"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
As with other narcotic analgesics, the most common serious adverse reactions reported to occur with SUBLIMAZE (fentanyl citrate) 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, diaphoresis, pruritus, urticaria, laryngospasm and anaphylaxis.
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 is used with SUBLIMAZE, 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 neuroleptics with SUBLIMAZE.
Cases of cardiac dysrhythmias, cardiac arrest, and death have been reported following the use of SUBLIMAZE with a neuroleptic agent.
Drug Abuse And Dependence
SUBLIMAZE (fentanyl citrate) is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore has the potential for being abused.
Read the Sublimaze (fentanyl citrate) Side Effects Center for a complete guide to possible side effects
Other CNS depressant drugs (e.g. barbiturates, tranquilizers, narcotics and general anesthetics) will have additive or potentiating effects with SUBLIMAZE. When patients have received such drugs, the dose of SUBLIMAZE required will be less than usual. Following the administration of SUBLIMAZE, the dose of other CNS depressant drugs should be reduced.
Last reviewed on RxList: 7/30/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Sublimaze Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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