"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"...
- Clinician Information:
Sublimaze Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Sublimaze (fentanyl citrate) is a narcotic analgesic indicated for general anesthesia, additional agent to induce general anesthesia, regional anesthesia for surgery, regional anesthesia for post-operative pain, acute pain following an operation, and severe pain. Side effects of Sublimaze can include slow heartbeat, abnormally low blood pressure; decrease in lung function, drowsiness, nausea, and vomiting.
Sublimaze dose should be individualized according to the patient's age, body weight, physical status, underlying pathological condition, as well as the use of other drugs and anesthesia. Other drugs may interact with Sublimaze. Tell your doctor all medications you use. Sublimaze should only be given to a pregnant woman when necessary and clearly needed. Administering Sublimaze to a pregnant woman may result in the infant experiencing withdrawal symptoms. Breastfeeding women should discuss a plan for breastfeeding with their doctors.
Our Sublimaze Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sublimaze FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Sublimaze (Fentanyl Citrate) »
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