Classifications: antineoplastic; Therapeutic: antineoplastic
Pregnancy Category: C
500 mg tablets
Cytotoxic agent with suppressant action on the adrenal cortex. Modifies peripheral metabolism of steroids and reduces production
of adrenal steroids. Extra-adrenal metabolism of cortisol is altered, leading to reduction in 17-hydroxycorticosteroids (17-OHCS);
however, plasma levels of corticosteroids do not fall.
Cytotoxic agent with suppressant action on the adrenal cortex.
Inoperable adrenal cortical carcinoma (functional and nonfunctional).
Cushing's syndrome secondary to pituitary disorders.
Pregnancy (category C), lactation; children.
Route & Dosage
Adult: PO 910 g/d in divided doses t.i.d. or q.i.d. (tolerated doses range: 216 g/d)
- Withhold temporarily and consult physician if emergency occurs, since adrenal suppression is its prime action. Exogenous
steroids may be required until the already depressed adrenal starts secreting steroids.
- Store at 15°30° C (59°86° F) in tight, light-resistant containers.
Adverse Effects (≥1%)CNS:
Vertigo, dizziness, drowsiness, tiredness, depression
, lethargy, sedation,
headache, confusion, tremors. CV:
Hypertension, hypotension, flushing GI: Anorexia, nausea, vomiting, diarrhea. Urogenital:
Hematuria, hemorrhagic cystitis
, albuminuria. Endocrine:
Adrenocortical insufficiency. Special Senses:
Blurred vision, diplopia
, lens opacity, toxic retinopathy. Body as a Whole:
Generalized aching, fever, muscle twitching, hypersensitivity reactions, hyperpyrexia. Skin: Rash, cutaneous
eruptions and pigmentation. Metabolic: Hypouricemia, hypercholesterolemia.
Diagnostic Test Interference
Mitotane decreases protein-bound iodine (PBI) and urinary 17-OHCS levels.
Potentiates sedative effects of alcohol
and other cns depressants
; may increase the metabolism
of phenytoin, phenobarbital, warfarin,
decreasing their effectiveness.
Approximately 40% absorbed from GI tract. Onset:
24 wk. Peak:
35 h. Distribution:
Deposits in most body tissues, especially adipose tissue
In liver. Elimination:
Small amount excreted in bile. Half-Life:
Assessment & Drug Effects
- Monitor pulse and BP for early signs of shock (adrenal insufficiency).
- Observe for symptoms of hepatotoxicity (see Appendix F). Report them promptly, since reduced hepatic capacity can increase
toxicity of mitotane and because dose may have to be decreased.
- Notify physician if following persist and become more severe: Aching muscles, fever, flushing, and muscle twitching.
- Monitor obese patient for symptoms of adrenal hypofunction. Because a large portion of the drug deposits in fatty tissue,
the obese are particularly susceptible to prolonged adverse effects.
- Make neurological and behavioral assessments at regular intervals throughout therapy.
Patient & Family Education
- Be aware that mitotane does not cure but does reduce tumor mass, pain, weakness, anorexia, and steroid symptoms.
- Report symptoms of adrenal insufficiency (weakness, fatigue, orthostatic hypotension, pigmentation, weight loss, dehydration,
anorexia, nausea, vomiting, and diarrhea) to physician.
- Exercise caution when driving or performing potentially hazardous tasks requiring alertness because of drug-induced drowsiness,
tiredness, dizziness. Symptoms tend to recede with continuation in therapy.
- Use contraceptive measures during therapy because of teratogenic properties of drug. Notify physician if you suspect you