"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA (remifentanil) . Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia.
In case of overdosage or suspected overdosage, discontinue administration of ULTIVA (remifentanil) , maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension.
Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA (remifentanil) is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity.
Due to the presence of glycine in the formulation, ULTIVA (remifentanil) is contraindicated for epidural or intrathecal administration. ULTIVA (remifentanil) is also contraindicated in patients with known hypersensitivity to fentanyl analogs.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2008
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