Article Contents ::

Details About Generic Salt ::  Mitotane

Main Medicine Class::    

(MY-toe-TANE)
Lysodren
Tablets, scored
500 mg
Class: Adrenal cortex suppressant

 Indications Inoperable adrenal cortical carcinoma.

 Contraindications Standard considerations.

 Route/Dosage

Inoperable Adrenal Cortical Carcinoma

ADULTS: PO Initially 1 to 6 g/day (£ 10 g/day) in divided doses, either tid or qid. Titrate ³ 9 to 10 g/day until adverse effects occur. The maximum tolerated dosage ranges from 2 to 16 g/day. Doses as high as 20 g/day have been used.

Interactions

CNS depressants (eg, narcotics, analgesics, alcohol, antiemetics, benzodiazepines, sedatives, tranquilizers)

Potentiation of CNS effects with mitotane.

Corticosteroids

May increase corticosteroid metabolism, requiring higher corticosteroid doses with long-term mitotane therapy.

Spironolactone

May block the adrenolytic effects of mitotane.

Warfarin

Increases warfarin metabolism; increased warfarin doses may be required

Lab Test Interferences Protein-bound iodine levels and urinary 17-hydroxycorticosteroids may be decreased by mitotane.

 Adverse Reactions

CNS: Depression (25%), lethargy and somnolence, vertigo or dizziness (15%); brain damage and functional impairment with long-term continuous administration (neurologic and behavioral assessment necessary in patients treated > 2 yr). DERMATOLOGIC: Maculopapular rashes, flushing, erythema. ENDOCRINE: Adrenocortical insufficiency requiring corticosteroid supplementation, gynecomastia. GI: Moderate potential for nausea and vomiting, GI disturbances, diarrhea. GU: Hemorrhagic cystitis. MUSCULOSKELETAL: Aching muscles, muscle twitching, arthralgia. SPECIALSENSES: Double vision, blurred vision, lens opacity, toxic retinopathy. OTHER: Fever.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Shock or severe trauma: Temporarily discontinue mitotane immediately following shock or severe trauma, because adrenal suppression is its prime action. Tumor tissue: Surgically remove all possible tumor tissue from large metastatic masses before administration to minimize the possibility of infarction and hemorrhage in the tumor caused by a rapid, cytotoxic effect of the drug. Long-term therapy: Continuous administration of high doses may lead to brain damage and impairment of function. Hepatic function impairment: Administer with care to patients with liver disease other than metastatic lesions of the adrenal cortex. Adjustment in hepatic insufficiency: Patients with hepatic insufficiency may require a decrease in mitotane dosage; however, specific recommendations are not established. Adrenal insufficiency: Adrenal insufficiency may develop; consider adrenal steroid replacement in these patients.

PATIENT CARE CONSIDERATIONS


 Administration/Storage

  • Store at room temperature in a tight, light-resistant container.
  • Initiate treatment in a hospital until a stable dosage regimen is achieved. Do not give mitotane with a fatty meal; fat may impair absorption of mitotane.
  • Administer PO.
  • Follow procedures for proper handling and disposal of anticancer drugs. Wear gloves and avoid skin exposure and inhalation of fumes.

 Assessment/Interventions

  • Continuous treatment with the maximum tolerated dosage of mitotane appears to be more effective than intermittent courses.
  • Temporarily discontinue mitotane and initiate corticosteroid therapy in situations that can cause acute adrenal insufficiency (eg, shock, trauma, infection).

 Patient/Family Education

  • Notify health care provider if nausea, vomiting, loss of appetite, diarrhea, mental depression, skin rash, or darkening of the skin occurs.
  • Medication may cause aching muscles, fever, flushing or muscle twitching; notify health care provider if these become pronounced.
  • May produce drowsiness, dizziness, and tiredness; observe caution when driving or performing other tasks requiring alertness.
  • Contraceptive measures are recommended during therapy.

Medicscientist Drug Facts

 

Drugs Class ::

(MY-toe-TANE)
Lysodren
Tablets, scored
500 mg
Class: Adrenal cortex suppressant

Indications for Drugs ::

 Indications Inoperable adrenal cortical carcinoma.

Drug Dose ::

 Route/Dosage

Inoperable Adrenal Cortical Carcinoma

ADULTS: PO Initially 1 to 6 g/day (£ 10 g/day) in divided doses, either tid or qid. Titrate ³ 9 to 10 g/day until adverse effects occur. The maximum tolerated dosage ranges from 2 to 16 g/day. Doses as high as 20 g/day have been used.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Shock or severe trauma: Temporarily discontinue mitotane immediately following shock or severe trauma, because adrenal suppression is its prime action. Tumor tissue: Surgically remove all possible tumor tissue from large metastatic masses before administration to minimize the possibility of infarction and hemorrhage in the tumor caused by a rapid, cytotoxic effect of the drug. Long-term therapy: Continuous administration of high doses may lead to brain damage and impairment of function. Hepatic function impairment: Administer with care to patients with liver disease other than metastatic lesions of the adrenal cortex. Adjustment in hepatic insufficiency: Patients with hepatic insufficiency may require a decrease in mitotane dosage; however, specific recommendations are not established. Adrenal insufficiency: Adrenal insufficiency may develop; consider adrenal steroid replacement in these patients.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CNS: Depression (25%), lethargy and somnolence, vertigo or dizziness (15%); brain damage and functional impairment with long-term continuous administration (neurologic and behavioral assessment necessary in patients treated > 2 yr). DERMATOLOGIC: Maculopapular rashes, flushing, erythema. ENDOCRINE: Adrenocortical insufficiency requiring corticosteroid supplementation, gynecomastia. GI: Moderate potential for nausea and vomiting, GI disturbances, diarrhea. GU: Hemorrhagic cystitis. MUSCULOSKELETAL: Aching muscles, muscle twitching, arthralgia. SPECIALSENSES: Double vision, blurred vision, lens opacity, toxic retinopathy. OTHER: Fever.

Drug Mode of Action ::  

(MY-toe-TANE)
Lysodren
Tablets, scored
500 mg
Class: Adrenal cortex suppressant

Drug Interactions ::

Interactions

CNS depressants (eg, narcotics, analgesics, alcohol, antiemetics, benzodiazepines, sedatives, tranquilizers)

Potentiation of CNS effects with mitotane.

Corticosteroids

May increase corticosteroid metabolism, requiring higher corticosteroid doses with long-term mitotane therapy.

Spironolactone

May block the adrenolytic effects of mitotane.

Warfarin

Increases warfarin metabolism; increased warfarin doses may be required

Drug Assesment ::

 Assessment/Interventions

  • Continuous treatment with the maximum tolerated dosage of mitotane appears to be more effective than intermittent courses.
  • Temporarily discontinue mitotane and initiate corticosteroid therapy in situations that can cause acute adrenal insufficiency (eg, shock, trauma, infection).

Drug Storage/Management ::

 Administration/Storage

  • Store at room temperature in a tight, light-resistant container.
  • Initiate treatment in a hospital until a stable dosage regimen is achieved. Do not give mitotane with a fatty meal; fat may impair absorption of mitotane.
  • Administer PO.
  • Follow procedures for proper handling and disposal of anticancer drugs. Wear gloves and avoid skin exposure and inhalation of fumes.

Drug Notes ::

 Patient/Family Education

  • Notify health care provider if nausea, vomiting, loss of appetite, diarrhea, mental depression, skin rash, or darkening of the skin occurs.
  • Medication may cause aching muscles, fever, flushing or muscle twitching; notify health care provider if these become pronounced.
  • May produce drowsiness, dizziness, and tiredness; observe caution when driving or performing other tasks requiring alertness.
  • Contraceptive measures are recommended during therapy.

Medicscientist Drug Facts

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