July 24, 2016
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Lysodren

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Lysodren

LYSODREN®
(mitotane) Tablets, USP




WARNING

ADRENAL CRISIS IN THE SETTING OF SHOCK OR SEVERE TRAUMA

In patients taking LYSODREN, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue LYSODREN until recovery [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

LYSODREN (mitotane) is an oral adrenal cytotoxic agent. The chemical name is (±)-1,1dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl) ethane (also known as o,p'-DDD). The chemical structure is:

LYSODREN® (mitotane) Structural Formula Illustration

Mitotane is a white granular solid composed of clear colorless crystals. It is tasteless and has a slight pleasant aromatic odor. It is soluble in ethanol and has a molecular weight of 320.05.

Inactive ingredients in LYSODREN are: microcrystalline cellulose, polyethylene glycol 3350, silicon dioxide, and starch.

What are the possible side effects of mitotane (Lysodren)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • fast or pounding heartbeats;
  • warmth, redness, or tingly feeling under your skin;
  • sweating, cold or clammy skin;
  • high fever, chills, uncontrolled shaking;
  • blurred or double vision;
  • confusion, problems with speech, balance, or walking;
  • pain or burning when you...

Read All Potential Side Effects and See Pictures of Lysodren »

What are the precautions when taking mitotane (Lysodren)?

Before taking mitotane, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infection (especially viral infections such as chickenpox, herpes), blood pressure problems, liver disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can make it difficult to control your blood pressure. To minimize dizziness and...

Read All Potential Precautions of Lysodren »

Last reviewed on RxList: 3/28/2016
This monograph has been modified to include the generic and brand name in many instances.

Lysodren - User Reviews

Lysodren User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lysodren sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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