Ketoprofen (By mouth)

How to Use This Medicine

Capsule, Long Acting Capsule, Tablet, Long Acting Tablet, Coated Tablet

• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• If you are using this medicine without a prescription, follow the instructions on the medicine label.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• It is best to take this medicine with food or milk so it does not upset your stomach.
• Use this medicine for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of ulcers or other stomach problems. Tell your doctor if you have bleeding problems, liver disease, or kidney disease. Make sure your doctor knows if you have high blood pressure, congestive heart failure (CHF), or other heart or circulation problems.
• 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).

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Flu-like symptoms.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Problems with vision, speech, or walking.
• Rapid weight gain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Skin rash or blisters with fever.
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness.
• Sudden or severe headache.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vomiting blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Changes in your vision.
• Constipation, gas, or upset stomach.
• Dizziness.
• Headache.
• Mild nausea, diarrhea, or stomach pain.
• Ringing in your ears.
• Unusual drowsiness, nervousness, or depression.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Ketoprofen (kee-toe-PROE-fen)

Treats pain caused by arthritis, menstrual cramps, and other medical problems. This medicine is a non-steroidal anti-inflammatory drug (NSAID).

Brand Name(s)

Orudis, Oruvail, Orudis KT

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to ketoprofen, aspirin, or other pain and arthritis medicines such as ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, Motrin®, or Vioxx®. The reaction may have included wheezing or trouble breathing, hives, rash, or swelling in your face. Do not use this medicine right before or right after having coronary artery bypass graft (CABG), a type of heart surgery.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, a blood thinner such as warfarin (Coumadin®), or a steroid such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®. Tell your doctor if you are using methotrexate (Trexall®), or a diuretic ("water pill") such as furosemide, hydrochlorothiazide (HCTZ), torsemide, Demadex®, or Lasix®. Make sure your doctor knows if you are using lithium (Eskalith®, Lithobid®) or probenecid (Probalan®).
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other NSAIDs are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®.