Drug Information for ISOFLURANE, USP (HOSPIRA, INC.): ADVERSE REACTIONS

Adverse reactions encountered in the administration of Isoflurane, USP are in general dose dependent extensions of pharmacophysiologic effects and include respiratory depression, hypotension and arrhythmias.

Shivering, nausea, vomiting and ileus have been observed in the postoperative period.

As with all other general anesthetics, transient elevations in white blood count have been observed even in the absence of surgical stress. See WARNINGS for information regarding malignant hyperthermia and elevated carboxyhemoglobin levels.

During marketing, there have been rare reports of mild, moderate and severe (some fatal) post-operative hepatic dysfunction and hepatitis.

Isoflurane, USP has also been associated with perioperative hyperkalemia (see WARNINGS).

There have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents, including Isoflurane, USP. Due to the spontaneous nature of these reports, the actual incidence and relationship of Isoflurane, USP to these events cannot be established with certainty.