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Lysodren (mitotane)

Indications

• Adrenal Cortical Carcinoma: You can use Lysodren to treat adrenal cortical carcinoma, a type of cancer affecting the outer layer of the adrenal glands, helping to slow down the growth of the tumor and manage symptoms.
• Cushing’s Syndrome: Your doctor may prescribe Lysodren to help control symptoms of Cushing’s syndrome, a condition caused by excess cortisol, helping to reduce hormone levels and alleviate symptoms like weight gain, high blood pressure, and skin changes.

Dosage and Administration

• Take Lysodren exactly as prescribed by your doctor.
• Swallow the tablets whole with a full glass of water.
• Take it with food to help reduce stomach upset.
• Follow your dosing schedule consistently to maintain the medication’s effectiveness.
• Inform your doctor about any other medications or supplements you are taking.
• Do not crush, chew, or break the tablets.
• Avoid skipping doses; take it as soon as you remember if you miss a dose, but do not double dose to make up for a missed one.
• Do not stop taking Lysodren without consulting your doctor, even if you feel better.
• Avoid alcohol as it can interfere with the medication’s effectiveness.

Mechanism of Action

Lysodren works by inhibiting the function of the adrenal cortex, the outer layer of the adrenal glands that produces hormones such as cortisol. It selectively destroys adrenal cortex cells, reducing hormone production and helping to manage conditions like adrenal cortical carcinoma and Cushing’s syndrome. This helps in controlling the growth of the tumor and alleviating symptoms caused by excess hormone production.

Contraindications

• Do not use Lysodren if you are allergic to mitotane or any of its ingredients.
• Avoid using this medication if you have severe liver disease.
• Pregnant women should not use Lysodren due to potential harm to the unborn baby.
• Breastfeeding women should not use Lysodren as it can pass into breast milk and harm the nursing baby.
• Do not use Lysodren if you have an active infection without consulting your doctor.

Side Effects

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Dizziness
• Drowsiness

Serious Side Effects

• Severe abdominal pain or persistent nausea/vomiting
• Unusual tiredness or weakness
• Severe or persistent diarrhea
• Changes in mental status, such as confusion or depression
• Severe skin reactions (rash, itching, blistering)

Precautions

• Inform your doctor about any existing health conditions, especially liver disease or infections.
• Regularly monitor your liver function and blood cell counts as directed by your doctor.
• Use effective contraception during treatment and for some time after stopping Lysodren to prevent pregnancy.
• Avoid contact with people who have infections, as Lysodren can lower your body’s resistance.
• Discuss all other medications you are taking with your doctor to avoid potential interactions.
• Limit alcohol consumption as it can increase the risk of liver damage and other side effects.

Storage Instructions

• Store Lysodren at room temperature, between 20°C to 25°C (68°F to 77°F).
• Keep the tablets in their original container, tightly closed.
• Protect from moisture and light.
• Keep out of reach of children and pets.
• Do not use after the expiration date on the label.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf