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FDA Approves Sporanox For Fungal Infections TITUSVILLE, NJ -- March 31, 1999 -- The United States Food and Drug Administration has approved Janssen Pharmaceutica’s Sporanox(R) (itraconazole) Injection, a new, intravenous treatment for several difficult-to-treat, potentially life-threatening fungal infections. Sporanox Injection is indicated for three systemic fungal infections: histoplasmosis, blastomycosis and refractory aspergillosis. These serious infections are usually found in individuals with immune systems compromised by chemotherapy, AIDS or HIV infection. Because their natural defences to fight off disease are limited, these persons are highly vulnerable to opportunistic infections. Sporanox capsules were first introduced in 1992, indicated for the treatment of histoplasmosis and blastomycosis. In 1994, the treatment of aspergillosis unresponsive to amphotericin B was added to the label. Sporanox capsules are also marketed by Janssen Pharmaceutica for the treatment of fingernail and toenail fungus (a common condition called onychomycosis). In addition, Sporanox oral solution (approved in 1997) is available for oropharyngeal and esophageal candidiasis (thrush). Sporanox Injection should not be co-administered with Seldane(R)(terfenadine), Hismanal(R) (astemizole) or Propulsid(R) (cisapride), which have been associated with potentially serious cardiovascular events - including death when used with contraindicated drugs. In addition, Sporanox Injection should not be co-administered with Halcion(R) (triazolam), Versed(R) (oral midazolam), Mevacor(R)(lovastatin) or Zocor(R) (simvastatin). Sporanox IV should not be used by patients with severe kidney impairment. In addition, post-marketing experience with Sporanox capsules and oral solution has included reports of elevated liver enzymes and rare cases of hepatitis. If clinical signs and symptoms consistent with liver disease develop, Sporanox Injection should be discontinued. In addition, Sporanox should not be administered to pregnant patients or to women contemplating pregnancy. Related Links: Sporanox, Janssen Pharmaceutica E-mail this page to a friend or colleague! To print, use this version