Lysodren

DRUG DESCRIPTION

LYSODREN® (mitotane tablets, USP) is an oral chemotherapeutic agent. It is best known by its trivial name, o,p'-DDD, and is chemically, 1,1-dichloro-2-(o-chlorophenyl)-2-(p-chlorophenyl) ethane. The chemical structure is shown below:

LYSODREN® (mitotane) Structural Formula Illustration

LYSODREN (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, isooctane and carbon tetrachloride. It has a molecular weight of 320.05.

Inactive ingredients in LYSODREN (mitotane) tablets are: avicel, Polyethylene Glycol 3350, silicon dioxide, and starch.

LYSODREN (mitotane) is available as 500 mg scored tablets for oral administration.

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...

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 »


Lysodren Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, nausea, diarrhea, loss of appetite, headache, or unusual weakness may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, flushing, fast/pounding heartbeat, shakiness (tremors), unusual/rapid weight loss, change in skin color/thickness.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, breast tenderness/enlargement (males), unwanted facial/body hair (females), mental/mood changes (e.g., depression, irritability, difficulty concentrating, confusion), speech problems, numbness/tingling of hands/feet, unsteadiness, pink urine, vision problems.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Mitotane can commonly cause a rash that usually goes away. However, you may not be able to tell it apart from a rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop a rash.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 lightheadedness, get up slowly when rising from a sitting or lying position.

If you have been using this product, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids (e.g., hydrocortisone), especially if your body is stressed due to a major infection, surgery or injury. Tell your doctor immediately if a stress situation (e.g., trauma, surgery, serious infection) is occurring or any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. This advice applies during and up to 8 months after stopping mitotane treatment. Carry an emergency card or bracelet with this information. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Lysodren Patient Information Including Side Effects

Brand Names: Lysodren

Generic Name: mitotane (Pronunciation: MYE toe tane)

  • What is mitotane (Lysodren)?
  • What are the possible side effects of mitotane (Lysodren)?
  • What is the most important information I should know about mitotane (Lysodren)?
  • What should I discuss with my healthcare provider before taking mitotane (Lysodren)?
  • How should I take mitotane (Lysodren)?
  • What happens if I miss a dose (Lysodren)?
  • What happens if I overdose (Lysodren)?
  • What should I avoid while taking mitotane (Lysodren)?
  • What other drugs will affect mitotane (Lysodren)?
  • Where can I get more information?

What is mitotane (Lysodren)?

Mitotane is a cancer medication. That interferes with the growth of cancer cells and slows their growth and spread in the body.

Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).

Mitotane may also be used for other purposes not listed in this medication guide.

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 urinate;
  • blood in your urine; or
  • unexpected weight loss.

Less serious side effects may include:

  • dizziness, spinning sensation;
  • drowsiness, tired feeling;
  • depressed mood;
  • mild skin rash;
  • nausea, vomiting, diarrhea; or
  • loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mitotane (Lysodren)?

You may receive your first few doses of mitotane in a hospital setting where you can be monitored in case the medication causes serious side effects.

You should not use this medication if you are allergic to mitotane.

Before taking mitotane, tell your doctor if you have liver disease, or if you have had a recent infection, surgery, or trauma.

Always wear rubber gloves when handling mitotane tablets. The medicine from a crushed or broken tablet can be dangerous if it gets on your skin.

You may need to take steroid medication along with mitotane to best treat your condition. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

If you have any type of infection, serious injury or medical emergency, you may need to stop taking this medication for a short time. Your doctor will determine when you can start taking mitotane again.

Carry an ID card or wear a medical alert bracelet stating that you are taking mitotane, in case of an emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using mitotane.

You must remain under the care of a doctor while taking mitotane. Do not miss any scheduled appointments.

It may take up to several months of using mitotane before your symptoms improve. Talk with your doctor if your symptoms do not improve or if they get worse.

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