Orudis KT (Oral)

Ketoprofen is used to relieve mild to moderate pain, including menstrual cramps or arthritis. This medicine does not cure arthritis and will only help you as long as you keep taking it.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that treats pain, inflammation, swelling, stiffness, and joint pain.

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

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

This medicine may increase 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. Check with your doctor right away if you have chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

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 (e.g., steroid or a blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver problem.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, fever, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness and weakness.

Your blood pressure might become too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Check with your doctor right away if you have blood in your urine, a decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be signs of a serious kidney problem.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medication, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other drugs. As well tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoprofen in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific issues that would limit the usefulness of ketoprofen in the elderly. Nevertheless, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving ketoprofen.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this drug while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medications is not advised. Your clinician may decide not to treat you with this drug or change some of the other drugs you take.

• Ketorolac

Using this drug with any of the following medicines is normally not advised, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the medications.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this drug with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the drugs.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical problems, especially:

• Anemia or
• Asthma or
• Bleeding issues or
• Blood clots or
• Congestive heart failure or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Stomach or bowel ulcers or bleeding or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to ease pain right before or after the surgery.

Along with its beneficial effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

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

More common

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

Less common

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

Rare

• Back pain
• bleeding from the rectum
• bleeding gums
• blistering, peeling, loosening of the skin
• blood in vomit
• bloody nose
• bloody, black, or tarry stools
• blurred vision
• body aches or pain
• burning feeling in the chest or stomach
• burning, dry or itching eyes
• change in color of eye
• chest pain or tightness
• chills
• clay-colored stools
• cold hands and feet
• coma
• confusion
• congestion
• constipation
• 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 of warmth or heat
• fever with or without chills
• flushing or redness of the skin, especially on the face and neck
• general tiredness and weakness
• heartburn
• increased sensitivity of the 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 the 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 the fingernails or loosening of the fingernails
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• scaly skin
• severe stomach cramping
• severe or continuing stomach pain
• severe sunburn
• skin rash, encrusted, scaly and oozing
• slow heartbeat
• slow or irregular breathing
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain or upset
• sweating
• swelling of face, ankles, or hands
• tender, swollen glands in the neck
• tenderness in the stomach area
• trouble in swallowing
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• voice changes
• vomiting of blood
• vomiting of material that looks like coffee grounds, severe and continuing
• yellow eyes or skin

Symptoms of overdose

• Change in consciousness
• difficulty or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• pain or discomfort in chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• seizures
• 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 the 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
• trouble concentrating
• trouble sleeping

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.

In the U.S.

• Orudis
• Orudis KT
• Oruvail

Available Dosage Forms:

• Capsule, Extended Release
• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Use this medicine exactly as ordered by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than ordered by your doctor. To do so may increase the chance of unwanted effects, especially in elderly patients.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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) 3 times a day or 50 mg 4 times a day. Your doctor may increase your dose as needed. However the dose is usually not more than 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 milligrams (mg) every 6 to 8 hours as needed. Some people may need to take as much as 75 mg every 6 to 8 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 milligrams (mg) once a 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.