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    Active Ingredient
    Clotiapine 40 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 X 40 mg

    full basket chart 807 5080

    Related information


    Dosage

    Clotiapine should not be chewed, should be administered with a small amount of water.
    Psychotic disorders
    Initial therapy: 3 to 5 tablets daily in 2 or 3 divided doses may prove sufficient. The daily oral dose may be increased to a maximum of 360 mg in divided doses, especially in cases of agitation/excitation. The initial dosage may be given for periods of weeks or even months.
    Maintenance and long-term treatment: 20 to 160 mg daily per os in 2 to 3 divided doses in underweight patients, patients with liver or kidney disease and in elderly patients, lower initial doses and a gradual dosage increase are indicated.
    Paediatric population No clinical experience with Clotiapine is available in patients under 16 years of age.           


    Indications

    For the treatment of severe mental and emotional disorders (Neuroleptic).


    Contra-Indications

    Known hypersensitivity to clotiapine or to any of the excipients. Comatose states or severe CNS depression. In patients susceptible to convulsions, high doses or abrupt changes of dosage must be avoided.


    Special Precautions

    In elderly patients, blood pressure should be carefully monitored. Clotiapine may induce orthostatic hypotension. Caution is indicated in patients with a history of thrombosis because Clotiapine may increase the risk of thrombo-embolism due to sedation and immobilisation of the patient. Caution is required in patients presenting with prostatic enlargement, narrow-angle glaucoma, bowel atony, epilepsy or post-encephalitic states. Treatment of hypotensive episodes. Clotiapine tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
    Class Effects: An increased risk of cerebrovascular adverse events has been seen 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. Caution should be exercised when treating patients with risk factors for stroke with Clotiapine. In elderly patients with dementia-related psychosis, the efficacy and safety of Clotiapine has not been studied. Observational studies suggest that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. In the published literature, risk factors that may predispose this patient population to increased risk of death when treated with antipsychotics include sedation, the presence of cardiac conditions (e.g. cardiac arrhythmias) or pulmonary conditions (e.g. pneumonia, with or without aspiration). Caution should be exercised when treating elderly patients with dementia with Clotiapine.
    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 Clotiapine and preventive measures undertaken. As with other antipsychotics, caution is advised in patients with known cardiovascular disease or family history of QT prolongation and caution should be exercised when Clotiapine is prescribed with medicines known to increase QTc interval. In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis has also been reported. Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. In patients with a history of a clinically significant low WBC or drug-induced leukopenia/neutropenia the complete blood count (CBC) should be monitored frequently during the first few months of therapy and discontinuation of Clotiapine should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue Clotiapine and have their WBC followed until recovery.


    Side Effects

    Agitation, confusion, vision blurred.
    See prescribing information for full details.


    Drug interactions

    Clotiapine may enhance: – the CNS effects of alcohol, sedatives, narcotic analgesics, hypnotics, MAO-inhibitors and antihistamines – the hypotensive action of antihypertensive agents – the toxicity of lithium As with other antipsychotics, caution should be exercised when Clotiapine is prescribed with medicines known to increase the QTc interval, or causing electrolyte imbalance.
    See prescribing information for full details.


    Pregnancy and Lactation

    During pregnancy and breast-feeding, Clotiapine should be prescribed only if strictly indicated.


    Overdose

    Symptoms: somnolence; hypotension, tachycardia, arrhythmia; respiratory depression; extrapyramidal symptoms; convulsions; coma.
    Treatment: gastric lavage followed by administration of activated charcoal; symptomatic treatment if necessary. For hypotension: plasma expanders, if treatment with a vasopressor, e.g. dopamine, proves necessary — as it might be in resistant cases; careful monitoring of the patient, particularly of cardiovascular function, is indicated. For convulsions: benzodiazepine.


    Important notes

    Storage: Do not store above 25°C and store in original package.
    Lactose: contains lactose.
    Effects on ability to drive and use machines: Clotiapine can impair the ability to drive a vehicle and operate machinery.


    Manufacturer
    Famar L'aigle
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