Mefenamic Acid
FDA Drug Information • Also known as: Mefenamic Acid
- Brand Names
- Mefenamic Acid
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
⚠ Boxed Warning (Black Box)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( see WARNINGS). Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS). Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS).
Description
Mefenamic Acid Capsules are a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each Size '1' Yellow-Yellow capsule, with 'ML' imprinted on the cap & '250' imprinted on the body, contains 250 mg of mefenamic acid for oral administration. Mefenamic acid is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004% at pH 7.1. The chemical name is N-2,3-xylylanthranilic acid. The molecular weight is 241.29. Its molecular formula is C 15H 15NO 2 and the structural formula of mefenamic acid is: Each capsule also contains lactose monohydrate. The capsule shell contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac. Description
What Is Mefenamic Acid Used For?
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Mefenamic acid is indicated: For relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). For treatment of primary dysmenorrhea.
Dosage and Administration
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). After observing the response to initial therapy with mefenamic acid, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of acute pain in adults and adolescents ≥14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week. For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting 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.
Side Effects (Adverse Reactions)
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events ( see WARNINGS) GI Bleeding, Ulceration and Perforation ( see WARNINGS) Hepatotoxicity ( see WARNINGS) Hypertension ( see WARNINGS) Heart Failure and Edema ( see WARNINGS) Renal Toxicity and Hyperkalemia ( see WARNINGS) Anaphylactic Reactions ( see WARNINGS) Serious Skin Reactions ( see WARNINGS) Hematologic Toxicity ( see WARNINGS) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking mefenamic acid or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Gastrointestinal experiences including - abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting, abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, tinnitus Additional adverse experiences reported occasionally and listed here by body system include: Body as a whole - fever, infection, sepsis Cardiovascular system - congestive heart failure, hypertension, tachycardia, syncope Digestive system - dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and lymphatic system - ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness; insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory system - asthma, dyspnea Skin and appendages - alopecia, photosensitivity, pruritus, sweat Special senses - blurred vision Urogenital system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a whole - anaphylactoid reactions, appetite changes, death Cardiovascular system - arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive system - eructation, liver failure, pancreatitis Hemic and lymphatic system - agranulocytosis, hemolytic anemia, aplastic anemia, lymph adenopathy, pancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsions, coma, hallucinations, meningitis Respiratory - respiratory depression, pneumonia Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens - Johnson syndrome, urticaria Special senses - conjunctivitis, hearing impairment To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contraindications
Mefenamic acid is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product ( see WARNINGS; ANAPHYLACTIC REACTIONS, SERIOUS SKIN REACTIONS) . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( see WARNINGS; ANAPHYLACTIC REACTION, EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY) . In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; CARDIOVASCULAR THROMBOTIC EVENTS) .
Overdosage
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare (see WARNINGS; CARDIOVASCULAR THROMBOTIC EVENTS, GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION, HYPERTENSION, RENAL TOXICITY AND HYPERKALEMIA). Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).
How Supplied
Mefenamic Acid Capsules USP 250 mg are Size ‘1’ yellow-yellow capsules with ‘ML’ imprinted on the cap & ‘250’ imprinted on the body. They are supplied as follows: Bottles of 30 Capsules NDC: 80425-0306-01 Bottles of 60 Capsules NDC: 80425-0306-02 Bottles of 90 Capsules NDC: 80425-0306-03 Dispense in a tight container as defined in the USP. Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. For inquiries call 1-855-839-8195 Manufactured by: Micro Labs Limited Goa- 403 722, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.