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ULTIVA
Anesthetics
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Drug Name:

ULTIVA CII

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

Company:
Mylan Inc.

Therapeutic Use:

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 full labeling. Should be administered only by trained persons in anesthetics and management of respiratory effects. Have resuscitative and intubation equipment, oxygen, and opioid antagonists available. 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. Individualize. 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: 1mcg/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 full labeling.

Children:

See full labeling. 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: 1mcg/kg (neonates may require smaller dose). Post-op anesthesia, monitored anesthesia care: not studied.

Contraindications:

Epidural or intrathecal administration.

Warnings/Precautions:

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor closely. Not for use as sole agent for induction of anesthesia. Decrease rate of infusion or temporarily discontinue if respiratory depression or muscle rigidity occurs. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Biliary tract disease. Acute pancreatitis. Drug abusers. Morbidly obese. Rapid offset of action (no residual analgesic activity after 5–10mins). Monitor vital signs routinely. Elderly. Cachectic. Debilitated. Labor & delivery: not recommended. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Nursing mothers: monitor infants.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol [avoid for 24hrs after surgery], other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms; if use warranted, monitor closely; consider discontinuing if inappropriate response and use alternatives. 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 agonist.

Adverse Reactions:

Respiratory depression, bradycardia, hypotension, skeletal muscle rigidity.

How Supplied:

Vial—10

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