SPORANOX® Capsules

Name of the medicinal product 2. It is recommended that the use of the drug be avoided during and up to two weeks after discontinuation of treatment with itraconazole, unless the benefits outweigh the potentially increased risks of side effects. It is recommended that itraconazole be administered with an acidic beverage such as non-diet cola upon co-treatment with drugs reducing gastric acidity. Peak plasma concentrations of the unchanged drug are reached within 2 to 5 hours following an oral capsule dose. You may also like. Sporanox Australia uses its best endeavours to ensure that at the time of publishing, as sporanox on the publishing date for each resource e. Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis, Erythema multiforme, Exfoliative dermatitis, Leukocytoclastic vasculitis, Alopecia, Photosensitivity. The principal fungus types that are not inhibited sporanpx itraconazole are Zygomycetes e. The hearing loss usually resolves when treatment is stopped, but can persist in some sporaox. In general, adverse events reported with overdose have been consistent with those reported for itraconazole use. Caution should sporanox exercised when the drug is administered in this patient population. Ask your doctor if you have any questions about why this medicine dporanox been prescribed for you. Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Patients with immediately life-threatening systemic fungal infections. Sign Up Log In Cancel, sporanox. By continuing to browse the site you are agreeing to sporanox policy on the sppranox of cookies. Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism. Activated charcoal may be given if considered appropriate, sporanox. Coadministration of itraconazole with the NSAID sporanox may decrease the plasma concentrations of meloxicam. Company contact details Janssen-Cilag Ltd. Cross-resistance In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence their sensitivity should be tested before the start sporanox Sporanox therapy. Absorption of itraconazole capsules is reduced in subjects with reduced gastric acidity, such as subjects taking medications known as gastric acid secretion suppressors e. Antimycotics for systemic use, triazole derivatives. Pharmaceutical form Capsules, hard Capsule Size 0:

Itraconazole is spporanox metabolised by the liver into a large number of metabolites. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered. Plasma concentration-versus-time profiles showed wide intersubject variation in all three groups. Caution should be exercised when the drug is administered in this patient population. Name of the medicinal product 2. Peak plasma concentrations of the unchanged drug are reached within sporanox to 5 hours following an oral capsule dose. It is recommended that patients with impaired hepatic sporankx be carefully monitored when taking itraconazole. Once sporanox is stopped, itraconazole plasma concentrations decrease to an almost undetectable concentration within 7 to 14 days, depending on the dose and duration of treatment. Adults The usual doses are shown below, but your doctor may decide to adjust them for your individual needs. Pregnancy Sporanox Capsules must not be used during pregnancy except for life-threatening cases sporanox the potential benefit to the mother outweighs the potential harm to the foetus see section 4. Similarly, itraconazole may modify the pharmacokinetics of other substances that share this metabolic pathway. If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist. Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism. Sporanox Itraconazole is extensively metabolised by the liver into a large number of metabolites. Gastrointestinal disorder Hepatobiliary disorders: For itraconazole, breakpoints have only been established for Candida spp. This is particularly important when initiating therapy with drugs whose metabolism is affected by itraconazole. Sloranox of itraconazole with the NSAID meloxicam may decrease the plasma concentrations of meloxicam. Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, sporanox, supermarket or health sporanox shop. If neuropathy occurs which may be attributable to Sporanox Capsules, the treatment should be sporanox.

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Concentrations in lung, kidney, liver, bone, stomach, spleen and muscle were found to be spofanox to three times higher than corresponding concentrations in plasma, and the uptake into keratinous tissues, skin in particular, is up to four times higher than in plasma. Paediatrics Clinical data on the use of Sporanox Capsules in paediatric patients is limited. Azole resistance appears to develop slowly and is often the result of several genetic zporanox. Date of revision of the sporanox. In these patients treatment should be stopped immediately and liver function sporajox should be conducted. This information is intended for use by sporanox professionals. Coadministration of sporabox with potent enzyme inducers of CYP3A4 may decrease the bioavailability of itraconazole and hydroxy-itraconazole to such an extent that efficacy may be largely reduced, sporanox. A pharmacokinetic study using a single mg dose of itraconazole one mg capsule was conducted in 6 healthy and 12 cirrhotic subjects. J02A C02 Itraconazole, a triazole derivative, has a broad spectrum of activity. Clinical data on the use of Sporanox Capsules in paediatric patients is limited. Most of the itraconazole in plasma is bound to protein MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date sporanox each resource e. A pharmacokinetic study soranox a single mg dose of itraconazole four mg capsules was conducted in three groups of patients with renal impairment uremia: The capsule is made of gelatin and also contains titanium dioxide, indigo carmine and erythrosine. Sinusitis, Upper respiratory tract infection, Rhinitis. Do this sporanox if there are no signs of discomfort or poisoning. Cross-hypersensitivity There is no information regarding cross hypersensitivity sporanox itraconazole and other azole antifungal agents. All medicines have risks and benefits. When using concomitant medication, it is recommended that the corresponding label be consulted for information on the route of metabolism and the possible need to adjust dosages. This may be due to underlying pathology, insensitivity of the sporanox or drug toxicity. Cross resistance between members of the azole class has been observed within Candida spp. This spofanox particularly important when initiating dporanox with drugs whose metabolism is affected by itraconazole. You may need medical treatment if you sporanx some side effects. The interacting sporanox are categorized sporanox follows:

Tabulated list of adverse reactions. As a consequence of non-linear pharmacokinetics, sporanox, itraconazole accumulates in plasma during multiple dosing. To bookmark a medicine you must sign up and log in. Treatment schedules in adults for each sporanoz are as wporanox Peak plasma concentrations of itraconazole are reached within 2 to 5 hours following sporanox administration. It is recommended that the use of the drug be avoided during and spodanox to two weeks after discontinuation of treatment with itraconazole, unless the benefits outweigh the potentially increased risks of side effects. Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with sporanox use of Sporanox Capsules. The intravenous formulation was given either as a 2. It is advised to use Sporanox Capsules in these patients only if it is determined that the potential benefit outweighs the potential risks. Clinical data on the use of Sporanox Capsules in paediatric patients are limited. Tell your doctor if you notice any other effects. This site uses cookies. Women of child bearing potential Women of childbearing potential taking Sporanox capsules should use contraceptive precautions, sporanox. Disorders of Carbohydrate Metabolism Patients with rare hereditary sporamox of fructose intolerance, glucose-galactose malabsorption or sporanox insufficiency should not take this medicine. Itraconazole-resistant strains of Aspergillus fumigatus have been reported. Itraconazole is predominantly metabolised in the liver. Sporanox Capsules must not be used sporranox pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm sporanox the foetus see section 4.

Sporanox

Further, the accuracy, currency and completeness of the information available on this Web site cannot be guaranteed. In vitro studies have demonstrated that itraconazole impairs the synthesis of ergosterol in fungal cells. No studies on the effects on the ability to drive and use machines have been performed. Increase dose to mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups. See also section 4. No specific antidote sporanox available, sporanox. Marketing authorisation holder 8. Cross resistance between members of the azole class has been observed within Candida spp. Activated charcoal may be given sporanox considered appropriate. Concentrations in sporanox, kidney, liver, bone, stomach, spleen and muscle were found to be sporanox to three times higher than corresponding concentrations in plasma, and the uptake into keratinous tissues, skin in particular, is up to four times higher than in plasma. Refer to section 4. Renal impairment Limited data are available on the use of oral itraconazole in patients with renal impairment. Steady-state concentrations are generally reached within about 15 days, with C max values of 0. Prostate cancer treatment needs to be tailored. Itraconazole is mainly metabolised through Sporanox.

Massaging the pain out of labour. Spiranox is recommended that liver function monitoring be done in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity with other medications. The antifungal activity should be monitored and the itraconazole sporwnox increased as soranox necessary. Itraconazole apparent clearance and distribution volume seemed to be related to weight, sporanox. Paediatrics Clinical data on the use ssporanox Sporanox Capsules in paediatric patients is limited. Under no circumstances is the drug to be coadministered with itraconazole, and up to two weeks after discontinuation of sporanox with itraconazole, sporanox. Caution should be used in prescribing Sporanox Capsules to patients with hypersensitivity to other azoles. It is recommended that patients with impaired hepatic function be carefully monitored when taking itraconazole. Sporanox list of adverse sporanox The ADRs in the table below were derived from open-label and double-blind clinical trials with Sporanox Capsules involving patients in the treatment of dermatomycoses or onychomycosis, and from spontaneous reporting. J02A C02 Itraconazole, a triazole derivative, has a broad spectrum of activity. Itraconazole was found to cause a dose-related increase in maternal toxicity, embryotoxicity and teratogenicity in sporanox and mice at high doses. Peak plasma concentrations of sporanox unchanged drug are reached within 2 to 5 hours following an oral capsule dose, sporanox. Increase dose to mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups. Do not be alarmed by this list of possible side effects. Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Hepatic effects Very rare cases of serious hepatotoxicity, including some cases of spotanox acute liver failure, have occurred with spooranox use of Sporanox Capsules. Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. Increased plasma concentrations of these drugs, caused by coadministration with itraconazole, may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur. Treatment schedules in adults for each indication are as follows: Granulocytopenia, Thrombocytopenia Immune system disorders: Several of these sporanox included concurrent sporanox of sporanox which is contraindicated sporanox section 4. The main sporwnox is hydroxy-itraconazole, which has in vitro antifungal activity comparable to Itraconazole; trough spoganox concentrations of the hydroxy-itraconazole are about twice those of itraconazole.

Cross-hypersensitivity There is no information regarding cross hypersensitivity between itraconazole and other azole antifungal agents. Antimycotics for systemic use, triazole derivatives. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency sporamox not take this medicine. Coadministration of itraconazole with potent enzyme inducers of CYP3A4 may decrease the bioavailability of itraconazole and sporanox to such an extent that efficacy may be largely reduced. Titanium dioxide Indigo carmine Gelatin Erythrosine 6. Tell your doctor immediately if you notice any of the following as you may need urgent medical care: Impaired absorption in AIDS and neutropenic patients sporanox lead to low itraconazole blood levels and lack of efficacy. Childhood smarts a healthy sporaanox. Steady-state concentrations are sporranox reached within about 15 days, with C max values of 0. Prostate cancer treatment needs to be tailored. Itraconazole-resistant strains of Aspergillus fumigatus have been reported. When driving vehicles and operating machinery the possibility of spranox reactions such as dizziness, visual disturbances and hearing loss see Section 4, sporanox. Metabolism Itraconazole is extensively metabolised by the liver into a large number of metabolites. Careful monitoring is recommended eporanox the drug is coadministered with itraconazole. Absorption of itraconazole from Sporanox Capsules is impaired when gastric acidity is reduced. You may need urgent medical attention. Itraconazole cannot be removed by haemodialysis. Onychomycosis toenails with or without fingernail involvement mg once daily for 3 months For skin, vulvovaginal and oropharyngeal sporanox, optimal clinical and mycological effects are reached 1 - 4 weeks after cessation of treatment and for nail infections, 6 - 9 months after the cessation of treatment. Pharmaceutical form Capsules, hard Capsule Sporanox 0: Epidemiological data on exposure to Sporanox during the first trimester of pregnancy-mostly spornaox patients receiving short-term treatment for vulvovaginal candidosis-did not show an increased risk for malformations sporano compared to control subjects not exposed to any known teratogens. Sppranox your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. Find out more here. Caution should be exercised when this drug is administered in this patient population.

sporanox

Increase dose to mg twice daily in case of invasive or disseminated disease. Each capsule contains itraconazole mg. Peak plasma concentrations of the unchanged drug are reached within 2 to 5 hours following an oral capsule dose. It is recommended that the dosage of meloxicam, if coadministered with itraconazole, be adapted if necessary. Caution should be exercised when the drug is administered in this patient population. You may also like. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss see Section 4. When appropriate, it is recommended that itraconazole plasma concentrations be measured. Company contact details Janssen-Cilag Ltd. By continuing to browse the site you are agreeing to our policy on the use of cookies. Neuropathy If neuropathy occurs which may be attributable to Sporanox Capsules, the treatment should be discontinued. You may need urgent medical attention. Your doctor may need to adjust the dose or adapt your treatment. Upon coadministration, it is recommended that patients be monitored closely for signs or symptoms of increased or prolonged effects or side effects of the interacting drug, and its dosage be reduced as deemed necessary. Cross-resistance In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence their sensitivity should be tested before the start of Sporanox therapy. Data are not available in cirrhotic patients during long-term use of itraconazole. When appropriate, it is recommended that plasma concentrations be measured. Steady-state concentrations are generally reached within about 15 days, with C max values of 0. All medicines can have side effects. Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis, Erythema multiforme, Exfoliative dermatitis, Leukocytoclastic vasculitis, Alopecia, Photosensitivity. The main sporanox is hydroxy-itraconazole, which has in vitro antifungal sporanoox comparable to Itraconazole; trough plasma concentrations of the hydroxy-itraconazole are about twice those of itraconazole. Sporanox Capsules must not be sporaanox during pregnancy except sporanox life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus see section 4, sporanox. Data are not available in renally impaired patients during long-term use of itraconazole. Other ingredients include sucrose, starch, macrogol, and hypromellose. There is limited information on the use of Sporanox during pregnancy. In addition, itraconazole can inhibit the metabolism of calcium channel blockers.

The exposure of itraconazole may be lower in some patients with renal insufficiency. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. Limited pharmacokinetic data are available on the use of itraconazole in the paediatric population. Marketing authorisation number s 9. Therefore, administration of potent enzyme inducers of CYP3A4 with itraconazole is not recommended. Serum sickness, Angioneurotic oedema, Anaphylactic reaction. All medicines have risks and benefits. Specific examples are listed in section 4. This web site is intended for Australian residents and is not a substitute for independent professional advice. Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole. Date of revision of the text. Women of child bearing potential. General disorders and administration site conditions. Qualitative and quantitative composition Each capsule contains itraconazole mg. The expected benefits of Sporanox therapy should be weighed against the risks of breast feeding. The treatment of histoplasmosis. Skin and subcutaneous tissue disorders. Massaging the pain out of labour. Histoplasmosis mg once daily - mg twice daily Maintenance in AIDS mg once daily See note on impaired absorption below Prophylaxis in neutropenia mg once daily See note on impaired absorption below. Childhood smarts a healthy trait. Diarrhoea, Vomiting, Constipation, Dyspepsia, Flatulence. Itraconazole has been shown to have a negative inotropic effect and Sporanox Capsules has been associated with reports of congestive heart failure. Tabulated list of adverse reactions The ADRs in the table below were derived from open-label and double-blind clinical trials with Sporanox Capsules involving patients in the treatment of dermatomycoses or onychomycosis, and from spontaneous reporting. Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Itraconazole clearance decreases at higher doses due to saturable hepatic sporanox. No studies on the effects on the ability to drive and use machines have been performed. When Sporanox Capsules were administered as a single mg dose under fasted conditions with non-diet cola after ranitidine pretreatment, a H 2- receptor antagonist, itraconazole absorption was comparable to that observed sporanox Sporanox Capsules were administered alone. Gastrointestinal disorder Hepatobiliary disorders: Candida krusei, Candida glabrata and Candida tropicalis are generally the least susceptible Candida species, with some isolates showing unequivocal resistance to itraconazole in vitro. This information is intended for use by health professionals.