CLOPIXOL (Zuclopenthixol dihydrochloride)

CLOPIXOL Information

It is intended for the Acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. It is also intended for Manic phase of manic depressive illness, Mental retardation associated with psychomotor hyperactivity, agitation, violence and other behavioral disturbances.

CLOPIXOL Warnings

The antiemetic effect observed with zuclopenthixol in animal studies may also occur in man. Therefore, the medicine may mask signs of toxicity due to over dosage of other medicines, or it may mask symptoms of disease such as brain tumour or intestinal obstruction. Photosensitivity reactions, pigmentary retinopathy and lenticular and corneal deposits have been reported with related agents. Lens opacity has been reported rarely with zuclopenthixol. The possibility of anaphylactoid reactions occurring in some patients should be borne in mind. Although not reported with zuclopenthixol, phenothiazines may depress the mechanism for regulation of temperature. Severe hypothermia may occur during swimming in cold water or in patients receiving antipyretic therapy. Heat stroke may occur in hot weather. Patients who develop pyrexia along with clouding of consciousness and rigidity should cease medication and undergo immediate investigation as these are the early symptoms of the Neuroleptic Malignant Syndrome, a potentially lethal adverse effect of major tranquillisers. Ambulant patients should be warned not to drive or operate machinery during the use of CLOPIXOL. Patients should be forewarned and reassured concerning the possible occurrence of extrapyramidal symptoms. Patients should be instructed to report any soreness of the mouth, gums, throat, or other symptoms which may indicate suppression of the immune system. If any soreness of the mouth, gums or throat, or any symptoms of upper respiratory infection occur and a confirmatory leucocyte count indicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.

Blood dyscrasias and liver damage have been reported with this class of medicine. Therefore, routine blood counts and hepatic function tests are advisable, particularly during the first months of therapy. Should either of these disorders occur, supportive treatment should be instituted and administration of the medicine ceased. Severe adverse reactions requiring immediate medical attention may occur and are difficult to predict. Therefore, the evaluation of tolerance and response, and establishment of adequate maintenance therapy require careful stabilization of each patient under continuous, close medical observation and supervision. CLOPIXOL should be used with caution in patients with Parkinsonism or severe arteriosclerosis and a history of convulsive disorders since zuclopenthixol may lower the convulsive threshold. Caution should be observed when using a medicine of this category in patients who have advanced cardiovascular disease or those who may have a propensity for development of cardiac conduction defects.

The safety of CLOPIXOL in pregnant women has not been established. CLOPIXOL should not be administered to women of child-bearing potential unless, in the opinion of the physician, the expected benefit to the patient outweighs the potential risk to the foetus. Zuclopenthixol passes into breast milk in small amounts; the milk/serum concentration ratio in women is, on average, 0.3. Since the safety and efficacy of CLOPIXOL in children have not been established, its use is not recommended in this age group.

Contraindications Known hypersensitivity to the thioxanthenes. The possibility of cross-sensitivity between the thioxanthenes and phenothiazine derivatives should be kept in mind. Acute alcohol, barbiturate or opiate intoxication. Presence of CNS depression due to any cause, comatose states, suspected or established subcortical brain damage, blood dyscrasias, phaeochromocytoma, liver damage, cerebrovascular or renal insufficiency and severe cardiovascular disorders. CLOPIXOL is not indicated for the management of severely apathetic, withdrawn or psychoneurotic patients. CLOPIXOL should not be used concomitantly with large doses of hypnotics due to the possibility of potentiation Drug Interactions: CLOPIXOL should not be used concomitantly with large doses of hypnotics due to the possibility of potentiation. Zuclopenthixol enhances the response to alcohol and the effects of barbiturates and other CNS depressants. Zuclopenthixol should not be given concomitantly with guanethidine or similar acting compounds since neuroleptics such as zuclopenthixol may block their antihypertensive effects. Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each other. Zuclopenthixol may reduce the effects of levodopa and adrenergic agents. Concomitant use of metoclopramide increases the risk of extrapyramidal symptoms.

CLOPIXOL Side Effects

The most common adverse reactions reported with zuclopenthixol have been drowsiness and extrapyramidal symptoms. Because zuclopenthixol shares many of the pharmacological properties of other thioxanthenes and phenothiazines, the possible occurrence of the known adverse effects of these medicine classes exists. Tardive dyskinesia may appear in some patients during long-term use or may occur after therapy has been discontinued. Elderly patients on high dose therapy, especially elderly females, may be at greater risk. The symptoms may be persistent and, in some patients, appear to be irreversible. It has been reported that if the medication is stopped at the first signs of fine vermicular movements of the tongue, which may be an early manifestation, the syndrome may not develop. Orthostatic dizziness may occur. Hypotension, hypertension, fluctuations in blood pressure, non-specific ECG changes and cardiac arrhythmias have been reported with related agents. Eosinophilia, jaundice and increased levels of SGOT, SGPT and alkaline phosphatase have been reported with related medicines. Other antipsychotic medicines have been associated with leucopaenia, agranulocytosis, thrombocytopaenic or non-thrombocytopaenic purpura, haemolytic anaemia and pancytopaenia. Skin reactions such as pruritus, rash, urticaria, erythema, seborrhoea, Eczema, exfoliative dermatitis and contact dermatitis have been reported with related agents.

CLOPIXOL Overdose

Over dosage is characterized by somnolence, coma, extrapyramidal symptoms, convulsions, cramps, decreased blood pressure, shock and hampered regulation of temperature (hyper- or hypothermia). There is no specific antidote for zuclopenthixol. Treatment should be symptomatic and supportive. Gastric lavage should be carried out immediately after oral ingestion and activated charcoal may be administered.

CLOPIXOL Usage guidelines

Dosage should be adjusted individually. In general, small doses should be used initially and increased to the optimal effective level as rapidly as possible, based on the response. The usual recommendation for dosing is once a day, normally given in the evening because of the sedative effect. However, if high doses are given it can be divided into two daily doses, mainly to avoid side effects. To be stored below 25°C.

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