Mefenamic acid (oral route)


    Brand Name

    US Brand Name

    Ponstel


    Description

    Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain. It may also be used to treat menstrual cramps and other conditions as determined by your doctor.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of mefenamic acid in children below 14 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mefenamic acid in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving mefenamic acid.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Ketorolac

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Aluminum Carbonate, Basic
    • Aluminum Hydroxide
    • Aluminum Phosphate
    • Amifampridine
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argatroban
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benzthiazide
    • Betrixaban
    • Bismuth Subsalicylate
    • Bivalirudin
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Bupropion
    • Calcium Carbonate
    • Cangrelor
    • Celecoxib
    • Certoparin
    • Chlorothiazide
    • Chlorthalidone
    • Choline Magnesium Trisalicylate
    • Choline Salicylate

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acebutolol
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Enalapril
    • Enalaprilat
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Irbesartan
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Perindopril
    • Pindolol
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Telmisartan
    • Timolol
    • Trandolapril

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Anemia or
    • Asthma or
    • Bleeding problems or
    • Blood clots or
    • Congestive heart failure or
    • Edema (fluid retention or body swelling) or
    • Heart attack, history of or
    • Hyperkalemia (high potassium in the blood) or
    • Hypertension (high blood pressure) or
    • Kidney disease or
    • Liver disease (eg, hepatitis) or
    • Stomach or intestinal ulcers or bleeding, history of or
    • Stroke, history of—Use with caution. May make these conditions worse.
    • Aspirin-sensitive asthma, history of or
    • Aspirin (or other NSAIDs) sensitivity, history of or
    • Kidney disease, severe or
    • Stomach ulcers, active—Should not be used in patients with these conditions.
    • Dehydration or
    • Hypovolemia (low blood volume)—Must be corrected first before using this medicine.
    • Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used for pain right before or after surgery.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

    If this medicine upsets your stomach, take it with food or milk.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (capsules):
      • For menstrual cramps:
        • Adults and children 14 years of age and older—At first, 500 milligrams (mg), then 250 mg every 6 hours as needed, for 2 to 3 days.
        • Children younger than 14 years of age—Use and dose must be determined by your doctor.
      • For mild to moderate pain:
        • Adults and children 14 years of age and older—At first, 500 milligrams (mg), then 250 mg every 6 hours as needed, for not more than 1 week.
        • Children younger than 14 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits. to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

    This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (eg, steroid medicine, blood thinner).

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

    Some possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

    Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

    Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

    This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

    This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

    Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

    Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Bloody urine
    • bloody, black, or tarry stools
    • decreased frequency or amount of urine
    • heartburn
    • increased bleeding time
    • increased blood pressure
    • increased thirst
    • indigestion
    • itching, skin rash
    • loss of appetite
    • lower back or side pain
    • nausea
    • pale skin
    • severe stomach pain, cramping, or burning
    • stomach bloating
    • swelling of the face, fingers, feet, or lower legs
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • vomiting of material that looks like coffee grounds, severe and continuing
    • weight gain
    • weight loss

    Less common

    • Bleeding gums
    • blood in vomit
    • blurred vision
    • burning feeling in the chest or stomach
    • chest pain or tightness
    • clay-colored stools
    • cloudy urine
    • confusion
    • constipation
    • cough or hoarseness
    • dark urine
    • difficult or labored breathing
    • difficult, burning, or painful urination
    • difficulty in swallowing
    • dilated neck veins
    • dizziness
    • fainting
    • fast, pounding, or irregular heartbeat or pulse
    • fever or chills
    • frequent urge to urinate
    • headache
    • increased volume of pale, dilute urine
    • irregular, rapid, or slow breathing
    • irregular heartbeat
    • large, flat, blue, or purplish patches in the skin
    • light-colored stools
    • lightheadedness
    • nervousness
    • noisy breathing
    • pain or burning feeling in the throat
    • pinpoint red or purple spots on the skin
    • pounding in the ears
    • redness, swelling, or soreness of the tongue
    • severe or continuing stomach pain
    • slow heartbeat
    • sore throat
    • sores, ulcers, or white spots on the lips or tongue or inside the mouth
    • stomach upset
    • swelling or inflammation of the mouth
    • swollen glands
    • tenderness in the stomach area
    • tremors
    • unpleasant breath odor
    • upper right stomach pain
    • yellow eyes and skin

    Rare

    • Blistering, peeling, or loosening of the skin
    • change in consciousness
    • chest discomfort
    • continuing vomiting
    • cracks in the skin
    • diarrhea
    • dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
    • drowsiness
    • fever with or without chills
    • flushed, dry skin
    • fruit-like breath odor
    • general body swelling
    • general feeling of illness
    • high fever
    • hives
    • increased hunger
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • leg pain
    • loss of consciousness
    • loss of heat from the body
    • no blood pressure
    • no breathing
    • no pulse
    • nosebleeds
    • painful glands
    • pain or discomfort in the arms, jaw, back, or neck
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • pale or blue lips, fingernails, or skin
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • racing heartbeat or pulse
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • red, swollen skin
    • redness or soreness of the skin
    • scaly skin
    • seeing, hearing, or feeling things that are not there
    • seizures
    • severe headache
    • sneezing
    • sores, welting, or blisters
    • stiff neck or back
    • sweating
    • swollen, painful, or tender lymph glands in the neck, armpit, or groin
    • unexplained weight loss

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Continuing ringing or buzzing or other unexplained noise in the ears
    • excess air or gas in the stomach or intestines
    • feeling of fullness
    • hearing loss
    • passing gas
    • stomach discomfort

    Less common

    • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • discouragement
    • dry mouth
    • fear
    • feeling of constant movement of self or surroundings
    • feeling sad or empty
    • hair loss, thinning of the hair
    • increased sensitivity of the skin to sunlight
    • irritability
    • lack of appetite
    • lack of interest or pleasure
    • lack or loss of strength
    • redness or other discoloration of the skin
    • sensation of spinning
    • severe sunburn
    • sleepiness
    • trouble concentrating
    • trouble sleeping

    Rare

    • Appetite changes
    • burning, dry, or itching eyes
    • change in hearing
    • discharge, excessive tearing
    • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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