"An intranasal form of naloxone hydrochloride (Narcan, Adapt Pharma, Inc), a drug that stops or reverses opioid overdose, has been approved by the US Food and Drug Administration (FDA) under a fast-track approval process.
There is limited clinical experience with REVIA overdosage in humans. In one study, subjects who received 800 mg daily REVIA for up to one week showed no evidence of toxicity.
In the mouse, rat and guinea pig, the oral LD50s were 1,100 to 1,550 mg/kg; 1,450 mg/kg; and 1,490 mg/kg; respectively. High doses of REVIA (generally ≥ 1,000 mg/kg) produced salivation, depression/reduced activity, tremors, and convulsions. Mortalities in animals due to high-dose REVIA administration usually were due to clonic-tonic convulsions and/or respiratory failure.
Treatment of Overdosage
In view of the lack of actual experience in the treatment of REVIA overdose, patients should be treated symptomatically in a closely supervised environment. Physicians should contact a poison control center for the most up-to-date information.
REVIA is contraindicated in:
- Patients receiving opioid analgesics.
- Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine).
- Patients in acute opioid withdrawal (see WARNINGS).
- Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids.
- Any individual with a history of sensitivity to REVIA or any other components of this product. It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.
Last reviewed on RxList: 10/21/2013
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