Orudis

Name: Orudis

What special precautions should I follow?

Before taking ketoprofen,

  • tell your doctor and pharmacist if you are allergic to ketoprofen, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in ketoprofen capsules or extended-release capsules. Ask your pharmacist for a list of the inactive ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); diuretics ('water pills'); lithium (Lithobid); medications for diabetes; methotrexate (Otrexup, Rasuvo, Trexall); phenytoin (Dilantin, Phenytek); and probenecid (Probalan). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
  • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; or liver or kidney disease.
  • tell your doctor if you are pregnant especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breastfeeding. If you become pregnant while taking ketoprofen, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ketoprofen.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • lack of energy
  • drowsiness
  • nausea
  • vomiting
  • stomach pain
  • shallow breathing
  • seizures
  • coma

Uses

Ketoprofen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to treat gout attacks.

Side effects

See also Warning section.Upset stomach, 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), unusual tiredness.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.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow/shallow breathing.

Side effects

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Orudis (ketoprofen) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Oruvail-treated (200 mg/day) patients in trials lasting from 4 to 16 weeks.

Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of Oruvail (ketoprofen) once a day or 75 mg of Orudis (ketoprofen) TID (225 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.

The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs (see "WARNINGS").

Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related (see "DOSAGE AND ADMINISTRATION"). Rare adverse reactions (incidence less than 1%) were collected from one or more of the following sources: foreign reports to manufacturers and regulatory agencies, publications, U.S. clinical trials, and/or U.S. postmarketing spontaneous reports.

Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.

Incidence Greater than 1% (Probable Causal Relationship)

Digestive: Dyspepsia (11%), nausea*, abdominal pain*, diarrhea*, constipation*, flatulence*, anorexia, vomiting, stomatitis.

Nervous System: Headache*, dizziness, CNS inhibition (i.e., pooled reports of somnolence, malaise, depression, etc.) or excitation (i.e., insomnia, nervousness, dreams, etc.)*.

Special Senses: Tinnitus, visual disturbance.

Skin and Appendages: Rash.

Urogenital: Impairment of renal function (edema, increased BUN)*, signs or symptoms of urinary-tract irritation.

* Adverse events occurring in 3 to 9% of patients.

Incidence Less than 1% (Probable Causal Relationship)

Body as a Whole: Chills, facial edema, infection, pain, allergic reaction, anaphylaxis.

Cardiovascular: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation.

Digestive: Appetite increased, dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, peptic ulcer, gastrointestinal perforation, hematemesis, intestinal ulceration, hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice.

Hemic: Hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.

Metabolic and Nutritional: Thirst, weight gain, weight loss, hyponatremia.

Musculoskeletal: Myalgia.

Nervous System: Amnesia, confusion, impotence, migraine, paresthesia, vertigo.

Respiratory: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

Skin and Appendages: Alopecia, eczema, pruritus, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Special Senses: Conjunctivitis, conjunctivitis sicca, eye pain, hearing impairment, retinal hemorrhage and pigmentation change, taste perversion.

Urogenital: Menometrorrhagia, hematuria, renal failure, interstitial nephritis, nephrotic syndrome.

Incidence Less than 1% (Causal Relationship Unknown)

The following rare adverse reactions, whose causal relationship to ketoprofen is uncertain, are being listed to serve as alerting information to the physician.

Body as a Whole: Septicemia, shock.

Cardiovascular: Arrhythmias, myocardial infarction.

Digestive: Buccal necrosis, ulcerative colitis, microvesicular steatosis, pancreatitis.

Endocrine: Diabetes mellitus (aggravated).

Nervous System: Dysphoria, hallucination, libido disturbance, nightmares, personality disorder, aseptic meningitis.

Urogenital: Acute tubulopathy, gynecomastia.

Read the entire FDA prescribing information for Orudis (Ketoprofen)

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Orudis Overview

Orudis is a brand name medication included in the following groups of medications: Antiinflammatory preparations, non steroids for topical use, Propionic acid derivatives. For more information about Orudis see its generic Ketoprofen

Commonly used brand name(s)

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)

Precautions While Using Orudis

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 .

Orudis Side Effects

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:

More common
  • 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
Less common
  • Bladder pain
  • cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • rash
  • swelling or inflammation of the mouth
Rare
  • 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
Symptoms of overdose
  • 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:

More common
  • 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
Less common
  • 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.

What are some things I need to know or do while I take Orudis?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this medicine (Orudis) for a long time. Talk with your doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this medicine for longer than you were told by your doctor.
  • Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this medicine (Orudis).
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are 65 or older, use this medicine (Orudis) with care. You could have more side effects.
  • NSAIDs like this medicine may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this medicine (Orudis) is stopped. Talk with your doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
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