The Food and Drug Administration (FDA) has approved Acetaminophen Injection in multiple doses, manufactured by B. Braun Medical Inc.

Acetaminophen Injection is indicated for the management of mild to moderate pain, and for moderate to severe pain with adjunctive opioid analgesics, in patients 2 years of age and older. It is also approved for the reduction of fever in adult and pediatric patients.

The product is available in flexible PAB® intravenous (IV) bags in 1000mg in 100mL and 500mg in 50mL doses. The PAB IV bags are PVC-, DEHP-, and latex-free.

Acetaminophen Injection may be given as a single or repeated dose for the treatment of acute pain or fever. The solution is intended for intravenous administration over 15 minutes. No dose adjustment is required when converting between oral acetaminophen and Acetaminophen Injection dosing in adults and adolescents who weigh 50kg and above.


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“With the approval of Acetaminophen Injection, we are pleased to offer health care providers a safe, effective and affordable treatment option,” said Angela Karpf, MD, Corporate Vice President of Medical Affairs.

References

  1. B. Braun receives the first and only FDA approval for Acetaminophen Injection in multiple doses. [press release]. Bethlehem, PA: B. Braun Medical Inc; February 25, 2021. 
  2. Acetaminophen Injection [package insert]. Bethlehem, PA: B. Braun Medical Inc. 2021.