Orudis KT

Orudis KT is part of the drug classes:

• Antiinflammatory preparations, non steroids for topical use

• Propionic acid derivatives

In the U.S.

• Orudis
• Orudis KT
• Oruvail

Available Dosage Forms:

• Tablet, Extended Release
• Tablet
• Capsule, Extended Release
• Solution
• Capsule
• Syrup
• Tablet, Enteric Coated

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

This medicine is available only with your doctor's prescription .

This section provides information on the proper use of a number of products that contain ketoprofen. It may not be specific to Orudis KT. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food, milk, or antacid unless your doctor tells you otherwise .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
    • Children—Use and dose must be determined by your doctor .
  • For mild to moderate pain or menstrual cramps:
    • Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
    • Children—Use and dose must be determined by your doctor .
• For oral dosage form (extended-release capsules):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every day.
    • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

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) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal pain
• bloody urine
• decreased frequency or amount of urine
• headache
• increased blood pressure
• increased thirst
• loss of appetite
• lower back or side pain
• nausea
• swelling of face, fingers, feet, or lower legs
• troubled breathing
• unusual tiredness or weakness
• vomiting
• weight gain

• Bladder pain
• cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• rash
• swelling or inflammation of the mouth

• Back pain
• bleeding from rectum
• bleeding gums
• blistering, peeling, loosening of skin
• blood in vomit
• bloody nose
• bloody, black, or tarry stools
• blurred vision
• body aches or pain
• burning feeling in chest or stomach
• burning, dry or itching eyes
• change in color of eye
• chest pain
• chills
• clay-colored stools
• cold hands and feet
• coma
• confusion
• congestion
• constipation
• convulsions
• cough or hoarseness
• coughing or spitting up blood
• cracks in the skin
• dark urine
• decreased urination
• decreased vision or other changes in vision
• diarrhea
• difficult or labored breathing
• difficulty swallowing
• dilated neck veins
• discharge, excessive tearing
• dryness or soreness of throat
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• fever with or without chills
• flushing or redness of skin, especially on face and neck
• general tiredness and weakness
• heartburn
• hives or welts
• increased sensitivity of skin to sunlight
• indigestion
• itching
• joint or muscle pain
• light-colored stools
• loss of heat from the body
• muscle pain or cramps
• nervousness
• noisy breathing
• pale or blue lips, fingernails, or skin
• pale skin
• pinpoint red or purple spots on skin
• pounding in the ears
• problems with bleeding or clotting
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• redness or other discoloration of skin
• redness or soreness around fingernails or loosening of the fingernails
• redness, pain, swelling of eye, eyelid, or inner lining of eyelid
• runny nose
• scaly skin
• severe abdominal cramping
• severe or continuing stomach pain
• severe sunburn
• shortness of breath
• skin rash, encrusted, scaly and oozing
• slow heartbeat
• slow or irregular breathing
• sores, ulcers, or white spots on lips or in mouth
• stomach pain or upset
• sweating
• swelling of face, ankles, or hands
• tender, swollen glands in neck
• tenderness in stomach area
• tightness in chest
• trouble in swallowing
• troubled breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• upper right abdominal pain
• voice changes
• vomiting of blood
• vomiting of material that looks like coffee grounds, severe and continuing
• wheezing
• yellow eyes or skin

• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast or shallow breathing
• pain or discomfort in chest, upper stomach, or throat
• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated
• discouragement
• dreams
• excess air or gas in stomach or intestines
• excitation
• feeling sad or empty
• full feeling
• general feeling of discomfort or illness
• irritability
• lack of appetite
• loss of interest or pleasure
• passing gas
• sleepiness
• sleeplessness
• trouble concentrating
• trouble sleeping
• unable to sleep

• Continuing ringing or buzzing or other unexplained noise in ears
• disturbed color perception
• double vision
• halos around lights
• hearing loss
• loss of vision
• night blindness
• overbright appearance of lights
• tunnel vision
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Applies to ketoprofen: oral capsule, oral capsule extended release, oral solution, oral syrup, oral tablet, oral tablet enteric coated, oral tablet extended release

Along with its needed effects, ketoprofen (the active ingredient contained in Orudis KT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ketoprofen:

• Abdominal pain
• bloody urine
• decreased frequency or amount of urine
• headache
• increased blood pressure
• increased thirst
• loss of appetite
• lower back or side pain
• nausea
• swelling of face, fingers, feet, or lower legs
• troubled breathing
• unusual tiredness or weakness
• vomiting
• weight gain

• Bladder pain
• cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• rash
• swelling or inflammation of the mouth

• Back pain
• bleeding from rectum
• bleeding gums
• blistering, peeling, loosening of skin
• blood in vomit
• bloody nose
• bloody, black, or tarry stools
• blurred vision
• body aches or pain
• burning feeling in chest or stomach
• burning, dry or itching eyes
• change in color of eye
• chest pain
• chills
• clay-colored stools
• cold hands and feet
• coma
• confusion
• congestion
• constipation
• convulsions
• cough or hoarseness
• coughing or spitting up blood
• cracks in the skin
• dark urine
• decreased urination
• decreased vision or other changes in vision
• diarrhea
• difficult or labored breathing
• difficulty swallowing
• dilated neck veins
• discharge, excessive tearing
• dryness or soreness of throat
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• fever with or without chills
• flushing or redness of skin, especially on face and neck
• general tiredness and weakness
• heartburn
• hives or welts
• increased sensitivity of skin to sunlight
• indigestion
• itching
• joint or muscle pain
• light-colored stools
• loss of heat from the body
• muscle pain or cramps
• nervousness
• noisy breathing
• pale or blue lips, fingernails, or skin
• pale skin
• pinpoint red or purple spots on skin
• pounding in the ears
• problems with bleeding or clotting
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• redness or other discoloration of skin
• redness or soreness around fingernails or loosening of the fingernails
• redness, pain, swelling of eye, eyelid, or inner lining of eyelid
• runny nose
• scaly skin
• severe abdominal cramping
• severe or continuing stomach pain
• severe sunburn
• shortness of breath
• skin rash, encrusted, scaly and oozing
• slow heartbeat
• slow or irregular breathing
• sores, ulcers, or white spots on lips or in mouth
• stomach pain or upset
• sweating
• swelling of face, ankles, or hands
• tender, swollen glands in neck
• tenderness in stomach area
• tightness in chest
• trouble in swallowing
• troubled breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• upper right abdominal pain
• voice changes
• vomiting of blood
• vomiting of material that looks like coffee grounds, severe and continuing
• wheezing
• yellow eyes or skin

• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast or shallow breathing
• pain or discomfort in chest, upper stomach, or throat
• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Some side effects of ketoprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated
• discouragement
• dreams
• excess air or gas in stomach or intestines
• excitation
• feeling sad or empty
• full feeling
• general feeling of discomfort or illness
• irritability
• lack of appetite
• loss of interest or pleasure
• passing gas
• sleepiness
• sleeplessness
• trouble concentrating
• trouble sleeping
• unable to sleep

• Continuing ringing or buzzing or other unexplained noise in ears
• disturbed color perception
• double vision
• halos around lights
• hearing loss
• loss of vision
• night blindness
• overbright appearance of lights
• tunnel vision
• weight loss

Applies to ketoprofen: compounding powder, oral capsule, oral capsule extended release, oral tablet

General

The most frequently reported side effects were gastrointestinal in nature and included dyspepsia, abdominal pain, nausea, diarrhea, constipation, and flatulence.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 11.5%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation, flatulence, anorexia, vomiting, stomatitis, nausea, gastralgia
Uncommon (0.1% to 1%): Gastritis
Rare (0.01% to 0.1%): Peptic ulcer
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, gastrointestinal (GI) perforation, hematemesis, intestinal ulceration, buccal necrosis, ulcerative colitis, microvesicular steatosis, ulcerative colitis exacerbated, Crohn's disease exacerbated, GI bleeding, mouth ulcer, sore tongue, GI hemorrhage[Ref]

Nervous system

Common (1% to 10%): Headache, central nervous system (CNS) inhibition, CNS excitation, somnolence, dizziness
Rare (less than 0.1%): Paresthesia
Frequency not reported: Amnesia, migraine, taste perversion, convulsions, drowsiness, dysgeusia, optic neuritis[Ref]

Cardiovascular

Frequency not reported: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation, shock, arrhythmia, myocardial infarction, heart failure exacerbated, atrial fibrillation, flushing, vasculitis[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, transaminases increased, bilirubin elevated
Frequency not reported: Hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice, liver function abnormal[Ref]

Renal

Frequency not reported: Renal failure/acute renal failure, interstitial nephritis, nephrotic syndrome, renal function tests abnormal, acute tubulopathy[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, nervousness
Frequency not reported: Confusion, dysphoria, hallucination, libido disturbance, nightmares, personality disorder, tension, anxiety, mood altered[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus
Frequency not reported: Purpura, alopecia, eczema, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, angioedema, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, bruising[Ref]

Ocular

Common (1% to 10%): Visual disturbance
Frequency not reported: Conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage, retinal pigmentation change[Ref]

Genitourinary

Common (1% to 10%): Urinary tract irritated
Frequency not reported: Impotence, menometrorrhagia, hematuria, gynecomastia[Ref]

Hematologic

Rare (less than 0.1%): Anemia, hemorrhagic anemia
Frequency not reported: Hypocoagulability, agranulocytosis, hemolysis, thrombocytopenia, neutropenia, bone marrow failure, bone marrow aplasia, hemolytic anemia, leukopenia[Ref]

Respiratory

Rare (less than 0.1%): Asthma/asthma attack
Frequency not reported: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema[Ref]

Metabolic

Frequency not reported: Appetite increased, hyponatremia, diabetes mellitus aggravated, hyperkalemia[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Immunologic

Rare (less than 0.1%): Anaphylaxis
Frequency not reported: Allergic reaction[Ref]

Local

Frequency not reported: Rectal bleeding, rectal pain, rectal burning, rectal pruritus, rectal tenesmus[Ref]

Other

Common (1% to 10%): Malaise, tinnitus, edema, BUN increased
Uncommon (0.1% to 1%): Fatigue
Rare (less than 0.1%): Weight gain
Frequency not reported: Infection, pain, facial edema, chills, weight loss, thirst, vertigo, hearing impaired, septicemia, aseptic meningitis[Ref]

Some side effects of Orudis KT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.