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RECORLEV (levoketoconazole)
- Cushing's disease
150 mg tablet
- 1 tablet (150 mg) by oral route 2 times per day
Default screening record
- 1 tablet (150 mg) by oral route 2 times per day
- 1 tablet (150 mg) by oral route once daily
- 4 tablets (600 mg) by oral route 2 times per day
- alfuzosin
- alprazolam
- Alprazolam Intensol
- apixaban
- avanafil
- Brilinta
- bromocriptine
- cabergoline
- Cafergot
- Camptosar
- conivaptan in 5 % dextrose
- Cycloset
- D.h.e.45
- Detrol La
- dihydroergotamine
- dronedarone
- dutasteride-tamsulosin
- Eliquis
- eplerenone
- ergoloid
- Ergomar
- ergotamine tartrate
- ergotamine-caffeine
- estazolam
- felodipine
- Flomax
- Inspra
- irinotecan
- isoniazid
- isoniazid-rifamp-pyrazinamide
- Jalyn
- Juxtapid
- Kombiglyze Xr
- Latuda
- Levitra
- lomitapide
- lurasidone
- mefloquine
- methylergonovine
- midazolam
- Migergot
- Migranal
- Multaq
- Niravam
- nisoldipine
- Parlodel
- Rapaflo
- Rifamate
- rifampin-isoniazid
- Rifater
- rivaroxaban
- Samsca
- saxagliptin-metformin
- silodosin
- Stendra
- Sular
- tamsulosin
- ticagrelor
- tolterodine
- tolvaptan
- triazolam
- Uroxatral
- Vaprisol
- vardenafil
- Xanax
- Xanax Xr
- Xarelto
Contraindicated
- Abstral
- Actiq
- Adempas
- Afinitor
- Afinitor Disperz
- Alfenta
- alfentanil
- colchicine
- colchicine-probenecid
- Colcrys
- Duragesic
- Endocet
- Endodan
- everolimus
- fentanyl
- fentanyl citrate
- fentanyl citrate (PF)
- Fentora
- guanfacine
- ibuprofen-oxycodone
- Intuniv Er
- Lazanda
- macitentan
- Marqibo
- Navelbine
- Olysio
- Opsumit
- Oxecta
- oxycodone
- oxycodone-acetaminophen
- oxycodone-aspirin
- Oxycontin
- Percocet
- Percodan
- Primlev
- riociguat
- Roxicet
- simeprevir
- Sublimaze (pf)
- Subsys
- Tenex
- vinblastine
- Vincasar Pfs
- vincristine
- vincristine sulfate liposomal
- vinorelbine
- Xartemis Xr
- Zortress
Severe
Moderate
- Abilify
- Abilify Discmelt
- Abilify Maintena
- Adcirca
- Ambien
- Ambien Cr
- Anti-diarrhea
- Anti-diarrheal (lope)-anti-gas
- Anti-diarrheal (loperamide)
- aripiprazole
- bosentan
- Cialis
- cilostazol
- cinacalcet
- darifenacin
- Detrol
- Diamode
- Edluar
- Enablex
- eszopiclone
- fesoterodine
- Fetzima
- Imodium Multi-symptom Relief
- Intermezzo
- ivacaftor
- Kalydeco
- levomilnacipran
- Lo-peramide
- loperamide
- loperamide-simethicone
- Lunesta
- Onglyza
- Pletal
- regorafenib
- Revatio
- saxagliptin
- Sensipar
- sildenafil
- solifenacin
- Stivarga
- tadalafil
- Toviaz
- Tracleer
- Ultra A-d
- Vesicare
- Viagra
- zolpidem
- Zolpimist
- Congenital long QT syndrome
- Hepatic cirrhosis
- Lactation
- Prolonged QT interval
- Torsades de pointes
Contraindicated
- Abnormal hepatic function tests
- Hypokalemia
- Hypomagnesemia
Severe
Moderate
- None
RECORLEV (levoketoconazole)
- Cushing's disease
- Cardiac arrhythmia
- Hemorrhage
- Hepatocellular damage
- Hypertension
- Hypokalemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Abnormal uterine bleeding
- Acute abdominal pain
- Arthritis
- Back pain
- Bruising
- Dyspepsia
- Erythema
- Fatigue
- Headache disorder
- Insomnia
- Myalgia
- Nausea
- Peripheral edema
- Sleep disorder
- Upper respiratory infection
- Vomiting
More Frequent
Severe
Less Severe
- Adrenocortical insufficiency
- Androgen deficiency
- Anorexia
- Diarrhea
- Dizziness
- Dry skin
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Hypersensitivity drug reaction
- Prolonged QT interval
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Levoketoconazole
Safety and effectiveness not established in pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established in pediatric patients.
Levoketoconazole
- Severity Level:
2
- Additional Notes: Insufficient human data available on developmental toxicity risk
Contraindicated
Levoketoconazole
Mfr does not recommend during treatment and for 1 day after final dose
General | Excretion Potential | Effect on Infant | Notes |
Drug should not be given to breast feeding mothers | Excreted | Not known; no or inclusive data | Mfr does not recommend during treatment and for 1 day after final dose |
Precaution Exists
None
General | Excretion Potential | Effect on Infant | Notes |
None |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- 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.<br /><br /> 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).<br /><br />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.
Pituitary-dependent cushing's disease | |
E24.0 | Pituitary-dependent cushing's disease |
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E24.0 | Pituitary-dependent cushing's disease |
Formulary Reference Tool