Country: United States
Language: English
Source: NLM (National Library of Medicine)
MEFENAMIC ACID (UNII: 367589PJ2C) (MEFENAMIC ACID - UNII:367589PJ2C)
Belcher Pharmaceuticals,LLC
MEFENAMIC ACID
MEFENAMIC ACID 250 mg
ORAL
PRESCRIPTION DRUG
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). 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. Mefenamic acid is contraindicated in patients with known hypersensitivity to mefenamic acid. Mefenamic acid should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma). Mefenamic acid is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (
Mefenamic acid is available as 250 mg green-banded, yellow capsules, imprinted with "BP" on the cap and "629" on the body in green ink. Bottles of 30, NDC# 62250-677-30. Dispense in a tight container as defined in the USP. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
Belcher Pharmaceuticals,LLC ---------- MEDGUIDE Mefenamic Acid Capsules USP, 250 mg Rx Only Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called "corticosteroids" and "anticoagulants" • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions.• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of all your medicines to show to your healthcare provider and ph Read the complete document
MEFENAMIC ACID- MEFENAMIC ACID CAPSULE BELCHER PHARMACEUTICALS,LLC ---------- MEFENAMIC ACID CAPSULES USP, 250 MG BOXED WARNING 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). 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 Mefenamic acid is 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 C H NO and the structural formula of mefenamic acid is: 15 15 2 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 _PHARMACODYNAMICS_ Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti- inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of mefenamic acid, like that of other NSAIDs, is not completely understood but may be related Read the complete document