Ultiva

ULTIVA- remifentanil hydrochloride injection, powder, lyophilized, for solution
Mylan Institutional LLC

WARNING: ADDICTION, ABUSE, AND MISUSE

Addiction, Abuse, and Misuse

ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing ULTIVA [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

ULTIVA is indicated for intravenous (IV) administration:

As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
For continuation as an analgesic into the immediate postoperative period in adult patients under the 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with ULTIVA and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

ULTIVA is for IV use only. Continuous infusions of ULTIVA should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion.

ULTIVA should not be administered without dilution.

Consider an alternative to ULTIVA for patients taking mixed agonist/antagonist and partial agonist opioid analgesics due to reduced analgesic effect or potential withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ULTIVA if patient is not responding appropriately to treatment.

Discard unused portion.

2.2 General Anesthesia

ULTIVA is not recommended as the sole agent in general anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. ULTIVA is synergistic with other anesthetics; therefore, clinicians may need to reduce doses of thiopental, propofol, isoflurane, and midazolam by up to 75% with the coadministration of ULTIVA. The administration of ULTIVA must be individualized based on the patient’s response.

Induction of Anesthesia

ULTIVA should be administered at an infusion rate of 0.5 to 1 mcg/kg/min with a hypnotic or volatile agent for the induction of anesthesia. If endotracheal intubation is to occur less than 8 minutes after the start of the infusion of ULTIVA, then an initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.

ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Maintenance of Anesthesia

After endotracheal intubation, the infusion rate of ULTIVA should be decreased in accordance with the dosing guidelines in Tables 1 (adults, predominately ASA physical status I, II, or III) and 2 (pediatric patients).

Due to the fast onset and short duration of action of ULTIVA, the rate of administration during anesthesia can be titrated upward in 25% to 100% increments in adult patients or up to 50% increments in pediatric patients, or downward in 25% to 50% decrements every 2 to 5 minutes to attain the desired level of µ-opioid effect.
In response to light anesthesia or transient episodes of intense surgical stress, supplemental bolus doses of 1 mcg/kg may be administered every 2 to 5 minutes.
At infusion rates > 1 mcg/kg/min, increases in the concomitant anesthetic agents should be considered to increase the depth of anesthesia. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Dosage and Administration, Table 2 (2.2).]
Table 1: Dosing Guidelines in Adults – General Anesthesia and Continuing as an Analgesic into the Postoperative Care Unit or Intensive Care Setting *
*
An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.

Phase

Continuous IV Infusion of

ULTIVA (mcg/kg/min)

Range of Infusion Dose

ULTIVA (mcg/kg/min)

Supplemental IV Bolus Dose of ULTIVA

(mcg/kg)

Induction of Anesthesia (through intubation)

0.5 – 1*

Maintenance of anesthesia with:

Nitrous oxide (66%)

0.4

0.1 – 2

1

Isoflurane (0.4 to 1.5 MAC)

0.25

0.05 – 2

1

Propofol (100 to 200 mcg/kg/min)

0.25

0.05 – 2

1

Continuation as an analgesic into the immediate postoperative period

0.1

0.025 – 0.2

not recommended

Table 2 summarizes the recommended doses in pediatric patients, predominantly ASA physical status I, II, or III. In pediatric patients, remifentanil was administered with nitrous oxide or nitrous oxide in combination with halothane, sevoflurane, or isoflurane. The use of atropine may blunt the potential for bradycardia that can occur upon administration of ULTIVA.

Table 2: Dosing Guidelines in Pediatric Patients – Maintenance of Anesthesia
*
An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
The clearance rate in neonates is highly variable, on average two times higher than in the young healthy adult population. Therefore, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The use of atropine may blunt the potential for bradycardia that can occur upon administration of ULTIVA. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Clinical Studies (14.4).]
Boluses of 1 mcg/kg were studied in ASA 1 and 2, full-term patients weighing at least 2500 gm, undergoing pyloromyotomy who received pretreatment with atropine. Neonates receiving supplementation with potent inhalation agents or neuraxial anesthesia, those with significant co-morbidities or undergoing significant fluid shifts, or those who have not been pretreated with atropine, may require smaller bolus doses to avoid hypotension and/or bradycardia.

Phase

Continuous IV Infusion of

ULTIVA (mcg/kg/min)

Range of Infusion Dose

ULTIVA (mcg/kg/min)

Supplemental IV Bolus Dose of ULTIVA

(mcg/kg)

Maintenance of anesthesia in patients aged 1 to 12 years old with * :

Halothane (0.3 to 1.5 MAC)

0.25

0.05 – 1.3

1

Sevoflurane (0.3 to 1.5 MAC)

0.25

0.05 – 1.3

1

Isoflurane (0.4 to 1.5 MAC)

0.25

0.05 – 1.3

1

Maintenance of anesthesia for patients from birth to 2 months of age with:

Nitrous oxide (70%)

0.4

0.4 – 1.0

1

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