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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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)

There is limited information regarding Ketoprofen FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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

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

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.

There is limited information regarding Ketoprofen Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

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

{{#ask: Page Name::Ketoprofen |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ketoprofen |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.