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Antifungal broad-spectrum drug, a triazole derivative. Inhibits the synthesis of ergosterol cell membrane of fungi. It is active against dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), and Candida spp. (including Candida albicans, Candida glabrata, Candida krusei), mold fungi (Cryptococcus neoformans, Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cosposporium seshne sf, Cladosporus, sf, sf, sid, scorpionus, Forsecae sf.
- Fungal keratitis;
- Onychomycoses caused by dermatophytes and / or yeasts and molds;
- Systemic mycoses, including systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioimicosis, blastomycosis;
- Candidomycosis with damage to the skin and mucous membranes, incl. vulvovaginal candidiasis;
- Visceral candidiasis;
- Pityriasis versicolor.
One capsule contains
Itraconazole - 100mg (in the form of pellets 22%)
Sugar granules, copolymer of methyl-, dimethylaminoethyl- and butyl methacrylate (Eudragit E-100), hydroxypropylmethylcellulose, polyethylene glycol.
The composition of the capsule shell:
Quinoline gelatin (E 104), patented blue V (E 131), brilliant black (E 151), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin, orange yellow (E 110).
Itraconazole is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Orungal||Janssen Pharmaceuticals N.V||Belgium||solution|
|Orungal||Janssen Pharmaceuticals N.V||Italy||capsules|
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Dosage and Administration
For optimal absorption of the drug should be taken Itraconazole capsules immediately after a meal.
Capsules should be swallowed whole.
On the part of the digestive system: often - dyspepsia, nausea, abdominal pain, constipation; possible anorexia, reversible increase in liver enzymes, cholestatic jaundice, hepatitis; in some cases - toxic damage to the liver, including case of acute liver failure with a fatal outcome.
On the part of the central nervous system and peripheral nervous system: possible headache, fatigue, dizziness, peripheral neuropathy.
On the part of the reproductive system: possible violations of the menstrual cycle.
On the part of the urinary system: hypercreatininemia, urine staining in a dark color.
Metabolism: edema, hyperkalemia.
Since the cardiovascular system: possible chronic heart failure and pulmonary edema.
Allergic reactions: itching, rash, urticaria, angioedema, Stevens-Johnson syndrome are possible.
Dermatological reactions: alopecia is possible.
Hypersensitivity to the drug.
The simultaneous use with rifampicin, rifabutin and phenytoin, which are strong inducers of liver microsomal enzymes, is not recommended, since these drugs can significantly reduce the bioavailability of itraconazole and hydroxyitraconazole, which leads to a significant decrease in the effectiveness of the drug. Studies on the interaction of itraconazole with other inducers of hepatic enzymes, such as carbamazepine, phenobarbital and isoniazid, have not been conducted, however, we can assume the development of a similar effect.
Since Itraconazole is mainly metabolized with the participation of CYP3A4 isoenzyme cytochrome P450, strong inhibitors of this enzyme (including ritonavir, indinavir, clarithromycin and erythromycin) can increase the bioavailability of itraconazole.
Itraconazole can inhibit the metabolism of drugs that are biotransformed with the participation of the CYP3A4 isoenzyme. The result of this may be strengthening or prolongation of their action, incl. and side effects. After cessation of treatment, plasma concentrations of itraconazole decrease gradually, depending on the dose and duration of treatment.
Terfenadine, astemizole, mizolastine, cisaprid, triazolam, midazolam (orally), dofetilide, quinidine, pimozide, metabolized by the CYP3A4 isoenzyme, HMG-CoA reductase inhibitors (simvastatin and catastrophins, and simvastatin and catastrophes, and simvastatin and catastrophes are not prescribed simultaneously with itraconazole.
Calcium channel blockers have a negative inotropic effect, which can enhance the similar effect of itraconazole; Itraconazole can reduce the metabolism of calcium channel blockers. Itraconazole should be used with caution simultaneously with calcium channel blockers.
Drugs, the use of which requires control of plasma concentrations: oral anticoagulants; HIV protease inhibitors (ritonavir, indinavir, saquinavir); some anticancer drugs (vinca pink alkaloids, busulfan, docetaxel, trimetrexate); calcium channel blockers, metabolized with the participation of the isoenzyme CYP3A4 (dihydropyridine and verapamil); some immunosuppressants (cyclosporine, tacrolimus, sirolimus); other drugs - digoxin, carbamazepine, buspirone, alfentanil, alprazolam, brotizolam, rifabutin, methylprednisolone, ebastine, reboxetine. With simultaneous use with itraconazole, if necessary, the dose of these drugs should be reduced.
No interaction between itraconazole and zidovudine and fluvastatin was detected.
No effect of itraconazole on the metabolism of ethinyl estradiol and norethisetron was noted.
In vitro studies have demonstrated a lack of interaction between itraconazole and drugs such as imipramine, propranolol, diazepam, cimetidine, indomethacin, tolbutamide, and sulfamethazine when bound to plasma proteins.
Pregnancy and Lactation
In pregnancy, Itraconazole is prescribed only in cases of extreme necessity, when the expected benefit of therapy for the mother exceeds the existing risk to the fetus.
Itraconazole is excreted in small amounts with breast milk. If necessary, the appointment of the drug Itraconazole during lactation should carefully evaluate the expected benefits of therapy for the mother and the potential risk to the infant. In case of doubt, the question of discontinuing breastfeeding should be resolved.
Women of childbearing age during the use of Itraconazole should use reliable methods of contraception during the entire course of treatment until the first menstruation after its completion.
Itraconazole has a negative inotropic effect. Considering this, Itraconazole should not be prescribed to patients with chronic heart failure (including in history), except for cases when the expected benefit of therapy far exceeds the potential risk. This should take into account such factors as the severity of indications, dosing regimen and individual risk factors for the development of chronic heart failure (including the presence of coronary artery disease, valvular heart disease, COPD, renal failure).
At low acidity of the stomach, absorption of itraconazole is impaired. Patients receiving antacid preparations (for example, aluminum hydroxide) are recommended to take them no earlier than 2 hours after taking Irunin. Patients with achlorhydria or using histamine H2-receptor blockers or proton pump inhibitors are recommended to take Itraconazole capsules with soda.
In very rare cases, when using itraconazole, severe toxic liver damage developed, including cases of acute liver failure with a fatal outcome. In most cases, this was observed in patients who already had liver disease, as well as in patients who received other drugs with a hepatotoxic effect. In this regard, it is recommended to regularly monitor liver function in patients receiving itraconazole therapy.
In the event of the appearance of symptoms suggesting the development of hepatitis, incl. anorexia, nausea, vomiting, weakness, pain in the abdomen and darkening of the urine, you must immediately stop taking the drug and conduct a study of the function of the liver. Patients with elevated levels of liver enzymes or liver disease in the active phase should not be given Itraconazole treatment unless the expected benefit justifies the risk of liver damage. In these cases, it is necessary to control the level of liver enzymes during treatment.
In the case of the development of neuropathy, which can be caused by oral administration of itraconazole, treatment should be discontinued.
There is no data on cross-hypersensitivity to itraconazole and other antifungal drugs derived from azole. Itraconazoleis capsules should be administered with caution to patients with hypersensitivity to other azoles.
Data overdose of the drug are not available.
Treatment: in case of accidental overdose during the first hour after taking the drug, gastric lavage should be done; if necessary, activated charcoal should be prescribed.
Symptomatic and maintenance therapy is indicated.
Itraconazole is not excreted by hemodialysis. The specific antidote is not known.
- Brand name: Orunit
- Active ingredient: Itraconazole
- Dosage form: The capsules are transparent, pink, with a blue cap.
- Manufacturer: Obolensky OP
- Country of Origin: Russia
- Freeze-drying of itraconazole-loaded nanosphere suspensions: a feasibility study
- Effect of itraconazole on the pharmacokinetics of digoxin in guinea pigs
- Plasma concentration of itraconazole in patients receiving chemotherapy for hematological malignancies: the effect of famotidine on the absorption of itraconazole
- Itraconazole-enhanced vindesine neurotoxicity in adult acute lymphoblastic leukaemia
- Effect of oral itraconazole on the pharmacokinetics of tacrolimus in a hematopoietic stem cell transplant recipient with CYP3A5*3/*3
- Drug interaction between lenalidomide and itraconazole
- Itraconazole and retinoid resistance
- Absence of clinically relevant drug interactions following simultaneous administration of didanosine-encapsulated, enteric-coated bead formulation with either itraconazole or fluconazole
- Effects of cysteine on the pharmacokinetics of itraconazole in rats with protein-calorie malnutrition
- Pharmacokinetic interaction of ketoconazole and itraconazole with ciprofloxacin
- Effect of itraconazole on the pharmacokinetics of everolimus administered by different routes in rats
- Pharmacokinetic interactions between ciprofloxacin and itraconazole in healthy male volunteers
- Bioanalytical methods for the determination of itraconazole and hydroxyitraconazole: overview from clinical pharmacology, pharmacokinetic, pharmacodynamic and metabolism perspectives
- Simultaneous determination of itraconazole and hydroxyitraconazole in human plasma by liquid chromatography–isotope dilution tandem mass spectrometry method
- A rapid HPLC method with fluorometric detection for determination of plasma itraconazole and hydroxy-itraconazole concentrations in cystic fibrosis children with allergic bronchopulmonary aspergillosis
- ChemInform Abstract: Synthesis of Benzothiophene Analogues of Ketoconazole and Itraconazole.
- ChemInform Abstract: Advances in the Development of Methods for the Synthesis of Triazole Antifungal Agents (Itraconazole (Sporanox), Fluconazole (Diflucan), Voriconazole (Vfend), Fosfluconazole (Prodif)]
- ChemInform Abstract: Design and Synthesis of Pyridine-Substituted Itraconazole Analogues with Improved Antifungal Activities, Water Solubility and Bioavailability.
- Determination of the absolute configuration and solution conformation of the antifungal agents ketoconazole, itraconazole, and miconazole with vibrational circular dichroism
- Stereoselective determination of the epimer mixtures of itraconazole in human blood plasma using HPLC and fluorescence detection
- Liposomal amphotericin B versus the combination of fluconazole and itraconazole as prophylaxis for invasive fungal infections during induction : Chemotherapy for patients with acute myelogenous leukemia and myelodysplastic syndrome
- Intravenous itraconazole for prophylaxis of systemic fungal infections in patients with acute myelogenous leukemia and high-risk myelodysplastic syndrome undergoing induction chemotherapy
- Itraconazole added to a lipid formulation of amphotericin B does not improve outcome of primary treatment of invasive aspergillosis