Ofirmev

What is Ofirmev?

Ofirmev (acetaminophen) injection is a non-salicylate antipyretic and non-opioid analgesic agent used for the management of pain.

Acetaminophen metabolism

What are the uses of this medicine?

Ofirmev (acetaminophen) injection is used 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
• the reduction of fever in adult and pediatric patients.

How does this medicine work?

• Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
• The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

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

What drug interactions can this medicine cause?

• Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential.
• Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.

Is this medicine FDA approved?

• Initial U.S. Approval: 1951

How should this medicine be used?

Recommended dosage: Adults and Adolescents Weighing 50 kg and Over:

• 1000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4000 mg per day.
• Minimum dosing interval of 4 hours.

Adults and Adolescents Weighing Under 50 kg:

• 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day.
• Minimum dosing interval of 4 hours.

Children:

• Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day.
• Minimum dosing interval of 4 hours.

Neonates and Infants:

• Neonates including premature neonates born at ≥ 32 weeks gestational age to 28 days chronological age, 12.5 mg/kg every 6 hours to a maximum of 50 mg/kg per day.
• Minimum dosing interval of 6 hours.

Infants (29 days to 2 years of age):

• 15 mg/kg every 6 hours to a maximum of 60 mg/kg per day.
• Minimum dosing interval of 6 hours.

Administration:

• OFIRMEV may be given as a single or repeated dose.
• OFIRMEV should be administered only as a 15-minute intravenous infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection for intravenous infusion: Each 100 mL glass vial or bag contains 1000 mg acetaminophen (10 mg/mL).

This medicine is available in fallowing brand namesː

• Ofirmev

What side effects can this medication cause?

The most common side effects of this medicine include: In adult patients:

• nausea
• vomiting
• headache
• insomnia

In pediatric patients:

• nausea
• vomiting
• constipation
• pruritus

What special precautions should I follow?

• Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death.
• Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
• Discontinue OFIRMEV immediately at the first appearance of skin rash and if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.
• Take care when prescribing, preparing, and administering OFIRMEV injection to avoid dosing errors which could result in accidental overdose and death.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hepatic necrosis
• Renal tubular necrosis
• hypoglycemic coma
• thrombocytopenia

Management of overdosage:

• If an acetaminophen overdose is suspected, obtain a serum acetaminophen assay as soon as possible, but no sooner than 4 hours following oral ingestion.
• Obtain liver function studies initially and repeat at 24-hour intervals.
• Administer the antidote N-acetylcysteine (NAC) as early as possible.
• The acetaminophen level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew).
• The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours.
• If serum level is above the lower line, administer the entire course of NAC treatment.
• Withhold NAC therapy if the acetaminophen level is below the lower line.

Can this medicine be used in pregnancy?

• Published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The effectiveness of OFIRMEV for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established.
• The safety and effectiveness of OFIRMEV in pediatric patients is supported by evidence from adequate and well controlled studies in adults with additional safety and pharmacokinetic data for this age group.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ACETAMINOPHEN

Inactive ingredients:

• MANNITOL
• CYSTEINE HYDROCHLORIDE
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• WATER
• NITROGEN

Who manufactures and distributes this medicine?

Manufactured for:

• Mallinckrodt Hospital Products Inc.

Hazelwood, MO USA

What should I know about storage and disposal of this medication?

• OFIRMEV should be stored at 20°C to 25°C (68°F to 77°F).
• For single-dose only.
• The product should be used within 6 hours after opening.
• Do not refrigerate or freeze.

• Dailymed label info on Ofirmev
• FDA Ofirmev

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