See Supplemental Patient Information
- Increased risk of serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke are associated with this drug. Patients with known CV disease or risk factors for CV disease are at higher risk. Remain alert for the development of such events, even in the absence of previous CV symptoms. Use lowest effective dose for the shortest duration possible for minimizing the potential risk for an adverse CV event in patients treated with an NSAID
- Onset of new hypertension or worsening of preexisting hypertension is associated with therapy with this drug. Patients having thiazides or loop diuretics may exhibit impaired response to therapy with this drug. Monitor blood pressure (BP) closely during the initiation of NSAID treatment and throughout the course of therapy
- Fluid retention and edema have occurred in patients taking NSAIDs
- Therapy is associated with serious and potentially fatal gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine
- Prescribe with extreme caution in those having a prior history of ulcer disease or GI bleeding. Patients having a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs have a >10 fold increased risk for developing a GI bleed compared to patients with neither of these risk factors
- Concurrent use of oral corticosteroids or anti-coagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status are the risk factors associated with increasing the risk for GI bleeding in patients treated with NSAIDs
- Use lowest effective dose for the shortest duration possible for minimizing the potential risk for an adverse GI event in patients treated with an NSAID. Remain alert and also advise patients to maintain alertness for the development of CV events and GI ulcerations and bleeding. Initiate additional evaluation and treatment on suspection of serious GI event. Discontinue therapy until a serious GI adverse event is ruled out. Consider alternate therapies that do not involve NSAIDs for high risk patients
- Prolong therapy with NSAIDs is associated with renal papillary necrosis and other renal injury. Renal toxicity has occurred in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, with precipitation of overt renal decompensation may occur in such patients. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the geriatrics are at highest risk. Discontinuation of therapy leads to recovery to the pretreatment state
- Therapy is not recommended in patients with advanced renal disease
- Anaphylactic reactions have occurred in patients. Avoid use in patients with the aspirin triad. Asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs are more susceptible. Provide emergency help when necessary
- Fatal serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) have occurred. Inform patients about the signs and symptoms of serious skin manifestations and about discontinuing therapy on appearance of skin rash or any other sign of hypersensitivity
- Avoid use in late pregnancy as it may cause premature closure of the ductus arteriosus
- Avoid using as a substitute for corticosteroids or to treat corticosteroid insufficiency. The pharmacological activity of this combination drug in reducing fever and inflammation diminishes the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions
- This drug is associated with ALT or AST >3x the ULN. Elevations of one or more liver tests have occurred during therapy. Even fatalities or liver transplantation have occurred. Severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure are reported. On developing clinical signs and symptoms consistent with liver disease or on occurrence of systemic manifestations discontinue therapy with this drug
- Anemia has occurred in patients. Monitor hemoglobin and hematocrit in patients on prolong therapy if they exhibit any signs or symptoms of anemia. Alterations in platelet function have occurred resulting in prolongation of prolong bleeding time. Carefully monitor patients with coagulation disorders or patients receiving anticoagulants
- Avoid administration in patients with aspirin sensitivity
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Hypertension
- Cardiovascular disease
- Risk of cardiac disease
- CHF
- Heart failure
- Fluid retention
- History of ulcer disease or GI bleeding
- Dehydration
- Inflammatory bowel disease
- Prolonged use
- Asthma
- Use of corticosteroid
- Use of anticoagulant
- Coagulation disorder
- Concurrent diuretics
- Smokers
- Use of alcohol
- Concomitant use with potentially hepatotoxic drugs
- Debilitated patients
- Geriatrics
Supplemental Patient Information
- Inform patients about the signs and/or symptoms of serious CV and GI events and the steps to take on development of such events
Pregnancy Category:C
Breastfeeding: If mefenamic acid is essential for the mother, it is not a reason to discontinue breastfeeding. This drug is potentially toxic. Prefer other agents especially while nursing a newborn or preterm infant as there is little published experience with mefenamic acid during breastfeeding. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 March 2011). According to manufacturer's data a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Ponstel 250 MG CAPS [Bottle] (SHIONOGI PHARMA)
100 mg = $1843.4
300 mg = $5446.66 - Mefenamic Acid 250 MG CAPS [Bottle] (PADDOCK)
30 mg = $429.99
90 mg = $1196.01
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Mefenamic Acid 250 MG Oral Capsule
Ingredient(s): Mefenamate
Imprint: URL-401
Color(s): White
Shape: Capsule
Size (mm): 20.00
Score: 1
Inactive Ingredient(s): lactose / citric acid / d&c yellow no. 10 / fd&c blue no. 1 / fd&c red no. 3 / fd&c yellow no. 6 / gelatin / glycerol monooleate / silicon dioxide / sodium benzoate / sodium lauryl sulfate / titanium dioxide
Drug Label Author:
SCIELE PHARMA INC
DEA Schedule:
CIII
Drug Name: Ponstel 250 MG Oral Capsule
Pill Image:
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Ingredient(s): Mefenamate
Imprint: FHPC;400;PONSTEL
Color(s): Blue, White
Shape: Capsule
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): lactose / citric acid / d&c yellow no. 10 / fd&c blue no. 1 / fd&c red no. 3 / fd&c yellow no. 6 / gelatin / glycerol monooleate / silicon dioxide / sodium benzoate / sodium lauryl sulfate / titanium dioxide
Drug Label Author:
Sciele Pharma Inc.
DEA Schedule:
CIII
