Fungal infections:

Indications for: Ketoconazole Tablets

Susceptible systemic fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis) in those who have failed or are intolerant to other therapies. Do not use for fungal meningitis.

Adult Dosage:

Initially 200mg daily; max 400mg daily. Usual duration: 6 months.

Children Dosage:

<2yrs: not studied. >2yrs: see full labeling.

Ketoconazole Tablets Contraindications:

Concomitant dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine, felodipine, nisoldipine, tolvaptan, irinotecan, lurasidone, alprazolam, oral midazolam, oral triazolam, eplerenone, ergot alkaloids, simvastatin, lovastatin, colchicine. Acute or chronic liver disease.

Ketoconazole Tablets Warnings/Precautions:

Should be used only when other effective antifungal therapy is not available or tolerated. Risk of serious hepatotoxicity; monitor closely. Obtain SGGT, ALT/AST, bilirubin, alkaline phosphatase, PT, INR, viral hepatitides at baseline. Monitor ALT weekly during therapy; if ALT is >30% baseline or symptoms develop, interrupt and perform full liver function tests. QT prolongation. Monitor adrenal function in adrenal insufficiency, borderline adrenal function, or under prolonged stress. Children. Pregnancy (Cat.C). Nursing mothers: not recommended.

Ketoconazole Tablets Classification:

Azole antifungal.

Ketoconazole Tablets Interactions:

See Contraindications. QT prolongation with concomitant dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Concomitant sirolimus, everolimus, temsirolimus, tamsulosin, rifabutin, rivaroxaban, salmeterol, dasatinib, lapatinib, nilotinib: not recommended. Potentiates alfentanil, sufentanil, fentanyl, buprenophine, oxycodone, calcium channel blockers, bosentan, buspirone, carbamazepine, cilostazol, cyclosporine, digoxin, oral anticoagulants, indinavir, saquinavir, sildenafil, vardenafil, tadalafil, tacrolimus, telithromycin, atorvastatin, tolterodine, trimetrexate, verapamil, vinca alkaloids, bortezomib, busulphan, docetaxel, erlotinib, imatinib, ixabepilone, paclitaxel, aripiprazole, quetiapine, ramelteon, risperidone; monitor and adjust doses. Avoid alcohol or other hepatotoxic drugs. Antagonized by carbamazepine, efavirenz, nevirapine, phenytoin, rifabutin, isoniazid, rifampicin: not recommended. Potentiated by CYP3A4 inhibitors (eg, ritonavir, ritonavir/darunavir, ritonavir/fosamprenavir); adjust ketoconazole dose as needed. Separate dosing of acid neutralizing drugs (eg, aluminum hydroxide) by at least 1hr before or 2hrs after ketoconazole; should give with acidic beverage (eg, non-diet cola). Caution with concomitant repaglinide, saxagliptin, praziquantel, maraviroc, H2-blockers, PPIs, and eletriptan (do not use within 72hrs of ketoconazole). Monitor digoxin, phenytoin, carbamazepine, oral anticoagulants. Consider reducing concomitant dabigatran dose in moderate renal impairment.

Adverse Reactions:

Nausea, vomiting, abdominal pain, urticaria, pruritus, insomnia, nervousness, CNS disorders, photophobia, orthostatic hypotension, myalgia, menstrual disorder, asthenia, fatigue, hot flush, malaise, edema peripheral, pyrexia, chills; hepatotoxicity, anaphylaxis, decreased testosterone levels, Torsades de pointes (may be fatal).


Formerly known under the brand name Nizoral.

How Supplied:

Contact supplier.