acetaminophen IV (Rx)

Brand and Other Names:Ofirmev
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
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Pain & Fever

Indicated for mild-to-moderate pain and moderate-to-severe pain with adjunctive opioid analgesics; also indicated for reduction of fever

<50 kg: 12.5 mg/kg IV q4hr OR 15 mg/kg IV q6hr; not to exceed 750 mg/dose or 3.75 g/day  

≥50 kg: 650 mg IV q4hr OR 1000 mg IV q6hr; not to exceed 4 g/day

Infuse IV over at least 15 minutes (also see Administration)

Dosage Modifications

Severe renal impairment (CrCl <30 mL/min): Longer dosing intervals and a reduced total daily dose may be warranted

Hepatic impairment

  • Severe hepatic impairment or severe active liver disease: Contraindicated
  • Mild-to-moderate hepatic impairment or active liver disease: Use caution; a reduced total daily dose may be warranted

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
more...

Pain

Indicated for the management of mild-to-moderate pain in pediatric patients aged ≥2 years; also indicated for management of moderate-to-severe pain with adjunctive opioid analgesics in children aged ≥2 years

Also see Administration

<2 years: Safety and efficacy not established

2-12 years: 12.5 mg/kg IV q4hr OR 15 mg/kg IV q6hr; not to exceed 75 mg/kg/day 

≥13 years

  • <50 kg: 12.5 mg/kg IV q4hr OR 15 mg/kg IV q6hr; not to exceed 750 mg/dose or 3.75 g/day
  • ≥50 kg: 650 mg IV q4hr OR 1000 mg IV q6hr; not to exceed 4 g/day

Fever

Indicated for reduction of fever

Also see Administration

Neonates

  • Neonates, including premature neonates born at ≥32 weeks gestational age, up to 28 days chronological age
  • 12.5 mg/kg IV q6hr
  • Maximum daily dose is 50 mg/kg/day, with a minimum dosing interval of 6 hr

Infants

  • 29 days to 2 years
  • 15 mg/kg IV q6hr
  • Maximum daily dose is 60 mg/kg/day, with a minimum dosing interval of 6 hr

Children aged 2-12 years

  • 12.5 mg/kg IV q4hr OR 15 mg/kg IV q6hr; not to exceed 75 mg/kg/day
  • Maximum single dose: 750 mg

Children aged ≥13 years

  • <50 kg: 12.5 mg/kg IV q4hr OR 15 mg/kg IV q6hr; not to exceed 750 mg/dose or 3.75 g/day; maximum single dose is 750 mg
  • ≥50 kg: 650 mg IV q4hr OR 1000 mg IV q6hr; not to exceed 4 g/day

Dosage Modifications

Severe renal impairment (CrCl <30 mL/min): Longer dosing intervals and a reduced total daily dose may be warranted

Hepatic impairment

  • Severe hepatic impairment or severe active liver disease: Contraindicated
  • Mild-to-moderate hepatic impairment or active liver disease: Use caution; a reduced total daily dose may be warranted

Reduced dose and/or dosage interval may be warranted in elderly patients with decreased renal or hepatic function

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Interactions

Interaction Checker

and acetaminophen IV

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (34%)

            Vomiting (15%)

            1-10%

            Headache (10%)

            Insomnia (7%)

            Pediatrics

            • Nausea (≥ 5%)
            • Vomiting (≥ 5%)
            • Constipation (≥ 5%)
            • Pruritus (≥ 5%)
            • Agitation (≥ 5%)
            • Atelectasis (≥ 5%)
            • Headache (≥ 1%)
            • Postmarketing Reports
              • Pleural effusion
              • Pulmonary edema
              • Stridor
              • Wheezing

            Frequency Not Defined

            Edema

            Hypervolemia

            Fatigue

            Hypokalemia

            Hypophosphatemia

            Hypomagnesemia

            Hypoalbuminemia

            Increased transaminase levels

            Anemia

            Infusion site pain

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            Warnings

            Black Box Warnings

            Medication errors and hepatotoxicity

            • Take care when prescribing, preparing, and administering acetaminophen IV 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 <50 kg
              • Infusion pumps are properly programmed
              • The total daily dose of acetaminophen from all sources does not exceed maximum daily limits
            • 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 maximum daily limits, and often involve more than one acetaminophen-containing product

            Contraindications

            Hypersensitivity

            Severe hepatic impairment or severe active liver disease

            Cautions

            Doses higher than recommended may result in hepatic injury, including risk of severe hepatotoxicity and death

            Do not exceed the maximum recommended daily dose

            Caution with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, G6PD deficiency, hypovolemia, or severe renal impairment (CrCl <30 mL/min)

            Discontinue immediately if symptoms associated with allergy or hypersensitivity occur

            Rare serious skin reactions reported including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal; discontinued at the first appearance of skin rash or any other sign of hypersensitivity

            Based on animal data use of acetaminophen may cause reduced fertility in males and females of reproductive potential; it is not known whether effects on fertility are reversible

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            Pregnancy & Lactation

            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

            Lactation

            There is no information regarding the presence of acetaminophen in human milk, effects on breastfed infant, or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits prostaglandin synthesis in the CNS and works peripherally to block pain impulse generation; acts on hypothalamus to produce antipyresis

            Pharmacokinetics

            Half-Life: 2.4 hr (adolescents); 2-3 hr (adults); 2-5 hr (children); 4-10 hr (neonates)

            Vd: 0.8 L/kg

            Peak plasma time: 0.25 hr (at end of infusion)

            Peak plasma concentration: 28 mcg/mL

            Metabolism: by conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI)

            Clearance: 0.27 L/hr/kg

            Protein binding: 10-25% (therapeutic concentrations); 8-43% (toxic concentrations)

            Excretion: <5% is excreted in the urine as unconjugated (free) acetaminophen and 60-80% as glucuronide metabolites

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            Administration

            IV Incompatibilities

            Additive: chlorpromazine, diazepam

            Syringe: chlorpromazine, diazepam

            Y-site: chlorpromazine, diazepam

            IV Preparation

            1 gram dose: Insert a vented IV set through septum of the 100 mL vial; may be administered without further dilution

            Dose <1 gram: Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from the intact sealed vial and place the measured dose in a separate empty, sterile container (eg, glass bottle, plastic IV container, or syringe) to avoid inadvertent delivery and administration of the total volume of the commercially available container

            Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes

            Vial is for single use; discard any unused portion

            IV Administration

            Administer by IV infusion over 15 minutes

            Storage

            Store at room temperature 20-25°C (68-77°F); do not refrigerate or freeze

            For single use only; discard any unused portion

            Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose within 6 hr

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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