DrugindexOnline^{2nd edition}

Generic Name: Ketoprofen Extended-Release Capsules (KEE-toe-PROE-fen)
Brand Name: Oruvail

Oruvail Extended-Release Capsules is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Oruvail Extended-Release Capsules for a long time. Do not use Oruvail Extended-Release Capsules right before or after bypass heart surgery. Oruvail Extended-Release Capsules may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Oruvail Extended-Release Capsules is used for:

Treating rheumatoid arthritis or osteoarthritis. It is also used to treat menstrual cramps and pain. It may also be used for other conditions as determined by your doctor.

Oruvail Extended-Release Capsules is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Oruvail Extended-Release Capsules if:

• you are allergic to any ingredient in Oruvail Extended-Release Capsules
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
• you have recently had or will be having bypass heart surgery
• you are also taking probenecid
• you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Oruvail Extended-Release Capsules:

Some medical conditions may interact with Oruvail Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
• if you have high blood pressure, blood disorders (eg, low blood albumin levels), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
• if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Oruvail Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because risk of stomach bleeding may be increased
• Probenecid because it may increase the risk of Oruvail Extended-Release Capsules�'s side effects
• Cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Oruvail Extended-Release Capsules
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Oruvail Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oruvail Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Oruvail Extended-Release Capsules:

Use Oruvail Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Oruvail Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oruvail Extended-Release Capsules refilled.
• Take Oruvail Extended-Release Capsules by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Swallow Oruvail Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Take Oruvail Extended-Release Capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Oruvail Extended-Release Capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Oruvail Extended-Release Capsules.

Important safety information:

• Oruvail Extended-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Oruvail Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Serious stomach ulcers or bleeding can occur with the use of Oruvail Extended-Release Capsules. Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Oruvail Extended-Release Capsules with food will NOT reduce the risk of these effects. If you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling, contact your doctor or emergency room right away.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Oruvail Extended-Release Capsules is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not take aspirin while you are using Oruvail Extended-Release Capsules unless your doctor tells you to.
• Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Oruvail Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Oruvail Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
• Oruvail Extended-Release Capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Oruvail Extended-Release Capsules may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oruvail Extended-Release Capsules while you are pregnant. It is not known if Oruvail Extended-Release Capsules is found in breast milk. Do not breast-feed while taking Oruvail Extended-Release Capsules.

Possible side effects of Oruvail Extended-Release Capsules:

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Oruvail Extended-Release Capsules:

Store Oruvail Extended-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oruvail Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
• Oruvail Extended-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Oruvail Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.