Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2148
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Fentanyl Citrate (Injection, Solution)
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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 . Vital signs should be monitored routinely.<br/>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.<br/>II. Adjunct to General Anesthesia: See Dosage Range Charts.<br/>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.<br/>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.<br/>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.<br/>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 fentanyl 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.
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| dailymed-instance:descripti... |
Fentanyl Citrate Injection is a sterile, non-pyrogenic solution for intravenous or intramuscular use as a potent narcotic
analgesic. Each mL contains fentanyl citrate equivalent to 50 mcg (0.05 mg) fentanyl base in Water for Injection. pH 4.0���7.5; sodium hydroxide and/or hydrochloric acid added, if needed,
for pH adjustment. Contains no preservative. Fentanyl citrate is chemically identified as N���(1���Phenethyl���4���piperidyl)propionanilide
citrate (1:1) with the following structural formula:
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| dailymed-instance:clinicalP... |
Fentanyl citrate is a narcotic analgesic. A dose of 100 mcg (0.1 mg) (2 mL) is approximately equivalent in analgesic activity to
10 mg of morphine or 75 mg of meperidine. The principal actions of therapeutic value are analgesia and sedation. Alterations in respiratory rate and alveolar ventilation, associated with
narcotic analgesics, may last longer than the analgesic effect. As the dose of narcotic is increased, the decrease in pulmonary exchange becomes greater. Large doses may produce apnea.
Fentanyl appears to have less emetic activity than either morphine or meperidine. Histamine assays and skin wheal testing in man indicate that clinically significant histamine release
rarely occurswith fentanyl. Recent assays in man show no clinically significant histamine release in dosages up to 50 mcg/kg (0.05 mg/kg) (1 mL/kg). Fentanyl preserves cardiac stability
and blunts stress-related hormonal changes at higher doses. The pharmacokinetics of fentanyl can be described as a three-compartment model, with a distribution time of 1.7 minutes,
redistribution of 13 minutes and a terminal elimination half-life of 219 minutes. The volume of distribution for fentanyl is 4 L/kg. Fentanyl plasma protein binding capacity increases with increasing ionization of the drug. Alterations in pH may affect its
distribution between plasma and the central nervous system. It accumulates in skeletal muscle and fat and is released slowly into the blood. Fentanyl, which is primarily transformed in
the liver, demonstrates a high first pass clearance and releases approximately 75% of an intravenous dose in urine, mostly as metabolites with less than 10% representing the unchanged
drug. Approximately 9% of the dose is recovered in the feces, primarily as metabolites. The onset of action of fentanyl is almost immediate when the drug is given intravenously; however, the maximal analgesic and
respiratory depressant effect may not be noted for several minutes. The usual duration of action of the analgesic effect is 30 to 60 minutes after a single intravenous dose of up to
100 mcg (0.1 mg) (2 mL). Following intramuscular administration, the onset of action is from seven to eight minutes, and the duration of action is one to two hours. As with longer acting
narcotic analgesics, the duration of the respiratory depressant effect of fentanyl may be longer than the analgesic effect. The following observations have been reported concerning
altered respiratory response to COstimulation following administration of fentanyl citrate to man:
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Fentanyl Citrate Injection is contraindicated in patients with known intolerance to the drug.
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| dailymed-instance:supply |
Fentanyl Citrate Injection, USP, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is available as follows: 2 mL DOSETTE ampuls packaged in 10s (NDC 10019-038-67) 5 mL DOSETTE ampuls packaged in 10s (NDC 10019-033-72) For Intravenous Use by Hospital Personnel Specifically Trained in the Use of Narcotic Analgesics: 10 mL DOSETTE ampuls packaged in 5s (NDC 10019-034-73) 20 mL DOSETTE ampuls packaged in 5s (NDC 10019-035-74) 30 mL Single Dose vials packaged individually (NDC 10019-036-82) 50 mL Single Dose vials packaged individually (NDC 10019-037-83)<br/>Storage: PROTECT FROM LIGHT. Keep covered in carton until time of use. Store at 20�����25��C (68�����77��F), excursions permitted to 15�����30��C (59�����86��F) [see USP Controlled Room
Temperature]. Baxter and Dosette are trademarks of Baxter International Inc., or its subsidiaries. Manufactured by Baxter Healthcare Corporation Deerfield, IL 60015 USA For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) MLT-32/1.0
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Manifestations: The manifestations of fentanyl overdosage are an extension of its pharmacologic actions as with other opioid analgesics. The intravenous LDof fentanyl is 3 mg/kg in rats, 1 mg/kg in cats, 14 mg/kg in dogs and 0.03 mg/kg in monkeys.<br/>Treatment: In the presence of hypoventilation or apnea, oxygen should be administered and respiration should be assisted or controlled as
indicated. A patent airway must be maintained; an oropharyngeal airway or endotracheal tube might be indicated. If depressed respiration is associated with muscular rigidity, an
intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration. The patient should be carefully observed for 24 hours; body warmth and
adequate fluid intake should be maintained. If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate
parenteral fluid therapy. A specific narcotic antagonist such as naloxone should be available for use as indicated to manage respiratory depression. This does not preclude the use of
more immediate countermeasures. The duration of respiratory depression following overdosage of fentanyl may be longer than the duration of narcotic antagonist action. Consult the
package insert of the individual narcotic antagonists for details about use.
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Fentanyl Citrate
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Fentanyl Citrate (Injection, Solution)
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| dailymed-instance:adverseRe... |
As with other narcotic analgesics, the most common serious adverse reactions reported to occur with fentanyl are respiratory
depression, apnea, rigidity and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur. Other adverse reactions that have been
reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis, laryngospasm and diaphoresis. It has been reported that secondary rebound respiratory depression may occasionally occur postoperatively. Patients should be
monitored for this possibility and appropriate countermeasures taken as necessary. When a tranquilizer such as droperidol is used with fentanyl citrate, the following adverse reactions can occur: chills and/or
shivering, restlessness and postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression); extrapyramidal symptoms (dystonia, akathisia and
oculogyric crisis) have been observed up to 24 hours postoperatively. When they occur, extrapyramidal symptoms can usually be controlled with anti-parkinson agents. Postoperative
drowsiness is also frequently reported following the use of droperidol.
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| dailymed-instance:warning |
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 durations 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 fullparalyzing dose of a non-depolarizing 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 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.<br/>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.
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Fentanyl Citrate Injection is indicated:
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Fentanyl Citrate
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