Action: FDA has approved ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a single-dose, prefilled syringe that delivers 5 milligrams (mg) of naloxone hydrochloride solution through intramuscular (in the muscle) or subcutaneous (under the skin) injection.
FDA has previously approved injectable naloxone hydrochloride products in 0.4 mg and 2 mg doses under the trade name, NARCAN.
Disease or Condition:
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A 5 mg/0.5 mL prefilled syringe of naloxone provides an additional option in the treatment of opioid overdoses.
Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.
Opioid-related overdose deaths—driven partly by prescription drug overdoses—are one of the leading causes of death in the United States. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention.