MEFENAMIC ACID- mefenamic acid capsule
Qualitest Pharmaceuticals
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 USP are a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each green-banded, yellow capsule 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�-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 C15 H15 NO2 Each capsule also contains lactose monohydrate. The capsule shell and band contain dimethicone, D&C yellow No. 10, FD&C blue No. 1 aluminum lake, FD&C yellow No. 6, gelatin, propylene glycol, shellac, titanium dioxide and yellow iron oxide.
CLINICAL PHARMACOLOGY
Mechanism of Action
Mefenamic acid has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of mefenamic acid, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Mefenamic acid is a potent inhibitor of prostaglandin synthesis in vitro. Mefenamic acid concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because mefenamic acid is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. INDICATIONS AND USAGE
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.