MEFENAMIC ACID 250 MG 30 CAP
Generic: Mefenamic acid
MEFENAMIC ACID 250 MG 30 CAP
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Identification
Mefenamic acid
Mefenamic acid
Micro Labs Limited
HUMAN PRESCRIPTION DRUG
Administration
CAPSULE
ORAL
ANDA090562
Active Ingredients
| Ingredient | Strength |
|---|---|
| MEFENAMIC ACID | 250 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1 ) For treatment of primary dysmenorrhea. ( 1.2 ) 1.1 Mild to Moderate Pain Mefenamic acid capsules are indicated for management of mild to moderate pain in adults and pediatric patients 14 years of age and older, when therapy will not exceed one week (7 days). 1.2 Dysmenorrhea Mefenamic acid capsules are indicated for treatment of primary dysmenorrhea.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults and adolescents 14 years of age and older: 500 mg given orally as an initial dose followed by 250 mg every 6 hours as needed ( 2.2 ) For the treatment of primary dysmenorrhea: 500 mg given orally as an initial dose followed by 250 mg every 6 hours ( 2.3 ) 2.1 Important Dosage and Administration Information Carefully consider the potential benefits and risks of mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.2) ] . After observing the response to initial therapy with mefenamic acid capsules, the dose and frequency should be adjusted to suit an individual patient's needs. 2.2 For the Management of Mild to Moderate Pain The recommended dosage in adults and pediatric patients 14 years of age and older is 500 mg given orally as an initial dose followed by 250 mg every 6 hours as needed. 2.3 Dysmenorrhea The recommended dose is 500 mg given orally as an initial dose followed by 250 mg every 6 hours starting with the onset of bleeding and associated symptoms.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Heart Failure and Edema [see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9 , 5.10) ] Hematologic Toxicity [see Warnings and Precautions (5.12) ] 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. The following adverse reactions associated with the use of mefenamic acid capsules were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure In patients taking mefenamic acid capsules or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1 to 10% of patients are: Gastrointestinal - Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting Auditory System – Tinnitus Genitourinary System - Abnormal renal function Hepatic System - Elevated liver enzymes Dermatologic - Pruritus, rashes Cardiovascular - Anemia, edema Central Nervous System - Dizziness, headache Hematopoetic and lymphatic system - Increased bleeding time Additional adverse experiences reported less frequently and listed here by body system include: General - anaphylactoid reactions, appetite changes, death, fever, infection, sepsis Cardiovascular - congestive heart failure, hypertension, tachycardia, syncope arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Gastrointestinal system - dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, eructation, liver failure, pancreatitis Hematopoetic and lymphatic system - ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymph-adenopathy, pancytopenia Metabolic - weight changes, hyperglycemia Central Nervous System - anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness; insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo, convulsions, coma, hallucinations, meningitis Respiratory system - asthma, dyspnea, respiratory depression, pneumonia Dermatologic - alopecia, photosensitivity, pruritus, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption (FDE), urticaria Special senses - blurred vision, conjunctivitis, hearing impairment Genitourinary system - cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure In patients taking mefenamic acid or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1 to 10% of patients are: 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 ( 6 ) 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
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families and their caregivers of the following information before initiating therapy with mefenamic acid capsules and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately [see Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop mefenamic acid capsules and seek immediate medical therapy [see Warnings and Precautions (5.3) ] . Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.5) ] . Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4), Warnings and Precautions (5.7) ] . Serious Skin Reactions, including DRESS Advise patients to stop mefenamic acid capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9) ] . Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including mefenamic acid capsules, may be associated with a reversible delay in ovulation. [see Use in Specific Populations (8.3) ]. Fetal Toxicity Inform pregnant women to avoid use of mefenamic acid capsules and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with mefenamic acid capsules are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.11), Use in Specific Populations (8.1) ] . Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of mefenamic acid capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2), Drug Interactions (7.1) ] . Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with mefenamic acid capsules until they talk to their healthcare provider [see Drug Interactions (7.1) ]. For inquiries call 1-855-839-8195 Manufactured by: Micro Labs Limited INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Revised: 01/2026
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.