System quality and safety executive
Jo Ann Brooks, PhD, RN, FCCP, FAAN

Jo Ann Brooks, PhD, RN, FCCP, FAAN, talks about the pharmacokinetic profiles for acetaminophen

The pharmacokinetics of OFIRMEV vs oral and rectal acetaminophen

OFIRMEV provides:

 
75% more drug available in the CSF vs oral acetaminophen
 
 

OFIRMEV provides 75% more drug available in the CSF, the believed site of action, than oral acetaminophen2

 
75% more drug available in the CSF vs oral acetaminophen

Singla et al. Three-way crossover, single-center, single-dose pharmacokinetic study of 6 healthy adult males. Each received 3 single-dose treatments of IV, oral, and rectal acetaminophen, separated by a washout period of 24 hours. Treatment dosage was
1 g IV and oral acetaminophen, and 1300 mg rectal. IV acetaminophen was administered over 15 minutes commencing at 0 hours. CSF and blood draws were performed prior to study medication administration and at 8 additional time points for 6 hours in each treatment period.

CSF, cerebrospinal fluid.
a Rectal acetaminophen data reflect standardization of the 1300-mg dose to 1 g (linear kinetics).
 
 

OFIRMEV was associated with greater peak plasma levels2

 
OFIRMEV was associated with greater peak plasma levels

Singla et al. Three-way crossover, single-center, single-dose pharmacokinetic study of 6 healthy adult males. Each received 3 single-dose treatments of IV, oral, and rectal acetaminophen, separated by a washout period of 24 hours. Treatment dosage was
1 g IV and oral acetaminophen, and 1300 mg rectal. IV acetaminophen was administered over 15 minutes commencing at 0 hours. CSF and blood draws were performed prior to study medication administration and at 8 additional time points for 6 hours in each treatment period.

a Rectal acetaminophen data reflect standardization of the 1300-mg dose to 1 g (linear kinetics).
 

References: 1. OFIRMEV [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products, Inc; 2014. 2. Singla NK, Parulan C, Samson R, et al. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012;12(7):523-532. 3. Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010;28(4):619-645.

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK 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

USE IN SPECIFIC POPULATIONS

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, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK 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 (IV) 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 (e.g., due to dehydration or blood loss), 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.
  • 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.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

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 RISK 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.

Tap for additional Important Risk Information

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK 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 (IV) 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 (e.g., due to dehydration or blood loss), 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.
  • 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.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

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.