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.

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.

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.

Usual Adult Dose for Cushing's Syndrome:

Initial dose: 150 mg orally twice a day
Maintenance dose: Titrate the dosage by 150 mg daily, no more frequently than every 2 to 3 weeks based on 24-hour urine free cortisol levels and patient's tolerability, until adequate response is achieved.
Maximum dose: 1200 mg per day, administered as 600 mg twice a day

Use: Treatment of endogenous hypercortisolemia in patients with Cushing's syndrome when surgery is not an option or has not been curative

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 levoketoconazole. Talk to your doctor about your risk.

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

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

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Do not drink alcohol. Dangerous side effects could occur.

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

Levoketoconazole may cause serious side effects. 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 of levoketoconazole 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.

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.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking levoketoconazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.