CLOPIXOL

Posology Adults The dosage range is 4-150 mg/day in divided doses. The usual initial dose is 20-30 mg/day (sometimes with higher dosage requirements in acute cases), increasing as necessary. The usual maintenance dose is 20-50 mg/day.

Maximum dosage per single dose is 40 mg. When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

Older patients In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older patients. Paediatic population Clopixol is not indicated for use in children due to lack of clinical experience.

Patients with renal impairment Clopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage. 4). Patients with compromised hepatic function should receive half the recommended dosages.

Serum-level monitoring is advised Method of administration The tablets are swallowed with water.

The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment. Extrapyramidal reactions may occur, especially in the early phase of treatment.

In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate it.

Reduction in dosage or, if possible, discontinuation of zuclopenthixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful. Blood and lymphatic system disorders Thrombocytopenia, neutropenia, leukopenia, agranulocytosis.

Immune system disorders Hypersensitivity, anaphylactic reaction. Endocrine disorders Hyperprolactinaemia. Increased appetite, weight increased. Decreased appetite, weight decreased. Metabolism and nutrition disorders Hyperglycaemia, glucose tolerance impaired, hyperlipidaemia.

Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, libido decreased. Psychiatric disorders Apathy, nightmare, libido increased, confusional state. Somnolence, akathisia, hyperkinesia, hypokinesia. Tremor, dystonia, hypertonia, dizziness, headache, paraesthesia, disturbance in attention, amnesia, gait abnormal.

Tardive dyskinesia, hyperreflexia, dyskinesia, parkinsonism, syncope, ataxia, speech disorder, hypotonia, convulsion, migraine. Nervous system disorders Neuroleptic malignant syndrome. Accommodation disorder, vision abnormal. Eye disorders Oculogyration, mydriasis.

Ear and labyrinth disorders Hyperacusis, tinnitus. Cardiac disorders Electrocardiogram QT prolonged. Vascular disorders Venous thromboembolism Respiratory, thoracic and medistianal disorders Nasal congestion, dyspnoea. Dry mouth. Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.

Gastrointestinal disorders Abdominal pain, nausea, flatulence. Hepato-biliary disorders Cholestatic hepatitis, jaundice. Skin and subcutaneous tissue disorders Rash, photosensitivity reaction, pigmentation disorder, seborrhoea, dermatitis, purpura.

Musculoskeletal and connective tissue disorder Muscle rigidity, trismus, torticollis. Renal and urinary disorders Micturition disorder, urinary retention, polyuria. 6) Ejaculation failure, erectile dysfunction, female orgasmic disorder, vulvovaginal dryness.

Reproductive system and breast disorders Gynaecomastia, galactorrhoea, amenorrhoea, priapism. General disorders and administration site conditions Thirst, injection site reaction, hypothermia, pyrexia. 4). Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown.

Abrupt discontinuation of zuclopenthixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation.

Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

g. alcohol withdrawal or brain damage); Parkinson’s disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.

Therefore, gradual withdrawal is advisable. 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, convulsions or advanced hepatic disease. Blood dyscrasias have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

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. g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

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.

5). As described for other psychotropics, zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients. Older people Older people require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion, and temperature changes.

Cerebrovascular An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical 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. Clopixol tablets are not licensed for the treatment of dementia-related behavioural disturbances.

Excipients The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains hydrogenated castor oil, which may cause stomach upset and diarrhoea.

1. g. intoxication with alcohol, barbiturates or opiates), coma.