Sporanox , Tolsura , Onmel. In addition, itraconazole can inhibit the metabolism of calcium channel blockers.
The pharmacokinetics of itraconazole are characterized by non-linearity. In patients with reduced gastric acidity, whether from disease e.
Clinical studies of Itraconazole Oral Solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Due to the pharmacokinetic properties see section 5.
Adverse drug reactions that have been first identified during post-marketing experience with Itraconazole Oral Solution all formulations are listed in Table 6 below.
Elimination Itraconazole is excreted via urine in the form of inactive metabolites at approx. Itraconazole Oral Solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure CHF or a history of CHF except for the treatment of life-threatening or other serious infections.
In invasive or disseminated disease, increase to 2 capsules twice daily in the morning and in the evening equivalent to 400 mg itraconazole.
Symptoms and signs In general, adverse events reported with overdose have been consistent with those reported for itraconazole use see section 4.
Patients with AIDS.
Special Populations Hepatic Insufficiency A pharmacokinetic study using a single 100 mg dose of itraconazole one 100 mg capsule was conducted in 6 healthy and 12 cirrhotic subjects. Use in patients with impaired renal function.
Special Populations. Body as a whole. Decreased concentrations may reduce Itraconazole Oral Solution efficacy. Superficial mycoses of skin, mucosae.
Antihelminthics, Antifungals and Antiprotozoals. Since clinical data on the use of itraconazole oral solution in paediatric patients is limited, its use in children is not recommended unless the potential benefit outweighs the potential risks. Hearing loss. These cases included skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations.
Quantitative methods are used to determine antifungal minimum inhibitory concentrations MICs.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Due to the design of the study, no formal conclusion with regard to efficacy could be derived. As seen in in vitro studies, CYP 3A4 is an important enzyme involved in the metabolization of itraconazole.