Dolfenal

Dolfenal

mefenamic acid

Manufacturer:

Amherst Lab

Distributor:

Westmont
Full Prescribing Info
Contents
Mefenamic acid.
Action
Pharmacologic Classification: Non Steroidal Anti-Inflammatory Drug.
Pharmacology: Mefenamic acid has anti-inflammatory, analgesic (pain-reducing), and antipyretic (fever-reducing) activities. It inhibits cyclooxygenase (COX)-1 and COX-2 isoenzymes which in turn inhibits synthesis and release of a group of chemicals called prostaglandins. Prostaglandins are involved in the way we feel pain and the development of fever and inflammation.
Pharmacokinetics: Bioavailability: Mefenamic acid is rapidly absorbed after oral administration. Peak plasma concentrations occur about 2 to 4 hours after ingestion. The plasma elimination half-life is approximately two hours. Mefenamic acid is extensively bound to plasma proteins. Over 50% of a dose is excreted in the urine as unchanged drug or conjugates of mefenamic acid and its metabolites. Small amounts have been detected in breast milk.
Indications/Uses
For symptomatic relief of mild to moderate pain including headache, dental pain, post-operative and post-partum pain, primary dysmenorrhea and menorrhagia.
For symptomatic relief of musculoskeletal and joint disorders including osteoarthritis and rheumatoid arthritis.
Dosage/Direction for Use
Like other NSAIDs, the lowest effective dose of mefenamic acid should be used for the shortest possible time.
250 mg: This medicine is given orally, preferably with food with a full glass of water.
Do not take for more than 7 days unless directed by a doctor.
Adults and Adolescents older than 14 years: 1 to 2 tablets every 8 hours as needed, or, as directed by a doctor.
For the relief of dysmenorrheal and premenstrual syndrome (PMS): 1 to 2 tablets every 8 hours while symptoms persist ("period pains" and other associated symptoms), or, as directed by a doctor.
500 mg: Orally, preferably with food.
Adults and Adolescents older than 14 years: 1 tablet every 8 hours as needed or as directed by a doctor.
For the relief of dysmenorrheal and premenstrual syndrome (PMS): 1 tablet every 8 hours while symptoms persist ("period pains" and other associated symptoms) or as directed by a doctor.
Do not take this medicine continuously for more than 10 days unless directed by a doctor.
Overdosage
Coma and tonic-clonic seizures have been reported in 1 13-year old girl after ingestion of 5-10 g of mefenamic acid. This was resolved following treatment with intravenous diazepam. In humans who reportedly ingested 1.5-50 g of mefenamic acid and have plasma drug concentrations ranging from 11-211 ug/mL, tonic-clonic seizures, muscle twitching, vomiting, and diarrhea were reported.
In the event of overdose, the stomach should be emptied immediately by inducing emesis or by gastric lavage followed by administration of activated charcoal. Since mefenamic acid is highly bound to proteins, forced diuresis, alkalanization of urine, or hemodialysis are probably of no value in enhancing elimination of the drug.
Special Precautions
Use with caution in patients with cardiac, liver or kidney disease. Dose adjustment like using the lowest effective dose and monitoring kidney and liver functions should be instituted.
Do not exceed the recommended dose or duration of treatment. Long term continuous use may increase the risk of heart attack or stroke.
250 mg: Patients who are pregnant, breastfeeding, allergic to mefenamic acid, aspirin or any other NSAID, and those who are about to have coronary bypass surgery should not take this medication. As well as patients who have peptic ulcer, diarrhea with this medicine in the past, and inflammation and/or ulceration of the lining of the stomach or bowel should not take this medicine.
Adverse Reactions
250 mg: Frequently reported adverse events: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastrointestinal ulcers (gastric/duodenal), vomiting, abnormal kidney function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and ringing in the ears (tinnitus).
Other reported adverse events: Body as a whole: fever, infection, bacterial infection in the bloodstream or tissues (sepsis), anaphylactoid reactions, death.
Cardiovascular: congestive heart failure, hypertension, hypotension, tachycardia, syncope, arrhythmia, myocardial infarction, palpitations, vasculitis.
Digestive: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, rectal bleeding, stomatitis, eructation, pancreatitis, proctocolitis.
Hepatic: hepatitis, jaundice, liver failure.
Hematologic: ecchymosis, eosinophilia, leukopenia, melena, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia, thrombocytopenia, agranulocytosis.
Metabolic and nutritional: weight changes, appetite changes, hyperglycemia.
Nervous: asthenia, anxiety, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo, convulsions, meningitis, hallucination.
Urogenital/Reproductive: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, non-oliguric kidney failure.
Respiratory: respiratory depression, pneumonia.
Skin and Appendages: alopecia, pruritus, sweat, angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria, purpura.
Special senses: conjunctivitis, hearing impairment, blurred vision.
500 mg: Frequently reported adverse events: Gastrointestinal: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) peptic ulcer, vomiting.
Hemic and lymphatic: anemia, increased bleeding time.
Hepatic: elevated liver enzymes.
Nervous: dizziness, headache.
Renal: abnormal renal function, edema.
Skin and appendages: pruritus, rash.
Others: tinnitus.
Occasionally reported adverse events: Body as a whole: fever, infection, sepsis.
Cardiovascular: congestive heart failure, hypertension, tachycardia, syncope.
Digestive: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice.
Hemic and lymphatic: ecchymosis, eosinophilia, leucopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia.
Metabolic and nutritional: weight changes.
Nervous: asthenia, anxiety, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.
Renal: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure.
Respiratory: asthma, dyspnea.
Skin and appendages: alopecia, photosensitivity, pruritus, sweat.
Special senses: blurred vision.
Rarely reported adverse events: Body as a whole: anaphylactoid reactions, appetite changes, death.
Cardiovascular: arryhthmia, hypotension, myocardial infarction, palpitations, vasculitis.
Digestive: eructation, liver failure, pancreatitis.
Hemic and lymphatic: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.
Metabolic and nutritional: hyperglycemia.
Nervous: convulsions, coma, hallucinations, meningitis.
Respiratory: respiratory depression, pneumonia.
Skin and appendages: angioedema, erythema multiforme, exfoliative dermatitis, Steven-Johnsons syndrome, toxic epidermal necrosis, urticaria.
Special senses: conjunctivitis, hearing impairment.
ATC Classification
M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, fenamates.
250 mg:Non-Rx;500 mg:Rx
Presentation/Packing
FC tab 250 mg x 100's. 500 mg x 100's.
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