytic, cholinolytic, serotoninolytic and antihystamine (on the H1 receptors) effects in the brain structures. It reduces enhanced emotional and motor excitation, but contrary to barbiturates, even in high dose, does not lead to narcosis. The medicine depresses the trigger zone, which is the cause for relive of the nausea, vomiting and intoxication in infectious diseases. In long-term treatment Chlorazin exerts antipsychotic action - wild ideas and hallucinations are relived and the normal mental activity are restored. It is supposed that many of the central effects are related to blocking of the D2-dopamine receptors in different parts of the brain.

Supplied

100 ampoules of 2 ml (50 mg). 50 ampoules of 5 ml (25 mg). 50 ampoules of 5 ml (50 mg).

Expiry

5 years.