Ponstan

Ponstan

mefenamic acid

Manufacturer:

Pfizer
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Contents
Mefenamic acid.
Action
Mefenamic acid is a nonsteroidal anti-inflammatory that acts by inhibiting prostaglandin synthesis process in body tissue by inhibiting cyclooxygenase enzymes, therefore it has analgesic, anti-inflammatory and antipyretic effects.
Indications/Uses
Mefenamic acid is indicated for relief of mild to moderate pain in: Rheumatoid arthritis; Osteoarthritis; Muscular, traumatic, dental pain; Headache; Post-operative, postpartum; Primary dysmenorrhea; Premenstrual syndrome.
Dosage/Direction for Use
Adults: The recommended initial dose is 500 mg, followed by 250 mg every 6 hrs as required.
Contraindications
Hypersensitivity to mefenamic acid or any of the component of Ponstan.
Patients experiencing bronchospasm, allergic rhinitis, and urticaria when treated with acetyl salicylic acid or other nonsteroidal anti-inflammatory drugs.
Patients with active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract.
Patients with preexisting renal disease.
Treatment or perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Patients with severe heart, renal and hepatic failure.
Special Precautions
The use of mefenamic acid with concomitant systemic non-aspirin NSAIDs including cyclooxygenase-2 (COX-2) inhibitors should be avoided. Concomitant use of a systemic NSAID and another systemic NSAID may increase frequency of gastrointestinal ulcers and bleeding.
Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and non-selective NSAIDs of up to three years duration have shown an increase risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal.
All NSAIDs, both COX-2 selective and non-selective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of acetyl salicylic acid mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of acetyl salicylic acid and an NSAID does increase the risk of serious GI events (see Gastrointestinal (GI) Effect - Risk of GI Ulceration, Bleeding, and Perforation as follows).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see Contraindications).
Hypertension: NSAIDS, including PONSTAN can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including PONSTAN, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with PONSTAN and throughout the course of therapy.
Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs, including PONSTAN. PONSTAN should be used with caution in patients with fluid retention or heart failure.
Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation: NSAIDs, including PONSTAN, can cause serious gastrointestinal events including, inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. These trends with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in patients ingesting alcohol or patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants or selective serotonin reuptake inhibitors, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Skin Reactions: Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including mefenamic acid. Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Mefenamic acid should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Renal Effects: In rare cases, NSAIDs, including mefenamic acid, may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. NSAIDs inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of an NSAID may precipitate overt renal decompensation, which is typically followed by recovery to pretreatment state upon discontinuation of NSAID therapy. Patients at greatest risk of such a reaction are those with congestive heart failure, liver cirrhosis, nephrotic syndrome, overt renal disease and the elderly. Such patients should be carefully monitored while receiving NSAID therapy.
Discontinuation of NSAID therapy is typically followed by recovery to the pre-treatment state. Since mefenamic acid metabolites are eliminated primarily by the kidneys, the drug should not be administered to patients with significantly impaired renal function.
Laboratory Tests: A false-positive reaction for urinary bile, using the diazo tablet test, may result following mefenamic acid administration. If biliuria is suspected, other diagnostic procedures, such as the Harrison spot test, should be performed.
Hematologic Effects: Mefenamic acid can inhibit platelet aggregation and may prolong prothrombin time in patients on warfarin therapy (see Interactions).
Hepatic Effects: Borderline elevations of one or more liver function tests may occur in some patients receiving mefenamic acid therapy. These elevations may progress, may remain essentially unchanged, or may be transient with continued therapy. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with mefenamic acid. If abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, mefenamic acid should be discontinued.
Use with Oral Anticoagulants: The concomitant use of NSAIDs, including mefenamic acid, with oral anticoagulants increases the risk of GI and non-GI bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran, rivaroxaban). Anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant (see Interactions).
Effects on the Ability to Drive or Operate Machinery: Undesirable effects eg, dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Fertility: Based on the mechanism of action, the use of NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including mefenamic acid should be considered.
Use in Pregnancy: Since there are no adequate and well-controlled studies in pregnant women, this drug should be used only if the potential benefits to the mother justify the possible risks to the fetus. It is not known if mefenamic acid or its metabolites cross the placenta. However, because of the effects of drugs in this class (i.e., inhibitors of prostaglandin synthesis) on the fetal CV system (e.g., premature closure of the ductus arteriosus), the use of mefenamic acid in pregnant women is not recommended and should be avoided during the third trimester of pregnancy. Mefenamic acid inhibits prostaglandin synthesis which may result in prolongation of pregnancy and interference with labor when administered late in the pregnancy. Women on mefenamic acid therapy should consult their physician if they decide to become pregnant.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
If used during second or third trimester of pregnancy, NSAIDs may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible. Pregnant women on mefenamic acid should be closely monitored for amniotic fluid volume.
Use in Lactation: Trace amounts of mefenamic acid may be present in breast milk and transmitted to the nursing infant. Therefore, mefenamic acid should not be taken by nursing mothers.
Use In Pregnancy & Lactation
Fertility: Based on the mechanism of action, the use of NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including mefenamic acid should be considered.
Pregnancy: Since there are no adequate and well-controlled studies in pregnant women, this drug should be used only if the potential benefits to the mother justify the possible risks to the fetus. It is not known if mefenamic acid or its metabolites cross the placenta. However, because of the effects of drugs in this class (i.e., inhibitors of prostaglandin synthesis) on the fetal CV system (e.g., premature closure of the ductus arteriosus), the use of mefenamic acid in pregnant women is not recommended and should be avoided during the third trimester of pregnancy. Mefenamic acid inhibits prostaglandin synthesis which may result in prolongation of pregnancy and interference with labor when administered late in the pregnancy. Women on mefenamic acid therapy should consult their physician if they decide to become pregnant.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
If used during second or third trimester of pregnancy, NSAIDs may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible. Pregnant women on mefenamic acid should be closely monitored for amniotic fluid volume.
Lactation: Trace amounts of mefenamic acid may be present in breast milk and transmitted to the nursing infant. Therefore, mefenamic acid should not be taken by nursing mothers.
Side Effects
Side effects are negligible at recommended dosages. Nausea, vomiting and diarrhea have been reported on a few occasions.
Agranulocytosis and haemolytic anemia may occur on long-term, continuous dosage of ≥2000 mg daily.
Drug Interactions
Enhanced effects of coumarin anticoagulants.
Storage
Store below 30°C. Avoid exposure from direct sunlight.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, fenamates.
Presentation/Packing
FC tab 500 mg x 100's.
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