Ansaid - Flurbiprofen (Oral Route)

    Ansaid – Flurbiprofen (Oral Route)

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    Description and Brand Names of Ansaid – Flurbiprofen (Oral Route)

    US Brand Name

    1. Ansaid

    Descriptions

    Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and 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 take it.

    Flurbiprofen may also be used for other problems as determined by your doctor.

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

    This product is available in the following dosage forms:

    • Tablet
    • Capsule, Extended Release

    Before Using Ansaid – Flurbiprofen (Oral Route)

    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 flurbiprofen 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 flurbiprofen in the elderly. However, elderly patients are more likely to have age-related kidney and gastrointestinal problems, which may require caution and an adjustment in the dose for patients receiving flurbiprofen.

    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
    • Apixaban
    • Ardeparin
    • Argatroban
    • Beta Glucan
    • Bivalirudin
    • Certoparin
    • Cilostazol
    • Citalopram
    • Clopidogrel
    • Clovoxamine
    • Cyclosporine
    • Dabigatran Etexilate
    • Dalteparin
    • Danaparoid
    • Desirudin
    • Dipyridamole
    • Duloxetine
    • Enoxaparin
    • Eptifibatide
    • Erlotinib
    • Escitalopram
    • Femoxetine
    • Feverfew
    • Flesinoxan
    • Fluoxetine
    • Fondaparinux
    • Ginkgo
    • Gossypol
    • Heparin
    • Lepirudin
    • Levomilnacipran
    • Meadowsweet
    • Methotrexate
    • Milnacipran
    • Nadroparin
    • Nefazodone
    • Parnaparin
    • Paroxetine
    • Pemetrexed
    • Pentosan Polysulfate Sodium
    • Pentoxifylline
    • Pralatrexate
    • Prasugrel
    • Protein C
    • Reviparin
    • Rivaroxaban
    • Sibutramine
    • Tacrolimus
    • Ticlopidine
    • Tinzaparin
    • Tirofiban
    • Venlafaxine
    • Vilazodone
    • Vortioxetine
    • Zimeldine

    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
    • Acenocoumarol
    • Acetohexamide
    • Alacepril
    • Alprenolol
    • Amiloride
    • Amlodipine
    • Arotinolol
    • Atenolol
    • Azilsartan Medoxomil
    • Azosemide
    • Befunolol
    • Bemetizide
    • Benazepril
    • Bendroflumethiazide
    • Benzthiazide
    • Bepridil
    • Betaxolol
    • Bevantolol
    • Bisoprolol
    • Bopindolol
    • Bucindolol
    • Bumetanide
    • Bupranolol
    • Buthiazide
    • Candesartan Cilexetil
    • Canrenoate
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Chlorothiazide
    • Chlorpropamide
    • Chlorthalidone
    • Cilazapril
    • Clopamide
    • Cyclopenthiazide
    • Delapril
    • Desvenlafaxine
    • Dicumarol
    • Dilevalol
    • Diltiazem
    • Enalaprilat
    • Enalapril Maleate
    • Eprosartan
    • Esmolol
    • Ethacrynic Acid
    • Felodipine
    • Flunarizine
    • Fosinopril
    • Furosemide
    • Gallopamil
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Gliquidone
    • Glyburide
    • Hydrochlorothiazide
    • Hydroflumethiazide
    • Imidapril
    • Indapamide
    • Irbesartan
    • Isradipine
    • Labetalol
    • Lacidipine
    • Landiolol
    • Levobetaxolol
    • Levobunolol
    • Lidoflazine
    • Lisinopril
    • Losartan
    • Manidipine
    • Mepindolol
    • Methyclothiazide
    • Metipranolol
    • Metolazone
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Nicardipine
    • Nifedipine
    • Nilvadipine
    • Nimodipine
    • Nipradilol
    • Nisoldipine
    • Nitrendipine
    • Olmesartan Medoxomil
    • Oxprenolol
    • Penbutolol
    • Pentopril
    • Perindopril
    • Phenprocoumon
    • Pindolol
    • Piretanide
    • Polythiazide
    • Pranidipine
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril
    • Spironolactone
    • Talinolol
    • Tasosartan
    • Telmisartan
    • Temocapril
    • Tertatolol
    • Timolol
    • Tolazamide
    • Tolbutamide
    • Torsemide
    • Trandolapril
    • Triamterene
    • Trichlormethiazide
    • Valsartan
    • Verapamil
    • Xipamide
    • Zofenopril

    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
    • Congestive heart failure or
    • Edema (fluid retention or body swelling) or
    • Heart attack, history of or
    • Heart disease or
    • Hypertension (high blood pressure) or
    • Kidney disease or
    • Liver disease (e.g., 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 or
    • Aspirin sensitivity, history of – Should not be used in patients with these conditions.
    • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery) – Should not be used to relieve pain right before or after the surgery.

    Proper Use of Ansaid – Flurbiprofen (Oral Route)

    For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

    This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

    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 one 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.

    To lessen stomach upset, you may take this medicine with food.

    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 (tablets):

      • For osteoarthritis and rheumatoid arthritis:

        • Adults – At first, 200 to 300 milligrams (mg) per day, divided into two to four equal doses. Your doctor may adjust your dose as needed. However, each dose usually is not more than 100 mg.
        • 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 to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

    This medicine may increase 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.

    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 are using certain other medicines such as steroids or a blood thinner).

    Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

    Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs are including black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, and/or lower legs; unusual bleeding or bruising; unusual weight gain; or yellow skin or eyes . Also, signs of serious heart problems could occur such as chest pain, fast or irregular heartbeat, slurring of speech, tightness in the chest, unusual flushing or warmth of the skin, or weakness. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

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

    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).

    Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

    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 of Ansaid – Flurbiprofen (Oral Route)

    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:

    Less common

    1. Abdominal or stomach pain
    2. bladder pain
    3. bloody or black, tarry stools
    4. bloody or cloudy urine
    5. constipation
    6. difficult, burning, or painful urination
    7. frequent urge to urinate
    8. lower back or side pain
    9. rash
    10. severe stomach pain
    11. swelling
    12. vomiting of blood or material that looks like coffee grounds

    Rare

    1. Back or leg pains
    2. bleeding gums
    3. blistering, peeling, or loosening of the skin
    4. bloody diarrhea
    5. bloody nose
    6. blurred vision
    7. burning feeling in the chest or stomach
    8. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    9. chest pain
    10. chills
    11. clay-colored stools
    12. cough
    13. cracks in the skin
    14. dark urine
    15. decreased urine output
    16. difficulty breathing
    17. difficulty swallowing
    18. dilated neck veins
    19. dizziness
    20. extreme fatigue
    21. fast heartbeat
    22. feeling faint, dizzy, or lightheaded
    23. feeling of warmth or heat
    24. fever with or without chills
    25. flushing or redness of the skin, especially on the face and neck
    26. general feeling of tiredness or weakness
    27. greatly decreased frequency of urination
    28. headache
    29. high fever
    30. hives
    31. hoarseness
    32. increased blood pressure
    33. increased sensitivity of the skin to sunlight
    34. increased thirst
    35. indigestion
    36. irregular breathing
    37. irregular heartbeat
    38. itching
    39. joint pain, stiffness, or swelling
    40. large, flat, blue, or purplish patches in the skin
    41. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    42. light-colored stools
    43. loss of appetite
    44. loss of heat from the body
    45. muscle pain
    46. nausea
    47. nervousness
    48. noisy breathing
    49. nosebleeds
    50. pale skin
    51. pinpoint red or purple spots on the skin
    52. pounding in the ears
    53. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    54. red skin lesions, often with a purple center
    55. red, irritated eyes
    56. red, swollen skin
    57. redness or other discoloration of the skin
    58. redness, swelling, or soreness of the tongue
    59. scaly skin
    60. severe or continuing stomach pain
    61. severe sunburn
    62. shakiness and unsteady walk
    63. shortness of breath
    64. skin rash, encrusted, scaly and oozing
    65. slow or fast heartbeat
    66. sore throat
    67. sores, ulcers, or white spots on the lips or in the mouth
    68. stomach bloating or cramping
    69. stomach upset
    70. sweating
    71. swelling of the face, fingers, feet, or lower legs
    72. swelling or inflammation of the mouth
    73. swollen or painful glands
    74. tenderness in the stomach area
    75. tightness in the chest
    76. troubled breathing
    77. unpleasant breath odor
    78. unsteadiness, trembling, or other problems with muscle control or coordination
    79. unusual bleeding or bruising
    80. unusual tiredness or weakness
    81. upper right abdominal or stomach pain
    82. vomiting
    83. weight gain
    84. weight loss
    85. wheezing
    86. yellow eyes or skin

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

    Symptom of overdose

    1. Change in consciousness
    2. fast or slow, or shallow breathing
    3. heartburn
    4. loss of consciousness
    5. pain or discomfort in the chest, upper stomach, or throat
    6. pale or blue lips, fingernails, or skin
    7. unusual drowsiness, dullness, 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:

    Less common

    1. Acid or sour stomach
    2. belching
    3. changes in vision
    4. continuing ringing or buzzing or other unexplained noise in the ear
    5. diarrhea
    6. discouragement
    7. excess air or gas in the stomach or intestines
    8. fear
    9. feeling of constant movement of self or surroundings
    10. feeling sad or empty
    11. full feeling
    12. general feeling of discomfort or illness
    13. hearing loss
    14. irritability
    15. lack of appetite
    16. lack or loss of strength
    17. lightheadedness
    18. loss of interest or pleasure
    19. loss of memory
    20. passing gas
    21. problems with memory
    22. runny nose
    23. sensation of spinning
    24. sleepiness
    25. sleeplessness
    26. sneezing
    27. stomach discomfort
    28. stuffy nose
    29. tremor
    30. trouble concentrating
    31. trouble sleeping
    32. unable to sleep

    Rare

    1. Burning, dry, or itching eyes
    2. confusion
    3. discharge or excessive tearing
    4. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
    5. transient, mild, pleasant aromatic odor
    6. twitching

    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.