ibuprofen (Rx, OTC)

Brand and Other Names:Advil, Motrin, more...PediaCare Children's Pain Reliever/Fever Reducer IB, PediaCare Infant's Pain Reliever/Fever Reducer IB
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg
  • 200mg
  • 400mg (Rx)
  • 600mg (Rx)
  • 800mg (Rx)

capsule

  • 200mg

tablet, chewable

  • 50mg
  • 100mg

oral suspension

  • 100mg/5mL
  • 40mg/mL

Pain/Fever/Dysmenorrhea

OTC: 200-400 mg PO q4-6hr; not to exceed 1200 mg unless directed by physician

Prescription: 400-800 mg PO q6hr; not to exceed 3200 mg/day

Inflammatory Disease

400-800 mg PO q6-8hr; not to exceed 3200 mg/day

Osteoarthritis

300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3200 mg/day

Monitor for gastrointestinal (GI) risks

Rheumatoid Arthritis

300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3200 mg/day

Monitor for GI risks

Dosage Modifications

Significantly impaired renal function: Monitor closely; consider reduced dosage if warranted

Severe hepatic impairment: Avoid use

Dosage Forms & Strengths

tablet

  • 100mg
  • 200mg
  • 400mg (Rx)
  • 600mg (Rx)
  • 800mg (Rx)

capsule

  • 200mg

tablet, chewable

  • 50mg
  • 100mg

oral suspension

  • 100mg/5mL
  • 40mg/mL

Fever

<6 months

  • Safety and efficacy not established

≥6 months

  • 5-10 mg/kg/dose PO q6-8hr; not to exceed 400 mg/dose or 40 mg/kg/day  

Pain

4-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day

Juvenile Idiopathic Arthritis

30-50 mg/kg/24hr PO divided q8hr; not to exceed 2.4 g/day  

Patent Ductus Arteriosus

See ibuprofen IV drug monograph

Cystic Fibrosis (Off-label)

<4 years: Safety and efficacy not established

≥4 years: PO administration q12hr, adjusted to maintain serum levels of 50-100 mcg/mL; may slow disease progression in younger patients with mild lung disease

Dosing Considerations

Potential toxic dose in children <6 years: 200 mg/kg  

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Interactions

Interaction Checker

and ibuprofen

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dizziness (3-9%)

            Epigastric pain (3-9%)

            Heartburn (3-9%)

            Constipation (1-3%)

            Nausea (3-9%)

            Rash (3-9%)

            Tinnitus (3-9%)

            Edema (1-3%)

            Fluid retention (1-3%)

            Headache (1-3%)

            Vomiting (1-3%)

            <1%

            Acute renal failure (sometimes with acute tubular necrosis or hyperkalemia, polyuria, azotemia, cystitis, hematuria, decreased creatinine clearance, elevations in blood urea nitrogen (BUN) or creatinine without other manifestations of renal failure)

            Agranulocytosis

            Aplastic anemia

            Erythema multiforme

            Erythematous macular rashes

            Exfoliative dermatitis

            Hemolytic anemia (with or without positive direct antiglobulin test results)

            Neutropenia

            Thrombocytopenia (with or without purpura)

            Toxic epidermal necrolysis (Lyell syndrome) and photosensitivity reactions

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Nonsteroidal anti-inflammatory drugs (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 existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, 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

            Hypersensitivity to drug, other NSAIDs, aspirin, or excipients

            Perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Cautions

            Use caution in asthma (bronchial), cardiac disease, congestive heart failure (CHF), hepatic or renal impairment, hypertension. bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus (SLE), ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers

            Junior Advil (100 mg): Doses higher than recommended may cause stomach bleeding

            May cause serious adverse reactions, including exfoliative dermatitis, toxic epidermal necrolysis, Steven's Johnson syndrome reported

            Children's and Junior Advil (50 mg, 100 mg): May cause severe and persistent sore throat

            Fever, rash, abdominal pain, nausea, liver dysfunction, and meningitis have occurred in patients with collagen-vascular disease, especially SLE

            Blurred vision, scotomate, and changes in color vision reported; discontinue therapy if symptoms occur

            Platelet aggregation and adhesion may be decreased; monitor patients with coagulation disorders receiving the therapy

            Risk of hyperkalemia may increase in patients with diabetes, the elderly, renal disease, or with concomitant use of agents that can induce hyperkalemia including ACE inhibitors; monitor potassium closely

            May cause drowsiness and dizziness; may impair physical or mental abilities to operate heavy machinery or driving

            NSAIDS, except aspirin, increase risk of heart attack, heart failure, and stroke; which can be fatal; the risk is higher if patients use more than it was directed or for longer than needed

            Use caution in patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, or had a stroke

            Patients should inform healthcare professional if they have symptoms of heart problems or stroke, chest pain, trouble breathing weakness in one part or side of body, slurred speech, leg swelling

            Not for use right before or after heart surgery

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

            Heart Failure (HF) risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

            Animal studies

            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
            • In animal studies, administration of prostaglandin synthesis inhibitors (eg, ibuprofen), resulted in increased pre- and post-implantation loss
            • Advise pregnant women of potential fetal risk

            Clinical considerations

            • There are no studies on effects during labor or delivery
            • In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Fetal toxicity

            • Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
            • Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy
            • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus
            • Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
            • There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of the drug combination
            • Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
            • In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
            • In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss
            • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
            • Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
            • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible
            • If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice

            Labor or Delivery

            • There are no studies on the effects of drug combination during labor or delivery; in animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Lactation

            No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on effects of ibuprofen on milk production or on a breastfed infant

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

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

            Absorption

            Rapidly absorbed (85%)

            Bioavailability: 80-100%

            Onset: 30-60 min

            Duration: 4-6 hr

            Peak plasma time (adults)

            • Conventional tablet: 120 min
            • Chewable tablet: 62 min
            • Oral suspension: 47 min

            Peak plasma time (febrile children)

            • Chewable tablet: 86 min
            • Oral suspension: 58 min

            Peak plasma concentration

            • Conventional tablet: 20 mcg/mL
            • Chewable tablet: 15 mcg/mL
            • Oral suspension: 19 mcg/mL

            Distribution

            Protein bound: 90-99%; concentrations >20 mcg/mL

            Vd: 0.12 L/kg (adults); 0.164 L/kg (children)

            Metabolism

            Rapidly metabolized in liver (primarily by CYP2C9; CYP2C19 substrate) via oxidation to inactive metabolites

            Metabolites

            • Metabolite A: (+)-2-[4'-(2-hydroxy-2-methylpropyl) phenyl] propionic acid
            • Metabolite B: (+)-2-[4'-(2-carboxypropyl) phenyl] propionic acid

            Elimination

            Half-life: 2-4 hr (adults); 1.6 hr (children 3 mon to 1 year; 35-51 hr (day 3), 20-33 hr (day 5)

            Excretion: Urine (50-60%; <10% unchanged); remainder in feces within 24 hr

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            Administration

            Instructions

            Take with food or 8-12 oz of water to avoid GI effects

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to 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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.