0000010625 00000 n Select one or more newsletters to continue. 0000027536 00000 n 1770 0 obj <> endobj
Common side effects of Sporanox injection include: nausea, vomiting, diarrhea, rash, low blood potassium (hypokalemia), pain, headache, and ; injection site reactions However, the clinical significance of this drug effect has not been clearly defined.Nevirapine is an inducer of CYP3A4. Coadministration of quinidine or dofetilide with SporanoxThe class IA antiarrhythmic disopyramide has the potential to increase the QT interval at high plasma concentrations. In rats, the teratogenicity consisted of major skeletal defects; in mice, it consisted of encephaloceles and/or macroglossia.During post-marketing experience, cases of congenital abnormalities have been reported.
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Following a single intravenous dose of 200 mg to subjects with severe renal impairment (creatinine clearance ≤ 19 mL/minute), clearance of hydroxypropyl-β-cyclodextrin was reduced six-fold compared with subjects with normal renal function. At a dosage level of 80 mg/kg/day (10× MRHD) over 1 year or 160 mg/kg/day (20× MRHD) for 6 months, itraconazole induced small tooth pulp with hypocellular appearance in some rats. In previous studies, the mean elimination half-life for itraconazole at steady-state after daily oral administration of 100 to 400 mg was 30–40 hours. These sarcomas may have been a consequence of hypercholesterolemia, which is a response of rats, but not dogs or humans, to chronic itraconazole administration. for two days, then 200 mg q.d. Protect from light and freezing.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 0000030532 00000 n 0000005849 00000 n In vivo data suggest that rifabutin is metabolized in part by CYP3A4. NOTE: The plasma concentrations reported below were measured by high-performance liquid chromatography (HPLC) specific for itraconazole. If signs or symptoms of congestive heart failure occur during administration of SporanoxSporanox® is the brand name for itraconazole, a synthetic triazole antifungal agent. Results of a pharmacokinetics study suggest that itraconazole may undergo saturable metabolism with multiple dosing. In vivo studies have shown that nevirapine induces the metabolism of ketoconazole, significantly reducing the bioavailability of ketoconazole. 0000027302 00000 n 0000030493 00000 n trailer Although the occurrence of squamous cell carcinoma in the lung is extremely uncommon in untreated rats, the increase in this study was not statistically significant.Hydroxypropyl-β-cyclodextrin (HP-β-CD), the solubilizing excipient used in SporanoxItraconazole produced no mutagenic effects when assayed in a DNA repair test (unscheduled DNA synthesis) in primary rat hepatocytes, in Ames tests with Itraconazole did not affect the fertility of male or female rats treated orally with dosage levels of up to 40 mg/kg/day (5× MRHD), even though parental toxicity was present at this dosage level. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. 0000027821 00000 n 0000007656 00000 n Coadministration of pimozide with SporanoxEdema has been reported in patients concomitantly receiving SporanoxCalcium channel blockers can have a negative inotropic effect which may be additive to those of itraconazole; itraconazole can inhibit the metabolism of calcium channel blockers such as dihydropyridines (e.g., nifedipine and felodipine) and verapamil. The induced defects included reduced bone plate activity, thinning of the zona compacta of the large bones, and increased bone fragility. ��� �L ��;� 0000009850 00000 n Sporanox is also indicated for prophylaxis of fungal infections in immunocompromised patients with severe neutropenia when standard therapy is considered inappropriate. %PDF-1.5 %���� 0000006091 00000 n for four doses, followed by 200 mg q.d.
It may be represented by the following structural formula and nomenclature:NOTE: The plasma concentrations reported below were measured by high-performance liquid chromatography (HPLC) specific for itraconazole. 0000012696 00000 n 1806 0 obj <>stream 4.2 Posology and method of administration Sporanox is for oral administration and must be taken immediately after a meal for maximal absorption.