ketoprofen
Orudis, Orudis KT, Oruvail

Available forms
Available by prescription only
Capsules: 25 mg, 50 mg, 75 mg
Capsules (extended-release): 100 mg, 150 mg, 200 mg
Available without a prescription
Tablets: 12.5 mg

Indications and dosages
 Rheumatoid arthritis and osteoarthritis. Adults: 75 mg P.O. t.i.d. or 50 mg q.i.d. Maximum dosage is 300 mg daily or 200 mg (extended-release capsules) P.O. daily.
 Mild to moderate pain, dysmenorrhea. Adults: 25 to 50 mg P.O. q 6 to 8 hours, p.r.n.
 Temporary relief of mild aches and pain, fever. Adults: 12.5 mg q 4 to 6 hours. Don’t exceed 75 mg in a 24-hour period.
≡ Dosage adjustment. For patients with mildly impaired renal function, maximum total daily dose is 150 mg. For patients with more severe renal impairment (glomerular filtration rate less than 25 ml/minute) or hepatic dysfunction, maximum total daily dosage is 100 mg.

Pharmacodynamics
Analgesic, antipyretic, and anti-inflammatory actions: Mechanisms of action are unknown; ketoprofen is thought to inhibit prostaglandin synthesis.

Pharmacokinetics
Absorption: Absorbed rapidly and completely.
Distribution: Highly protein-bound. Extent of body tissue fluid distribution isn’t known, but therapeutic levels range from 0.4 to 6 mcg/ml.
Metabolism: Metabolized in the liver.
Excretion: Excreted in urine as parent drug and its metabolites.

Contraindications and precautions
Contraindicated in patients hypersensitive to drug and those with a history of aspirin-induced or NSAID-induced asthma, urticaria, or other allergic-type reactions. Use cautiously in patients with impaired renal or hepatic function, peptic ulcer disease, heart failure, hypertension, or fluid retention.

Interactions
Drug-drug. Acetaminophen, gold compounds, other anti-inflammatories: Increases nephrotoxicity. Avoid use together.
Antihypertensives, diuretics: Decreases effectiveness of these drugs; increases nephrotoxic potential from diuretics. Don’t use together.
Anti-inflammatories, corticosteroids, corticotropin, salicylates: May cause GI ulceration and hemorrhage. Avoid use together.
Aspirin: Decreases bioavailability of ketoprofen. Avoid use together.
Coumarin derivatives, heparin, nifedipine, phenytoin, streptokinase, urokinase, verapamil: Increases risk of bleeding and toxicity. Monitor patient, PT, and INR closely.
Drugs that inhibit platelet aggregation, such as aspirin, parenteral carbenicillin, cefamandole, cefoperazone, dextran, dipyridamole, mezlocillin, piperacillin, plicamycin, salicylates, sulfinpyrazone, ticarcillin, valproic acid, other anti-inflammatories: May cause bleeding problems. Monitor patient for signs of bleeding.
Insulin, oral antidiabetics: Because of the influence of prostaglandins on glucose metabolism, concurrent use may potentiate hypoglycemic effects. Monitor blood glucose levels.
Lithium, methotrexate: Decreases renal clearance of lithium and methotrexate. Monitor patient closely.
Drug-herb. Dong quai, feverfew, garlic, ginkgo, ginger, horse chestnut, red clover: May increase the risk of bleeding. Discourage use together.
Drug-lifestyle. Alcohol use: Increases GI adverse effects, including ulceration and hemorrhage. Discourage alcohol use.
Prolonged sun exposure: Increases risk of photosensitivity reaction. Advise patient to take precautions.

Adverse reactions
CNS: headache, dizziness, CNS excitation or depression.
CV: peripheral edema.
EENT: tinnitus, visual disturbances.
GI: nausea, abdominal pain, diarrhea, constipation, flatulence, dyspepsia, anorexia, vomiting, stomatitis, peptic ulceration.
GU: nephrotoxicity.
Hematologic: prolonged bleeding time, thrombocytopenia, agranulocytosis.
Respiratory: dyspnea, bronchospasm,laryngeal edema.
Skin: rash, photosensitivity, exfoliative dermatitis.

Effects on lab test results
• May increase BUN, ALT, and AST levels.
• May increase bleeding time. May decrease platelet and granulocyte counts.

Overdose and treatment
Signs and symptoms of overdose include nausea and drowsiness.
 Induce emesis with ipecac syrup or empty the stomach via gastric lavage; administer activated charcoal via nasogastric tube. Provide symptomatic and supportive measures (respiratory support and correction of fluid and electrolyte imbalances). Monitor laboratory parameters and vital signs closely. Hemodialysis may be useful in removing ketoprofen and assisting in care of renal failure.

Special considerations
• Administer ketoprofen with foods or antacids to minimize GI distress.
• In vitro interactions with glucose determinations have been reported with glucose oxidase and peroxidase methods resulting in falsely elevated blood glucose concentrations.
• Ketoprofen may interfere with serum iron determination (false increases or decreases depending on method used), and may cause falsely elevated serum bilirubin levels.
Breast-feeding patients
• Most NSAIDs appear in breast milk; however, distribution of ketoprofen is unknown. Avoid use in breast-feeding women.
Pediatric patients
• Safe use in children younger than age 12 hasn’t been established.
Geriatric patients
• Patients older than age 60 may be more susceptible to toxic effects of ketoprofen. Use cautiously. The effects of drug on renal prostaglandins may cause fluid retention and edema, a significant drawback for elderly patients and those with heart failure. The manufacturer recommends reducing initial dose by 33% to 50% in elderly patients.

Patient education
• Instruct patient in prescribed drug regimen and proper medication administration, to avoid alcoholic beverages during therapy, and to report adverse reactions.
• Tell patient to seek medical approval before taking OTC medications (especially aspirin and products containing aspirin).
• Caution patient to avoid activities that require alertness or concentration; stress need for safety measures to prevent injury.
• Advise patient of potential photosensitivity reactions. Recommend use of sunscreen.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use