OFIRMEV is proven to reduce pain in multiple settings1-18

Select your area of specialty to learn about OFIRMEV efficacy for pain:
2x higher pain relief
Cattabriga et al. In a cardiothoracic surgery study, patients receiving IV acetaminophen 1 g with IV
tramadol (n=56) vs placebo with IV tramadol (n=57) reported 2 times greater pain relief at 12, 18, and 24
hours following surgery, P<0.01

IMPORTANT SAFETY INFORMATION

35 percent less pain
Memis et al. In a major abdominal and pelvic surgery study, patients receiving IV acetaminophen 1 g
with IV opioids (n=20) reported significantly lower pain scores vs placebo with IV opioids (n=20), P<0.01
70 percent less pain
Bektas et al. In a study of acute renal colic, patients receiving IV acetaminophen (n=46) reported
a 70% reduction in pain, based on median visual analog scale (VAS) score, which was significantly
different from that reported by patients receiving placebo (n=51), P=0.005

IMPORTANT SAFETY INFORMATION

More than 4x pain relief
Wininger et al. OFIRMEV 1 g every 6 hours (q6h) with rescue (n=92) significantly reduced sum of pain intensity differences vs
placebo with rescue (n=108) over 24 hours, P<0.007

In an abdominal hysterectomy study, starting OFIRMEV earlier helped maximize pain control13

Mean pain intensity scores
VAS, visual analog scale.
 
Arici et al. Randomized, placebo-controlled, parallel-group, single-site study. Patients scheduled for total
abdominal hysterectomy received IV acetaminophen 1 g 30 minutes prior to induction (pre-op, n=28), IV
acetaminophen 1 g prior to skin closure (intra-op, n=27), or placebo (n=27). Patient-controlled analgesia (PCA)
morphine was available to all patients. Pain intensity, based on VAS score, at rest and with movement, sedation,
and total morphine consumption were measured at 15 and 30 minutes, and 1, 2, 4, 8, 12, and 24 hours.

IMPORTANT SAFETY INFORMATION

More than 2x higher maximal pain relief
Sinatra et al. In an orthopedic surgery study, patients receiving OFIRMEV 1 g with patient-controlled
analgesia (PCA) morphine (n=49) reported more than 2 times higher maximal pain relief scores vs
placebo with PCA morphine (n=52), P<0.05

IMPORTANT SAFETY INFORMATION

References: 1. Cattabriga I, Pacini D, Lamazza G, et al. Intravenous paracetamol as adjunctive treatment for postoperative pain after cardiac surgery: a double blind randomized controlled trial. Eur J Cardiothorac Surg. 2007;32(3):527-531. 2. 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(3):458-462. 3. Bektas F, Eken C, Karadeniz O, Goksu E, Cubuk M, Cete Y. Intravenous paracetamol or morphine for the treatment of renal colic: a randomized, placebo-controlled trial. Ann Emerg Med. 2009;54(4):568-574. 4. Vahdati SS, Baghi HRM, Ghobadi J, Ghafouri RR, Habibollahi P. Comparison of paracetamol (Apotel) and morphine in reducing post pure head trauma headache. Anesth Pain Med. 2014;4(3):e14903. doi:10.5812/aapm.14903. 5. Eken C, Serinken M, Elicabuk H, Uyanik E, Erdal M. Intravenous paracetamol versus dexketoprofen versus morphine in acute mechanical low back pain in the emergency department: a randomised double-blind controlled trial. Emerg Med J. 2014;31(3):177-181. 6. Wininger SJ, Miller H, Minkowitz HS, et al. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010;32(14):2348-2369. 7. Atef A, Fawaz AA. Intravenous paracetamol is highly effective in pain treatment after tonsillectomy in adults. Eur Arch Otorhinolaryngol. 2008;265(3):351-355. 8. Koteswara CM, Sheetal D. A study on pre-emptive analgesic effect of intravenous paracetamol in functional endoscopic sinus surgeries (FESSs): a randomized, double-blinded clinical study. J Clin Diagn Res. 2014;8(1):108-111. 9. Arslan M, Celep B, Çiçek R, Kalender HÜ, Yılmaz H. Comparing the efficacy of preemptive intravenous paracetamol on the reducing effect of opioid usage in cholecystectomy. J Res Med Sci. 2013;18(3):172-177. 10. Gokten OE, Kilicarslan H, Dogan HS, Turker G, Kordan Y. Efficacy of levobupivacaine infiltration to nephrosthomy tract in combination with intravenous paracetamol on postoperative analgesia in percutaneous nephrolithotomy patients. J Endourol. 2011;25(1):35-39. 11. Salihoglu Z, Yildirim M, Demiroluk S, et al. Evaluation of intravenous paracetamol administration on postoperative pain and recovery characteristics in patients undergoing laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009;19(4):321-323. 12. Hong JY, Kim WO, Chung WY, Yun JS, Kil HK. Paracetamol reduces postoperative pain and rescue analgesic demand after robot-assisted endoscopic thyroidectomy by the transaxillary approach. World J Surg. 2010;34(3):521-526. 13. Arici S, Gurbet A, Türker G, Yavaşcaoğlu B, Şahin Ş. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Ağri. 2009;21(2):54-61. 14. Hassan HIEA. Perioperative analgesic effects of intravenous paracetamol: preemptive versus preventive analgesia in elective cesarean section. Anesth Essays Res. 2014;8(3):339-344. 15. 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(4):822-831. 16. Sinatra RS, Jahr JS, Reynolds L, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012;12(5):357-365. 17. Singla NK, Hale ME, Davis JC, et al. IV acetaminophen: efficacy of a single dose for postoperative pain after hip arthroplasty: subset data analysis of 2 unpublished randomized clinical trials. Am J Ther. 2015;22(1):2-10. 18. Khan ZU, Iqbal J, Saleh H, El Deek AM. Intravenous paracetamol is as effective as morphine in knee arthroscopic day surgery procedures. Pak J Med Sci. 2007;23(6):851-853.

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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

SCROLL DOWN FOR ADDITIONAL IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tap for additional Important Risk Information

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and the reduction of fever in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with
    known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
    severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue OFIRMEV immediately at the first sign of skin rash.
  • Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors, which could result in accidental overdose and death.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. Discontinue OFIRMEV immediately upon occurrence of signs or symptoms associated with allergy or hypersensitivity. Do not use OFIRMEV in patients with acetaminophen allergy.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy, and hypersensitivity.
  • The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, and pruritus in pediatric patients.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.