levoketoconazole 150 mg tablet

Generic name:
Levoketoconazole - oral

Pronunciation
(LEE-voe-KEE-toe-KON-a-zole)

Brand name(s)
Recorlev

Levoketoconazole has rarely caused very serious (possibly fatal) liver problems. It should not be used by people with severe liver disease, gallstones, or by people who had liver problems caused by azole antifungal drugs (such as ketoconazole). Get medical help right away if you develop symptoms of liver problems, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Levoketoconazole may also cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. Levoketoconazole must not be used with other medications that may also affect the heart rhythm (QT prolongation) or be used by people with a history of certain heart diseases (such as ventricular arrhythmias, long QT syndrome). Tell your doctor and pharmacist about all the medications and products you take before you start levoketoconazole treatment. See also Precautions and Drug Interactions sections.

To reduce the risk of these very serious side effects, your doctor should order tests (such as liver function, EKG) before you start this medication and while you are taking it.

This medication is used to treat high levels of a certain hormone (cortisol) in people with Cushing's syndrome. Levoketoconazole works by decreasing the amount of cortisol made by the body.

Read the Medication Guide provided by your pharmacist before you start taking levoketoconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice a day. The dosage is based on your medical condition, lab tests, and response to treatment.

If you are taking an antacid, take levoketoconazole at least 2 hours before taking the antacid, or levoketoconazole may not be absorbed into the body. See also Drug Interactions section for more information.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Nausea, vomiting, upset stomach, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• easy bleeding/bruising

Although this is unlikely, levoketoconazole may lower your cortisol levels too much and cause an adrenal gland problem (adrenal insufficiency). It may also decrease testosterone levels and sperm production. The adrenal gland problem may make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication. Tell your doctor right away if you have any serious side effects, including:

• unusual tiredness
• weakness
• dizziness upon standing
• diarrhea
• weight loss
• menstrual period changes
• mental/mood changes (such as depression)
• decreased sexual interest or ability
• enlarged/tender breasts in men

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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

See also Warning and Side Effects sections.

Before taking levoketoconazole, tell your doctor or pharmacist if you are allergic to it; or to azole antifungal drugs (such as ketoconazole, itraconazole); 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:

• liver problems
• alcohol use
• low testosterone levels
• little or no stomach acid production (achlorhydria)

Levoketoconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using levoketoconazole, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using levoketoconazole safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit drinking alcoholic beverages while taking this medication because alcohol increases the risk of serious liver problems. Alcoholic beverages may also cause a rare reaction with levoketoconazole that may result in flushing, headache, and nausea.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for one day after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Levoketoconazole interacts with many prescription and nonprescription drugs. While you are taking levoketoconazole, it is very important to tell your doctor or pharmacist of any changes in medications that you are taking.

Some products that may interact with this drug are:

• other drugs that can cause liver problems (such as acetaminophen)

Other medications can affect the removal of levoketoconazole from your body, which may affect how levoketoconazole works. Examples include encorafenib, HIV protease inhibitors (such as fosamprenavir), isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication can slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include some benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some statin drugs (such as lovastatin, simvastatin), among others.

Many drugs besides levoketoconazole may affect the heart rhythm (QT prolongation), including amiodarone, bosutinib, disopyramide, dofetilide, dronedarone, methadone, pacritinib, pimozide, quinidine, ranolazine, among others.

Levoketoconazole requires acid in the stomach to be well absorbed. If you are taking drugs that decrease the amount of stomach acid (including sucralfate, H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as lansoprazole/omeprazole), ask your doctor or pharmacist for advice on how to reduce or avoid this interaction. Antacids may be taken at least 2 hours after taking levoketoconazole.

Levoketoconazole is very similar to ketoconazole. Do not use medications containing ketoconazole while using levoketoconazole.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as EKG, urine/blood cortisol levels, liver function, blood potassium/magnesium levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.