(kee toe proe' fen)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||
|Administration||Should be taken with food. Preferably taken w/ or after meals.
|Overdosage||Symptoms: Lethargy, drowsiness, nausea, vomiting, epigastric pain. Respiratory depression, coma, convulsions (large overdoses). Rarely GI bleeding, hypotension, hypertension or acute renal failure. Management: Symptomatic and supportive.|
|Contraindications||Acute or history of peptic ulcer or dyspepsia. Hypersensitivity to aspirin or other NSAIDs or those suffering from bronchial asthma, angioedema, urticaria or rhinitis. Severe renal insufficiency.|
|Special Precautions||Pregnancy, lactation. Renal or hepatic impairment. Elderly. Heart failure.|
|Adverse Drug Reaction(s)||Acute interstitial nephritis, reversible decline in renal function; GI symptoms e.g. discomfort, nausea, diarrhoea; pain and tissue damage at inj site (IM).
Potentially Fatal: Rarely, idiosyncrasy, anaphylaxis; very rarely GI haemorrhage.
|Drug Interactions||Risk of nephrotoxicity increased with ACE inhibitors, ciclosporin, tacrolimus or diuretics. Increased risk of hyperkalaemia with ACE inhibitors and potassium-sparing diuretics. Reduces effects of antihypertensives (e.g. ACE inhibitors, Î²-blockers). Increased risk of convulsions with quinolones. Increased risk of adverse effects with aspirin. Increased risk of GI bleeding and ulceration with corticosteroids, SSRIs, clopidogrel and ticlopidine. Increased risk of haematotoxicity with zidovudine. May alter the efficacy of mifepristone. Increased plasma levels with probenecid.
Potentially Fatal: Enhances effects of oral anticoagulants, phenytoin and sulfonylureas. Increases plasma concentrations of lithium, methotrexate and cardiac glycosides. Please consult detailed drug interactions before prescribing.
|Pregnancy Category (FDA)||
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
Category D: In 3rd trimester or near delivery. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
|Storage||Intramuscular: Store below 30Â°C. Oral: Store at room temperature 15-30Â°C (59-86Â°F). Rectal: Store below 25Â°C. Topical/Cutaneous: Store below 25Â°C.|
|Pharmacology||Ketoprofen exhibits anti-inflammatory, analgesic and antipyretic activities. It potently inhibits the enzyme cyclooxygenase resulting in prostaglandin synthesis inhibition. It also prevents formation of thromboxane A2 by platelet aggregation.
Absorption: Readily absorbed from the GI tract (oral); reduced absorption with food. Peak plasma concentrations after 0.5-2 hr. Well absorbed (IM, rectal); minimal (topical).
Distribution: Synovial fluid (substantial concentrations). Protein-binding: 99%.
Metabolism: Hepatic via conjugation with glucuronic acid.
Excretion: Urine (as glucuronide conjugates); 1.5-4 hr (elimination half-life).
|ATC Classification||M02AA10 - ketoprofen; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AE03 - ketoprofen; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products. Used in the treatment of inflammation and rheumatism.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|KEFEN||Techno Drugs||Ketoprofen 100mg/2ml||Injection||10 amps: 125.00 MRP|
|KETO-A||The Acme Laboratories Ltd.||Ketoprofen 50mg & 100mg||Tablet||50's each: 175.50 & 276.00 MRP|
|KETO-A Injection||The Acme Laboratories Ltd.||Ketoprofen 100mg/2ml||Injection||10 amps: 195.80 MRP|
|KETO-A Suppository||The Acme Laboratories Ltd.||Ketoprofen 100mg||Suppository||10's: 120.50 MRP|
|KETO-SR||Hudson Pharmaceuticals Ltd||Ketoprofen 100mg||Capsule (sustained release)||100's: 350.00 MRP|
|KETONAC||Navana Pharmaceuticals Limited||Ketoprofen 50mg & 100mg||Tablet||50's each: 125.50 & 251.00 MRP|
|KETRON SR||ACI Ltd.||Ketoprofen 100mg||Capsule||50's: 351.50 MRP|
|KONTROL TR 100||Silva Pharmaceuticals Limited||Ketoprofen 100mg||Capsule (timed release)||30's: 180.68 MRP|
|KOP 100||Square Pharmaceuticals Ltd.||Ketoprofen 100mg||Capsule||5x10's: 551.50 MRP|
|KOP 200||Square Pharmaceuticals Ltd.||Ketoprofen 200mg||Capsule||3x10's: 601.80 MRP|
|KOP 50||Square Pharmaceuticals Ltd.||Ketoprofen 50mg||Tablet||5x10's: 301.00 MRP|
|KOP GEL||Square Pharmaceuticals Ltd.||Ketoprofen 25mg/gm||Gel||20 gm: 70.21 MRP|
|KOP IM||Square Pharmaceuticals Ltd.||Ketoprofen 100mg/2 ml||IM Injection||2x5's: 351.10 MRP|
|KYNOL TR||Eskayef Bangladesh Ltd||Ketoprofen BP 100mg & 200mg||Capsule(timed release)||100mg x50's & 200mg x30's MRP: 350.00 & 300.00|
|ORKET||Orion Pharma Ltd.||Ketoprofen 100mg/2ml||Injection||5 amps: 75.30 MRP|
|PROFENID||Sanofi||Ketoprofen 100mg/2ml||IM Injection||10 amps: 451.70 MRP|
|PROFENID CR||Sanofi||Ketoprofen 100mg & 200mg||Capsule (constant release)||50's each: 507.50 & 913.50 MRP|
|PROFENID Gel||Sanofi||Ketoprofen 30gm||Gel||30gm: 101.53 MRP|
|PROFENID-E||Sanofi||Ketoprofen 50mg & 100mg||Tablet||50's each: 251.00 & 426.50 MRP|
|TOP||Biopharma Laboratories Ltd||Ketoprofen 50mg & 100mg||Tablet||50mg x50's, 100mg x30's: 175.50 & 180.60 MRP|
|TRAMP CR||Bristol Pharma Limited||Ketoprofen 100mg||Capsule (constant release)||50's: 505.50 MRP|
|XYNOFEN SR||Beximco Pharmaceuticals Ltd||Ketoprofen BP 100mg||Capsule (Sustained Release)||50's: 377.00 MRP|
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. 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); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). 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 doctorwill 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 doctorif 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 medication 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.
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 doctorto 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.
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 for more information.
What special precautions should I follow?
- tell your doctorif you are allergic to ketoprofen, aspirin or other NSAIDs such as ibuprofen and naproxen, any other medications, or any of the inactive ingredients in ketoprofen capsules or extended release capsules.
- tell your doctorwhat 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, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril and trandolapril; diuretics ('water pills'); lithium; medications for diabetes; methotrexate; phenytoin; probenecid; and sulfa antibiotics such as sulfisoxazole and sulfamethoxazole. 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); 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 breast-feeding. 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.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget 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 medication cause?
Ketoprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
sores in the mouth
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
swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
unusual bleeding or bruising
lack of energy
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
cloudy, discolored, or bloody urine
difficult or painful urination
Ketoprofen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
lack of energy
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
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.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.