Ponstan Capsules

Carefully consider the potential benefits and risks of mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Mefenamic acid capsules are 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.

• 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
• 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

• Safety and effectiveness
• Pediatric patients below the age of 14 have not been established

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects (see Warnings ; Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation , Hepato …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed
• Inform patients, families and their caregivers of the following information before initiating therapy with mefenamic acid and periodically during the course of ongoing therapy
• Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see Warnings; Cardiovascular Thrombotic Events ). …

• Mefenamic acid capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product (see WARNINGS ; Anaphylactic Reactions, Serious Skin Reactions )
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. …

See Table 2 for clinically significant drug interactions with mefenamic acid. $ Table 2: Clinically Significant Drug Interactions with Mefenamic Acid Drugs That Interfere with Hemostasis Clinical Impact: Mefenamic acid and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of mefenamic acid and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. …

Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. …

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see Warnings ) GI Bleeding, Ulceration and Perforation (see Warnings ) Hepatotoxicity (see Warnings ) Hypertension (see Warnings ) Heart Failure and Edema (see Warnings ) Renal Toxicity and Hyperkalemia (see Warnings ) Anaphylactic Reactions (see Warnings ) Serious Skin Reactions (see Warnings ) Hematologic Toxicity (see Warnings ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another …

Pregnancy Risk Summary Use of NSAIDs, including mefenamic acid, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of mefenamic acid use between about 20 and 30 weeks of gestation, and avoid mefenamic acid use at about 30 weeks of gestation and later in pregnancy [ see Warnings ; Fetal Toxic …

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare (see Warnings ; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hypertension , Renal Toxicity and Hyperkalemia ). Manage patients with symptomatic and supportive care following an NSAID overdosage. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.