Itraconazole


Generic Medicine Info
Administration
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.
Contraindications
Hypersensitivity. Non-life-threatening indications in patients with ventricular dysfunction (e.g. CHF, history of CHF). Severe renal impairment (IV). Pregnancy (non-life-threatening infection). Coadministration with astemizole, bepridil, cisapride, disopyramide, dofetilide, dronedarone, eplerenone, ergot alkaloids, felodipine, halofantrine, irinotecan, ivabradine, lercanidipine, levacetylmethadol, lovastatin, lurasidone, methadone, midazolam (oral), misolaztine, nisoldipine, pimozide, quinidine, ranolazine, sertindole, simvastatin, terfenadine, or triazolam; colchicine in patients with varying degrees of renal or hepatic impairment.
Special Precautions
Patients with risk factors for CHF (e.g. ischaemic or valvular disease, oedematous disorders, renal failure, COPD), reduced gastric acidity (e.g. achlorhydria), immediate life-threatening systemic fungal infections, cystic fibrosis, or immunocompromised patients (e.g. neutropenic, AIDS, organ transplant patients). Coadministration with Ca channel blockers or drugs that reduce gastric acidity. Renal and hepatic impairment. Elderly. Pregnancy (life-threatening infection) and lactation. Patient Counselling This drug may cause dizziness, visual disturbances and hearing loss, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs, renal function tests, serum trough concentrations for other infections. Assess for signs and symptoms of heart failure.
Adverse Reactions
Significant: Heart failure, pulmonary oedema, neuropathy, transient or permanent hearing loss, transient asymptomatic decrease of LVEF, hepatotoxicity, hypersensitivity reactions. Blood and lymphatic system disorders: Granulocytopenia, leukopenia, thrombocytopenia. Cardiac disorders: Chest pain, tachycardia. Ear and labyrinth disorders: Tinnitus. Eye disorders: Visual disturbance, blurred vision, diplopia. Gastrointestinal disorders: Nausea, abdominal pain, vomiting, diarrhoea, dyspepsia, constipation. General disorders and administration site conditions: Oedema, fatigue, pyrexia. Hepatobiliary disorders: Jaundice, hepatitis, hyperbilirubinaemia. Immune system disorders: Urticaria. Investigations: Elevated liver enzymes, increased serum creatine phosphokinase. Metabolism and nutrition disorders: Hypokalaemia, hypertriglyceridaemia. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Nervous system disorders: Headache, dizziness, paraesthesia, dysgeusia. Renal and urinary disorders: Pollakiuria, urinary incontinence. Reproductive system and breast disorders: Menstrual disorder, erectile dysfunction. Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, sinusitis, rhinitis. Skin and subcutaneous tissue disorders: Rash, pruritus, photosensitivity, alopecia. Vascular disorders:Hypertension, hypotension.
Potentially Fatal: Rarely, acute liver failure.
Drug Interactions
May decrease plasma concentrations with carbamazepine, phenobarbital, phenytoin isoniazid, rifabutin, rifampicin, nevirapine, efavirenz. May reduce absorption with antimuscarinics, antacids, PPIs, histamine H2-receptor antagonists. May increase plasma concentrations with indinavir, ritonavir, telaprevir, erythromycin, clarithromycin, ciprofloxacin. May reduce plasma concentration of meloxicam. May increase serum concentrations of digoxin, alfentanil, oxycodone, repaglinide, bilastine, alprazolam, midazolam (IV), buspirone, saquinavir, praziquantel, bosentan, aprepitant, reboxetine, fesoterodine, solifenacin, tamsulosin, tadalafil, sildenafil, cinacalcet, tolvaptan, antineoplastic agents (e.g. busulfan, docetaxel, trimetrexate, vinca alkaloids), immunosuppressants (e.g. ciclosporin, tacrolimus), corticosteroids (e.g. budesonide, dexamethasone, fluticasone), oral anticoagulants (e.g. apixaban, cilostazol, coumarins). May increase risk of respiratory depression with fentanyl. May enhance negative inotropic effects of verapamil.
CIMS Class
Antifungals
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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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