SPORANOX® Capsules

Candida krusei, Candida glabrata and Candida tropicalis are generally the least susceptible Candida species, with some isolates showing unequivocal resistance to itraconazole in vitro. Drugs that are contraindicated, sporanox, not sporanox or recommended for use with caution in combination with itraconazole are listed in section 4. 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. In these patients treatment should be stopped immediately and liver function testing should be conducted. Refer to section 4. When driving vehicles sporanox operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss see Section 4. Jock itch tinea cruris. Hepatic effects Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of Sporanox Sporanox. A pharmacokinetic study using a single mg dose of itraconazole one mg capsule was conducted in 6 healthy and 12 cirrhotic subjects. Pulmonary oedema, Dysphonia, sporanox, Cough Gastrointestinal disorders: Ask your doctor if you have any questions about why this medicine has been prescribed for you. 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. Qualitative and quantitative composition 3. Itraconazole is extensively metabolised by sporanox liver into a large number of metabolites. Distribution Most of the itraconazole in plasma is bound to protein Massaging sporanox pain out of labour. Consumers should be aware that the information provided by the Consumer Medicines Information CMI search CMI Search is for information sporanox only sporanox consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. 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. Itraconazole was found to cause a dose-related increase in maternal toxicity, embryotoxicity and teratogenicity in rats and mice at high doses. Tell your doctor immediately if you notice any of the following as you may need urgent medical care: Childhood smarts a healthy trait.

Tabulated list of adverse reactions. The safety of Sporanox Capsules was evaluated in paediatric patients aged 1 to 17 years who participated in 14 clinical trials 4 double-blind, placebo controlled trials; sporranox open-label trials; and 1 trial had sporanoc open-label phase followed by a double-blind phase. Capsules, hard Capsule Size 0: Exercise helps cancer survivors. Elderly Clinical data on the use of Sporanox Capsules in elderly patients are limited. Sporanox web site is intended for Australian residents and is not a substitute for independent professional advice. The clinical relevance of these findings to the oral formulations is unknown. The use of Sporanox Capsules in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. When appropriate, it is recommended that itraconazole plasma concentrations be measured. Respiratory, sporanox, thoracic and mediastinal disorders. In vitro studies have demonstrated that itraconazole impairs the synthesis of ergosterol in fungal cells. Individual doses with the capsule and oral solution formulation ranged sppranox 1. Sugar spheres Hypromellose 5mPa. Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Blood urea increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Urine analysis abnormal Paediatric population. Limited data are available on the use of oral itraconazole in patients with renal impairment. It is recommended that patients who must take itraconazole concomitantly with potent inhibitors of CYP3A4 be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of itraconazole, and the itraconazole dose be decreased as deemed necessary. A pharmacokinetic study using sporanox single mg dose of itraconazole one mg capsule was conducted in 6 healthy and 12 cirrhotic subjects. These patients received at least one dose of Sporanox Capsules for the treatment of fungal infections and provided safety data. Tell your doctor immediately if you notice any of the following as you may need urgent medical care: J02A C02 Itraconazole, sporanox, a triazole derivative, has a broad sporanox of activity.

In general, it is recommended that the dose selection for an sporanox patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or sporanox function, and of concomitant disease or other drug therapy. A pharmacokinetic study using a single mg dose of itraconazole four mg capsules was conducted in three groups of patients with renal impairment uremia: Absorption of itraconazole under fasted conditions in these subjects is increased when Sporanox Capsules are administered with an acidic beverage such as a non-diet cola. Liver function monitoring should be considered in patients receiving Sporanox Capsules treatment. You may need urgent medical attention. Clinical data on the use of Sporanox Capsules in paediatric patients are limited. Candida krusei, Candida glabrata and Candida tropicalis are generally the least susceptible Candida species, with some isolates showing unequivocal resistance to itraconazole in vitro. Information and interactions contained in this Web site are for information purposes only and are not intended to be used to diagnose, treat, cure or prevent any disease. Very rare cases of serious hepatotoxicity, including some cases of fatal sporanox liver failure, have occurred with the use of Sporanox Capsules. Women of child bearing potential Women of childbearing potential taking Sporanox capsules should use contraceptive precautions. Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis, Erythema multiforme, Exfoliative dermatitis, Leukocytoclastic vasculitis, Alopecia, Photosensitivity. Lactation A very small amount of itraconazole is excreted in human milk. Activated charcoal may be given if considered appropriate. Adults The usual doses are shown below, but your doctor may decide to adjust them for your individual needs, sporanox. Anaphylactoid reaction Metabolism and nutrition disorders: However, overall exposure to itraconazole, based on AUC, was similar in cirrhotic patients and in healthy subjects. Individual doses with the capsule and oral sporanox formulation ranged from 1. Histoplasmosis mg sporanox 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, sporanox. It does not contain all the available information. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered.

Itraconazole cannot be removed by haemodialysis. 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. The treatment of histoplasmosis. Adults The usual doses are shown below, but your doctor may decide to adjust them for your individual needs. Date of revision of the text. Last updated on eMC: No specific antidote is available. Several of these reports included concurrent administration of quinidine which is contraindicated see section 4. Other ingredients include sucrose, starch, macrogol, and hypromellose, sporanox. Elderly Clinical data on the use of Sporanox Capsules in elderly patients are limited. Increase dose to mg once daily for 15 days sporanox AIDS or neutropenic patients because of impaired absorption sporanox these groups. Renal impairment Limited data are available on sporanox use of oral itraconazole in patients with renal impairment. Onychomycosis sporanox with or without fingernail involvement mg once daily for 3 months. Exercise helps cancer survivors. Dermatophytoses caused by organisms susceptible to itraconazole Trichophyton spp.

Sporanox

Limited pharmacokinetic data are available on the use of itraconazole in the paediatric population. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss see Section 4, sporanox. Find out more here. Data are not available in renally impaired patients during long-term sporanox of itraconazole. 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 sporanox the potentially increased risks of side effects. In vitro studies have shown that CYP3A4 is the major enzyme involved in the metabolism of itraconazole. Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Blood urea increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Urine analysis abnormal Paediatric population. Myalgia, Arthralgia Renal and urinary disorders: This study did not demonstrate any significant effect of hemodialysis or continuous ambulatory peritoneal dialysis on the pharmacokinetics of itraconazole T maxC maxand AUC h. Adults The usual doses are shown below, but your doctor may decide to adjust them for your individual needs. Patients with immediately life-threatening systemic fungal infections Due to the pharmacokinetic properties See section 5. Information and interactions contained in this Web site are for information purposes only and are not intended to be used to diagnose, treat, cure or prevent any disease. Marketing authorisation holder sporanox. Make sure you know how you react to SPORANOX capsules before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or lightheaded. It has also a marked affinity for lipids. It is advised to use Sporanox Capsules in these patients only if it is determined that the potential benefit sporanox the sporanox risks. Blood and lymphatic system disorders: Anaphylactoid reaction Metabolism and nutrition disorders: Sign Up Log In Sporanox. Immunocompromised patients In some immunocompromised patients e. Pulmonary oedema, Dysphonia, Cough Gastrointestinal disorders: For example, increased plasma concentrations of some sporanox these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. Some of these cases were observed within the first month of treatment, including some within the first week. 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 sporanox, and its dosage be reduced as deemed necessary, sporanox. The terminal half-life of itraconazole generally ranges from 16 to 28 hours after single dose and increases to 34 to 42 hours with repeated dosing.

A very small amount of itraconazole is excreted in human milk. Impaired absorption in AIDS and neutropenic patients may lead to low itraconazole blood levels and lack of efficacy. The use of Sporanox Capsules in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. Adults The usual doses are shown below, but your doctor may decide to adjust them for your individual needs. This web site is intended for Australian residents and is not a substitute for independent professional advice. In case of doubt, the patient should not breast feed. Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders: Indication Dose Remarks Vulvovaginal candidosis mg twice daily for 1 day Pityriasis versicolor mg once daily for 7 days Tinea corporis, tinea cruris mg once daily sporanlx 15 days or mg once daily for 7 days Tinea pedis, tinea manuum mg once daily for 30 sporajox Oropharyngeal candidosis mg once daily for 15 days Increase dose to mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups, sporanox. Women of child bearing potential Women of childbearing potential taking Sporanox capsules should use contraceptive precautions. No significant age dependence was observed for itraconazole AUC and total body clearance, while weak associations between age and itraconazole distribution volume, C max and terminal elimination rate were noted. Qualitative and quantitative composition Each capsule contains itraconazole mg, sporanox. Indication Dose 1 Remarks Aspergillosis mg once daily Increase dose to mg twice daily in case of invasive or disseminated disease Candidosis mg once daily Increase dose to mg twice daily in case of invasive or disseminated disease Non-meningeal Cryptococcosis mg once daily Cryptococcal meningitis mg twice daily See 4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. Caution should be used in prescribing Sporanox Sporanox sporaonx patients with hypersensitivity to other azoles. It is recommended that itraconazole be administered with an acidic beverage such as non-diet cola upon co-treatment with drugs reducing gastric acidity. The exposure of itraconazole may be lower in some patients with renal insufficiency. The interacting drugs are categorized as follows: Some of these cases were observed within the sporanox month of treatment, including sporanox within the sporanox week. Elderly Clinical data on the use of Sporanox Capsules in elderly patients are limited. No studies on the effects on the ability to drive ssporanox use machines have been performed. There is limited information on the use of Sporanox during pregnancy. Sporanox mg Capsules.

Itraconazole has been shown to have a negative inotropic effect and Sporanox Capsules has been associated with reports of congestive heart failure. It is advised to use Sporanox Capsules in these patients only if it is determined that the sporanox benefit outweighs the potential risks. Granulocytopenia, Thrombocytopenia Immune system disorders: The capsule is made of gelatin and also contains titanium dioxide, indigo carmine and erythrosine. See also section 4. There is no information regarding cross hypersensitivity between spornox and sporanox azole antifungal agents. If you experience this or similar effects, you should avoid driving and using machines. Itraconazole-resistant strains of Aspergillus fumigatus have been reported. Cross-resistance In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, sporanox, hence their sensitivity sporanox be tested before the start of Sporanox therapy. Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism. If your doctor tells you to stop taking SPORANOX capsules or your medicines has passed its expiry date, sporaonx your pharmacist what to do with any medicine which may be left over. Cross-hypersensitivity There is no information sporanox cross hypersensitivity between itraconazole and other azole antifungal agents, sporanox. Capsules, hard Capsule Size 0: Metabolism Itraconazole is extensively metabolised by the liver into a large number of metabolites. Reduced gastric acidity Absorption of itraconazole from Sporanox Capsules is impaired when gastric acidity is reduced. It is recommended that these drugs be used with caution when coadministered with itraconazole capsules:

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In the event of overdosage, supportive measures should be employed. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource e. Patients with immediately life-threatening systemic fungal infections, sporanox. Itraconazole has been shown to have a negative inotropic effect and Sporanox Capsules has been associated with reports of congestive heart failure. In vitro studies have demonstrated that itraconazole impairs the synthesis of ergosterol in fungal cells. Jock itch tinea cruris. Further, sporanox, the accuracy, currency and completeness of the information available on this Web site cannot be guaranteed. Sinusitis, Upper respiratory tract infection, Rhinitis. Most of the itraconazole in plasma is bound to protein Absorption Itraconazole is rapidly absorbed after oral administration. Be careful driving or operating machinery. Sporanox is recommended sporanox liver function monitoring be done in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity with other medications. It sporanox recommended that patients who must take itraconazole concomitantly with potent inhibitors of CYP3A4 be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of itraconazole, and the itraconazole sporanox be decreased as deemed necessary. No specific antidote is available. During post-marketing experience, cases sporanox congenital abnormalities have been reported, sporanox. Potent inhibitors of CYP3A4 may increase the bioavailability of itraconazole. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered. Itraconazole apparent clearance and distribution volume seemed to be related to weight. Serum sickness, Angioneurotic oedema, Anaphylactic reaction. Dialysis has no effect on the half-life or clearance of itraconazole or hydroxy-itraconazole. Find out more here.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Absorption Itraconazole is rapidly absorbed after oral administration. Make sure you know how you react to SPORANOX capsules before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or lightheaded. Tonic Digital Media Pty Ltd, its affiliates and their respective servants and agents do not accept any liability for any injury, loss or damage incurred by use of or reliance on the information made available via or through myDr whether arising from negligence or otherwise. In patients with hepatic cirrhosis or in subjects receiving CYP3A4 inhibitors, the decline in plasma concentrations may be even more gradual. Refer to subsection Tabulated list of adverse reactions for the frequencies and for other observed ADRs. In general, the nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients. You may need medical treatment if you get some side effects. Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis, Erythema multiforme, Exfoliative dermatitis, Leukocytoclastic vasculitis, Alopecia, Photosensitivity. Clinical data on the use of Sporanox Capsules in paediatric patients is limited. Itraconazole clearance decreases at higher doses due to saturable hepatic metabolism. The hearing loss usually resolves when treatment is stopped, but can persist in some patients. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered. Heart failure was more frequently reported among spontaneous reports of mg total daily dose than among those of lower total daily doses, suggesting that the risk of heart failure might increase with the total daily dose of itraconazole. Data are not available in renally impaired patients during long-term use of itraconazole. You may not experience any of them. Blood and lymphatic system disorders: Most of the itraconazole in plasma is bound to protein It is recommended that these drugs be used with caution when coadministered with itraconazole capsules: Sometimes they are serious, most of the time they are not. The CLSI breakpoints are as follows:

Absorption of itraconazole under fasted conditions in these subjects is increased when Sporanox Capsules are administered with an acidic beverage such as a non-diet cola. Other ingredients include sucrose, starch, macrogol, and hypromellose. As a consequence of non-linear pharmacokinetics, itraconazole accumulates in plasma during multiple dosing. Sometimes they are serious, most of the time they are not. In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. Increase dose to mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups. The capsule is made of gelatin and also contains titanium dioxide, indigo carmine and erythrosine. To view the changes to a medicine you must sign up and log in. It does not take the place of talking to your doctor or pharmacist. This site uses cookies. No studies on the effects on the ability to drive and use machines have been performed. Dialysis has no effect on the half-life or clearance of itraconazole or hydroxy-itraconazole. Anaphylactoid reaction Metabolism and nutrition disorders: In these patients treatment should be stopped immediately and liver function testing should be conducted. A very small amount of itraconazole is excreted in human milk. Concentrations in the cerebrospinal fluid are much lower than in plasma, but efficacy has been demonstrated against infections present in the cerebrospinal fluid. It is recommended that the use of these drugs be avoided from 2 weeks before and during treatment with itraconazole, unless the benefits outweigh the risk of potentially reduced itraconazole efficacy. Drugs that may decrease itraconazole plasma concentrations. Effective contraception should be continued until the menstrual period following the end of Sporanox Capsules therapy. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Jock itch tinea cruris. Renal impairment, Urinary incontinence General disorders and administration site conditions: Data are not available in renally impaired patients during long-term use of itraconazole. 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. Information and interactions contained in this Web site are for information purposes only and are not intended to be used to diagnose, treat, sporanox, cure or prevent any disease. When spkranox, it is recommended that plasma concentrations be measured. Then the spiranox is repeated, once for sporanox and twice for toenail infections sporanox or without fingernail infections. Interpretive breakpoints have not been established for the filamentous fungi. Women of child bearing potential Women of childbearing potential taking Sporanox capsules should sporanox contraceptive precautions. Histoplasmosis mg once daily - mg twice daily Maintenance in AIDS mg once daily See note on impaired absorption below Prophylaxis sporanoz neutropenia mg once daily See note on impaired absorption below. It sporanox xporanox that itraconazole be administered with an acidic beverage such as non-diet cola upon co-treatment with drugs reducing gastric acidity, sporanox. By continuing to browse the site you are agreeing to our policy on the use of cookies. Other ingredients include sucrose, starch, macrogol, and hypromellose.

Drugs that may increase itraconazole plasma concentrations. Concentrations in the cerebrospinal fluid are much lower than in plasma, but efficacy has been demonstrated against infections present in the cerebrospinal fluid. Symptoms and signs In general, adverse events reported with overdose have been consistent with those reported for itraconazole use. However, overall exposure to itraconazole, based on AUC, was similar in cirrhotic patients and in healthy subjects. Blood and lymphatic system disorders: Liver function monitoring should be considered in patients receiving Sporanox Capsules treatment. Itraconazole has been shown to have a negative inotropic effect and Sporanox Capsules has been associated with reports of congestive heart failure. Sporanox Capsules must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus see section 4. Most of the itraconazole in plasma is bound to protein In general, adverse events reported with overdose have been consistent with those reported for itraconazole use. By continuing to browse the site you are agreeing to our policy on the use of cookies. Limited pharmacokinetic data are available on the use of itraconazole in the paediatric population. 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 1 The duration of treatment should be adjusted depending on the clinical response. The principal fungus types that are not inhibited by itraconazole are Zygomycetes e. In these patients treatment should be stopped immediately and liver function testing should be conducted. The CLSI breakpoints are as follows: Marketing authorisation holder 8. Drugs that may increase itraconazole plasma concentrations Potent inhibitors of CYP3A4 may increase the bioavailability of itraconazole. Itraconazole is rapidly absorbed after oral administration. Increase dose to mg once daily for 15 days in AIDS or neutropenic patients because of impaired absorption in these groups. Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalised exanthematous pustulosis, Erythema multiforme, Exfoliative dermatitis, Leukocytoclastic vasculitis, Alopecia, Photosensitivity. You may not experience any of them. The main metabolite is hydroxy-itraconazole, which has in vitro antifungal activity comparable to Itraconazole; trough plasma concentrations of the hydroxy-itraconazole are about twice those of itraconazole. Sporanox should not be used sporanox patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. Company contact details Janssen-Cilag Ltd. Data are not available in renally impaired patients during long-term use of itraconazole.