CLOPIXOL (Zuclopenthixol) is an antipsychotic medication used for the management of the manifestations of schizophrenia. CLOPIXOL (Zuclopenthixol) is intended for the initial treatment of acute psychotic episodes or exacerbation of psychosis associated with schizophrenia. CLOPIXOL (Zuclopenthixol) is intended for maintenance treatment. CLOPIXOL (Zuclopenthixol) tablets may be used during either phase. PRECATUIONS: Neuroleptic malignant syndrome (NMS) is a rare, sometimes fatal, neurological disorder that has been reported in association with antipsychotic drugs including CLOPIXOL (Zuclopenthixol) (see Adverse Effects). NMS is characterized by hyperthermia, muscle rigidity, altered consciousness, and signs of autonomic instability including irregular blood pressure, tachycardia, cardiac arrhythmias and diaphoresis. Additional signs may include greatly elevated creatine phosphokinase, myoglobinuria and acute renal failure. The management of NMS should include immediate discontinuation of all antipsychotic drugs including CLOPIXOL (Zuclopenthixol), intensive monitoring of symptoms, and treatment of any associated medical problems. There is no general agreement about specific pharmacological treatment for NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the reintroduction of therapy should be carefully considered, since recurrence of NMS has been reported. Tardive Dyskinesia: Tardive dyskinesia is a potentially irreversible neurological syndrome associated with the use of antipsychotic drugs, including CLOPIXOL (Zuclopenthixol) (see Adverse Effects). It is characterized by stereotypical, repetitive, involuntary movements of the jaw, tongue and in some cases, the extremities. Tardive dyskinesia occurs more frequently in elderly patients. However, patients of any age can be affected. The risk of developing tardive dyskinesia, and the chance of it becoming irreversible, are believed to increase as the duration of treatment and the cumulative dose of antipsychotic drugs increase. However, the syndrome can develop, although less commonly, after relatively brief periods of treatment at low doses. Tardive dyskinesia may remit, partially or completely, if antipsychotic drug treatment is withdrawn. Antipsychotic drug treatment itself, however, may suppress the signs and symptoms of tardive dyskinesia, thereby masking the underlying process. In view of these considerations,CLOPIXOL (Zuclopenthixol) should be prescribed in a manner that is most likely to minimize the risk of tardive dyskinesia. The lowest effective dose of CLOPIXOL (Zuclopenthixol) and the shortest duration of treatment should be used, and treatment should be discontinued at the earliest opportunity, or if a satisfactory response cannot be obtained. If the signs and symptoms of tardive dyskinesia appear during CLOPIXOL (Zuclopenthixol) treatment, discontinuation of CLOPIXOL (Zuclopenthixol) should be considered. (This inforamtion was adapted from the website cited in the Side Effects section).
The most common CLOPIXOL side effects reported were drowsiness, fatigue, dizziness and extrapyramidal symptoms. CLOPIXOL side effects reported in clinical trials, occurring at rates of 1% or less are summarized below for all three formulations together: Body as a Whole CLOPIXOL side effects: allergic reaction, application site disorder, arthritis, back pain, chest pain, precordial chest pain, conjunctivitis, faintness, fever, hot flushes and toothache. Psychiatric CLOPIXOL side effects: drug dependence, excitability, irritability, increased libido, melancholia and paroniria. Neurological CLOPIXOL side effects: acute dyskinesia, ataxia, convulsions, hyperreflexia, hypotonia, migraine, oculogyric crisis, and speech disorder. Gastrointestinal CLOPIXOL side effects: abdominal pain, dysphagia, gastric ulcer, glossitis and meteorism. Cardiovascular CLOPIXOL side effects: hypotension. Respiratory CLOPIXOL side effects: dyspnea, nasal congestion, pharyngitis and rhinitis. Hematological CLOPIXOL side effects: purpura. Special Senses CLOPIXOL side effects: mydriasis, hyperacusis and tinnitus. Skin and Appendages CLOPIXOL side effects: dermatitis, photosensitivity reaction, abnormal pigmentation, rash, erythematous rash and psoriasiform rash. Urinary CLOPIXOL side effects: polyuria, urinary incontinence, urinary infection and urinary retention. Reproductive CLOPIXOL side effects: 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 CLOPIXOL side effects have been rarely reported: Neuroleptic Malignant Syndrome (57 cases) (see Warnings); apnea and respiratory depression (13 cases); sudden death (5 cases), agranulocytosis (5 cases). CLOPIXOL side effects like Alterations in liver function, particularly increased bilirubin levels have occasionally been reported. Transient increases in ALT and ALP values may also occur. Transient, benign leukopenia has been reported rarely.CLOPIXOL side effects like Peripheral edema has occasionally been reported. Symptoms And Treatment Of Overdose: Symptoms and Treatment: Although there have not been any cases of overdosage reported, the symptoms are likely to be CLOPIXOL side effects like somnolence, coma, extrapyramidal symptoms, convulsions, hypotension, shock, or hyper- or hypothermia. There is no specific antidote for zuclopenthixol. Treatment of CLOPIXOL side effects should be symptomatic and supportive. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal should be considered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted.CLOPIXOL side effects like Hypotension and circulatory collapse may be counteracted by use of i.v fluids. Epinephrine must not be used as a further lowering of blood pressure may result. In cases of severe CLOPIXOL side effects like extrapyramidal reactions, antiparkinsonian medication should be administered. Close monitoring and medical supervision should continue until the patient recovers. In managing overdose, the physician should consider the possibility of multiple drug involvement. The above information has been modified from the following website:(http://www.rxmed.com/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%20Monographs/CPS-%20(General%20Monographs-%20C)/CLOPIXOL.html)
CLOPIXOL is a thioxanthene derivative, has high affinity for both dopamine D1 receptors and dopamine D2 receptors. CLOPIXOL (Zuclopenthixol) also has high affinity for a1-adrenergic and 5-HT2 receptors. It has weaker histamine H1 receptor blocking activity, and even lower affinity for muscarinic cholinergic and a2-adrenergic receptors. Clopixol-Acuphase: Each mL contains: zuclopenthixol acetate 50 mg (equivalent to zuclopenthixol 45.25 mg/mL) in fractionated coconut oil. Colorless glass ampuls of 1 and 2 mL. Packages of 5. Store between 15 and 25°C. Protect from light. Clopixol Depot: Each mL contains: zuclopenthixol decanoate 200 mg (equivalent to zuclopenthixol 144.4 mg/mL) in fractionated coconut oil. Colorless vials of 10 mL. Store between 15 and 25°C. Protect from light.