Drug Action
Mitotane selectively inhibits the activity of the adrenal cortex, necessitating corticosteroid replacement therapy.
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Drug reference
Mitotane selectively inhibits the activity of the adrenal cortex, necessitating corticosteroid replacement therapy.
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Symptomatic treatment of advanced or inoperable adrenocortical carcinoma ▶BY MOUTH ▶Adult: Initially 2–3 g daily in 2–3 divided doses adjusted according to plasma-concentration monitoring, in severe illness initial dose can be increased up to 6 g daily, reduce dose or interrupt treatment if signs of toxicity, discontinue if inadequate response after 3 months
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Avoid in Acute porphyrias p. 1120. risk of accumulation in overweight patients
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Corticosteroid replacement therapy Corticosteroid replacement therapy is necessary with treatment with mitotane. The dose of glucocorticoid should be increased in case of shock, trauma, or infection.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: mitotane
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▶Common or very common Adrenal insufficiency. anaemia. appetite decreased. asthenia. cognitive impairment. confusion. diarrhoea. dizziness. drowsiness. dyslipidaemia. gastrointestinal discomfort. gynaecomastia. headache. hepatic disorders. leucopenia. movement disorders. mucositis. muscle weakness. nausea . paraesthesia. polyneuropathy. rash. thrombocytopenia. vertigo. vomiting ▶Frequency not known Encephalopathy. eye disorders. flushing. fungal infection. generalised pain. growth retardation. haemorrhage. hyperpyrexia. hypersalivation . hypertension. hypothyroidism. hypouricaemia. lens opacity. neuro-psychological retardation. ovarian cyst. postural hypotension. proteinuria. taste altered. thyroid disorder. vision disorders
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Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (limited information available). Monitoring In mild to moderate hepatic impairment, monitoring of plasma-mitotane concentration is recommended.
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Manufacturer advises caution in mild to moderate impairment. Avoid in severe impairment. Monitoring In mild to moderate renal impairment, monitoring of plasma-mitotane concentration is recommended.
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▶Plasma-mitotane concentration for optimum response 14–20 mg/litre. ▶Monitor plasma-mitotane concentration—consult product literature.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 2, 10, 21 ▶Lysodren (HRA Pharma UK Ltd) Mitotane 500 mg Lysodren 500mg tablets | 100 tablet P £590.97 DT = £590.97
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Patients should be warned to contact doctor immediately if injury, infection, or illness occurs (because of risk of acute adrenal insufficiency). Driving and skilled tasks Central nervous system toxicity may affect performance of skilled tasks (e.g. driving).
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Initially 2–3 g daily in 2–3 divided doses
First-line fragment. Read the complete Indications and Dose section above.
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