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Meclofenamate (Meclofenamic Acid)

    DAE Class; Rx

    Common Brand Names

    • NSAIDs

    Anthranilic acid (fenamate) NSAID for mild to moderate pain; may cause an increased risk of serious gastrointestinal adverse effects and serious cardiovascular events; use lowest effective dose for the shortest possible duration.

    Indicated sor the treatment of dysmenorrhea.
    For the treatment of fever or mild pain and moderate pain. 
    For the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, or acute painful shoulder (i.e., acute subacromial bursitis/supraspinatus tendinitis).
    For the treatment of juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA).

    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

    >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

    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

    Pregnancy 

    Avoid meclofenamate use during the third trimester of pregnancy (starting at 30 weeks of gestation) due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the neonate. 

    Lactation:

    Adults

    400 mg/day PO.

    Geriatric

    400 mg/day PO.

    Adolescents

    14 to 17 years: 400 mg/day PO.
    13 years: Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Meclofenamate (Meclofenamic Acid)

    capsule

    • 50mg
    • 100mg