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  • Clopixol Tablets
    / Lundbeck

    Active Ingredient
    Zuclopenthixol (as dihydrochloride) 2, 10, 25 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    50 X 2 mg

    partial basket chart 8217 3628

    Film Coated Tablets

    50 X 10 mg

    partial basket chart 8218 3629

    Film Coated Tablets

    100 X 10 mg

    partial basket chart 2355 9443

    Film Coated Tablets

    50 X 25 mg

    partial basket chart 8219 3630

    Film Coated Tablets

    100 X 25 mg

    partial basket chart 2359 9444

    Related information


    Adults: Dosage should be individually adjusted according to the condition of the patient. In general, small doses should be used initially and increased to the optimal effective level as rapidly as possible based on the therapeutic response. The maintenance dose can usually be given as a single dose at bedtime.
    Acute schizophrenia and other acute psychoses: Usually 10-50 mg/day. In moderate to severe cases initially 20 mg/day increased, if necessary, by 10-20 mg every 2 to 3 days to 75 mg or more daily. Maximum dosage per single dose is 40 mg and a total of 150 mg/day.
    Older patients: Older patients should receive dosages in the lower end of the dosage range.
    Children: Clopixol is not recommended for use in children due to lack of clinical experience.
    Reduced renal function: Clopixol can be given in usual doses to patients with reduced renal function.
    Reduced liver function: Careful dosing and, if possible, a serum level determination is advisable.
    For full details see prescribing information.


    Acute schizophrenia and other acute psychoses.


    As for other neuroleptics, intolerance to thioxanthenes. Acute alcohol, barbiturate and opiate intoxications, comatose states.

    Special Precautions

    The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation and opiate and alcohol abuse are over-represented among fatal cases.
    Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful. Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs. Like other neuroleptics zuclopenthixol should be used with caution in patients with organic brain syndrome, convulsion and advanced hepatic disease. As described for other psychotropics zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients. Patients on long-term therapy, particularly on high doses, should be monitored carefully and evaluated periodically to decide whether the maintenance dosage can be lowered. As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, zuclopenthixol should be used with caution in susceptible individuals (with hypokalemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Concomitant treatment with other antipsychotics should be avoided. Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with zuclopenthixol and preventive measures undertaken.
    Older people
    An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical 3 antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Zuclopenthixol should be used with caution in patients with risk factors for stroke.
    Increased Mortality in Older people with Dementia: Data from two large observational studies showed that older people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Zuclopenthixol is not licensed for the treatment of dementia-related behavioural disturbances.
    Excipients: The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine. The tablets contain hydrogenated castor oil, may cause stomach upset and diarrhoea.
    Pregnancy and lactation: Should not be administered during pregnancy, particularly the first and last trimesters, unless the importance of control of psychotic symptoms outweighs the theoretical hazard of the fetal malformation. Clopixol is excreted in small amounts with breast milk, therefore women should not breast-feed.

    Side Effects

    Extrapyramidal reactions in the form of acute dystonias (including oculogyric crisis). Parkinsonian rigidity, tremor, akinesia and akathisia have been reported and may occur even at low dosage in susceptible patients. Such effect would usually be encountered early in treatment, but delayed reactions may also occur. Anti-parkinson agents should not be prescribed routinely because of possible risk of causing anticholinergic side effects, precipitating toxic-confusional states or impairing therapeutic efficacy. They should only be given if required and their requirement reassessed at regular intervals. Initial drowsiness has been reported and in a few patients, slight changes in weight, occasional local reactions such as erythema, swelling or tender fibrous nodules have been reported. Tardive dyskinesia, galactorrhea and amenorrhea are adverse effects of the general group of neuroleptic drugs. The concurrent use of anticholinergic anti-parkinson drugs may exacerbate this effect. Confusional states or epileptic fits can occur. The hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinemia, which may be associated with galactorrhea, gynecomastia, oligomenorrhea or amenorrhea. Sexual function including libido, erection and ejaculation is rarely impaired. Body temperature regulation, especially in the elderly, may possible be compromised. Hypothermia has been reported rarely. Jaundice and other liver abnormalities have been reported rarely. Drowsiness, sedation, dry mouth and nasal stuffiness may occur, particularly with high dosage and at the start of treatment. Postural hypotension may occur, particularly in the elderly. Other anticholinergic type side effects that should be borne in mind include blurring of vision, tachycardia, constipation and urinary hesitancy or retention. The ability to drive a car or operate machinery may be affected.
    For full details see prescribing information.

    Drug interactions

    Alcohol, barbiturates and other CNS depressants. Guanethidine or similar acting compounds, tricyclic antidepressants. Levodopa, adrenergic drugs, anticonvulsants, metoclopramide, piperazine, Lithium.
    For full details see prescribing information.

    Pregnancy and Lactation

    Pregnancy: Zuclopenthixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Neonates exposed to antipsychotics (including zuclopenthizol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully. Animal studies have shown reproductive toxicity.
    Breast-feeding: As zuclopenthixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 1% of the weight related maternal dose (in mg/kg). Breast-feeding can be continued during zuclopenthixol therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
    Fertility: In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, erectile dysfunction and ejaculation failure have been reported. These events may have a negative impact on female and/or male sexual function and fertility. If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation. Administration of zuclopenthixol to male and female rats was associated with a slight delay in mating. In an experiment where zuclopenthixol was administered via the diet, impaired mating performance and reduced conception rate was noted.


    Symptoms: Somnolence, coma, movement disorders, convulsions, shock, hyperthermia/hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when zuclopenthixol has been taken in overdose together with drugs known to affect the heart. The highest orally administered dose of zuclopenthixol in clinical trials was 450 mg daily.
    Treatment: Treatment is symptomatic and supportive. Measures to support the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) should not be used as further lowering of blood pressure may result. Convulsions may be treated with diazepam and movement disorders symptoms with biperiden.

    Lundbeck A/S, Denmark
    Licence holder