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.
uses
What is Recorlev (Oral) used for?
- Cushing's Syndrome
warnings
What is the most important information I should know about Recorlev (Oral)?
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.
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Side Effects
What are the side effects of Recorlev (Oral)?
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.
Pregnancy & Breastfeeding
Can I take Recorlev (Oral) if I’m pregnant or breastfeeding?
May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while using this medicine, and for at least 1 day after your last dose.
Interactions
What drugs and food should I avoid while taking Recorlev (Oral)?
Do not drink alcohol. Dangerous side effects could occur.
Dosage Guidelines & Tips
How to take Recorlev (Oral)?
Use Recorlev (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Recorlev (Oral)?
(800) 222-1222
911
Images
LEV 150
Color: pink
Shape: round
Form: film coated
Imprint: LEV 150