Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Orudis
  2. Orudis KT
  3. Oruvail

Descriptions


Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can 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:

  • Tablet, Extended Release
  • Tablet
  • Capsule, Extended Release
  • Capsule
  • Tablet, Enteric Coated

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 ketoprofen in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

Pregnancy

Information about this ketoprofen-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • 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
  • Warfarin
  • 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
  • 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
  • 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
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • 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
  • Asthma or
  • Bleeding problems or
  • Blood clots or
  • Edema (fluid retention or body swelling) or
  • Heart attack, history of or
  • Heart disease (e.g., congestive heart failure) or
  • High blood pressure or
  • Kidney disease or
  • Liver disease (e.g., hepatitis) or
  • Stomach or intestinal ulcers or bleeding or
  • Stroke, history of—Use with caution. This medicine may make these conditions worse .
  • Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition.
  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine 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 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 .

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, milk, or antacid unless your doctor tells you otherwise .

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—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
      • Children—Use and dose must be determined by your doctor .
    • For mild to moderate pain or menstrual cramps:
      • Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
      • Children—Use and dose must be determined by your doctor .
  • For oral dosage form (extended-release capsules):
    • For osteoarthritis and rheumatoid arthritis:
      • Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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 take 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 .

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, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid 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 skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

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

This medicine may also 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 while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

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

  1. Abdominal pain
  2. bloody urine
  3. decreased frequency or amount of urine
  4. headache
  5. increased blood pressure
  6. increased thirst
  7. loss of appetite
  8. lower back or side pain
  9. nausea
  10. swelling of face, fingers, feet, or lower legs
  11. troubled breathing
  12. unusual tiredness or weakness
  13. vomiting
  14. weight gain

Less common

  1. Bladder pain
  2. cloudy urine
  3. difficult, burning, or painful urination
  4. frequent urge to urinate
  5. rash
  6. swelling or inflammation of the mouth

Rare

  1. Back pain
  2. bleeding from rectum
  3. bleeding gums
  4. blistering, peeling, loosening of skin
  5. blood in vomit
  6. bloody nose
  7. bloody, black, or tarry stools
  8. blurred vision
  9. body aches or pain
  10. burning feeling in chest or stomach
  11. burning, dry or itching eyes
  12. change in color of eye
  13. chest pain
  14. chills
  15. clay-colored stools
  16. cold hands and feet
  17. coma
  18. confusion
  19. congestion
  20. constipation
  21. convulsions
  22. cough or hoarseness
  23. coughing or spitting up blood
  24. cracks in the skin
  25. dark urine
  26. decreased urination
  27. decreased vision or other changes in vision
  28. diarrhea
  29. difficult or labored breathing
  30. difficulty swallowing
  31. dilated neck veins
  32. discharge, excessive tearing
  33. dryness or soreness of throat
  34. extreme fatigue
  35. fast, irregular, pounding, or racing heartbeat or pulse
  36. feeling faint, dizzy, or lightheadedness
  37. feeling of warmth or heat
  38. fever with or without chills
  39. flushing or redness of skin, especially on face and neck
  40. general tiredness and weakness
  41. heartburn
  42. hives or welts
  43. increased sensitivity of skin to sunlight
  44. indigestion
  45. itching
  46. joint or muscle pain
  47. light-colored stools
  48. loss of heat from the body
  49. muscle pain or cramps
  50. nervousness
  51. noisy breathing
  52. pale or blue lips, fingernails, or skin
  53. pale skin
  54. pinpoint red or purple spots on skin
  55. pounding in the ears
  56. problems with bleeding or clotting
  57. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  58. red skin lesions, often with a purple center
  59. red, irritated eyes
  60. red, swollen skin
  61. redness or other discoloration of skin
  62. redness or soreness around fingernails or loosening of the fingernails
  63. redness, pain, swelling of eye, eyelid, or inner lining of eyelid
  64. runny nose
  65. scaly skin
  66. severe abdominal cramping
  67. severe or continuing stomach pain
  68. severe sunburn
  69. shortness of breath
  70. skin rash, encrusted, scaly and oozing
  71. slow heartbeat
  72. slow or irregular breathing
  73. sores, ulcers, or white spots on lips or in mouth
  74. stomach pain or upset
  75. sweating
  76. swelling of face, ankles, or hands
  77. tender, swollen glands in neck
  78. tenderness in stomach area
  79. tightness in chest
  80. trouble in swallowing
  81. troubled breathing with exertion
  82. unpleasant breath odor
  83. unusual bleeding or bruising
  84. upper right abdominal pain
  85. voice changes
  86. vomiting of blood
  87. vomiting of material that looks like coffee grounds, severe and continuing
  88. wheezing
  89. yellow eyes or skin

Symptoms of overdose

  1. Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  2. fast or shallow breathing
  3. pain or discomfort in chest, upper stomach, or throat
  4. 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

  1. Acid or sour stomach
  2. belching
  3. bloated
  4. discouragement
  5. dreams
  6. excess air or gas in stomach or intestines
  7. excitation
  8. feeling sad or empty
  9. full feeling
  10. general feeling of discomfort or illness
  11. irritability
  12. lack of appetite
  13. loss of interest or pleasure
  14. passing gas
  15. sleepiness
  16. sleeplessness
  17. trouble concentrating
  18. trouble sleeping
  19. unable to sleep

Less common

  1. Continuing ringing or buzzing or other unexplained noise in ears
  2. disturbed color perception
  3. double vision
  4. halos around lights
  5. hearing loss
  6. loss of vision
  7. night blindness
  8. overbright appearance of lights
  9. tunnel vision
  10. weight loss

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.