meclofenamate (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg

Rheumatoid Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis, including acute exacerbations of chronic disease

200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Osteoarthritis

Indicated for relief of signs and symptoms of osteoarthritis, including acute exacerbations of chronic disease

200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Ankylosing Spondylitis

Indicated for acute or long-term use for relief of signs and symptoms of ankylosing spondylitis

200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Bursitis/Tendinitis

Indicated for acute or long-term use for relief of signs and symptoms of acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)

200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Gouty Arthritis

Indicated for acute or long-term use for relief of signs and symptoms of gouty arthritis

200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Primary Dysmenorrhea

Indicated for primary dysmenorrhea and idiopathic heavy menstrual blood loss

100 mg PO TID for up to 6 days; initiate at onset of menstrual flow

Mild-to-Moderate Pain

50 mg PO q4-6hr; may increase t

100 mg/dose if needed Not to exceed 400 mg/day

Fever

50 mg PO q4-6hr; may increase to 100 mg/dose if needed

Not to exceed 400 mg/day

Dosage Modifications

Renal impairment

  • Kidney Disease Improving Global Outcomes (KDIGO) recommendations
    • eGFR 30-60 mL/ min/1.73 m²: Temporarily discontinue in patients with concurrent illness that increases risk of acute kidney injury
    • eGFR <30 mL/min/1.73 m²: Avoid use

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg

Juvenile Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis, including acute exacerbations of chronic disease

<14 years: Safety and efficacy not established

≥14 years: 200-400 mg/day PO divided in 3-4 equal doses; initiate at lower dose, and then increase according to response

After satisfactory response achieved, attempt to reduce dose for long-term administration

Not to exceed 400 mg/day

Primary Dysmenorrhea

Indicated for primary dysmenorrhea and idiopathic heavy menstrual blood loss

<14 years: Safety and efficacy not established

≥14 years: 100 mg PO TID for up to 6 days; initiate at onset of menstrual flow

Risk for effects on kidneys and bleeding risk may be increased in elderly individuals

Use lowest effect dose for the shortest duration

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Interactions

Interaction Checker

and meclofenamate

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 (10-33%)

            Nausea, with or without vomiting (11%)

            1-10%

            Pyrosis (3-9%)

            Flatulence (3-9%)

            Rash (3-9%)

            Headache (3-9%)

            Dizziness (3-9%)

            Anorexia (1-3%)

            Constipation (1-3%)

            Stomatitis (1-3%)

            Peptic ulcer (1-3%)

            Edema (1-3%)

            Pruritus (1-3%)

            Urticaria (1-3%)

            Tinnitus (1-3%)

            <1%

            Gastrointestinal: Bleeding and/or perforation with or without obvious ulcer formation, colitis, cholestatic jaundice

            Renal: Renal failure

            Hematologic: Neutropenia, thrombocytopenic purpura, leukopenia, agranulocytosis, hemolytic anemia, eosinophilia, decrease in hemoglobin and/or hematocrit

            Dermatologic: Erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis

            Hepatic: Alteration of liver function tests

            Allergic: Lupus and serum sickness-like symptoms

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            Warnings

            Black Box Warnings

            Cardiovascular thrombotic events

            • NSAIDs may increase risk of serious cardiovascular (CV) 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 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

            Hypersensitivity

            Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; severe, rarely fatal, anaphylacticlike reactions to NSAIDs have been reported in such patients

            In the setting CABG surgery

            Cautions

            Increased risk of serious CV thrombotic events, including MI, and stroke, which can be fatal (see Black Box Warnings)

            Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of MI and stroke (see Contraindications)

            Use of NSAIDs in the post-MI period increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment in an observational study; avoid use after a recent MI (see Black Box Warnings)

            Can lead to new-onset hypertension or worsening of preexisting hypertension; patients taking thiazides or loop diuretics may have impaired response to these treatments while taking an NSAID

            May cause fluid retention and edema; avoid use with severe heart failure

            Can cause serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal

            Long-term administration has resulted in renal papillary necrosis and other renal injury; patients at greatest risk include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and elderly individuals

            Anaphylactoid reactions reported (see Contraindications)

            Can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

            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

            Pregnancy category: C; D in third trimester (may cause 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

            Drug excreted in breast milk with multiple doses

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the 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

            Nonsteroidal anti-inflammatory drug (NSAID) that elicits anti-inflammatory, analgesic, and antipyretic activity

            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

            Peak plasma time: 0.5-2 hr

            Peak plasma concentration: 4.8 mcg/mL

            Food decreases rate and extent of absorption (bioavailability decreased by 26%; Cmax decreased 4-fold; time to Cmax delayed by 3 hr)

            Distribution

            Vd: 23.3 L

            Metabolism

            Extensively metabolized to an active metabolite (Metabolite I; 3-hydroxymethyl metabolite of meclofenamic acid) and at least 6 other less well-characterized minor metabolites

            Elimination

            Half-life: 0.8-5.3 hr (single-dose); 0.8-2.1 hr (TID x14 days); 15 hr (Metabolite I)

            Clearance: 206 mL/min

            Excretion: 70% urine; ~30% feces via biliary excretion

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            Administration

            Oral Administration

            Take on empty stomach; if GI complaints occur, may take with meals or milk (see Pharmacokinetics)

            Storage

            Store at controlled room temperature 20-25°C (68-77°F)

            Protect from light and moisture

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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.

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