MECLOFENAMATE SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MECLOFENAMATE SODIUM (MECLOFENAMATE SODIUM).
Meclofenamate sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), thereby reducing prostaglandin synthesis, which mediates inflammation, pain, and fever.
| Metabolism | Primarily hepatic via cytochrome P450 enzymes, including CYP2C9 and CYP3A4. |
| Excretion | Renal (60-70% as metabolites and conjugates), biliary/fecal (20-30%) |
| Half-life | 2-4 hours (terminal half-life; may be prolonged in hepatic impairment or elderly) |
| Protein binding | >99% (primarily to albumin) |
| Volume of Distribution | 0.5-1.0 L/kg (indicates extensive tissue distribution) |
| Bioavailability | 100% (oral, well absorbed) |
| Onset of Action | 30-60 minutes (oral) |
| Duration of Action | 4-6 hours (sustained up to 8 hours for analgesia) |
| Molecular Weight | 295.29 Da (as sodium salt) |
50 mg or 100 mg orally three times daily; maximum 400 mg/day.
| Dosage form | CAPSULE |
| Renal impairment | eGFR 30-59 mL/min: use with caution, reduce dose by 50%; eGFR <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Not recommended for children under 14 years; for adolescents ≥14 years, same as adult dosing. |
| Geriatric use | Initiate at lowest effective dose (50 mg twice daily); monitor renal function and GI bleeding risk. |
| 1st trimester | Avoid use; associated with increased risk of miscarriage and cardiac defects. |
| 2nd trimester | Avoid use; may cause oligohydramnios and premature ductus arteriosus closure. |
| 3rd trimester | Contraindicated; risk of premature ductus arteriosus closure and neonatal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for MECLOFENAMATE SODIUM (MECLOFENAMATE SODIUM).
| Placental transfer | Crosses placenta; fetal concentrations are about 50-60% of maternal serum levels. |
| Breastfeeding | Excreted into breast milk in low amounts; use with caution due to potential adverse effects in infants, especially gastrointestinal or renal. |
| Lactation Rating |
■ FDA Black Box Warning
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. Meclofenamate is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
Hypersensitivity to meclofenamate or any NSAIDActive peptic ulcer disease or gastrointestinal bleedingSevere renal impairment (CrCl <30 mL/min)Third trimester of pregnancyHistory of asthma, urticaria, or allergic-type reactions after aspirin or NSAIDsCoronary artery bypass graft (CABG) surgery perioperative pain
| Precautions | Cardiovascular thrombotic events, Gastrointestinal bleeding, ulceration, and perforation, Hypertension and edema, Renal toxicity, Anaphylactoid reactions, Exacerbation of asthma, Hematologic toxicity including anemia, Hepatic enzyme elevations |
| Food/Dietary | Avoid high-fat meals as they may delay absorption. Limit salt intake to reduce fluid retention. Do not consume alcohol as it increases the risk of GI bleeding. Meclofenamate may decrease the effectiveness of diuretics and antihypertensive medications when taken with potassium-rich foods; monitor potassium levels. |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | Avoid in 1st and 2nd trimester; contraindicated in 3rd trimester due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment. Associated with cardiovascular malformations if used in 1st trimester. |
| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of bleeding. Fetal ultrasound for amniotic fluid volume and ductus arteriosus patency if used after 20 weeks. |
| Fertility Effects | May impair fertility in women of reproductive potential by suppressing prostaglandin-mediated follicular rupture; reversible upon discontinuation. |
| Clinical Pearls | Meclofenamate sodium is a nonsteroidal anti-inflammatory drug (NSAID) used for mild to moderate pain, dysmenorrhea, and inflammatory arthropathies. It has a higher incidence of gastrointestinal (GI) side effects, especially diarrhea, which can be dose-limiting. Monitor renal function and blood pressure, as it may cause fluid retention and worsening of hypertension. Use with caution in patients with a history of peptic ulcer disease or bleeding disorders. It is contraindicated in perioperative pain in coronary artery bypass graft (CABG) surgery. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Avoid alcohol and aspirin while taking this medication. · Report signs of GI bleeding (black, tarry stools; blood in vomit) immediately. · May cause diarrhea; notify your doctor if it becomes severe or persistent. · Do not take with other NSAIDs without consulting your doctor. · Stay hydrated, but avoid excessive salt intake to prevent fluid retention. · Inform your doctor if you have kidney disease, high blood pressure, or a history of stomach ulcers. · Do not use during pregnancy, especially in the third trimester. |