"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"...
The manifestations of SUBLIMAZE (fentanyl citrate) overdosage are an extension of its pharmacologic actions (see CLINICAL PHARMACOLOGY) as with other opioid analgesics. The intravenous LD50 of SUBLIMAZE is 3 mg/kg in rats, 1 mg/kg in cats, 14 mg/kg in dogs and 0.03 mg/kg in monkeys.
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 nalorphine, levallorphan or 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 SUBLIMAZE may be longer than the duration of narcotic antagonist action. Consult the package insert of the individual narcotic antagonists for details about use.
SUBLIMAZE (fentanyl citrate) is contraindicated in patients with known intolerance to the drug or other opioid agonists.
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
Report Problems to the Food and Drug Administration
Chronic Pain/Back Pain
Find tips and advances in treatment.