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SPORANOX® (itraconazole) Oral Solution [PDF].pdf

SPORANOX-Oral Solution-pi.pdf
Preview of SPORANOX® (itraconazole) Oral Solution [PDF]
🔗 Source: janssenlabels.com
📊 Size: 486 KB
📄 Pages: 29 pages
⬇️ Downloads: 139

Summary

SPORANOX® (itraconazole) Oral Solution has a BOXED WARNING for Congestive Heart Failure, Cardiac Effects, and Drug Interactions. It can cause negative inotropic effects and is contraindicated with certain CYP3A4 substrates, such as methadone, disopyramide, and ergot alkaloids. Coadministration with colchicine, fesoterodine, and solifenacin is also contraindicated in subjects with renal or hepatic impairment. Itraconazole is an azole antifungal agent with a molecular weight of 705.64, insoluble in water, and freely soluble in dichloromethane. The oral solution contains 10 mg of itraconazole per mL, solubilized by hydroxypropyl-β-cyclodextrin. Peak plasma concentrations are reached within 2.5 hours, and steady-state concentrations are generally reached within 15 days. Itraconazole is extensively metabolized by the liver into a large number of metabolites, mainly by CYP3A4, and is excreted mainly as inactive metabolites in urine and feces. Limited data are available on the use of oral itraconazole in patients with renal impairment.

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Description

SPORANOX® (itraconazole) Oral Solution has a BOXED WARNING for Congestive Heart Failure, Cardiac Effects, and Drug Interactions.

Technical Information

  • File Format: PDF
  • File Size: 486 KB
  • Pages: 29
  • Language: EN
  • Total Downloads: 139
  • Last Updated: 5 days ago

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