Well-established safety and tolerability profile1
Safety and tolerability information is derived from controlled clinical studies conducted in a variety of surgical procedures of varying duration, using a variety of premedications and other anesthetics, and in patient populations with diverse characteristics including underlying disease. Based on this extensive clinical experience, ULTIVA:
- Is well-studied in adult and pediatric patients*1
- Can be used in patients with renal or hepatic impairment1
- Can be used with caution in obese patients*1
- Can be used with caution in elderly patients*1
ULTIVA contains remifentanil, a Schedule II controlled substance. Because opioids are sought by drug abusers and people with addiction disorders, employ strategies to reduce the risks such as proper storage and control practices.
ULTIVA is contraindicated for epidural or intrathecal administration due to the presence of glycine in the formulation and in patients with hypersensitivity to remifentanil (eg, anaphylaxis).1
ULTIVA has not been studied in pediatric patients in monitored anesthesia care (MAC).1
Approximately 2,770 adult patients were exposed to ULTIVA in controlled clinical trials. The frequencies of adverse events during general anesthesia with the recommended doses of ULTIVA are provided in the table below. Each patient was counted once for each type of adverse event.1
1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2016.