Dolfenal

Dolfenal

mefenamic acid

Manufacturer:

Amherst Lab

Distributor:

Westmont
Concise Prescribing Info
Contents
Mefenamic acid
Indications/Uses
Symptomatic relief of mild to moderate pain including headache, dental pain, post-op & post-partum pain, primary dysmenorrhea & menorrhagia; musculoskeletal & joint disorders including OA & RA.
Dosage/Direction for Use
Adult & adolescent >14 yr 250 mg 1-2 tab every 8 hr, as needed. 500 mg 1 tab every 8 hr, as needed. Should not be taken >7 days. Symptomatic relief of dysmenorrhea & premenstrual syndrome 250 mg 1-2 tab every 8 hr while symptoms persist. 500 mg 1 tab every 8 hr while symptoms persist. Should not be taken >2-3 days for the relief of primary dysmenorrhea.
Administration
Should be taken with food: Take w/ food or milk if stomach upset occurs.
Contraindications
Hypersensitivity to mefenamic acid, aspirin or NSAIDs, or to other ingredients in the product. Currently taking aspirin or other NSAIDs. Bronchospasm, angioedema, nasal polyps, allergic-type reactions after taking aspirin or other NSAIDs. Suffering from stomach ulcers, bleeding or other stomach problems eg, inflammatory bowel disease. Diarrhea in the past w/ previous therapy. Cerebrovascular bleeding or other bleeding disorders. Known hyperkalemia. Dengue fever. Severe cardiac, hepatic or renal disease. Pregnancy (3rd trimester) & lactation. Childn & adolescents <14 yr. 500 mg: GI bleeding or perforation related to previous NSAID therapy; previous or active ulceration or chronic inflammation of either the upper or lower GIT. Treatment of perioperative pain in the setting of CABG surgery. Asthma, urticaria, allergic-type reactions, severe, rarely fatal, anaphylactoid reactions to NSAIDs.
Special Precautions
May increase risk of serious CV thrombotic events, MI, & stroke. Ischemic heart disease, cerebrovascular disease, &/or CHF (NYHA II-IV); intracranial hemorrhage & bleeding diathesis; fluid retention or heart failure; history of ulcer disease or GI bleeding; ulcerative colitis & Crohn's disease; dehydration; preexisting asthma. Not recommended for use w/ other NSAIDs except low-dose aspirin. Onset of new or worsening of preexisting HTN; closely monitor BP during initiation & throughout the course of therapy. Not to be used as substitute for corticosteroids. Serious GI adverse events including inflammation, bleeding, ulceration, & perforation of the stomach, small or large intestines. Patients at greater risk of are those w/ impaired renal function, heart failure, liver dysfunction, taking diuretics & ACE inhibitors. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any sign of hypersensitivity. Check for Hb or hematocrit in patients w/ long-term treatment w/ NSAIDs. Prolonged use for headaches. Increased risk of aseptic meningitis in patients w/ SLE. Epilepsy. Liver dysfunction, rash, blood dyscrasias or development of diarrhea should be monitored in patients on prolonged therapy. Not recommended in patients w/ advanced renal disease. May affect ability to drive or operate machinery. Pregnancy & lactation. Elderly patients suffering from impaired renal or hepatic cardiac function.
Adverse Reactions
Abdominal pain, abnormal kidney function, anemia, constipation, diarrhea, dyspepsia, edema, elevated liver enzymes (eg, ALT or AST), flatulence, GI ulcers (gastric/duodenal), gross bleeding/perforation, headache, heartburn, nausea, increased bleeding time; nausea, pruritus, rashes, tinnitus, & vomiting.
Drug Interactions
Increased risk of renal impairment w/ ACE inhibitors (eg, captopril, fosinopril, imidapril, enalapril) & AIIA (eg, losartan, telmisartan). May reduce excretion of aminoglycosides (eg, gentamicin) & MTX. Increased Cmax & AUC w/ antacid. Increased risk of GI ulceration or bleeding w/ anticoagulants (eg, warfarin), antiplatelet agents (eg, aspirin, clopidogrel, cilostazol), corticosteroids & SSRIs (eg, fluoxetine, citalopram, sertraline). Increased adverse effects w/ aspirin, other NSAIDs (eg, ibuprofen, ketorolac, meloxicam) including COX-2 selective inhibitors (eg, celecoxib, etoricoxib). Reduced GFR & increase plasma cardiac glycoside levels w/ cardiac glycosides (eg, digoxin). Increased risk of nephrotoxicity w/ ciclosporin & tacrolimus. Reduced the natriuretic effects w/ diuretics (eg, thiazides, furosemide). Altered safety & efficacy w/ drugs affecting hepatic microsomal enzymes. Reduce renal excretion w/ lithium. Reduced effects of mifepristone. Increased risk of hypoglycemia w/ sulfonylureas. Reduced metabolism & elimination of NSAIDs & metabolites. Concomitant use w/ protein-bound drugs (eg, hydantoins, sulfonamides & sulfonylureas). Increased risk of convulsions w/ quinolones. Increased risk of hematological toxicity w/ zidovudine.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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
Form
Dolfenal FC tab 250 mg
Packing/Price
100's
Form
Dolfenal FC tab 500 mg
Packing/Price
100's
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