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) |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MECLOFENAMATE SODIUM (MECLOFENAMATE SODIUM).
| Breastfeeding | Excreted into breast milk in small amounts; M/P ratio not established. Use caution due to potential adverse effects in neonates (e.g., gastrointestinal bleeding, platelet dysfunction). |
| 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 |
■ 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 other NSAID","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Perioperative pain in setting of CABG surgery","Active peptic ulcer disease or gastrointestinal bleeding"]
| 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"] |
Loading safety data…
| 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. |