"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
The manifestations of overdosage with Lazanda are expected to be similar to those for intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant adverse effect being hypoventilation [see CLINICAL PHARMACOLOGY].
Immediate management of opioid overdose includes removal of the Lazanda pectin gel, if still in the nostril, ensuring a patent airway, physical and verbal stimulation of the patient, and assessment of level of consciousness, ventilatory status, and circulatory status.
Treatment Of Overdosage (Accidental Ingestion) In Opioid Non-Tolerant Patients
Provide ventilatory support, obtain intravenous access, and administer naloxone or other opioid antagonists as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary. Consult the package insert of the individual opioid antagonist for details about such use.
Treatment Of Overdose In Opioid-Tolerant Patients
Provide ventilatory support and obtain intravenous access as clinically indicated. Judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
General Considerations For Overdose
Management of severe Lazanda overdose includes: securing a patent airway, assisting or controlling ventilation, and establishing intravenous access. In the presence of hypoventilation or apnea, assist or control ventilation, and administer oxygen as indicated.
Carefully observe and appropriately manage overdosed patients until their clinical condition is well controlled.
Although muscle rigidity interfering with respiration has not been observed following the use of Lazanda, this is possible with fentanyl and other opioids. If it occurs, manage by the use of assisted or controlled ventilation, by administration of an opioid antagonist, and, as a final alternative, by the administration of a neuromuscular blocking agent.
Lazanda is contraindicated in the management of pain in opioid non-tolerant patients, because life-threatening hypoventilation could occur at any dose in patients not already taking around-the-clock opioid therapy.
Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.
Lazanda is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.
Last reviewed on RxList: 1/27/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Lazanda Information
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