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nabumetone (Rx)Brand and Other Names:Relafen

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 500mg
  • 750mg
more...

Osteoarthritis

1000 mg PO once daily initially; maintenance: 1000-2000 mg/day PO in single daily dose or divided q12hr; not to exceed 2000 mg/day

Rheumatoid Arthritis

1000 mg PO once daily initially; maintenance: 1000-2000 mg/day PO in single daily dose or divided q12hr; not to exceed 2000 mg/day

Dosing Modifications

Moderate renal impairment (CrCl: 30-49 mL/min): 750 mg/day initially; not to exceed 1500 mg/day

Severe renal impairment (CrCl: <30 mL/min): 500 mg/day initially; not to exceed 1000 mg/day

Not recommended

Juvenile Rheumatoid Arthritis (Orphan)

Orphan indication sponsor

  • Cook Pharma, 109 Graylyn Drive, Chapel Hill, NC 27516
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Interactions

Interaction Checker

nabumetone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (14%)

            Dyspepsia (13%)

            Abdominal pain (12%)

            1-10%

            Constipation (3-9%)

            Dizziness (3-9%)

            Edema (3-9%)

            Flatulence (3-9%)

            Headache (3-9%)

            Nausea (3-9%)

            Positive stool guaiac (3-9%)

            Pruritus (3-9%)

            Rash (3-9%)

            Tinnitus (3-9%)

            Dry mouth (1-3%)

            Fatigue (1-3%)

            Gastritis (1-3%)

            Increased sweating (1-3%)

            Insomnia (1-3%)

            Nervousness (1-3%)

            Somnolence (1-3%)

            Stomatitis (1-3%)

            Vomiting (1-3%)

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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

            Absolute: Aspirin allergy, severe renal impairment; perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Relative: Duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus, ulcerative colitis, late pregnancy (may cause premature closure of ductus arteriosus)

            Cautions

            Use caution in asthma (bronchial), bleeding disorders, cardiac disease, hepatic impairment, hypertension, renal impairment

            May not be sufficiently activated in patients with hepatic dysfunction; use with caution

            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 inhibitors, or angiotensin-receptor blockers

            Risk of serious GI toxicity, including bleeding, ulcers, perforation

            May cause drowsiness, dizziness, blured vision, and other neurologic effects

            May decrease platelet adhesion and aggregation, prolonging bleeding time; monitor closely patients with history of coagulation disorders

            May increase risk of hyperkalemia

            May cause photosensitivity reactions

            Severe skin reactions may occur; discontinue use at first sign of rash

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            Pregnancy & Lactation

            Pregnancy category: C; D if used for prolonged periods or near term (premature closure of ductus arteriosus)

            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 approximately 2.6% of controls

            Lactation: Unknown whether drug is excreted in breast milk; effect on infant unknown; do not give to nursing mothers

            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 cyclooxygenase (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

            Onset: Several days

            Peak serum time: 2-4 hr (PO)

            Distribution

            Protein bound: >99%

            Vd: 29-82 L (6-methoxy-2-naphthylacetic acid [6-MNA] metabolite)

            Metabolism

            Metabolized in liver

            Metabolites: 6-MNA (unchanged and conjugated), 4-(6-hydroxy-2-naphthyl)-butan-2-ol (conjugated), O-desmethyl-nabumetone (conjugated), unidentified minor metabolites

            Enzymes inhibited: COX-1. COX-2

            Elimination

            Half-life: 24 hr (6-MNA)

            Dialyzable: No

            Excretion: Urine (80%), feces (9%)

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            Images

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            Formulary

            FormularyPatient Discounts

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

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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.
            • 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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