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Drugs reference index «Ketoprofen»


Pronunciation: (KEY-toe-PRO-fen)Class: NSAID

Trade Names:Ketoprofen- Capsules 50 mg- Capsules 75 mg- Capsules, extended-release 100 mg- Capsules, extended-release 150 mg- Capsules, extended-release 200 mg

APO-Keto (Canada)APO-Keto-E (Canada)APO-Keto SR (Canada)


Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.



Immediate-release form is released in the stomach; T max is 0.5 to 2 h. Sustained-release form is released in the small intestine; T max is 6 to 7 h. Bioavailability is approximately 90%. Food does not change AUC, but the rate of absorption for either form is slowed.


More than 99% protein bound, mainly to albumin. Vd is 0.1 L/kg.


Metabolic pathway is glucuronide conjugation. The metabolite is acylglucuronide, which can be converted back to the parent drug. There are no known active metabolites.


Oral immediate release t ½ is 2 to 4 h. Sustained-release t ½ is approximately 5.4 h. Cl is approximately 0.08 L/kg/h.


Within 30 min.


Persisted for up to 6 h.

Special Populations


Plasma and renal Cl are reduced and the unbound fraction increases.

Hypoalbuminemia and Renal Function Impairment

Patients with these conditions may be at greater risk of adverse reactions due to increased fractions of free drug. Give these patients lower doses of the drug and monitor them closely.

Indications and Usage

Treatment of rheumatoid arthritis and osteoarthritis.

Immediate-release form only

Treatment of mild to moderate pain and primary dysmenorrhea.


Temporary relief of minor aches and pains associated with common cold, headache, toothache, muscular aches, backache, minor arthritis pain, menstrual cramps, and reduction of fever.

Unlabeled Uses

Treatment of juvenile rheumatoid arthritis, sunburn, migraine prophylaxis.


Patients in whom aspirin, iodides, or any NSAID have caused allergic-type reactions.

Dosage and Administration

Rheumatoid Arthritis or OsteoarthritisAdults Immediate-release

PO 75 mg 3 times daily or 50 mg 4 times daily; do not exceed 300 mg/day.

Maintenance dose

Reduce initial dosage to 75 to 150 mg/day in elderly or disabled patients or those with renal function impairment.


PO 200 mg once daily can be used in patients already stabilized on that dose.

Mild to Moderate Pain, Primary DysmenorrheaAdults

PO 25 to 50 mg every 6 to 8 h as needed; do not exceed 300 mg/day.

OTC UseAdults

PO 12.5 mg with a full glass of liquid every 4 to 6 h. If pain or fever persists after 1 h, follow with 12.5 mg. Do not exceed 25 mg in a 4- to 6-h period or 75 mg in a 24-h period. Use the smallest effective dose.


PO Do not give to children younger than 16 yr of age unless directed by a health care provider.

Mild To Severe Renal Function Impairment

Maximum recommended total daily dose is 150 mg. In patients with more severe renal function impairment (GFR less than 25 mL/min or end-stage renal impairment), the max total daily dose should not exceed 100 mg.

Hepatic Function Impairment

For patients with impaired hepatic function and serum albumin concentration less than  3.5 g/dL, the max initial total daily dose should be 100 mg.


Store at room temperature in tightly closed, light-resistant container.

Drug Interactions


Increased risk of gastric erosion and bleeding.


Additive GI toxicity.


Nephrotoxicity of both agents may be increased.


Serum lithium levels may be increased.


Increased methotrexate levels.

Laboratory Test Interactions

May prolong bleeding time.

Adverse Reactions


Peripheral edema; fluid retention; CHF.


Headache; dizziness; lightheadedness; drowsiness; vertigo.


Rash; pruritus.


Visual disturbances; stomatitis.


Peptic ulcer; GI bleeding; dyspepsia; nausea; diarrhea; constipation; abdominal pain; flatulence; anorexia; vomiting.




Bronchospasm; laryngeal edema; rhinitis; dyspnea.



Category B .


Excreted in breast milk.


Safety and efficacy not established.


Increased risk of adverse reactions.


Hypersensitivity may occur; use caution in aspirin-sensitive individuals because of possible cross-sensitivity.

Renal Function

Lower doses may be necessary.

Hepatic Function

Avoid sustained-release product.


Bleeding, ulceration or perforation can occur at any time, with or without warning symptoms.


Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia and renal papillary necrosis may occur.



Drowsiness, dizziness, confusion, disorientation, lethargy, numbness, vomiting, gastric irritation, nausea, abdominal pain, headache, tinnitus, convulsions, acute renal failure.

Patient Information

  • Advise patient to take medication with food, milk, or antacids. Capsule should be swallowed whole, not chewed or crushed.
  • Warn patient not to take aspirin or other NSAIDs.
  • Caution patient to report changes in stool (eg, color, consistency, frequency), fluid retention and shortness of breath.
  • Instruct patient to report the following symptoms to health care provider: skin rash, itching, visual disturbances, weight gain, edema, black stools, or persistent headache.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
  • Caution patient to avoid exposure to sunlight and other sources of ultraviolet light and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
  • Instruct patient not to ingest alcohol or take OTC medications without notifying health care provider.

Copyright © 2009 Wolters Kluwer Health.

  • Ketoprofen Detailed Consumer Information (PDR)
  • Ketoprofen Prescribing Information (FDA)
  • Ketoprofen MedFacts Consumer Leaflet (Wolters Kluwer)
  • ketoprofen Concise Consumer Information (Cerner Multum)
  • ketoprofen Advanced Consumer (Micromedex) - Includes Dosage Information
  • Orudis Prescribing Information (FDA)
  • Oruvail Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

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