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Basic Drug Info
Drug Name:Fentanyl Citrate
Manufacturer:Hospira, Inc.
Other Info:CIIRx only



Clinical Trials:


Indications and Usage
Fentanyl citrate injection 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 such as droperidol injection 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.
Absence of sensation --

Contraindications
Fentanyl citrate injection is contraindicated in patients with known intolerance to the drug.
Warnings

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 fentanyl is administered with a tranquilizer such as droperidol, 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 fentanyl 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 1/4 to 1/3 those usually recommended.Fentanyl may cause muscle rigidity, particularly involving the muscles of respiration.

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 1/4 of the full paralyzing dose of a nondepolarizing neuromuscular blocking agent just prior to administration of fentanyl citrate; 2) administration of a full paralyzing dose of a neuromuscular blocking agent following loss of eyelash reflex when fentanyl is used in anesthetic doses titrated by slow intravenous infusion; or, 3) simultaneous administration of fentanyl citrate and a full paralyzing dose of a neuromuscular blocking agent when fentanyl citrate 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 fentanyl. 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 fentanyl.

It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.Fentanyl 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.Head Injuries and Increased Intracranial Pressure — Fentanyl 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, fentanyl may obscure the clinical course of patients with head injury.
Branded Drugs
The following US Branded drugs contain Fentanyl Citrate


FENTANYL CITRATE AND DROPERIDOL -- ASTRAZENECA LP

FENTANYL CITRATE AND DROPERIDOL -- HOSPIRA INC

INNOVAR -- AKORN MANUFACTURING INC

FENTANYL CITRATE PRESERVATIVE FREE -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

FENTANYL CITRATE PRESERVATIVE FREE -- HOSPIRA INC

FENTANYL CITRATE PRESERVATIVE FREE -- MARSAM PHARMACEUTICALS LLC

SUBLIMAZE PRESERVATIVE FREE -- AKORN MANUFACTURING INC

FENTORA -- CEPHALON INC

FENTANYL -- CEPHALON INC

ACTIQ -- CEPHALON INC


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