Generic Name: Mefenamic Acid
Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Chemical Name: N-(2,3-xylyl)anthranilic acid
Molecular Formula: C15H15NO2
CAS Number: 61-68-7
- Cardiovascular Risk
Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).125 500 502 508 b Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)
Contraindicated in the setting of CABG surgery.505
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).100 104 125 b Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.100 101 104 125 b Geriatric individuals are at greater risk for serious GI events.125 b (See GI Effects under Cautions.)
Prototypical NSAIA; anthranilic acid derivative (fenamate); structurally and pharmacologically related to meclofenamate sodium.125 a
Uses for Ponstel
Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.125 b Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.125 b
Relief of mild to moderate pain in patients ≥14 years of age when the duration of therapy ≤1 week.125 b
Treatment of primary dysmenorrhea.125 b
Has been used for reduction of fever† associated with infection in children; routine use as an antipyretic not recommended because of potential adverse effects.a
Ponstel Dosage and Administration
Consider potential benefits and risks of mefenamic acid therapy as well as alternative therapies before initiating therapy with the drug.125 b
Administer orally.125 May be administered in divided doses up to 4 times daily.125
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.125 b Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.125 b
Adolescents ≥14 years of age should receive dosage recommended for adults.125 (See Adult Dosage.)
For mild to moderate pain in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.125
For relief of primary dysmenorrhea in adults, 500 mg initially followed by 250 mg every 6 hours as necessary.125 Initiate at onset of bleeding and associated symptoms; treatment should not be necessary for >2–3 days.125
Duration of therapy usually should not exceed 1 week.125
Duration of therapy usually should not exceed 1 week.125
Therapy should not be necessary for more than 2–3 days.125
Dosage reduction may be required.125
Dosage reduction may be required if used in patients with renal impairment.125
Use not recommended in patients with preexisting renal disease or substantial renal impairment.125
Select dosage carefully since may be more likely to have decreased renal function.125 b
Cautions for Ponstel
Known hypersensitivity to mefenamic acid or any ingredient in the formulation.125 b
History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.125 b
In the setting of CABG surgery.508
Active ulceration or chronic inflammation of upper or lower GI tract.125
Preexisting renal disease.125
Cardiovascular Thrombotic Effects
NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508
Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500
Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508
Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508
In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508
In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505 508
Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511
Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.133 134 135 136 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.125 500 508 b
Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.125 502 508 b (See Specific Drugs under Interactions.)
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.100 104 124 125 126 b
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;124 127 h i alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)124 h i or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).125 h
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.125 b Use with caution in patients with hypertension; monitor BP.125 b
Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur.125 508 b (See Specific Drugs under Interactions.)
Heart Failure and Edema
Fluid retention and edema reported.125 508 b
NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.500 501 504 507 508
NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)
Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508
Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.125 b
Potential for overt renal decompensation.125 b Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.125 128 b (See Renal Impairment under Cautions.)
Anaphylactoid reactions reported.125 b
Immediate medical intervention and discontinuance for anaphylaxis.125 b
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.125 b
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.125 b Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).125 b
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.125 b
Elevations of serum ALT or AST reported.125 b
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.125 b Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.125 b
Anemia reported rarely.125 b Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.125 b
May inhibit platelet aggregation and prolong bleeding time.125 b
Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.125 a
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.125 b
May mask certain signs of infection.125 b
Obtain CBC and chemistry profile periodically during long-term use.125 b
Category C.125 b Avoid use in third trimester because of possible premature closure of the ductus arteriosus.125 b
Distributed into milk.125 c Discontinue nursing or the drug.125
Safety and efficacy not established in children <14 years of age.125
Use with caution in patients ≥65 years of age.125 b Geriatric adults appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.125 b Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.125 b
Substantially eliminated by kidneys; periodic monitoring of renal function may be useful since geriatric patients are more likely to have decreased renal function.125 (See Geriatric Patients under Dosage and Administration and Renal Impairment under Cautions.)
Use not recommended in patients with preexisting renal disease or substantial renal impairment.125
Common Adverse Effects
Abdominal pain,125 constipation,125 diarrhea,125 dyspepsia,125 flatulence,125 gross bleeding/perforation,125 heartburn,125 nausea,125 GI ulcers (gastric/duodenal),125 vomiting,125 abnormal renal function,125 anemia,125 dizziness,125 edema,125 elevated liver enzymes,125 headaches,125 increased bleeding time,125 pruritus,125 rashes,125 tinnitus.125
Interactions for Ponstel
Possible pharmacokinetic interaction; potential for mefenamic acid to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).125 a f Observe for adverse effects if used with other protein-bound drugs.a
Drugs Affecting Hepatic Microsomal Enzymes
Inhibitors of CYP2C9: possible altered safety and efficacy of mefenamic acid.125
Reduced BP response to ACE inhibitor possible 125 128 b
Possible deterioration of renal function in individuals with renal impairment128
Angiotensin II receptor antagonists
Reduced BP response to angiotensin II receptor antagonist possible128
Possible deterioration of renal function in individuals with renal impairment128
Increased peak plasma concentrations and AUC of mefenamic acid125 d
Anticoagulants (e.g., warfarin)
Possible bleeding complications125 128 a b e
Use with caution; frequent monitoring of PT advised125 128 a e
Increased risk of GI ulceration or other complications 125 128 b
No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs125 502 508 b
Concomitant use generally not recommended125 b
Diuretics (furosemide, thiazides)
Reduced natriuretic effects possible125 b
Monitor for diuretic efficacy and renal failure125 b
Increased plasma lithium concentrations105 125 b
Monitor for lithium toxicity105 125 b
Possible toxicity associated with increased plasma methotrexate concentrations during concomitant NSAIA use125 b
Caution advised125 b
Rapidly absorbed following oral administration.125 a Peak plasma concentrations usually attained within 2–4 hours.125 a
Effect of food on rate and extent of absorption not known.125
Appears to cross the placenta.g
Distributed into milk in small amounts.125 c
Plasma Protein Binding
Metabolized by CYP2C9 to 3′-hydroxymethyl mefenamic acid; further oxidation to 3′-carboxymefenamic acid may occur. 125 Mefenamic acid and its metabolites also are glucuronidated.125
Excreted in urine (52%) primarily as glucuronic acid conjugates of the drug and its metabolites and in feces (<20%).125
Mefenamic acid: approximately 2 hours.125 Half-lives of 3′-hydroxymethyl mefenamic acid and 3′-carboxymefenamic acid may be longer than parent compound.125
Half-life 5 times longer in preterm infants compared with adults.125
In patients with renal or hepatic impairment, clearance of metabolites may be decreased.125
Not substantially removed by hemodialysis.125 a
20–25°C (may be exposed to 15–30°C).125 a
Inhibits cyclooxygenase-1 (COX-1) and COX-2.117 118 119 120 121 122
Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.125 a
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.125 b
Risk of serious cardiovascular events (e.g., MI, stroke).125 500 508 b Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.125 500 508 b
Risk of GI bleeding and ulceration.100 104 125 b Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.125 b
Importance of discontinuing mefenamic acid and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.125 b Importance of seeking immediate medical attention if an anaphylactic reaction occurs.125 b
Risk of hepatotoxicity.125 b Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.125 b
Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.125 508 b
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.125 Importance of avoiding mefenamic acid in late pregnancy (third trimester).125
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.125
Importance of informing patients of other important precautionary information.125 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Mefenamic Acid Capsules
AHFS DI Essentials. © Copyright 2018, Selected Revisions March 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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