Ketoconazole

Should be taken with food.

Hypersensitivity. Concomitant use with CYP3A4 substrates (e.g. cisapride, dofetilide, dronedarone, quinidine, disopyramide, pimozide, sertindole, mizolastine, lurasidone, quetiapine, methadone, ranolazine, eplerenone, halofantrine, triazolam, alprazolam, midazolam, nisoldipine, felodipine, irinotecan, everolimus, sirolimus, paritaprevir/ombitasvir, saquinavir/ritonavir), HMG-CoA reductase (e.g. simvastatin, lovastatin), ergot alkaloids (e.g. ergotamine, ergometrine); colchicine, telithromycin, clarithromycin, fesoterodine and solifenacin. Acute or chronic hepatic impairment. Pregnancy (with Cushing syndrome) and lactation (oral).

Patients with achlorhydria, prostate cancer, CNS infection, adrenal insufficiency; under prolonged stress (e.g. major surgery, intensive care). Children. Pregnancy and lactation (topical). Patient Counselling Oral: This drug may cause dizziness and somnolence, if affected, do not drive or operate machinery. Topical: Avoid use of shampoo within 48 hours of applying hair dye, straightening or waving preparations. Avoid exposure to open flame or other source of ignition during or after application. Avoid contact with eyes and other mucous membrane. Monitoring Parameters Monitor LFT, bilirubin, adrenal function and QTc interval at baseline and at frequent intervals during therapy; serum Ca and phosphorus periodically (long-term use). Assess signs and symptoms of hepatotoxicity and hypocortisolism.

Significant: Adrenal suppression, QT prolongation, bone fragility, abnormal LFTs, hypersensitivity reactions (e.g. anaphylaxis, angioedema). Blood and lymphatic system disorders: Thrombocytopenia. Eye disorders: Photophobia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, constipation, abdominal pain, flatulence. General disorders and administration site conditions: Asthenia, malaise, hot flush; topical: oily/dry hair, application site reactions (e.g. irritation, burning sensation, erythema, swelling). Hepatobiliary disorders: Jaundice, hepatitis. Immune system disorders: Urticaria. Investigations: Increased hepatic enzymes, decreased platelet count. Metabolism and nutrition disorders: Alcohol intolerance, anorexia, peripheral oedema. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Nervous system disorders: Headache, dizziness, somnolence, dysgeusia, paraesthesia. Psychiatric disorders: Insomnia, nervousness. Reproductive system and breast disorders:Menstrual disorder, erectile dysfunction, azoospermia, gynaecomastia. Skin and subcutaneous tissue disorders: Pruritus, rash, alopecia, photosensitivity, dermatitis, xeroderma. Vascular disorders: Epistaxis, orthostatic hypotension.
Potentially Fatal: Hepatotoxicity e.g. hepatic necrosis, cirrhosis and failure or requiring liver transplantation.

Increased risk of hyperkalaemia and hypotension with eplerenone. Increased risk of hepatotoxicity and QTc interval prolongation with telithromycin and clarithromycin Increased risk of oedema and CHF with felodipine and nisoldipine. Increased risk of liver damage with paracetamol. May reduce absorption with antacids, antimuscarinics, PPIs, H₂-receptor antagonists. May decrease plasma concentration with CYP3A4 inducers (e.g. rifampicin, rifabutin, carbamazepine, phenytoin, isoniazid, nevirapine, mitotane). May increase serum level with CYP3A4 inhibitors (e.g. ritonavir-boosted darunavir and fosamprenavir). May increase plasma concentrations of buprenorphine, alfentanil, fentanyl, oxycodone, digoxin, apixaban, warfarin, cilostazol, repaglinide, praziquantel, saxaliptin, isavuconazole, eletriptan, buspirone, aripiprazole, reboxitine, risperidone, midazolam (IV), maraviroc, indinavir, nadolol, verapamil, aliskiren, bosentan, domperidone, naloxegol, ciclosporin, budesonide, dexamethasone, fluticasone, sildenafil, vardenafil, cinacalcet, ibrutinib, busulfan, docetaxel, vinca alkaloids (e.g. vincristine, vinblastine). May increase risk of QTc interval prolongation with haloperidol, salmeterol, ebastine, pasireotide and tolterodine.

Antifungals / Psoriasis, Seborrhea & Ichthyosis Preparations / Topical Antifungals & Antiparasites

H02CA03 - ketoconazole
G01AF11 - ketoconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
J02AB02 - ketoconazole ; Belongs to the class of imidazole derivatives. Used in the systemic treatment of mycotic infections.