Levoketoconazole

Generic name: Levoketoconazole
Brand names: Recorlev
Dosage form: oral tablet (150 mg)
Drug class: Adrenal corticosteroid inhibitors

Usage of 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.

Levoketoconazole side effects

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.

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 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.

Relate drugs

How to use Levoketoconazole

Usual Adult Dose for Cushing's Syndrome:

Initial dose: 150 mg orally twice a dayMaintenance 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 dayUse: Treatment of endogenous hypercortisolemia in patients with Cushing's syndrome when surgery is not an option or has not been curative

Warnings

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 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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.