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Drug Description

PONSTEL®
(mefenamic acid) Capsules, USP 250 mg

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).
PONSTEL® (mefenamic acid) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (See WARNINGS).

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (See WARNINGS).

DESCRIPTION

Ponstel® (mefenamic acid) is a member of the fenamate group of nonsteroidal anti- inflammatory drugs (NSAIDs). Each blue-banded, ivory 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 C15H15NO2 and the structural formula of mefenamic acid is:

Ponstel® (mefenamic acid) structural formula illustration

Each capsule also contains lactose, NF. The capsule shell and/or band contains citric acid, USP; D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, NF; glycerol monooleate; silicon dioxide, NF; sodium benzoate, NF; sodium lauryl sulfate, NF; titanium dioxide, USP.

Indications & Dosage

INDICATIONS

Carefully consider the potential benefits and risks of PONSTEL (mefenamic acid) and other treatment options before deciding to use PONSTEL (mefenamic acid) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

PONSTEL (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

After observing the response to initial therapy with PONSTEL (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.4

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.5

HOW SUPPLIED

Ponstel (mefenamic acid) is available as 250 mg blue-banded, ivory capsules, imprinted with "FHPC 400" and "PONSTEL® (mefenamic acid) ".