Orudis

DRUG DESCRIPTION

Ketoprofen is a nonsteroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula:

Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4).

Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95 C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20 C.

Orudis(ketoprofen) capsules contain 25 mg, 50 mg, or 75 mg of ketoprofen for oral administration. The inactive ingredients present are D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, gelatin, lactose, magnesium stearate, and titanium dioxide. The 25 mg dosage strength also contains D&C Red 28 and FD&C Red 40.

Each Oruvail(ketoprofen) 100 mg, 150 mg, or 200 mg capsule contains ketoprofen in the form of hundreds of coated pellets. The dissolution of the pellets is pH dependent, with optimum dissolution occurring at pH 6.5 - 7.5. There is no dissolution at pH 1.

In addition to the active ingredient, each 100 mg, 150 mg, or 200 mg capsule of Oruvail contains the following inactive ingredients: D&C Red 22, D&C Red 28, FD&C Blue 1, ethyl cellulose, gelatin, shellac, silicon dioxide, sodium lauryl sulfate, starch, sucrose, talc, titanium dioxide, and other proprietary ingredients. The 100 and 150 mg capsules also contain D&C Yellow 10 and FD&C Green 3.

What are the possible side effects of ketoprofen (Actron, Orudis KT)?

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...

Read All Potential Side Effects and See Pictures of Orudis

What are the precautions when taking ketoprofen (Orudis)?

Before taking ketoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, growths in the nose (nasal polyps),...

Read All Potential Precautions of Orudis


Orudis Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, unusual tiredness, constipation, diarrhea, dizziness, lightheadedness, drowsiness, loss of appetite, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), mental/mood changes (such as confusion, depression), persistent/severe headache, stomach pain, sudden/unexplained weight gain, swelling of the hands or feet, vision changes (such as blurred vision).

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, change in amount of urine, signs of infection (such as fever, chills, persistent sore throat), symptoms of meningitis (such as unexplained stiff neck, fever).

This drug may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ketoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, blood disorders (such as anemia), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, kidney disease, liver disease, growths in the nose (nasal polyps), throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers), stroke, swelling of the ankles/feet/hands, a severe loss of body water (dehydration).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may cause stomach/intestinal bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may infrequently make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of the drug, especially bleeding in the stomach/intestines. Using high doses for a long time may increase this risk.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk or may harm a nursing infant. Consult your doctor before breast-feeding.


Orudis Patient Information Including Side Effects

Brand Names: Actron, Orudis KT

Generic Name: ketoprofen (Pronunciation: kee toe PROE fen)

  • What is ketoprofen (Orudis)?
  • What are the possible side effects of ketoprofen (Orudis)?
  • What is the most important information I should know about ketoprofen (Orudis)?
  • What should I discuss with my healthcare provider before taking ketoprofen (Orudis)?
  • How should I take ketoprofen (Orudis)?
  • What happens if I miss a dose (Orudis)?
  • What happens if I overdose (Orudis)?
  • What should I avoid while taking ketoprofen (Orudis)?
  • What other drugs will affect ketoprofen (Orudis)?
  • Where can I get more information?

What is ketoprofen (Orudis)?

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 other purposes not listed in this medication guide.

What are the possible side effects of ketoprofen (Orudis)?

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.

Less serious side effects may include:

  • 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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.

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