OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.
Do not exceed the maximum recommended daily dose of acetaminophen.
Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.
OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation.
Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.
OFIRMEV should be administered only as a 15-minute infusion.
Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur.
Do not use in patients with acetaminophen allergy.
The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients
The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain.
To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc.
at 1-877-647-2239 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
References: 1. Data on file. Cadence Pharmaceuticals, Inc. 2. OFIRMEV™ (acetaminophen) injection prescribing information. 3. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 4. Atef A, Fawaz AA. Intravenous paracetamol is highly effective in pain treatment after tonsillectomy in adults. Eur Arch Otorhinolaryngol. 2008;265:351-355. 5. Memis D, Inal MT, Kavalci G, Sezer A, Sut N. Intravenous paracetamol reduced the use of opioids, extubation time, and opioid-related adverse effects after major surgery in intensive care unit. J Crit Care. 2010;25:458-462.
*Patient-controlled analgesia.
†Subjects were asked to evaluate the study treatments, overall, using a 4-point categorical scale.
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