Drug Name:
LYSODREN Rx

Generic Name and Formulations:
Mitotane 500mg; scored tabs.
Company:
Bristol-Myers Squibb
Therapeutic Use:
Indications for LYSODREN:
Inoperable adrenal cortical carcinoma.
Adult:
2–6g/day in divided doses (3–4 times/day). Doses may be increased incrementally to achieve a blood concentration of 14–20mg/L, or as tolerated. Dose modifications: see full labeling.
Children:
Not established.
Warnings/Precautions:
Discontinue temporarily following shock or severe trauma. CNS toxicity (esp. with high doses). Adrenal insufficiency: give steroid replacement as clinically indicated; measure free cortisol and ACTH levels. Ovarian macrocysts in premenopausal women. Hepatic impairment. Pregnancy; avoid. Use effective contraception during and after discontinuation until mitotane levels are undetectable. Nursing mothers: not recommended.
Interactions:
Concomitant oral anticoagulants, CYP3A4 substrates; monitor for change in dose requirements.
Pharmacological Class:
Adrenal cytotoxic agent.
Adverse Reactions:
Anorexia, nausea, vomiting, diarrhea, depression, dizziness, vertigo, rash, neutropenia, growth retardation, hypothyroidism, confusion, headache, ataxia, mental impairment, weakness, dysarthria, maculopathy, hepatitis, elevated liver enzymes, gynecomastia, hypercholesterolemia, hypertriglyceridemia.
How Supplied:
Tabs—100
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