Ketoprofen

Ketoprofen
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

Warning See full prescribing information for complete Boxed Warning. Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ketoprofen capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.

Overview

Ketoprofen is a Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent and Musculoskeletal Agent that is FDA approved for the treatment of rheumatoid arthritis, osteoarthritis, pain and dysmenorrhea. There is a Black Box Warning for this drug as shown here. Common adverse reactions include edema, rash, abdominal pain, constipation, diarrhea, flatulence, indigestion, nausea, increased liver function test, CNS depression, CNS stimulation, dizziness, headache, abnormal vision, tinnitus and renal impairment..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Reumatoid Arthritis

• Dosage: 5 mg PO q8h or 50 mg PO q6h
• The recommended maximum daily dose of ketoprofen capsules is 300 mg/day.

Osteoarthritis

• Dosage: 5 mg PO q8h or 50 mg PO q6h
• The recommended maximum daily dose of ketoprofen capsules is 300 mg/day.

Pain and Dysmenorrhea

• Dosage: 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.

Fever

• Dosage: 12.5 mg q4h-q6h
  • Maximum dose: 75 mg/day (six 12.5mg tablets)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Migraine Prophylaxis

• Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketoprofen in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

FDA doesn't indicate Ketoprofen for patients under 18 years old

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ketoprofen in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketoprofen in pediatric patients.

Contraindications

• Ketoprofen immediate- and extended-release capsules should not be given to patients who

have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs.

• Ketoprofen immediate- and extended-release capsules are contraindicated for the treatment of

peri-operative pain in the setting of coronary artery bypass graft.

Warnings

Warning See full prescribing information for complete Boxed Warning. Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ketoprofen capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation). Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, including ketoprofen capsules, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ketoprofen capsules, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Peripheral edema has been observed in approximately 2% of patients taking ketoprofen. Ketoprofen capsules should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects

Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including ketoprofen capsules, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10 fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a non-steroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of ketoprofen capsules in patients with advanced renal disease. Therefore, treatment with ketoprofen capsules is not recommended in these patients with advanced renal disease. If ketoprofen capsule therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ketoprofen capsules. Ketoprofen capsules should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including ketoprofen capsules, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, ketoprofen capsules should be avoided because they may cause premature closure of the ductus arteriosus.

Adverse Reactions

Clinical Trials Experience

Incidence > 1% with probable causal relationship

Digestive Effects

• Dyspepsia
• Nausea
• Abdominal pain
• Diarrhea
• Constipation
• Flatulence
• Anorexia
• Vomiting
• Stomatitis

Nervous System Effects

• Headache
• Dizziness
• CNS inhibition: somnolence, malaise and depression.
• CNS excitation: insomnia and nervousness

Special Senses

• Tinnitus
• Visual disturbances

Skin and Appendages

• Rash

Urogenital

• Renal impairment
• Urinary Tract Infections (UTI's)

Incidence < 1% with Probable Cause

Body as a Whole

• Chills
• Facial edema
• Infections
• Pain
• Anaphylaxis

Cardiovascular

• Hypertension
• Palpitations
• Tachycardia
• Congestive Heart Failure (CHF)
• Peripheral vascular disease
• Vasodilation

Digestive Effects

• Appetite increased
• Dry mouth
• Eructation
• Gastritis
• Rectal hemorrhage
• Melena
• Fecal occult blood
• Salivation
• Peptic ulcer,
• Gastrointestinal perforation
• Hematemesis
• Intestinal ulceration
• Hepatic dysfunction
• Hepatitis
• Cholestatic hepatitis
• Jaundice

Hematological Effects

• Hypocoagulability
• Agranulocytosis
• Anemia
• Hemolysis
• Purpura
• Thrombocytopenia

Metabolic and Nutritional Effects

• Thirst
• Weight gain
• Weight loss
• Hyponatremia

Musculoskeletal Effects

• Myalgia

Nervous System Effects

• Amnesia
• Confusion
• Impotence
• Migraine
• Paresthesia
• Vertigo

Respiratory Effects

• Dyspnea
• Hemoptysis
• Epistaxis
• Pharyngitis
• Rhinitis
• Bronchospasm
• Laryngeal edema

Skin and Appendages

• Alopecia
• Eczema
• Pruritus
• Purpuric rash
• Sweating
• Urticaria
• Bullous rash
• Exfoliative dermatitis
• Photosensitivity
• Skin discoloration
• Onycholysis
• Toxic epidermal necrolysis
• Erythema multiforme
• Stevens-Johnson syndrome

Special Senses

• Conjunctivitis
• Conjunctivitis sicca
• Eye pain
• Hearing impairment
• Retinal hemorrhage and pigmentation change
• Taste perversion

Urogenital

• Menometrorrhagia
• Hematuria
• Renal failure
• Interstitial nephritis
• Nephrotic syndrome

Postmarketing Experience

There is limited information regarding Ketoprofen Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ketoprofen Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ketoprofen in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ketoprofen in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ketoprofen during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ketoprofen in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ketoprofen in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ketoprofen in geriatric settings.

Gender

There is no FDA guidance on the use of Ketoprofen with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ketoprofen with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ketoprofen in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ketoprofen in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ketoprofen in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ketoprofen in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ketoprofen Administration in the drug label.

Monitoring

There is limited information regarding Ketoprofen Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ketoprofen and IV administrations.

Overdosage

There is limited information regarding Ketoprofen overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ketoprofen Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ketoprofen Mechanism of Action in the drug label.

Structure

There is limited information regarding Ketoprofen Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ketoprofen Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ketoprofen Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ketoprofen Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ketoprofen Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ketoprofen How Supplied in the drug label.

Storage

There is limited information regarding Ketoprofen Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Ketoprofen Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ketoprofen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ketoprofen Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ketoprofen Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Ketoprofen

File:Ketoprofen.png
Clinical data
ATC code	M01AE03 (WHO) M01AE17 (WHO), M02AA10 (WHO)
Pharmacokinetic data
Protein binding	99%
Elimination half-life	2-2.5 hours
Identifiers
IUPAC name 2-(3-benzoylphenyl)propanoic acid
CAS Number	22071-15-4
PubChem CID	3825
DrugBank	APRD01059
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C16H14O3
Molar mass	254.281 g/mol

Ketoprofen, (RS)2-(3-benzoylphenyl)-propionic acid (chemical formula C₁₆H₁₄O₃) is one of the propionic acid class of non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects. It acts by inhibiting the body's production of prostaglandin.

Ketoprofen was available over-the-counter in the United States in the form of 12.5 mg coated tablets (Orudis KT®), but the product has been discontinued. It is available by prescription as 25, 50, 75, 100, 150, and 200 mg capsules.

Ketoprofen also comes in a 2,5% gel for topical application.

Brand names in the US are Orudis and Oruvail. It is available in the UK as Ketoflam and Oruvail, and in France as Bi-Profénid.

In Lithuania, Ketoprofen is called Ketoprofenum and/or Ketoprofenas. For topical application: the name brands are Fastum with 2.5% (gel) which is over the counter and Ketospray with 10% (liquid spray) which must be prescribed.

In some countries, the optically pure (S)-enantiomer (dexketoprofen) is available; its trometamol salt is said to be particularly rapidly reabsorbed from the gastrointestinal tract, having a rapid onset of effects.

Ketoprofen is generally prescribed for arthritis-related inflammatory pains or severe tooth-aches that result in the inflation of the gum.

Use in horses

Ketoprofen (Ketofen) is a common NSAID, antipyretic, and analgesic used in horses and other equines. It is most commonly used for muscoskeletal pain, joint problems, and soft tissue injury, as well as laminitis. It does not treat the underlying problem, nor does it speed the healing process. It is also used to control fevers and prevent endotoxemia. However, they may mask the symptoms of the underlying problem, and therefore make diagnosis more difficult for a veterinarian.

Side effects and precautions

Side effects are relatively uncommon if used as recommended, and less common than 2 other commonly used NSAIDs: flunixin or phenylbutazone. Side effects include gastrointestinal ulcers, drop in red blood cell count (a result of GI bleeding), and rarely kidney damage, protein loss, and bleeding disorders. It should therefore be used with caution in horses with liver or kidney disease, or gastrointestinal problems.

Additionally, it should not be used in horses allergic to aspirin.

Uses with other drugs

Ketoprofen should not be used in with other NSAIDs or corticorticeriods, as this increases the risk of GI ulceration. It should also be used with caution with other anticoagulants. It is commonly used with omeprazole, sucralfate, and cimetidine to help protect the GI tract.

Administration

Ketoprofen is labeled to be administered intravenously only, and is recommended for a maximum of five days of use. Its analgesic and antipyretic effects begin to occur 1-2 hours following administration. The most common dosage is 1 mg/lb, once per day, although this dosage may be lowered for ponies, who are most susceptible to NSAID side effects.

References

• Kantor, T. G. Ketoprofen: a review of its pharmacologic and clinical properties. Pharmacotherapy. 1986 May-Jun;6(3):93-103.
• Forney, Barbara C, MS, VMD.Equine Medications, Revised Edition. Blood Horse Publications. Lexington, KY. Copyright 2007.