Sublimaze
Loading...Sublimaze Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
SUBLIMAZE (fentanyl citrate) SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS ANESTHETICS AND MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
See also discussion of narcotic antagonists in PRECAUTIONS and OVERDOSAGE.
If SUBLIMAZE is administered with a tranquilizer, the user should become familiar with the special properties of each drug, particularly the widely differing duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available.
As with other potent narcotics, the respiratory depressant effect of SUBLIMAZE may persist longer than the measured analgesic effect. The total dose of all narcotic analgesics administered should be considered by the practitioner before ordering narcotic analgesics during recovery from anesthesia. It is recommended that narcotics, when required, should be used in reduced doses initially, as low as ¼ to ⅓ those usually recommended.
SUBLIMAZE may cause muscle rigidity, particularly involving the muscles of respiration. This rigidity has been reported to occur or recur infrequently in the extended postoperative period usually following high dose administration. In addition, skeletal muscle movements of various groups in the extremities, neck and external eye have been reported during induction of anesthesia with fentanyl; these reported movements have, on rare occasions, been strong enough to pose patient management problems. This effect is related to the dose and speed of injection and its incidence can be reduced by: 1) administration of up to ¼ of the full paralyzing dose of a non-depolarizing neuromuscular blocking agent just prior to administration of SUBLIMAZE; 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of eyelash reflex when SUBLIMAZE is used in anesthetic doses titrated by slow intravenous infusion; or, 3) simultaneous administration of SUBLIMAZE and a full paralyzing dose of a neuromuscular blocking agent when SUBLIMAZE is used in rapidly administered anesthetic dosages. The neuromuscular blocking agent used should be compatible with the patient's cardiovascular status.
Adequate facilities should be available for postoperative monitoring and ventilation of patients administered anesthetic doses of SUBLIMAZE. Where moderate or high doses are used (above 10 mcg/kg), there must be adequate facilities for postoperative observation, and ventilation if necessary, of patients who have received SUBLIMAZE. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
SUBLIMAZE may also produce other signs and symptoms characteristic of narcotic analgesics including euphoria, miosis, bradycardia and bronchoconstriction.
Severe and unpredictable potentiation by MAO inhibitors has been reported for other narcotic analgesics. Although this has not been reported for fentanyl, there are insufficient data to establish that this does not occur with fentanyl. Therefore, when fentanyl is administered to patients who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is indicated.
SUBLIMAZE should be used with caution in patients who may be particularly susceptible to respiratory depression, such as comatose patients who may have a head injury or brain tumor. In addition, SUBLIMAZE may obscure the clinical course of patients with head injury.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
SUBLIMAZE (fentanyl citrate) Injection is a potent narcotic analgesic. Each milliliter of solution contains fentanyl citrate equivalent to 50 mcg of fentanyl base, adjusted to pH 4.0 to 7.5 with sodium hydroxide. SUBLIMAZE is chemically identified as N-(1-phenethyl-4-piperidyl) propionanilide citrate (1:1) with a molecular weight of 528.60. The empirical formula is C22H28N2O • C6H8O7. The structural formula of SUBLIMAZE is:
SUBLIMAZE is a sterile, non-pyrogenic, preservative free aqueous solution for intravenous or intramuscular injection.
Sources
Sublimaze Manufacturers
-
Taylor Pharmaceuticals
![Sublimaze (Fentanyl Citrate) Injection, Solution [Taylor Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sublimaze | Taylor Pharmaceuticals
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 AnestheticWhen 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.
Login To Your Free Account