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indicated for the management of the manifestations of schizophrenia. Clopixol-Acuphase is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia. Clopixol Depot is intended for maintenance treatment. Clopixol tablets may be used during either phase.


Acute alcohol, barbiturate or opiate intoxication; CNS depression due to any cause, comatose states, suspected or established subcortical brain damage, circulatory collapse, blood dyscrasias, or pheochromocytoma; Known hypersensitivity to the thioxanthenes, zuclopenthixol or any of the excipients of the product

Adverse reactions:

The most common adverse events reported were drowsiness, fatigue, dizziness, and extrapyramidal symptoms. Body as a Whole: Allergic reaction, application site disorder, arthritis, back pain, chest pain, precordial chest pain, conjunctivitis, faintness, fever, hot flushes and toothache. Psychiatric: Drug dependence, excitability, irritability, increased libido, melancholia and paroniria. Neurological: Acute dyskinesia, ataxia, convulsions, hyperreflexia, hypotonia, migraine, oculogyric crisis, and speech disorder. Gastrointestinal: Abdominal pain, dysphagia, gastric ulcer, glossitis and meteorism. Cardiovascular: Hypotension. Respiratory: Dyspnea, nasal congestion, pharyngitis and rhinitis. Hematological: Purpura. Special Senses: Mydriasis, hyperacusis and tinnitus. Skin and Appendages: Dermatitis, photosensitivity reaction, abnormal pigmentation, rash, erythematous rash and psoriasiform rash. Urinary: Polyuria, urinary incontinence, urinary infection and urinary retention. Reproductive: Erectile dysfunction, galactorrhea, gynecomastia and dry vagina. In the worldwide postmarketing surveillance database (1964 to 1993; >1,000,000 treated; >80% of the database from Scandinavia, Netherlands, Switzerland and the UK) the following additional serious adverse events have been rarely reported: Neuroleptic Malignant Syndrome (57 cases); apnoea and respiratory depression (13 cases); sudden death (5 cases), agranulocytosis (5 cases). Alterations in liver function, particularly increased bilirubin levels have occasionally been reported. Transient increases in ALT and ALP values may also occur. Transient, benign leucopenia has been reported rarely. Peripheral edema has occasionally been reported.


Zuclopenthixol enhances the sedative response to alcohol and the effects of barbiturates and other CNS depressants. It should not be administered with high doses of hypnotics due to the possibility of potentiation. Zuclopenthixol should not be given concomitantly with guanethidine or similar acting compounds, since antipsychotic drugs such as zuclopenthixol may block the antihypertensive effect of these compounds. Many antipsychotic and antidepressant drugs may mutually inhibit the metabolism of each other. Concomitant use of metoclopramide or piperazine increases the risk of extrapyramidal symptoms. Zuclopenthixol may antagonize the effects of levodopa and dopamine agonists


Occupational Hazards Sedative Effects: Since sedation is known to occur with zuclopenthixol, patients should be cautioned against performing activities requiring a high degree of mental alertness and physical coordination (such as driving a car or operating machinery) until the effect of the drug is determined. Anticholinergic Effects: Although its anticholinergic effects are weak, zuclopenthixol use should be avoided in patients who are known to have, or suspected of having narrow angle glaucoma. Zuclopenthixol may potentiate anticholinergic effects of concurrent medications. Endocrine Effects: Antipsychotic drugs elevate prolactin levels with the effect persisting during chronic administration. Since tissue culture experiments indicate that approximately one third of human breast cancers are prolactin dependent in vitro, zuclopenthixol should only be administered to patients with previously detected breast cancer if the benefits outweigh the potential risks. Caution should also be exercised when considering zuclopenthixol treatment in patients with pituitary tumors. Possible manifestations associated with elevated prolactin levels are amenorrhea, galactorrhea, and menorrhagia. Chronic administration of zuclopenthixol (30 mg/kg/day for two years) in rats resulted in small, but significant, increases in the incidence of thyroid parafollicular carcinomas and, in females, of mammary adenocarcinomas and of pancreatic islet cell adenomas and carcinomas. An increase in the incidence of mammary adenocarcinomas is a common finding for D2 antagonists which increase prolactin secretion when administered to rats. An increase in the incidence of pancreatic islet cell tumors has been observed for some other D2 antagonists. The physiological differences between rats and humans with regard to prolactin make the clinical significance of these findings unclear. Antiemetic Effects: An antiemetic effect of zuclopenthixol has been observed in animals. Since this effect may also occur in man, zuclopenthixol may mask signs of toxicity due to overdosage of other drugs, or may mask symptoms of disease such as brain tumor or intestinal obstruction. Photosensitivity Reactions: Photosensitivity reactions, pigmentary retinopathy and lenticular and corneal deposits have been reported with related drugs. Lens opacity has been reported rarely with zuclopenthixol. Seizures: Zuclopenthixol should be used with caution in patients with a history of convulsive disorders, as drugs of this class are known to lower seizure threshold. Cardiovascular Disease: Caution should be used when using zuclopenthixol in patients with advanced cardiovascular disease or in those at risk of developing conduction abnormalities. Pregnancy: The safe use of zuclopenthixol during pregnancy has not been established. Zuclopenthixol was not teratogenic in either rats or rabbits, however, increases in the number of stillbirths, reduced pup survival and delayed development of pups were seen in rats. The clinical significance of these findings is unclear. It has been shown that zuclopenthixol crosses the placenta of mice. Zuclopenthixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the potential risk to the fetus. Lactation: Zuclopenthixol is excreted in human milk with an average milk/serum concentration ratio of approximately 0.3. Because the safe use of zuclopenthixol during lactation has not been established, it is recommended that breast feeding should not be undertaken in women receiving zuclopenthixol. Children: The safety and efficacy of zuclopenthixol in children under the age of 18 years has not been established, therefore its use is not recommended. Use in the Elderly: The pharmacokinetics, safety, and efficacy of zuclopenthixol in elderly patients with schizophrenia has not been systematically evaluated in clinical trials. Caution should thus be exercised in dose selection for an elderly patient, recognizing the more frequent hepatic, renal and cardiac dysfunctions in this population. Impaired Liver Function: The use of zuclopenthixol in patients with impaired liver function has not been studied. As zuclopenthixol is extensively metabolized by the liver and primarily excreted in the bile, caution should be exercised in dose selection for patients with this condition. Impaired Renal Function: The use of zuclopenthixol in patients with impaired renal function has not been studied. Caution should thus be exercised in dose selection for patients with this condition.



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