Brand Name

    US Brand Name

    Feldene

    Canadian Brand Name

    Alti-Piroxicam


    Description

    Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and help relieve symptoms of arthritis (eg, osteoarthritis, rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to use it.

    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 piroxicam in the pediatric population. 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 piroxicam in the elderly. However, elderly patients may be more sensitive to the stomach side effects (eg, ulcers, bleeding) of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving piroxicam.

    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
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argatroban
    • Asciminib
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benzthiazide
    • Betrixaban
    • Bismuth Subsalicylate
    • Bivalirudin
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Cangrelor
    • Carbamazepine
    • Celecoxib
    • Ceritinib
    • Certoparin
    • Chlorothiazide
    • Chlorthalidone
    • Choline Magnesium Trisalicylate
    • Choline Salicylate
    • Cilostazol
    • Citalopram
    • Clomipramine

    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
    • Anisindione
    • 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

    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
    • Bleeding problems or
    • Blood clots or
    • Congestive heart failure or
    • Dehydration or
    • Edema (fluid retention or body swelling) or
    • Heart attack, recent or
    • Heart or blood vessel disease or
    • Hyperkalemia (high levels of potassium in the blood) or
    • Hypertension (high blood pressure) or
    • Kidney disease or
    • Liver disease 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 sensitivity, history of or
    • Kidney disease, severe—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 to relieve pain right before or after the surgery.

    Proper Use

    For safe and effective use of this medicine, do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Using too much of this medicine may increase the chance of unwanted effects.

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

    Swallow the capsule whole. Do not crush, break, or chew it.

    When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within 1 week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

    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 osteoarthritis and rheumatoid arthritis:
        • Adults—20 milligrams (mg) once a day or 10 mg 2 times a day.
        • Children—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. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. 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. People who use this medicine for a long time might also have a higher risk. 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 any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

    Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the 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 also cause serious allergic reaction called anaphylaxis, which can be life-threatening and requires medical attention. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). 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.

    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.

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

    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.

    Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

    Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

    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

    • Bloating
    • bloody or black, tarry stools
    • burning upper stomach pain
    • cloudy urine
    • constipation
    • decrease in urine output or decrease in urine-concentrating ability
    • headache
    • heartburn
    • indigestion
    • itching skin or rash
    • loss of appetite
    • nausea or vomiting
    • pale skin
    • severe stomach pain, cramping, or burning
    • severe and continuing nausea
    • swelling
    • swelling of the face, fingers, feet, or lower legs
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting of blood or material that looks like coffee grounds
    • weight changes

    Less common

    • Bleeding gums
    • blood in the urine
    • bloody nose
    • blurred vision
    • burning feeling in the chest or stomach
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • chest pain or tightness
    • clay-colored stools
    • confusion
    • cough or hoarseness
    • dark urine
    • difficult or labored breathing
    • difficult, burning, or painful urination
    • difficulty with swallowing
    • dilated neck veins
    • dizziness
    • fainting
    • fever or chills
    • flushing or redness of the skin
    • frequent urge to urinate
    • increased sensitivity of the skin to sunlight
    • increased thirst
    • increased volume of pale, dilute urine
    • large, flat, blue, or purplish patches in the skin
    • lightheadedness
    • lower back or side pain
    • nervousness
    • noisy breathing
    • numbness or tingling in the hands, feet, or lips
    • pain or burning in the throat
    • peeling of the skin
    • pinpoint red or purple spots on the skin
    • pounding in the ears
    • rapid, shallow breathing
    • redness or other discoloration of the skin
    • redness, swelling, or soreness of the tongue
    • severe sunburn
    • slow, fast, pounding, or irregular heartbeat or pulse
    • 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
    • unpleasant breath odor
    • unusually warm skin
    • weakness or heaviness of the legs
    • yellow eyes or skin

    Rare

    • Anxiety
    • back or leg pains
    • burning, dry, or itching eyes
    • cold sweats
    • coma
    • cracks in the skin
    • diarrhea
    • discharge or excessive tearing
    • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
    • dry mouth
    • flushed, dry skin
    • fruit-like breath odor
    • general body swelling
    • general feeling of discomfort or illness
    • high fever
    • increased hunger
    • increased urination
    • inflammation of the joints
    • irregular, fast or slow, or shallow breathing
    • joint pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • loss of heat from the body
    • muscle aches and pains
    • nightmares
    • no blood pressure
    • no breathing
    • no pulse
    • 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
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
    • runny nose
    • scaly skin
    • seeing, hearing, or feeling things that are not there
    • seizures
    • severe headache
    • shakiness
    • shivering
    • sleepiness
    • slurred speech
    • sneezing
    • sores, welting, or blisters
    • stiff neck or back
    • stomach pain, continuing
    • suddenly sweating
    • swollen, painful, or tender lymph glands in the neck, armpit, or groin
    • trouble sleeping

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

    Symptoms of overdose

    • Agitation
    • depression
    • hives
    • hostility
    • irritability
    • muscle twitching
    • pain or discomfort in the chest, upper stomach, or throat
    • rapid weight gain
    • stupor
    • swelling of the ankles or hands
    • 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

    • Acid or sour stomach
    • belching
    • continuing ringing or buzzing or other unexplained noise in the ears
    • excess air or gas in the stomach or intestines
    • hearing loss
    • passing gas
    • stomach discomfort or upset

    Less common

    • Feeling of constant movement of self or surroundings
    • hair loss or thinning of the hair
    • lack or loss of strength
    • sensation of spinning
    • shakiness in the legs, arms, hands, or feet
    • trembling or shaking of the hands or feet

    Rare

    • Change in hearing
    • changes in appetite
    • inability to sit still
    • mood alterations
    • need to keep moving
    • restlessness

    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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