(kee toe proe' fen)

Brand Name(s): Actron^®¶, Nexcede^®¶, Orudis^®¶, Orudis^® KT¶, Oruvail^®¶; also available generically

IMPORTANT WARNING:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin, such as ketoprofen, may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as ketoprofen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ketoprofen right before or right after the surgery.

NSAIDs such as ketoprofen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink more than three alcoholic drinks per day while taking ketoprofen. Tell your doctor if you drink large amounts of alcohol or if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines or other bleeding disorders. If you experience any of the following symptoms, stop taking ketoprofen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ketoprofen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prescription ketoprofen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

WHY is this medicine prescribed?

Prescription ketoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Prescription ketoprofen capsules are also used to relieve pain, including menstrual pain (pain that occurs before or during a menstrual period). Nonprescription ketoprofen is used to relieve minor aches and pain from headaches, menstrual periods, toothaches, the common cold, muscle aches, and backaches, and to reduce fever. Ketoprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Are there OTHER USES for this medicine?

Ketoprofen is also sometimes used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children), ankylosing spondylitis (arthritis that mainly affects the spine), Reiter's syndrome (condition in which many parts of the body including the joints, eyes, genitals, bladder, and digestive system become swollen), shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone), and gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints). Talk to your doctor about the risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Prescription ketoprofen comes as a capsule and extended-release (long-acting) capsule to take by mouth. The capsules are usually taken three or four times a day for arthritis or every 6 to 8 hours as needed for pain. The extended-release capsules are usually taken once daily. If you take ketoprofen regularly, take it at around the same times every day.

Nonprescription ketoprofen comes as a tablet to take by mouth. It is usually taken with a full glass of water or other liquid every 4 to 6 hours as needed.

Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ketoprofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or written on the label.

Ketoprofen may be taken with food or milk to prevent upset stomach. Your doctor may also recommend that you take ketoprofen with an antacid to reduce stomach upset.

Your doctor may start you on an average dose of prescription ketoprofen and may increase or decrease on your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully.

Stop taking nonprescription ketoprofen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days or your fever lasts for more than 3 days.

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); medications for diabetes; diuretics ('water pills'); lithium (Lithobid); 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, plan to become pregnant; or are breast-feeding. Ketoprofen may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take ketoprofen around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking ketoprofen, call your doctor.

• talk to your doctor about the risks and benefits of taking ketoprofen if you are 75 years of age or older. Do not take this medication for a longer period of time or at a higher dose than recommended by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ketoprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• sores in the mouth
• headache
• dizziness
• nervousness
• drowsiness
• difficulty falling asleep or staying asleep
• ringing in the ears

Some side effects may be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ketoprofen until you speak to your doctor.

• changes in vision
• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling of the abdomen, feet, ankles, or lower legs
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, arms, or hands
• hoarseness
• difficulty swallowing
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• nausea
• pain in the upper right part of the stomach
• flu-like symptoms
• yellowing of the skin or eyes
• pale skin
• fast heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Ketoprofen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

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

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ketoprofen.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2021.