Generic Medicine Info
Oral soln: Should be taken on an empty stomach. Take on an empty stomach & refrain from eating for at least 1 hr after intake.
Cap: Should be taken with food. Take immediately after a full meal.
Hypersensitivity. Non-life-threatening indications (e.g. onychomycosis) in patients with evidence of ventricular dysfunction, such as CHF or a history of CHF. Severe renal impairment (IV). Pregnancy (for non-life-threatening cases). Concomitant use with methadone, levacetylmethadol, disopyramide, dofetilide, dronedarone, quinidine, astemizole, mizolastine, terfenadine, halofantrine, isavuconazole, ergot alkaloids (e.g. dihydroergotamine, ergometrine, ergotamine, methylergometrine), irinotecan, lurasidone, oral midazolam, pimozide, sertindole, triazolam, bepridil, felodipine, nisoldipine, lercanidipine, ivabradine, ranolazine, eplerenone, cisapride, domperidone, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor; colchicine, fesoterodine, solifenacin, and telithromycin (in patients with varying degrees of renal or hepatic impairment). Coadministration with eliglustat (in poor or intermediate CYP2D6 metabolisers and those taking strong or moderate CYP2D6 inhibitors).
Special Precautions
Patient with risk factors for CHF (e.g. COPD, oedematous disorders, renal failure, ischaemic or valvular disease), hypersensitivity to other azole antifungals, cystic fibrosis; abnormal gastrointestinal motility, reduced gastric acidity such as achlorhydria (cap). Immunocompromised patients (e.g. neutropenic, AIDS, organ transplant patients). Oral preparations are not recommended for initiation of treatment in patients with immediately life-threatening systemic fungal infections due to pharmacokinetic properties. Oral solution and capsules are not interchangeable. Coadministration with Ca channel blockers or drugs that reduce gastric acidity. Renal and hepatic impairment. Pregnancy (for life-threatening indications); lactation. Patient Counselling This drug may cause dizziness, visual disturbances and hearing loss, if affected, do not drive or operate machinery. Monitoring Parameters Monitor hepatic and renal functions, and serum trough concentrations for certain infections; signs and symptoms of CHF and liver toxicity during treatment.
Adverse Reactions
Significant: Transient or permanent hearing loss, peripheral neuropathy (prolonged use), peripheral or pulmonary oedema, hypersensitivity reactions. Blood and lymphatic system disorders: Granulocytopenia, thrombocytopenia, leucopenia. Cardiac disorders: Left ventricular failure, tachycardia. Ear and labyrinth disorders: Tinnitus. Eye disorders: Visual disturbance, diplopia, blurred vision. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, dysgeusia. General disorders and administration site conditions: Generalised oedema, face oedema, chest pain, fatigue, chills, pyrexia, pain; inj site inflammation (IV). Hepatobiliary disorders: Hepatitis, jaundice. Investigations: Increased ALT/AST, blood alkaline phosphatase, blood lactate dehydrogenase, blood urea, and gamma-glutamyltransferase; abnormal urine analysis. Metabolism and nutrition disorders: Hyperglycaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyperbilirubinaemia, hypertriglyceridaemia. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache, dizziness, somnolence, tremor, paraesthesia. Psychiatric disorders: Confusional state. Renal and urinary disorders: Renal impairment, urinary incontinence, pollakiuria. Reproductive system and breast disorders: Erectile dysfunction, menstrual disorder. Respiratory, thoracic and mediastinal disorders: Dysphonia, cough, dyspnoea, sinusitis, rhinitis, upper respiratory tract infection. Skin and subcutaneous tissue disorders: Erythematous rash, rash, hyperhidrosis, alopecia, urticaria, pruritus. Vascular disorders: Hypertension, hypotension.
Potentially Fatal: CHF or exacerbation of CHF. Rarely, serious hepatotoxicity (including liver failure).
Drug Interactions
Absorption of itraconazole capsules may be decreased by drugs that neutralise gastric acidity (e.g. Al hydroxide, H2-receptor antagonists, PPIs). Plasma concentrations may be decreased by rifampicin, rifabutin, isoniazid, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz. Plasma concentrations may be increased by ciprofloxacin, clarithromycin, erythromycin, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir, ritonavir, telaprevir, cobicistat. May increase the plasma concentrations of tamsulosin, certain opioid analgesics (e.g. alfentanil, sufentanil, buprenorphine, fentanyl, oxycodone), digoxin, certain anticoagulants (e.g. apixaban, rivaroxaban, cilostazol, coumarins, dabigatran), repaglinide, saxagliptin, praziquantel, certain antihistamines (e.g. bilastine, ebastine), certain antineoplastics (e.g. axitinib, docetaxel, dasatinib, vinca alkaloids, trabectedin, trastuzumab emtansine, olaparib, idelalisib, sonidegib, imatinib, panobinostat, busulfan), certain antipsychotics, anxiolytics and hypnotics (e.g. risperidone, alprazolam, buspirone, quetiapine aripiprazole, haloperidol, midazolam IV), verapamil, nadolol, aliskiren, bosentan, riociguat, aprepitant, certain corticosteroids (e.g. budesonide, fluticasone, methylprednisolone, ciclesonide), salmeterol, certain immunosuppressants (e.g. ciclosporin, tacrolimus), certain urological drugs (e.g. tadalafil, sildenafil, darifenacin, tolterodine), cinacalcet, mozavaptan, tolvaptan, delamanid, artemether and lumefantrine, simeprevir, atorvastatin, alitretinoin. May decrease the plasma concentration of meloxicam.
CIMS Class
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Disclaimer: This information is independently developed by CIMS based on itraconazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 CIMS. All rights reserved. Powered by
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