Generic Name and Formulations:
Remifentanil HCl 1mg, 2mg, 5mg; per vial; pwd for IV inj after reconstitution and dilution; preservative-free.

Company:
Mylan Inc.
Indications for ULTIVA:
As an analgesic for use during induction and maintenance of general anesthesia. Analgesia in the immediate postoperative period in adult patients under direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. As an analgesic component of monitored anesthesia care in adult patients.

Adult:
See literature. Give by IV infusion; continuous infusions should be administered by infusion device. Inj site should be close to venous cannula and IV tubing should be cleared at the time of discontinuation. General anesthesia: Induction: 0.5–1mcg/kg/min administered over 30–60 seconds. Maintenance w. nitrous oxide (66%): Continuous IV infusion: 0.4mcg/kg/min; infusion dose range: 0.1–2mcg/kg/min. Maintenance w. isoflurane (0.4 to 1.5 MAC): Continuous IV infusion: 0.25mcg/kg/min; infusion dose range: 0.05–2mcg/kg/min. Maintenance w. propofol (100–200mcg/kg/min): Continuous IV infusion: 0.25mcg/kg/min; infusion dose range: 0.05–2mcg/kg/min. For all: supplemental IV bolus dose: 1microgram/kg. Continuation as an analgesic into the immediate postoperative period: Continuous IV infusion: 0.1mcg/kg/min; infusion dose range: 0.025–0.2mcg/kg/min; supplemental IV bolus dose: not recommended. Monitored anesthesia care: Single IV dose: give 90 seconds before local anesthetic; 1mcg/kg over 30–60 seconds; w. midazolam: 0.5mcg/kg over 30–60 seconds. Continuous IV infusion: Beginning 5 minutes before local anesthetic: 0.1mcg/kg/min; w. midazolam: 0.05mcg/kg/min. After local anesthetic: 0.05mcg/kg/min (range: 0.025–0.2mcg/kg/min); w. midazolam: 0.025mcg/kg/min (range: 0.025–0.2mcg/kg/min). Elderly (>65yrs): reduce dose by 50%, titrate cautiously. Obese patients: base dose on ideal body weight. Use in coronary artery bypass surgery: see literature.

Children:
See literature. Maintenance of anesthesia: Birth–2months (w. nitrous oxide 70%): Continuous IV infusion: 0.4mcg/kg/min; infusion dose range: 0.4–1mcg/kg/min. 1–12yrs: With halothane (0.3 to 1.5 MAC), sevoflurane (0.3 to 1.5 MAC), or isoflurane (0.4 to 1.5 MAC): Continuous IV infusion: 0.25mcg/kg/min; infusion dose range: 0.05–1.3mcg/kg/min. For all: Supplemental IV bolus dose: 1microgram/kg (neonates may require smaller dose).

Contraindications:
Epidural or intrathecal administration.

Warnings/Precautions:
To be administered under the supervision of experienced clinicians. Have intubation, artificial respiration, oxygen therapy and reversal agents available. Not for use as sole agent for induction of anesthesia. Decrease rate of infusion or temporarily discontinue if respiratory depression or muscle rigidity occurs. Rapid offset of action (no residual analgesic activity after 5 to 10 minutes). Morbidly obese. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Interactions:
Potential inactivation by nonspecific esterases in blood products; do not administer into the same IV tubing. Intraoperative awareness possible in patients <55yrs with concomitant propofol infusion rates of ≤75mcg/kg/min. Synergistic with other anesthetics: may need to reduce doses of thiopental, propofol, isoflurane, midazolam by up to 75%.

Pharmacological Class:
Opioid.

Adverse Reactions:
GI upset, hypotension, muscle rigidity, bradycardia, tachycardia, respiratory depression, apnea, shivering, fever, sweating, dizziness, hypertension.

How Supplied:
Vial—10