High-Dose Naloxone Injection Approved to Treat Opioid Overdose

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October 18, 2021 – The U.S. FDA has approved ZimhiTM (naloxone HCl) 5mg/0.5mL, a high-dose naloxone injection, to treat opioid overdoses.

  • Zimhi comes in a single-dose, prefilled syringe that can be used by individuals with or without medical training. It is currently the only FDA-approved 5mg dosage form of naloxone injection.
  • Under the recommended dosing, one single-dose syringe should be injected into the thigh either intramuscularly (into the muscle) or subcutaneously (under the skin) as soon as possible in the event of a known or suspected opioid overdose. Emergency medical assistance should be sought immediately after delivery of the first dose.
    • If the patient does not respond to treatment or relapses into respiratory depression, additional doses can be given every two to three minutes while waiting for emergency medical assistance.
  • Manufacturer Adamis Pharmaceuticals plans to launch Zimhi in the first quarter of 2022.