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Formulation : Extended Release Tablet
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Indications

Orudis SR is a medication that contains the active ingredient ketoprofen. It belongs to a family of medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs) and is used to relieve pain and reduce inflammation in conditions such as rheumatoid arthritis and osteoarthritis.

Use and Dosage

Read the Medication Guide provided by your pharmacist before you start taking ketoprofen and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 3 to 4 times a day or as needed. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. If stomach upset occurs while taking this medication, it may be taken with food, milk, or an antacid.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 2 weeks of taking this drug regularly until you get the full benefit. If you use this medication for migraine headaches and the pain is not relieved, or if it worsens after the first dose, tell your doctor right away.

If you are taking this drug “as needed” (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, or feeling short of breath.

Serious side effects include:

  • Shortness of breath (even with mild exertion)
  • Swelling or rapid weight gain
  • Nausea, diarrhea, flu-like symptoms (fever, swollen glands, muscle aches, severe weakness)
  • Skin rash, no matter how mild
  • Signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
  • Liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
  • Kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath
  • Low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet

Common side effects of ketoprofen may include:

  • Heartburn, stomach pain, gas, nausea, vomiting
  • Diarrhea, constipation
  • Dizziness

This is not a complete list of side effects and others may occur.

Cautions

  • Before taking ketoprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other 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 using 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/clotting problems, blood disorders (such as anemia), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, swelling (edema, fluid retention), stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers).
  • Kidney problems can sometimes occur with the use of NSAID medications, including ketoprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have pink/bloody urine or any unusual change in the amount of urine.
  • This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
  • This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk of stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.
  • This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
  • 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 at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.
  • Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.
  • This drug passes into breast milk. Consult your doctor before breast-feeding.

Forms and Strengths

Orudis SR is available in the following forms and strengths:

  • Orudis SR Extended-Release Tablet:
    • 200 mg

FAQ

What happens if I miss a dose?

Since ketoprofen is used when needed, you may not be on a dosing schedule. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention.

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking ketoprofen?

Do not take ketoprofen regular capsules and extended-release capsules at the same time.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ketoprofen (such as aspirin, ibuprofen, or naproxen).

Resources:

  1. https://www.webmd.com/drugs/2/drug-9387/orudis-oral/details
  2. https://www.drugs.com/mtm/ketoprofen.html#side-effects
  3. https://www.news-medical.net/drugs/Orudis-SR.aspx

Additional information

Formulation:

Extended Release Tablet