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Pronunciation: LEE voe KEE toe KON a zole

Brand: Recorlev

What is the most important information I should know about levoketoconazole?

Call your doctor at once if you have signs or symptoms of liver problems: swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Levoketoconazole can also cause a serious heart problem. Call your doctor at once if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

What is levoketoconazole?

Levoketoconazole is used to treat high cortisol levels in adults with Cushing's syndrome who cannot have surgery or who have had surgery that did not cure their Cushing's syndrome.

Levoketoconazole is not used to treat fungal infections.

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

What should I discuss with my healthcare provider before taking levoketoconazole?

You should not use levoketoconazole if you are allergic to it or to ketoconazole, or if you have:

  • liver problems;
  • a heart rhythm disorder; or
  • long QT syndrome (in you or a family member).

You should not take levoketoconazole while taking other medicines that cause QT prolongation or affect how your liver works.

Tell your doctor if you have ever had:

  • liver problems;
  • gallstones;
  • a heart rhythm disorder;
  • congestive heart failure;
  • long QT syndrome (in you or a family member); or
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Levoketoconazole may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine. Talk to your doctor about your risk.

Do not breastfeed while using this medicine, and for at least 1 day after your last dose.

How should I take levoketoconazole?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take levoketoconazole with or without food.

Your treatment may be changed, delayed, or permanently discontinued if you have certain side effects.

You will need blood tests before and during treatment with levoketoconazole to check your liver function and your blood electrolyte levels.

Your doctor will check your heart function using an electrocardiogram or ECG (sometimes called an EKG).

Your doctor will collect blood or urine samples to measure your cortisol.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking levoketoconazole?

Do not drink alcohol. Dangerous side effects could occur.

What are the possible side effects of levoketoconazole?

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

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • decreased adrenal gland hormones --nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;
  • males --breast enlargement and erectile dysfunction (impotence);
  • females --low desire for sex and mood changes;
  • low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • severe lightheadedness or if you faint.

Common side effects may include:

  • nausea, vomiting, stomach pain, upset stomach;
  • low potassium;
  • easy bleeding, easy bruising;
  • high blood pressure;
  • headache;
  • abnormal uterine bleeding;
  • redness of the skin;
  • tiredness;
  • muscle and back pain;
  • sleep problems;
  • fluid retention; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 other drugs will affect levoketoconazole?

Some medicines can make it harder for your body to absorb levoketoconazole. If you take an antacid, take it 2 hours before you take levoketoconazole. Tell your doctor if you also take a stomach acid reducer, such as Nexium, Prevacid, Prilosec, Protonix, Zantac, and others.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Levoketoconazole can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect levoketoconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about levoketoconazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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