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All about: Orudis

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Generic Name: ketoprofen (kee toe PROE fen)
Brand Names: Actron, Orudis, Orudis KT, Oruvail

What is Orudis (ketoprofen)?

Ketoprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketoprofen works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

Ketoprofen may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Orudis (ketoprofen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ketoprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before taking Orudis (ketoprofen)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to ketoprofen, or to aspirin or other NSAIDs.

Before taking ketoprofen, tell your doctor if you are allergic to any drugs, or if you have:

  • a history of heart attack, stroke, or blood clot;

  • heart disease, congestive heart failure, high blood pressure;

  • a history of stomach ulcers or bleeding, bowel problems, diverticulosis;

  • liver or kidney disease;
  • asthma;

  • polyps in your nose; or

  • if you smoke.

If you have any of these conditions, you may not be able to use ketoprofen, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketoprofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take Orudis (ketoprofen)?

Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Ketoprofen should not be used to treat minor aches and pains.

The maximum amount of ketoprofen for adults is 300 milligrams (mg) of over-the counter ketoprofen (Orudis), or 200 mg of prescription ketoprofen (Oruvail). Know the amount of ketoprofen in the specific product you are taking.

If you take ketoprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store ketoprofen at room temperature, away from moisture, heat, and light.

What happens if I miss a dose?

Since ketoprofen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a ketoprofen overdose may include nausea, vomiting, dizziness, drowsiness, black or bloody stools, coughing up blood, urinating less than usual or not at all, shallow breathing, fainting, seizure (convulsion), or coma.

What should I avoid while taking Orudis (ketoprofen)?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to ketoprofen (such as aspirin, ibuprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or naproxen. Do not drink alcohol while taking ketoprofen. Alcohol can increase the risk of stomach bleeding.

Orudis (ketoprofen) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ketoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:
  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • confusion, tremors or shaking;

  • urinating less than usual or not at all;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • bruising, severe tingling, numbness, pain, muscle weakness.

Keep taking ketoprofen and talk to your doctor if you have any of these less serious side effects:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

  • dizziness, headache, nervousness;

  • skin itching or rash;

  • dry mouth;

  • increased sweating, runny nose;

  • blurred vision; or

  • ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Orudis (ketoprofen)?

Before taking ketoprofen, tell your doctor if you are taking any of the following drugs:

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • lithium (Eskalith, Lithobid);

  • methotrexate (Rheumatrex, Trexall);

  • probenecid (Benemid);

  • a blood thinner such as warfarin (Coumadin), or an anti-platelet medication such as clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and others;

  • steroids (prednisone and others);

  • aspirin or NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

If you are using any of these drugs, you may not be able to use ketoprofen or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ketoprofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has information about ketoprofen written for health professionals that you may read.

What does my medication look like?

Ketoprofen is available with a prescription under the brand names Orudis and Oruvail. Ketoprofen is also available over the counter under the brand names Actron and Orudis KT. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Orudis 25 mg--dark-green/red capsule

  • Orudis 50 mg--dark-green/light-green capsules

  • Orudis 75 mg--dark-green/white capsules

  • Oruvail 200 mg--pink/off-white capsules

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 7.02. Revision Date: 1/24/07 4:06:52 PM.

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