Keep all medicines away from children and pets. Do not wash the treated area for at least 3 hours after applying this medication. Wait at least 20 minutes before applying or to the treated skin. Prompt recognition of liver injury is essential. During the course of treatment, serum ALT should be monitored weekly for the duration of treatment. If ALT values increase to a level above the upper limit of normal or 30 percent above baseline, or if the patient develops symptoms, ketoconazole treatment should be interrupted and a full set of liver tests should be obtained. Liver tests should be repeated to ensure normalization of values. Hepatotoxicity has been reported with restarting oral ketoconazole rechallenge. If it is decided to restart oral ketoconazole, monitor the patient frequently to detect any recurring liver injury from the drug.
IV amphotericin B, oral itraconazole. Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Chien RN, Yang LJ, Lin PY, Liaw YF "Hepatic injury during ketoconazole therapy in patients with onychomycosis: a controlled cohort study.
Tablets for a condition for which it was not prescribed. Ivabradine: CYP3A4 Inhibitors Strong may increase the serum concentration of Ivabradine. ABCB1 Inhibitors may increase the serum concentration of Silodosin. Ketoconazole Tablets may increase the risk of skeletal muscle toxicity, including rhabdomyolysis.
Safety and efficacy not established and not labeled by FDA for this use. Clissold SP. Pharmacokinetic properties. In: Jones HE, ed. Ketoconazole today: a review of clinical experience. Advise patient not to take antacids for at least 2 hours after oral ketoconazole.
Tetrahydrocannabinol: CYP3A4 Inhibitors Strong may increase the serum concentration of Tetrahydrocannabinol. Chodakewitz J, Wagner JA. Effect of different durations of ketoconazole dosing on the single-dose pharmacokinetics of midazolam: shortening the paradigm. Tablets, and up to one week after discontinuation of treatment with ketoconazole. Inflammation of the esophagus. Esophagitis can be due to irritation as from reflux or radiation treatment or infection. ABCB1 Inhibitors may increase the serum concentration of Naldemedine. Consult current IDSA clinical practice guidelines available at 426 and current CDC, NIH, and IDSA clinical practice guidelines on prevention and treatment of opportunistic infections in HIV-infected individuals available at for additional information on management of coccidioidomycosis. Midostaurin: CYP3A4 Inhibitors Strong may increase the serum concentration of Midostaurin. Management: Seek alternatives to the concomitant use of midostaurin and strong CYP3A4 inhibitors if possible. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions. In vitro, the plasma protein binding is about 99% mainly to the albumin fraction. Ketoconazole is widely distributed into tissues; however, only a negligible proportion reaches the cerebrospinal fluid. Spinillo A, Capuzzo E, Gulminetti R et al. Prevalence of and risk factors for fungal vaginitis caused by non-albicans species. Am J Obstet Gynecol. 1997; 176: 138-41. Lacosamide: CYP3A4 Inhibitors Strong may increase the serum concentration of Lacosamide. If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule.
Hypersensitivity reactions: Cases of hypersensitivity reactions including rare cases of anaphylaxis have been reported; some reactions occurred after the initial dose. Tell your doctor if your condition does not get better or if it gets worse. 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. Tablets in the pediatric population. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Ketoconazole is used to treat certain serious fungal infections in the body. Ketoconazole belongs to the class of drugs called azole antifungals. It works by stopping the growth of the fungus. Achlorhydria: Absorption is reduced in patients with achlorhydria; administer with acidic liquids eg, soda pop. Avoid concomitant use of drugs that decrease gastric acidity eg, proton pump inhibitors, antacids, H 2-blockers. Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis What other drugs will affect ketoconazole? Fluticasone Nasal: CYP3A4 Inhibitors Strong may increase the serum concentration of Fluticasone Nasal. Lopinavir: Ketoconazole Systemic may increase the serum concentration of Lopinavir. Lopinavir may increase the serum concentration of Ketoconazole Systemic. The following adverse reactions have been identified during postapproval use of Ketoconazole Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Corticosteroids Systemic: CYP3A4 Inhibitors Strong may increase the serum concentration of Corticosteroids Systemic. Exceptions: MethylPREDNISolone; PrednisoLONE Systemic; PredniSONE. Prostatic cancer. From: PDQ Information for Health Care Professionals database. Bethesda, MD: National Cancer Institute; 1997 Dec.
If your symptoms do not improve or if they become worse, check with your doctor. CNS infections: Ketoconazole has poor penetration into cerebral-spinal fluid and should not be used to treat fungal meningitis. Brigatinib: CYP3A4 Inhibitors Strong may increase the serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with strong CYP3A4 inhibitors when possible. If combination cannot be avoided, reduce the brigatinib dose by approximately 50%, rounding to the nearest tablet strength ie, from 180 mg to 90 mg, or from 90 mg to 60 mg. Bradsher RW. Therapy of blastomycosis. Semin Respir Infect. AbbVie, Inc. Technivie ombitasvir, paritaprevir, and ritonavir tablets prescribing information. North Chicago, IL; 2016 Jan. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Debruyne D, Coquerel A "Pharmacokinetics of antifungal agents in onychomycoses. Williams G. Ketoconazole for prostate cancer. Lancet. Davies SF, Sarosi GA. Epidemiological and clinical features of pulmonary blastomycosis. Semin Respir Infect. Keep all regular medical and laboratory appointments.
These drugs should be used with caution when coadministered with Ketoconazole Tablets. Tadalafil: Ketoconazole Systemic may increase the serum concentration of Tadalafil. Assaf RR, Weil ML. The superficial mycoses. Dermatol Clin. Ketoconazole is to be used only by the patient for whom it is prescribed. Do not share it with other people. Pillans PI, Cowan P, Whitelaw D "Hyponatraemia and confusion in a patient taking ketoconazole. Dijke CP, Veerman FR, Haverkamp HC "Anaphylactic reactions to ketoconazole. ALPRAZolam: Ketoconazole Systemic may increase the serum concentration of ALPRAZolam. Dosage may be increased to 400 mg once daily if expected clinical response not achieved. The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Meijden WI, van der Hoek JC, Staal HJ et al. Double-blind comparison of 200-mg ketoconazole oral tablets and 1200-mg miconazole vaginal capsule in the treatment of vaginal candidosis. Eur J Obstet Gynecol Reprod Biol.
Interaction studies have only been performed in adults. The relevance of the results from these studies in pediatric patients is unknown. The opinions expressed in WebMD User-generated content areas like communities, reviews, ratings, or blogs are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of WebMD. User-generated content areas are not reviewed by a WebMD physician or any member of the WebMD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. Doble N, Hykin P, Shaw R et al. Pulmonary Mycobacterium tuberculosis in acquired immune deficiency syndrome. BMJ. Ramelteon: CYP3A4 Inhibitors Strong may increase the serum concentration of Ramelteon. Didanosine: May decrease the absorption of Antifungal Agents Azole Derivatives, Systemic. Enteric coated didanosine capsules are not expected to affect these antifungals. If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day. Reproductive System and Breast Disorders: erectile dysfunction; with doses higher than the recommended therapeutic dose of 200 or 400 mg daily, azoospermia. Theodore FH, Jakobiec FA, Juechter KB et al. The diagnostic value of a ring infiltrate in Acanthamoebic keratitis. Ophthalmology. Iloperidone: CYP3A4 Inhibitors Strong may increase serum concentrations of the active metabolites of Iloperidone. Specifically, concentrations of the metabolites P88 and P95 may be increased. CYP3A4 Inhibitors Strong may increase the serum concentration of Iloperidone. Management: Reduce iloperidone dose by half when administered with a strong CYP3A4 inhibitor. Tkach JR, Rinaldi MG. Severe hepatitis associated with ketoconazole therapy for chronic mucocutaneous candidiasis. Cutis. Indium 111 Capromab Pendetide: Antiandrogens may diminish the diagnostic effect of Indium 111 Capromab Pendetide.
Despommier DD, Gwadz RW, Hotez PJ. Parasitic Diseases. Some brands of this product may contain sugar, alcohol, or aspartame. Sufentanil: No human pharmacokinetic data of an interaction with ketoconazole are available. Fexofenadine: Ketoconazole Systemic may increase the serum concentration of Fexofenadine. May see clinical improvement fairly soon after start of therapy; duration of 2 weeks recommended to reduce possibility of recurrence. Bosentan: Coadministration of bosentan 125 mg twice daily and ketoconazole, increased the plasma concentrations of bosentan by approximately 2-fold in normal volunteers. No dose adjustment of bosentan is necessary, but patients should be monitored for increased pharmacologic effects and adverse reactions of bosentan. Allen JM, Kerle DJ, Ware H et al. Combined treatment with ketoconazole and luteinising hormone releasing hormone analogue: a novel approach to resistant progressive prostatic cancer. BMJ. Erlotinib: CYP3A4 Inhibitors Strong may increase the serum concentration of Erlotinib. Management: Avoid use of this combination when possible. When the combination must be used, monitor the patient closely for the development of severe adverse reactions, and if such severe reactions occur, reduce the erlotinib dose in 50 mg decrements. Pre-clinical electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QT c interval.
Oral bioavailability is maximal when the tablets are taken with a meal. Cohen EJ, Buchanan HW, Laughrea PA et al. Diagnosis and management of Acanthamoeba keratitis. Am J Ophthalmol. Dall L, Salzman G. Treatment of pulmonary sporotrichosis with ketoconazole. Rev Infect Dis. Considerable interindividual variations in peak plasma concentrations and AUCs have been reported. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. The use of Ketoconazole Tablets are contraindicated in patients with acute or chronic liver disease. Maraviroc: CYP3A4 Inhibitors Strong may increase the serum concentration of Maraviroc. Management: Reduce the adult dose of maraviroc to 150 mg twice daily when used with a strong CYP3A4 inhibitor. Holmes B, Brogden RN, Richards DM. Norfloxacin: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. Nintedanib: Combined Inhibitors of CYP3A4 and P-glycoprotein may increase the serum concentration of Nintedanib.
Gastrointestinal intolerance may resolve with continued therapy and may improve if ketoconazole is taken with food. Herrod HG. Chronic mucocutaneous candidiasis in childhood and complications of non- Candidal infection: a report of the Pediatric Immunodeficiency Collaborative Study Group. J Pediatr. It causes peeling, which is just what you want to loosen up the scales. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Astemizole: Ketoconazole Systemic may enhance the QTc-prolonging effect of Astemizole. Ketoconazole Systemic may increase the serum concentration of Astemizole. Best TR, Jenkins JK, Murphy FY, et al "Persistent adrenal insufficiency secondary to low-dose ketoconazole therapy. Consider use of fluva-, rosuva-, pitava-, or pravastatin when possible. Red Yeast Rice: CYP3A4 Inhibitors Strong may increase the serum concentration of Red Yeast Rice. Specifically, concentrations of lovastatin and related compounds found in Red Yeast Rice may be increased. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. If using the over-the-counter strength of the shampoo 1% apply the shampoo, lather, and rinse thoroughly. Repeat this process. thoroughly after the second rinse. Tolvaptan: Ketoconazole 200 mg administered with tolvaptan increased tolvaptan exposure by 5-fold. Larger doses would be expected to produce larger increases in tolvaptan exposure. There is not adequate experience to define the dose adjustment that would be needed to allow safe use of tolvaptan with strong CYP3A inhibitors such as ketoconazole. Elvitegravir: Ketoconazole Systemic may increase the serum concentration of Elvitegravir. Sobel JD. Pathogenesis and treatment of recurrent vulvovaginal candidiasis. Clin Infect Dis. Pharmacokinetics not substantially affected by renal or hepatic impairment. IV amphotericin B or oral itraconazole are drugs of choice. 428 436 440 IV amphotericin B preferred for initial treatment of severe, life-threatening infections, especially in immunocompromised patients including HIV-infected patients. 428 436 440 Other azole antifungals fluconazole, ketoconazole, posaconazole, voriconazole considered second-line alternatives to oral itraconazole.
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Eli Lilly and Company. Cialis tadalafil tablets prescribing information. Indianapolis, IN; 2016 Apr. Disopyramide, dofetilide, dronedarone, quinidine: The potential increase in plasma concentrations of these drugs when coadministered with ketoconazole may increase the risk of serious cardiovascular events including QT prolongation. Ketoconazole interacts with many prescription and nonprescription drugs. While you are taking ketoconazole, it is very important to tell your doctor or pharmacist of any changes in medications that you are taking. Serious hepatotoxicity reported, including cases that were fatal or required liver transplantation.
Umstead GS, Babiak LM, Tejwani S "Immune hemolytic anemia associated with ketoconazole therapy. Moore MB, McCulley JP, Luckenbach M et al. Acanthamoeba keratitis associated with soft contact lenses. Am J Ophthalmol. Sildenafil: Ketoconazole Systemic may increase the serum concentration of Sildenafil. Management: Concurrent ketoconazole is not recommended when sildenafil is used for treatment of pulmonary arterial hypertension. If sildenafil is used to treat erectile dysfunction, an initial dose of 25 mg is recommended with concurrent ketoconazole. Consult current IDSA clinical practice guidelines available at 428 and current CDC, NIH, and IDSA clinical practice guidelines on prevention and treatment of opportunistic infections in HIV-infected individuals available at 440 441 for additional information on management of histoplasmosis.
When treating pityriasis, this may not cause an immediate return to normal color. It may take several months after treatment is completed for your natural skin color to return. Store ketoconazole topical at room temperature away from moisture and heat. Alosetron: CYP3A4 Inhibitors Strong may increase the serum concentration of Alosetron. It is for external use only. This protects your mouth from moisture so the sores can heal.
DIC associated with prostatic carcinoma. 152 178 Consider risk of toxicity, including risk of depressed adrenocortical function, if dosage exceeds 400 mg daily see Cautions. Acute or chronic liver disease. Levobupivacaine: CYP3A4 Inhibitors Strong may increase the serum concentration of Levobupivacaine.