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ketoprofen (Oral route)

Pronunciation

kee-toe-PROE-fen

Oral route(Tablet;Capsule;Capsule, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ketoprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

  • Orudis
  • Orudis KT
  • Oruvail

Available Dosage Forms:

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

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For ketoprofen

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. ketoprofen does not cure arthritis and will help you only as long as you continue to take it .

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

ketoprofen is available only with your doctor's prescription .

Before Using ketoprofen

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 ketoprofen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketoprofen 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

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.

Breast Feeding

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.

Interactions with Medicines

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 ketoprofen, 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 ketoprofen 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 ketoprofen 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 ketoprofen 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

Interactions with Food/Tobacco/Alcohol

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 ketoprofen. 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. ketoprofen may make these conditions worse .
  • Aspirin sensitivity, history of—ketoprofen should NOT be used in patients with this condition.
  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—ketoprofen should NOT be used to relieve pain right before or after the surgery .

Proper Use of ketoprofen

For safe and effective use of ketoprofen, 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 ketoprofen may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, ketoprofen must be taken regularly as ordered by your doctor in order for it to help you. ketoprofen 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 ketoprofen.

To lessen stomach upset, you may take ketoprofen with food, milk, or antacid unless your doctor tells you otherwise .

Dosing

The dose of ketoprofen 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 ketoprofen. 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 ketoprofen, 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 While Using ketoprofen

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 .

ketoprofen 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 ketoprofen for a long time might also have a higher risk .

ketoprofen 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 ketoprofen. Check with your doctor right away if you have any of the following symptoms while taking ketoprofen: 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 ketoprofen 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 ketoprofen and check with your doctor immediately if you notice any of these warning signs.

ketoprofen 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 ketoprofen while you are pregnant can harm your unborn baby. If you think you have become pregnant while using ketoprofen, tell your doctor right away .

ketoprofen 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
  • Abdominal pain
  • bloody urine
  • decreased frequency or amount of urine
  • headache
  • increased blood pressure
  • increased thirst
  • loss of appetite
  • lower back or side pain
  • nausea
  • swelling of face, fingers, feet, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Bladder pain
  • cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • rash
  • swelling or inflammation of the mouth
Rare
  • Back pain
  • bleeding from rectum
  • bleeding gums
  • blistering, peeling, loosening of skin
  • blood in vomit
  • bloody nose
  • bloody, black, or tarry stools
  • blurred vision
  • body aches or pain
  • burning feeling in chest or stomach
  • burning, dry or itching eyes
  • change in color of eye
  • chest pain
  • chills
  • clay-colored stools
  • cold hands and feet
  • coma
  • confusion
  • congestion
  • constipation
  • convulsions
  • cough or hoarseness
  • coughing or spitting up blood
  • cracks in the skin
  • dark urine
  • decreased urination
  • decreased vision or other changes in vision
  • diarrhea
  • difficult or labored breathing
  • difficulty swallowing
  • dilated neck veins
  • discharge, excessive tearing
  • dryness or soreness of throat
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling faint, dizzy, or lightheadedness
  • feeling of warmth or heat
  • fever with or without chills
  • flushing or redness of skin, especially on face and neck
  • general tiredness and weakness
  • heartburn
  • hives or welts
  • increased sensitivity of skin to sunlight
  • indigestion
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of heat from the body
  • muscle pain or cramps
  • nervousness
  • noisy breathing
  • pale or blue lips, fingernails, or skin
  • pale skin
  • pinpoint red or purple spots on skin
  • pounding in the ears
  • problems with bleeding or clotting
  • 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
  • red, swollen skin
  • redness or other discoloration of skin
  • redness or soreness around fingernails or loosening of the fingernails
  • redness, pain, swelling of eye, eyelid, or inner lining of eyelid
  • runny nose
  • scaly skin
  • severe abdominal cramping
  • severe or continuing stomach pain
  • severe sunburn
  • shortness of breath
  • skin rash, encrusted, scaly and oozing
  • slow heartbeat
  • slow or irregular breathing
  • sores, ulcers, or white spots on lips or in mouth
  • stomach pain or upset
  • sweating
  • swelling of face, ankles, or hands
  • tender, swollen glands in neck
  • tenderness in stomach area
  • tightness in chest
  • trouble in swallowing
  • troubled breathing with exertion
  • unpleasant breath odor
  • unusual bleeding or bruising
  • upper right abdominal pain
  • voice changes
  • vomiting of blood
  • vomiting of material that looks like coffee grounds, severe and continuing
  • wheezing
  • yellow eyes or skin
Symptoms of overdose
  • Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fast or shallow breathing
  • pain or discomfort in chest, upper stomach, or throat
  • 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
  • bloated
  • discouragement
  • dreams
  • excess air or gas in stomach or intestines
  • excitation
  • feeling sad or empty
  • full feeling
  • general feeling of discomfort or illness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • passing gas
  • sleepiness
  • sleeplessness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
Less common
  • Continuing ringing or buzzing or other unexplained noise in ears
  • disturbed color perception
  • double vision
  • halos around lights
  • hearing loss
  • loss of vision
  • night blindness
  • overbright appearance of lights
  • tunnel vision
  • 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.

See also: Side effects (in more detail)

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