Sublimaze (Fentanyl Citrate) - Indications and Dosage

INDICATIONS AND USAGE

SUBLIMAZE (fentanyl citrate) is indicated:

• —for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
• —for use as a narcotic analgesic supplement in general or regional anesthesia.
• —for administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• —for use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

DOSAGE AND ADMINISTRATION

50 mcg = 0.05 mg = 1 ml

Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).

Vital signs should be monitored routinely.

• I.Premedication — Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs) — 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly 30 to 60 minutes prior to surgery.
• II.Adjunct to General Anesthesia — See Dosage Range Chart
• III.Adjunct to Regional Anesthesia - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required.
• IV.Postoperatively (recovery room) - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed.

Usage in Children: For induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.

DOSAGE RANGE CHART

TOTAL DOSAGE
Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 ml/kg) SUBLIMAZE. SUBLIMAZE in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, SUBLIMAZE may also provide some pain relief in the immediate postoperative period.	Moderate Dose — 2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 ml/kg) SUBLIMAZE. Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary and careful observation of ventilation postoperatively is essential.	High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 ml/kg) SUBLIMAZE. During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg) (0.4 to 1 ml) of SUBLIMAZE with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce "stress free" anesthesia.

DOSAGE RANGE CHART

MAINTENANCE DOSAGE
Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 ml/kg) SUBLIMAZE. Additional dosages of SUBLIMAZE are infrequently needed in these minor procedures.	Moderate Dose — 2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 ml/kg) SUBLIMAZE. 25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2.0 ml) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia.	High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mcg/kg) (0.4 to 1.0 ml/kg) SUBLIMAZE. Maintenance dosage (ranging from 25 mcg (0.025 mg) (0.5 ml) to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.

As a General Anesthetic

When attenuation of the responses to surgical stress is especially important, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 ml/kg) may be administered with oxygen and a muscle relaxant. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 ml/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.

As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.

See WARNINGS and PRECAUTIONS for use of SUBLIMAZE (fentanyl citrate) with other CNS depressants, and in patients with altered response.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

SUBLIMAZE (fentanyl citrate) Injection is available as:

NDC 11098-030-02	50 mcg/ml of fentanyl base,	2 ml ampoules in packages of 10
NDC 11098-030-05	50 mcg/ml of fentanyl base,	5 ml ampoules in packages of 10
NDC 11098-030-10	50 mcg/ml of fentanyl base,	10 ml ampoules in packages of 5
NDC-11098-030-20	50 mcg/ml of fentanyl base,	20 ml ampoules in packages of 5

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.