Ketoconazole Tablets

  • Fungal infections

Ketoconazole Tablets Generic Name & Formulations

General Description

Ketoconazole 200mg.

Pharmacological Class

Azole antifungal.

How Supplied

Contact supplier.

Ketoconazole Tablets Indications


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.

Ketoconazole Tablets Dosage and Administration


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


<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 Boxed Warnings

Not Applicable

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 Pharmacokinetics

See Literature

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.

Ketoconazole Tablets Adverse Reactions

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).

Ketoconazole Tablets Clinical Trials

See Literature

Ketoconazole Tablets Note


Formerly known under the brand name Nizoral.

Ketoconazole Tablets Patient Counseling

See Literature