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MEFENAMIC is a brand name for Mefenamate (also known as Mefenamic Acid), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adult (>18 years old) MEFENAMIC (mefenamic acid) is indicated for the relief of pain of moderate severity in conditions such as: • muscular aches and pains • primary dysmenorrhea • headache • dental pain For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Use of MEFENAMIC should be limited to the lowest effective dose for the shortest possible duration of treatment (see 1 INDICATIONS). 4 Drug-Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDS). • For geriatric patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, 7 WARNINGS AND PRECAUTIONS, Gastrointestinal and 7 WARNINGS AND PRECAUTIONS, Renal).
2 Recommended Dose and Dosage Adjustment Treatment of Acute Pain in Adults: MEFENAMIC 250 mg capsules: 500 mg (2 capsules) as an initial dose, followed by 250 mg (1 capsule) every 6 hours as needed. Treatment usually should not exceed one week.
Treatment of Primary Dysmenorrhea:
MEFENAMIC 250 mg capsules: 500 mg (2 capsules) as an initial dose, followed by 250 mg (1 capsule) every 6 hours. Treatment may start with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.
3 Pediatrics). 4 Administration Administration is by the oral route, preferably with food. 5 Missed Dose If a dose is missed, patient should take it as soon as they remember. If it is near the time of the next dose, the missed dose should be skipped and the usual dosing schedule should be resumed.
The dose should not be doubled to catch up.
and 4 DOSAGE AND ADMINISTRATION). Certain patients who develop diarrhea may be unable to tolerate the drug because of recurrence of the symptoms on subsequent MEFENAMIC (mefenamic acid capsules) Page 11 of 42 exposure. Caution should be taken if prescribing MEFENAMIC to patients with a prior history of peptic / duodenal ulcer disease or gastrointestinal bleeding as these individuals have a greater than 10- fold higher risk for developing a GI bleed when taking a NSAID than patients with neither of these risk factors.
, citalopram, fluoxetine, paroxetine, sertraline) Genitourinary Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with a NSAID.
Should urinary symptoms occur, in the absence of an alternate explanation, treatment with MEFENAMIC should be stopped to ascertain if symptoms disappear. This should be done before urological investigations or treatments are carried out.
Hematologic NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from haemophilia or platelet disorders should be carefully observed when MEFENAMIC is administered.
Anti-coagulants:
Numerous studies have shown that the concomitant use of NSAIDs and anti- coagulants increases the risk of bleeding. Concurrent therapy of MEFENAMIC with warfarin requires close monitoring of the international normalized ratio (INR).
4 Drug-Drug Interactions, Anti-coagulants). 75%) in patients in whom the concentration had been initially lowered by anticoagulant therapy. Caution, therefore, should be exercised in administering MEFENAMIC to patients on anticoagulant therapy and should not be given when prothrombin concentration is in the range of 10 to 20% normal.
1 Pregnant Women 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ............................................................................................................... 1 Pediatrics ......................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................. 5 Missed Dose .................................................................................................................
7 5 OVERDOSAGE ............................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 8 7 WARNINGS AND PRECAUTIONS ....................................................................................
and 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). Use of MEFENAMIC should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Cardiovascular, and 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).
MEFENAMIC, as a NSAID, does NOT treat clinical disease or prevent its progression. MEFENAMIC, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it. 3 Pediatrics). 4 Geriatrics).
2 CONTRAINDICATIONS MEFENAMIC is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, MEFENAMIC (mefenamic acid capsules) Page 5 of 42 including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • The peri-operative setting of coronary artery bypass graft surgery (CABG). Although mefenamic acid has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.
1 Pregnant Women). 2 Breastfeeding). • Severe uncontrolled heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/ angioedema, nasal polyps, asthma).
Fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. The potential for cross-reactivity between different NSAIDs must be kept in mind (see 7 WARNINGS AND PRECAUTIONS, Immune, Anaphylactoid Reactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mefenamate in Canada.
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Careful monitoring of blood coagulation factors is recommended.
Anti-platelet Effects:
NSAIDs inhibit platelet aggregation and have been shown to prolong MEFENAMIC (mefenamic acid capsules) Page 12 of 42 bleeding time in some patients. Unlike acetylsalicylic acid (ASA), their effect on platelet function is quantitatively less, or of shorter duration, and is reversible.
Mefenamic acid and other NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. , ASA) should NOT be discontinued.
4 Drug-Drug Interactions, Acetylsalicylic Acid (ASA) or other NSAIDs). Concomitant administration of MEFENAMIC with low dose ASA increases the risk of GI ulceration and associated complications.
Blood dyscrasias:
Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of NSAIDs are rare, but could occur with severe consequences. Anemia is sometimes seen in patients receiving NSAIDs, including MEFENAMIC.
This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including MEFENAMIC, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.
Hepatic/Biliary/Pancreatic As with other NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy.
MEFENAMIC should be used with caution in patients with hepatic impairment. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with this drug.
Severe hepatic reactions including jaundice and cases of fatal hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs. g. g. ), this drug should be discontinued. If there is a need to prescribe this drug in the presence of impaired liver function, it must be done under strict observation.
MEFENAMIC (mefenamic acid capsules) Page 13 of 42 Immune Anaphylactoid Reactions:
As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to mefenamic acid. In post-marketing experience, rare cases of anaphylactic/ anaphylactoid reactions and angioedema have been reported in patients receiving mefenamic acid.
MEFENAMIC should NOT be given to patients with the ASA-triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking ASA or other NSAIDs (see 2 CONTRAINDICATIONS).
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1 Special Populations .................................................................................................... 1 Pregnant Women .......................................................................................................
2 Breastfeeding ............................................................................................................. 3 Pediatrics ....................................................................................................................
4 Geriatrics .................................................................................................................... 18 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
3 Less Common Clinical Trial Adverse Reactions .......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...............................................................................................................
5 Post-market Adverse Reactions ................................................................................. 19 9 DRUG INTERACTIONS ..................................................................................................
1 Serious Drug Interactions........................................................................................... 2 Drug Interactions Overview .......................................................................................
3 Drug-Behaviour Interactions ...................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions .............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................. 25 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action .................................................................................................
2 Pharmacodynamics .................................................................................................... 3 Pharmacokinetics .......................................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 27 PART II: SCIENTIFIC INFORMATION ......................................................................................
28 13 PHARMACEUTICAL INFORMATION .............................................................................. 28 14 CLINICAL TRIALS..........................................................................................................
2 Comparative Bioavailability Studies........................................................................... 28 15 MICROBIOLOGY […]
• Active gastric / duodenal / peptic ulcer, active GI bleeding (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal). • Cerebrovascular bleeding or other bleeding disorders. • Inflammatory bowel disease. • Severe liver impairment or active liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see7 WARNINGS AND PRECAUTIONS, Renal).
• Known hyperkalemia (see 7 WARNINGS AND PRECAUTIONS, Renal, Fluid and Electrolyte Balance). • Children and adolescents less than 18 years of age.