ibuprofen IV (Rx)

Brand and Other Names:Caldolor, NeoProfen
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 100mg/mL (Caldolor)
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Pain

Indicated for management of mild-to-moderate pain, or for moderate-to-severe pain as an adjunct to opioid analgesics

Caldolor: 400-800 mg IV infused over 30 minutes q6hr PRN; not to exceed 4200 mg/day

Fever

Caldolor: 400 mg IV infused over 30 minutes, THEN

400 mg q4-6hr or 100-200 mg q4hr PRN; not to exceed 4200 mg/day

Dosing Considerations

Patients must be well hydrated before administration

Must further dilute Caldolor before administration (undiluted solution may result in hemolysis)

Dosage Forms & Strengths

IV solution

  • 10mg/mL (NeoProfen)
  • 100mg/mL (Caldolor)
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Patent Ductus Arteriosus

Indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500-1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective

Initial NeoProfen dose: 10 mg/kg IV, THEN 

Additional 2 NeoProfen doses of 5 mg/kg each, after 24 and 48 hr

If renal dysfunction, withhold 2nd/3rd dose until renal function normal

If ductus arteriosus fails to close, then a second course of ibuprofen IV, alternative pharmacological therapy, or surgery may be needed

Pain

Caldolor

  • Indicated for management of mild-to-moderate pain and the management of moderate-to-severe pain as an adjunct to opioid analgesics
  • <6 months: Safety and efficacy not established
  • 6 months to <12 years: 10 mg/kg IV q4-6 hr prn; not to exceed 400 mg/dose; maximum daily dose is 40 mg/kg or 2400 mg, whichever is less
  • 12-17 years: 400 mg IV q4-6 hr prn
  • Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients aged <17 yr
  • Must dilute solution; undiluted solution may result in hemolysis (see IV preparation)

Fever

Caldolor

  • Indicated for management of mild-to-moderate pain and the management of moderate-to-severe pain as an adjunct to opioid analgesics
  • <6 months: Safety and efficacy not established
  • 6 months to <12 years: 10 mg/kg IV q4-6 hr prn; not to exceed 400 mg/dose; maximum daily dose is 40 mg/kg or 2400 mg, whichever is less
  • 12-17 years: 400 mg IV q4-6 hr prn
  • Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients aged <17 yr
  • Must dilute solution; undiluted solution may result in hemolysis (see IV preparation)
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Interactions

Interaction Checker

and ibuprofen IV

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10% (Caldolor)

            Nausea (53-57%)

            Anemia (20-36%)

            Vomiting (15-22%)

            Flatulence (7-16%)

            Bacteremia (13%)

            Hypoproteinemia (up to 13%)

            Headache (9-11%)

            >10% (NeoProfen)

            Sepsis (43%)

            Anemia (32%)

            Total bleeding (32%; placebo 29%)

            Intraventricular hemorrhage (29%; placebo 24%)

            Apnea (28%; placebo 26%)

            Non-necrotizing enterocolitis (22%; placebo 18%)

            Respiratory infection (19%)

            Skin lesion/irritation (16%)

            Hypoglycemia (12%)

            1-10% (Caldolor)

            Hypertension (10%)

            Hypernatremia (10%)

            Serum blood urea nitrogen raised (10%)

            Hypotension (7-10%)

            Diarrhea (7-10%)

            Hemorrhage (4-10%)

            Bacterial pneumonia (3-7%)

            Hypoalbuminemia (3-10%)

            Serum lactate dehydrogenase level elevated (3-7%)

            Thrombocytosis (3-7%)

            Dizziness (4-6%)

            Dyspepsia (1-4%)

            Hypokalemia (1-4%)

            Decreased hemoglobin (2-3%)

            Wound hemorrhage (1-3%)

            Cough (1-3%)

            1-10% (NeoProfen)

            Respiratory failure (10%)

            Adrenal insufficiency (7%)

            Hypernatremia (7%)

            Increased blood urea (7%)

            Renal impairment (6%)

            Edema (4%)

            Atelectasis (4%)

            Decreased renal output (3%)

            Increased blood creatinine (3%)

            Renal failure (1%)

            Postmarketing Reports

            Pulmonary hypertension

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            Warnings

            Black Box Warnings

            These warnings are specific for Caldolor

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or with existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI and stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, and
            • perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Caldolor

            • Hypersensitivity
            • History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
            • Coronary artery bypass graft (CABG): Increased risk of MI and stroke if administered in the first 10-14 days following CABG

            NeoProfen

            • Untreated proven or suspected infection
            • Congenital heart disease where PDA patency is necessary for satisfactory pulmonary or systemic blood flow (eg, pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta)
            • Bleeding, especially active intracranial hemorrhage or GI bleeding
            • Thrombocytopenia; coagulation defects
            • Necrotizing enterocolitis
            • Significant renal impairment

            Cautions

            Caldolor

            • Increased risk for serious CV thrombotic events, myocardial infarction (MI), and stroke (use lowest effective dose for shortest duration possible); additionally, increased MI and stroke if administered in the first 10-14 days following CABG (see Contraindications)
            • Risk of GI ulceration, bleeding, and perforation
            • May cause borderline LFT elevations; rare reports of notable ALT or AST (ie, 3xULN) or severe hepatic reactions (eg, jaundice, fulminant hepatitis, liver necrosis, hepatic failure)
            • May cause new onset hypertension, or exacerbation of existing hypertension
            • Fluid retention and edema observed; caution in patients with heart failure
            • Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs
            • Anaphylactoid reactions reported (see Contraindications)
            • Serious skin reactions may occur (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
            • Avoid in pregnancy after 30 weeks gestation; associated with premature closure of the ductus arteriosus
            • Diminishes utility of inflammation and fever as diagnostic signs for infection
            • Must be diluted prior to use; infusing undiluted may result in hemolysis
            • Patients with asthma may have aspirin-sensitive asthma; use of aspirin or NSAIDs may cause severe bronchospasm in these patients
            • Blurred or diminished vision, scotomata, and changes in color vision reported with oral ibuprofen
            • Aseptic meningitis with fever and coma observed with oral ibuprofen therapy

            NeoProfen

            • Diminishes utility of inflammation and fever as diagnostic signs for infection
            • Inhibits platelet aggregation; caution with underlying hemostatic defects (see Contraindications)
            • Displaces bilirubin from albumin binding-sites
            • Administer cautiously to avoid extravasation
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            Pregnancy & Lactation

            Pregnancy Category: C; D from 30 weeks of gestation onward, may cause premature closure of the ductus arteriosus

            The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)

            Lactation: excreted into breast milk; not recommended (AAP Committee states "compatible with nursing")

            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

            Elicits anti-inflammatory, analgesic, and antipyretic activity

            Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

            May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation; these effects may contribute to its anti-inflammatory activity

            Absorption

            Peak Plasma Concentration: 39.2-72.6 mcg/mL (Caldolor)

            AUC: 109.3-192.8 mcg•h/mL (Caldolor)

            Distribution

            Protein Bound: >99% (saturable at >20 mcg/mL)

            Vd: 320 mL/kg (NeoProfen)

            Metabolism

            Racemic mixture of R- and S-isomers; in vivo and in vitro studies indicate the S-isomer is active and the R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~60%) interconverted into the active S species in adults

            Hepatic CYP2C9 (primarily); CYP2C19 substrate

            Metabolites: (+)-2-[4'-(2-hydroxy-2-methylpropyl) phenyl] propionic acid (metabolite A), (+)-2-[4'-(2-carboxypropyl) phenyl] propionic acid (metabolite B)

            Elimination

            Half-life: 2.22-2.44 hr (Caldolor); >10 times that of adults (neonates), 43.1 hr (3 days old) and 26.8 hr (5 days old)

            Renal clearance: 3 mL/kg/hr (NeoProfen); increases rapidly postnatally by 0.5 mL/kg/hr per day

            Excretion: Urine (predominantly) and bile

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            Administration

            IV Preparation

            Caldolor

            • Dilute to a final concentration of ≤4 mg/mL in 0.9% NaCl, D5W or LR
            • 100 mg dose: Dilute 1 mL in at least 100 mL of diluent
            • 200 mg dose: Dilute 2 mL in at least 100 mL of diluent
            • 400 mg dose: Dilute 4 mL in at least 100 mL of diluent
            • 800 mg dose: Dilute 8 mL in at least 200 mL of diluent

            NeoProfen

            • Dilute in dextrose or 0.9% NaCl
            • Administer within 30 minutes of dilution

            IV Administration

            Caldolor

            • Adults: Infuse over at least 30 minutes
            • Pediatric patients aged 6 mo to 17 yr: Infuse over at least 10 minutes

            NeoProfen

            • Infuse over 30 minutes
            • Use IV port nearest to insertion site
            • Do NOT coadminister with TPN in same line (allow 15 min discontinuation of TPN if necessary)
            • Discard unused portion - no preservatives

            Storage

            Caldolor: Store unopened vial at room temperature; diluted solutions are stable for up to 24 hr at room temperature and room lighting

            NeoProfen: Store vial at room temperature, protect from light

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            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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