etodolac (Rx)

Brand and Other Names:Lodine
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 400mg
  • 500mg

capsule

  • 200mg
  • 300mg

tablet, extended-release

  • 400mg
  • 500mg
  • 600mg

Pain

Immediate release: 200-400 mg PO q6-8hr; not to exceed 1000 mg/day (not evaluated)

Osteoarthritis

Immediate release: 600-1000 mg/day PO divided q8-12hr or 900 mg/day PO divided q8hr; doses >1000 mg/day not evaluated

Extended release: 400-1000 mg PO once daily; not to exceed 1200 mg/day (not evaluated)

Rheumatoid Arthritis

Immediate release: 600-1000 mg/day PO divided q8-12hr or 900 mg/day PO divided q8hr; doses >1000 mg/day not evaluated

Extended release: 400-1000 mg PO once daily; not to exceed 1200 mg/day (not evaluated)

Dosing Considerations

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

<60 kg: Not to exceed 20 mg/kg PO  

Mild-to-moderate renal impairment: Dose adjustment not necessary

Severe renal impairment; Not recommended

Hepatic impairment: Dose adjustment not necessary

Malignant Glioma (Orphan)

Orphan designation for treatment of malignant glioma (plus propranolol)

Sponsor

  • Vicus Therapeutics, LLC; 55 Madison Avenue, Suite 400; Morristown, NJ 07960

Dosage Forms & Strengths

tablet, extended-release

  • 400mg
  • 500mg
  • 600mg

Juvenile Rheumatoid Arthritis

<6 years

  • Safety and efficacy not established

6-16 years

  • 20-30 kg (extended release): 400 mg PO once daily
  • 31-45 kg (extended release): 600 mg PO once daily
  • 46-60 kg (extended release): 800 mg PO once daily
  • >60 kg (extended release): 1000 mg PO once daily

Dosing considerations

  • Safety and effectiveness of conventional tablets for juvenile rheumatoid arthritis not established
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Interactions

Interaction Checker

and etodolac

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dyspepsia (10%)

            Dizziness (3-9%)

            Nervousness (1-3%)

            Pruritus (1-3%)

            Blurred vision (1-3%)

            Depression (1-3%)

            Chills/fever (1-3%)

            >1%

            Asthenia, malaise

            Blurred vision

            Bronchospasm

            Dysuria, urinary frequency

            Edema

            Melena

            Rash

            Tinnitus

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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 risk factors for or existing cardiovascular 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

            • Perioperative pain associated with coronary artery bypass graft
            • Previous allergic reactions or asthma after taking aspirin or other NSAIDs

            Cautions

            Patients with asthma may have aspirin-sensitive asthma; yhe use of aspirin in patients with aspirin-sensitive asthmas has been associated with severe bronchospasm which can be fatal; since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in aspirin-sensitive patients, therapy should not be administered to patients with this form of aspirin sensitivity and should be used with caution in all patients with pre-existing asthma

            Caution in bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

            To minimize potential risk for an adverse CV event in patients treated with an NSAID, use lowest effective dose should for shortest duration possible; physicians and patients should remain alert for development of such events, even in absence of previous CV symptoms; patients should be informed about signs and/or symptoms of serious CV events and steps to take if they occur

            There is no consistent evidence that concurrent use of aspirin mitigates increased risk of serious CV thrombotic events associated with NSAID use; concurrent use of aspirin and an NSAID does increase risk of serious GI events

            NSAIDs can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to increased incidence of CV events; patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs; NSAIDs should be used with caution in patients with hypertension; monitor blood pressure (BP) closely during initiation of NSAID treatment and throughout course of therapy

            Therapy can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal; these serious events may occur without warning; patients should be informed about signs and symptoms of serious skin manifestations and use of drug should be discontinued at first appearance of skin rash or any other sign of hypersensitivity

            Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in maintenance of renal perfusion; In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation; caution is recommended in patients with pre-existing kidney disease

            Treatment is not recommended in patients with advanced renal disease; if therapy must be initiated, close monitoring of patient’s renal function is advisable

            Anaphylactoid reactions may occur in patients without prior exposure to drug; drug should not be given to patients with aspirin triad; this symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs; fatal reactions reported; emergency help should be sought in cases where an anaphylactoid reaction occurs

            Borderline elevations of one or more liver tests may occur in up to 15%; rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, reported; patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of development of a more severe hepatic reaction while on therapy with Lodine; if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc.), discontinue therapy

            Anemia sometimes; may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis; patients on long-term treatment with NSAIDs, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia

            NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients; patients may experience alterations in platelet function, such as those with coagulation disorders or receiving anticoagulants; carefully monitor

            Gastrointestinal Effects

            • NSAIDs can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal; these serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs; physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur
            • Factors that increase risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status; most spontaneous reports of fatal GI events are in elderly or debilitated patients, and therefore, special care should be taken in treating this population
            • To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration
            • Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected; this should include discontinuation of NSAID until a serious GI adverse event is ruled out; for high risk patients, alternate therapies that do not involve NSAIDs should be considered

            Heart Failure risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads tosodium 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 category: C; avoid in late pregnancy (may cause premature closure of ductus arteriosus)

            Quebec Pregnancy Registry identified 4705 women who had a spontaneous abortion by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had a spontaneous abortion; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortion and approximately 2.6% of controls

            Lactation: Unknown whether drug is excreted in breast milk; not recommended

            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

            Bioavailability: 80-100%

            Onset: 2-4 hr

            Duration: 4-6 hr

            Peak plasma time: Immediate release, 1-2 hr (adults); extended release, 5-7 hr (children)

            Distribution

            Protein bound: ≥99%

            Vd: 0.4 L/kg (Immediate release); 0.57 L/kg (adults; extended release) or 0.08 L/kg (children; extended release)

            Metabolism

            Hepatic

            Metabolites: Hydroxylated metabolites (6-, 7-, 8-OH), hydroxylated metabolite glucuronides, unidentified metabolites (33%)

            Elimination

            Half-life: Immediate release, 5-8 hr (adults); extended release, 12 hr (children)

            Dialyzable: No

            Excretion: Urine (73%), feces (16%)

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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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.