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.
Use of naloxone in patients who are opioid-dependent may result in opioid withdrawal, characterized by rapid onset of severe body aches, vomiting, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
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