Mefenamic Acid
500mg Capsule
Non-Steroidal Anti-Inflammatory
FORMULATION:
Each capsule contains:
Mefenamic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mg
DESCRIPTION:
Mefenamic Acid is a non-steroidal anti-inflammatory drug used in painful and inflammatory conditions and in menstrual disorders. The main adverse effects are gastrointestinal, especially diarrhea.
INDICATION:
For the relief of pain including muscular, rheumatic, traumatic, dental, post-operative and post-partum pain and headache.
DOSAGE AND ADMINISTRATION:
The usual dose is up to 500 mg three times daily, or as prescribed by the physician.
CONTRAINDICATIONS:
Not to be given to those patients who have history of:
– Stroke: Cerebrovascular accident, CVA
– Heart Attack: Myocardial infarction, MI
– Coronary artery bypass graft: CABG
– Uncontrolled hypertension
– Congestive heart failure (CHF) NYHA II-IV
PRECAUTIONS:
Contraindicated in patients with history of hypersensitivity to ASA or any other NSAIDs. Contraindicated in patients with ulceration or inflammation of the gastrointestinal tract.
Use with caution in patients with impaired renal or liver functions. Dose adjustment like using the lowest effective dose and monitoring of renal and liver functions should be instituted.
WARNING:
If diarrhea or skin rash appear, Mefenamic acid should be discontinued immediately. Blood counts and liver function should be monitored during long-term therapy. Mefenamic acid may enhance the effects of oral anticoagulants.
Caution should be exercised in the administration of Mefenamic acid to patients suffering from dehydration and or renal disease, particularly the elderly. Bronchoconstriction may occur with Mefenamic acid in asthmatic patients with aspirin sensitivity. Mefenamic acid and its metabolites may give a false positive reaction to certain urine tests for the presence of bile.
DRUG INTERACTIONS:
Anticoagulants: Patients receiving an anticoagulant drug concurrently with Mefenamic acid have had a prolongation of prothrombin time. Mefenamic acid is contraindicated for patients taking an anticoagulant drug if careful and continuous monitoring of the levels of prothrombin Factors VII, IX and X is not available.
Lithium: Patients receiving lithium concurrently with Nonsteroidal Anti-inflammatory drugs including Mefenamic acid, have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Thus, when Mefenamic acid and lithium are administered concurrently, patients should be observed carefully for signs of lithium toxicity.
ADVERSE EFFECTS:
The common side-effects occurring during therapy with non-steroidal anti-inflammatory drugs (NSAIDS) are generally gastrointestinal disturbances; these are usually mild and reversible but in some patients peptic ulcer and severe gastrointestinal bleeding have been reported.
These adverse effects on the gastrointestinal tract may be associated with the inhibition of the form of cyclo-oxygenase known as cyclo-oxygenase-1 (Cox-1) andNSAIDS that are highly selective inhibitors of the formknown as Cox-2 may have less gastrointestinal toxicity.
OVERDOSE AND TREATMENT:
Mefenamic acid overdose has been associated with CNS toxicity, especially with convulsions. Coma has also been reported. Treatment of overdosage is entirely supportive.
Gastric lavage and activated charcoal may be of benefit within 1 hour of ingestion of a potentially toxic amount.
Multiple doses of activated charcoal may be useful in enhancing elimination of NSAIDs with long half-lives such as piroxicam and sulindac. Forced diuresis, haemodialysis, or haemoperfusion are unlikely to be of benefit for NSAID overdosage, although haemodialysis may be required if oliguric renal failure develops.
PHARMACOKINETICS:
Mefenamic Acid is absorbed from the gastrointestinal tract. Peak plasma concentrations occur about two to four hours after ingestion. The plasma elimination half-life is reported to be 2 to 4 hours. Mefenamic acid is extensively bound to plasma proteins. Small amounts have been detected in breast milk. Over 50% of a dose may be recovered in the urine, as unchanged drug or conjugates of Mefenamic Acid and its metabolites.
PREGNANCY AND LACTATION:
Mefenamic acid may be passed to your unborn baby.
Do not take these tablets if you are pregnant or planning to become pregnant unless advised by your doctor.
Mefenamic acid may be present in breast milk therefore should not be taken by nursing mothers
CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Registration Number: DRP-7092
Date of First Authorization: Feb. 11,2012
Seek medical attention immediately at the first sign of any adverse drug reaction. For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph
AVAILABILITY:
Alu/Clear PVC Blister Pack x 10’s(Box of 100 Capsules)
STORAGE CONDITION:
Store at temperatures not exceeding 30ºC
Manufactured by:
Lloyd Laboratories, Inc.
No. 10 Lloyd Ave., First Bulacan Industrial City, City of Malolos, Bulacan
For:
Innogen Pharmaceuticals, Inc.
124-126 Dr. Lazcano St., Brgy. Sacred Heart, Quezon City
Distributed By:
Rose Pharmacy, Incorporated
3rd Floor, FLC Center, 888 Hernan Cortes St, Subangdaku, Mandaue City, 6014, Cebu, Philippines
