RVP

Drug Catalog - Product Detail

MEFENAMIC ACID, USP CP 250MG 30

NDC Mfr Size Str Form
51991-0839-33 BRECKENRIDGE 30 250MG CAPSULE
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Description
DESCRIPTION Mefenamic Acid Capsules are a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each white opaque 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 C 15 H 15 N0 2 and the structural formula of mefenamic acid is: Each capsule also contains lactose monohydrate. The capsule shell contains gelatin, titanium dioxide, and edible Green Ink SB-4020. The ink is composed of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, FD&C Blue No. 2, Aluminum Lake, and titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Mefenamic acid capsules are available as 250 mg white opaque capsules, imprinted with "B" and "839" in green. Bottles of 30 NDC 51991-839-33 Bottles of 100 NDC 51991-839-01 Storage Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].
Indications & Usage
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 ). After observing the response to initial therapy with mefenamic acid, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of acute pain in adults and adolescents ≥14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week. For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.