Classes
DAE Class; Rx
Common Brand Names;
- NSAIDs
Description
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.
Indications
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
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
Warnings
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 and Lactation
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:
Maximum Dosage
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.
How supplied
Meclofenamate (Meclofenamic Acid)
capsule
- 50mg
- 100mg