Ketoprofen

What is Ketoprofen?

• Ketoprofen is a nonsteroidal antiinflammatory drug (NSAID) used in treatment of acute pain and chronic arthritis.

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Ketoprofen

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What are the uses of this medicine?

Ketoprofen is used for:

• the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
• the management of pain.
• treatment of primary dysmenorrhea.

• 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.

• KETOFEN (ketoprofen injection) is recommended for the alleviation of inflammation and pain associated with
• musculoskeletal disorders in the horse.

How does this medicine work?

• Ketoprofen (kee" toe proe' fen) belongs to the propionic derivative class of NSAIDs similar to naproxen and ibuprofen.
• Like other NSAIDs, ketoprofen is a cyclo-oxygenase (Cox-1 and -2) inhibitor that blocks the formation of prostaglandins that are important in pain and inflammatory pathways.
• Ketoprofen has analgesic as well as antipyretic and antiinflammatory activities.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to ketoprofen
• who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• coronary artery bypass graft (CABG) surgery

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention any of the following:

• Anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)aspirin
• other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn)
• 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)
• serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR).
• 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)
• probenecid (Probalan)

Is this medicine FDA approved?

• Ketoprofen was approved in the United States in 1986 and is still widely used.
• Current indications include chronic joint pain due to osteoarthritis and rheumatoid arthritis as well as mild-to-moderate acute pain and dysmenorrhea.

How should this medicine be used?

Recommended dosage: Rheumatoid Arthritis and Osteoarthritis:

• The recommended starting dose of ketoprofen capsules in otherwise healthy patients is 75 mg three times or 50 mg four times a day.
• Smaller doses of ketoprofen capsules should be utilized initially in small individuals or in debilitated or elderly patients.
• The recommended maximum daily dose of ketoprofen capsules is 300 mg/day.

Management of Pain and Dysmenorrhea:

• The usual dose of ketoprofen capsules recommended for mild-to-moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary.
• A larger dose may be tried if the patient's response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia.
• Daily doses above 300 mg are not recommended because they have not been adequately studied.

KETOFEN dosage:

• The recommended dosage is 1 mg/lb (1 mL/100 lbs) of body weight administered intravenously once daily.
• Treatment may be repeated for up to five days.
• Onset of activity is within two hours with peak response by 12 hours.
• Use contents within 4 months of first vial puncture.

Administration:

• 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• Ketoprofen is available by prescription in the form of capsules or tablets of 25, 50 and 75 mg in both generic and trade formulations (Orudis, Oruvail, among others).
• Extended release formulations of 100, 150 and 200 mg are also available for once daily dosing.
• Ketoprofen is also available in over-the-counter formulations of 12.5 mg tablets for treatment of mild-to-moderate pain and dysmenorrhea.

This medicine is available in fallowing brand namesː

• Actron
• Nexcede
• Orudis
• Orudis
• Oruvail

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache, dizziness, somnolence, gastrointestinal upset, nausea, abdominal discomfort, diarrhea, peripheral edema and hypersensitivity reactions

What special precautions should I follow?

• Ketoprofen capsules cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
• Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including ketoprofen capsules. Such patients should be closely monitored, and a reduction of dosage should be anticipated to avoid high blood levels of ketoprofen and/or its metabolites.
• Anemia is sometimes seen in patients receiving NSAIDs, including ketoprofen capsules. Patients receiving ketoprofen capsules who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
• Patients with asthma may have aspirin-sensitive asthma. ketoprofen capsules should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
• Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately.
• Ketoprofen capsules, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death.
• Advise patients to stop taking ketoprofen capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.
• Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur.
• Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
• Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help
• Ketoprofen has been linked to a low rate of serum enzyme elevations during therapy and to rare instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy
• drowsiness
• nausea
• vomiting
• epigastric pain
• Respiratory depression
• coma
• convulsions
• Gastrointestinal bleeding
• hypotension
• hypertension
• acute renal failure

Management of overdosage:

• Patients should be managed by symptomatic and supportive care following an NSAID overdose.
• There are no specific antidotes.
• Gut decontamination may be indicated in patients with symptoms seen within 4 hours or following a large overdose (5 to 10 times the usual dose).
• This should be accomplished via emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) with a saline cathartic or sorbitol added to the first dose.
• Forced diuresis, alkalinization of the urine, hemodialysis or hemoperfusion would probably not be useful due to ketoprofen's high protein binding.

Can this medicine be used in pregnancy?

• Use of NSAIDs, including ketoprofen capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ketoprofen capsules.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 18 have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• KETOPROFEN

Inactive Ingredients:

• SILICON DIOXIDE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POVIDONE K30
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• FD&C YELLOW NO. 6
• GELATIN
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

Distributed by:

• Avet Pharmaceuticals Inc.
• East Brunswick, NJ

• Mylan Pharmaceuticals Inc.
• Morgantown, WV

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).

Nonsteroidal Antiinflammatory Drugs (NSAIDs)

Acetaminophen, Celecoxib, Diclofenac, Diflunisal, Etodolac, Fenoprofen, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Nimesulide, Oxaprozin, Phenylbutazone, Piroxicam, Rofecoxib, Sulindac, Tolmetin

• Dailymed label info on Ketoprofen
• FDA Ketoprofen

Ketoprofen Resources
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