Description
Levoketoconazole is used to treat endogenous hypercortisolemia (high cortisol levels) in patients with Cushing's syndrome who cannot have surgery or who had surgery that did not work well.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of levoketoconazole in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levoketoconazole in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abemaciclib
- Acalabrutinib
- Adagrasib
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avanafil
- Avapritinib
- Azithromycin
- Bedaquiline
- Bepridil
- Bosutinib
- Brotizolam
- Budesonide
- Buprenorphine
- Buserelin
- Buspirone
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobimetinib
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abacavir
- Acarbose
- Acetazolamide
- Adalimumab
- Albendazole
- Allopurinol
- Alprazolam
- Ambrisentan
- Anidulafungin
- Apalutamide
- Atomoxetine
- Atorvastatin
- Atovaquone
- Azacitidine
- Balsalazide
- Bexarotene
- Bicalutamide
- Boceprevir
- Bortezomib
- Bosentan
- Busulfan
- Captopril
- Carbamazepine
- Caspofungin
- Cefadroxil
- Cefdinir
- Chenodiol
- Chlorzoxazone
- Cimetidine
- Clofarabine
- Clopidogrel
- Cobicistat
- Cyproheptadine
- Dactinomycin
- Danazol
- Dantrolene
- Deferasirox
- Dexlansoprazole
- Dexmethylphenidate
- Diclofenac
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cholelithiasis (gallbladder stones), recurrent or
- Heart rhythm problems (eg, long QT syndrome, torsades de pointes, ventricular fibrillation, ventricular tachycardia), history of or
- Liver disease (eg, cirrhosis), active or poorly controlled or
- Liver injury caused by medicines (eg, ketoconazole), history of—Should not be used in patients with these conditions.
- Hypokalemia (low levels of potassium), history of or
- Hypomagnesemia (low levels of magnesium), history of—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Do not take carbamazepine, efavirenz, isoniazid, mifepristone, mitotane, nevirapine, phenytoin, rifabutin, rifampicin, ritonavir, ritonavir-boosted darunavir, and ritonavir-boosted fosamprenavir 2 weeks before and during treatment with levoketoconazole.
Take antacids (eg, aluminum hydroxide) at least 2 hours after you take this medicine.
Do not drink alcohol while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For hypercortisolemia:
- Adults—At first, 150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1200 mg per day (600 mg 2 times a day).
- Children—Use and dose must be determined by your doctor.
- For hypercortisolemia:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
You should not use this medicine together with alfentanil (Alfenta®), avanafil (Stendra®), bosutinib (Bosulif®), buspirone (Buspar®), cisapride (Prepulsid®), clarithromycin (Biaxin®), cobimetinib (Cotellic™), conivaptan (Vaprisol®), crizotinib (Xalkori®), dabigatran (Pradaxa®), darifenacin (Enablex®), darunavir (Prezista®), digoxin (Lanoxin®), disopyramide (Norpace®), dofetilide (Tikosyn®), dronedarone (Multaq®), ebastine (Ebast®), eliglustat (Cerdelga®), everolimus (Afinitor®), fexofenadine (Allegra®), ibrutinib (Imburvica™), ivabradine (Corlanor®), lomitapide (Juxtapid®), lovastatin (Mevacor®), lurasidone (Latuda®), methadone (Methadose®), midazolam (Versed®), midostaurin (Rydapt®), naloxegol (Alfenta®), nicardipine (Cardene®), nisoldipine (Alfenta®), pimozide (Alfenta®), quinidine (Alfenta®), ranolazine (Movantik®), saquinavir (Invirase®), simvastatin (Zocor®), sirolimus (Rapamune®), tacrolimus (Astagraf XL®), tipranavir (Aptivus®), triazolam (Halcion®), or vardenafil (Levitra®).
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.
Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems (eg, low cortisol levels).
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.
This medicine may decrease testosterone levels in men and women. Check with your doctor right away if you have decreased interest in sexual intercourse, inability to have or keep an erection, loss in sexual ability, desire, drive, or performance, mood changes swelling of the breasts or breast soreness.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- body aches or pain
- chills
- cough
- coughing up blood
- darkening of the skin
- decreased interest in sexual intercourse
- decreased urine
- diarrhea
- difficulty in swallowing
- dizziness
- dry mouth
- ear congestion
- fainting
- fever
- headache
- inability to have or keep an erection
- increased menstrual flow or vaginal bleeding
- increased thirst
- loss in sexual ability, desire, drive, or performance
- loss of appetite
- loss of voice
- mental depression
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- paralysis
- prolonged bleeding from cuts
- pounding in the ears
- rapid weight gain
- red or black, tarry stools
- red or dark brown urine
- seizures
- slow or fast heartbeat
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Swelling of the breasts or breast soreness in both females and males
Incidence not known
- Bulging soft spot on head of an infant
- change in ability to see colors, especially blue or yellow
- chest tightness
- dark urine
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- pinpoint red spots on skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain, severe
- trouble sleeping
- unusual bleeding or bruising
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- back pain
- belching
- difficulty in moving
- heartburn
- indigestion
- loss or thinning of the hair
- muscle aches or stiffness
- pain, swelling, or redness in the joints
- stomach discomfort or upset
Incidence not known
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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