Class: Other Nonsteroidal Anti-inflammatory Agents
Chemical Name: 3-Benzoyl-α-methylbenzeneacetic acid
Molecular Formula: C16H14O3
CAS Number: 22071-15-4
Brands: Oruvail
- Cardiovascular Risk
Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 Risk may increase with duration of use.1 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.1 (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.1
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals are at greater risk for serious GI events.1 (See GI Effects under Cautions.)
Introduction
Prototypical NSAIA; propionic acid derivative.1 2 3 4 30 53 93 205
Uses for Ketoprofen
Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.1 Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.1
Inflammatory Diseases
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.1 36 96 97 98 99 100 101 102 103 104 105 106 107 108 131 132 134 135 136 137 138 139 147 148 150 153 154 158 205
Has been used in the symptomatic treatment of ankylosing spondylitis†.97 104 105 106 108 109 138 142 143 144 146 175 205
Pain
Relief of pain.1 121 160 166 171 173 174 235 236 238 239
Dysmenorrhea
Symptomatic management of primary dysmenorrhea.1 50 161 164 234
Ketoprofen Dosage and Administration
General
Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.1
Administration
Oral Administration
Administer orally once daily as extended-release capsules or 3 or 4 times daily as conventional capsules.1
Administration with antacids,1 97 102 115 116 142 149 food,1 104 or milk1 may minimize adverse GI effects.
Ketoprofen extended-release capsules are not recommended for the management of acute pain because of slow onset of action.1
Dosage
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.1 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.1
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Conventional capsules: Initially, 75 mg 3 times daily or 50 mg 4 times daily.1 Base subsequent dosage on clinical response and tolerance.1
Extended-release capsules: Initially, 200 mg once daily.1 Base subsequent dosage on clinical response and tolerance.1
Pain
Oral
Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.1
Dysmenorrhea
Oral
Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.1
Prescribing Limits
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Conventional capsules: Maximum 300 mg daily.1
Extended-release capsules: Maximum 200 mg daily.1
Pain or Dysmenorrhea
Oral
Conventional capsules: Maximum 300 mg daily.1
Special Populations
Hepatic Impairment
Maximum recommended initial total dosage is 100 mg daily in patients with hepatic impairment and serum albumin concentrations <3.5 g/dL.1
Renal Impairment
Mild renal impairment: Maximum recommended dosage is 150 mg daily.1
Severe renal impairment (GFR <25 mL/minute per 1.73 m2 or end-stage renal impairment): Maximum recommended dosage is 100 mg daily.1 (See Renal Impairment under Cautions.)
Geriatric Patients
Consider reduced initial dosage in patients >75 years of age.1
Cautions for Ketoprofen
Contraindications
Known hypersensitivity to ketoprofen or any ingredient in the formulation.1
History of asthma, urticaria, or other sensitivity reactions precipitated by aspirin or other NSAIAs.1 26 48 83 86 89 90 91 92 177
Treatment of perioperative pain in the setting of CABG surgery.1
Warnings/Precautions
Warnings
Cardiovascular Effects
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.284 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.288 289 290 Information not available on risk associated with ketoprofen at this time.288 289 290
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary. 1
Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).284
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 (See Specific Drugs under Interactions.)
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 Use with caution in patients with hypertension; monitor BP.1 Impaired response to certain diuretics may occur.1 (See Specific Drugs under Interactions.)
Fluid retention and edema reported.1 Caution in patients with fluid retention or heart failure.1
GI Effects
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;1 241 242 245 increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.1 233 270 281
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;244 270 273 274 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)244 270 273 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).273
Renal Effects
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1
Potential for overt renal decompensation.1 9 15 26 48 83 177 198 Increased risk of renal toxicity in patients with renal1 15 48 83 177 198 or hepatic1 15 26 48 83 177 198 impairment or heart failure,1 26 48 83 177 198 in geriatric patients,1 48 177 in patients with volume depletion,1 16 26 48 83 177 198 224 and in those receiving a diuretic,1 ACE inhibitor,1 or angiotensin II receptor antagonist.286 (See Renal Impairment under Cautions.)
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylactoid reactions reported.1
Immediate medical intervention and discontinuance for anaphylaxis.1
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.1
Dermatologic Reactions
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported;1 142 can occur without warning.1 Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).1
General Precautions
Hepatic Effects
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.1
Elevations of serum ALT or AST reported.1
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.1 209 210
Hematologic Effects
Anemia reported rarely.1 141 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.1 209 210
May inhibit platelet aggregation and prolong bleeding time.1 34 40 41 47 54
Other Precautions
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1
May mask certain signs of infection.1 83 177 209 210
Obtain CBC and chemistry profile periodically during long-term use.1
Specific Populations
Pregnancy
Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1
Lactation
Not known whether distributed into milk in humans.1 Use not recommended.1
Pediatric Use
Safety and efficacy not established in children <18 years of age.1
Geriatric Use
Caution advised.1 Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.1 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.1
Select dosage with caution because of age-related decreases in renal function.1 Dosage adjustment recommended in geriatric patients >75 years of age.1 May be useful to monitor renal function.1
Hepatic Impairment
Monitor closely.1 Reduced dosage may be necessary; use lowest effective dosage.1 (See Hepatic Impairment under Dosage and Administration.)
Renal Impairment
Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.1
Reduced maximum dosage recommended.1 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
Dyspepsia,1 99 100 102 104 105 109 114 118 123 134 136 139 234 nausea,1 96 99 104 106 109 115 123 125 129 132 135 136 137 138 139 140 234 abdominal pain,1 104 115 127 135 136 137 138 140 234 diarrhea,1 102 104 105 107 114 127 132 133 234 constipation,1 99 104 105 107 109 118 132 135 143 flatulence,1 96 109 137 147 149 155 anorexia,1 107 109 135 137 147 vomiting,1 104 105 109 125 135 136 137 139 stomatitis,1 105 132 146 149 headache,1 99 102 104 105 106 109 118 123 127 129 234 dizziness,1 104 106 109 118 127 131 132 138 234 CNS depression,106 109 138 147 155 158 173 190 CNS excitation,1 104 105 132 150 155 161 tinnitus,1 118 119 164 visual disturbances,1 rash,1 96 104 105 127 132 135 155 190 renal impairment.1 105 118 125 135 158 187 205 224
Interactions for Ketoprofen
Protein-bound Drugs
Potential for ketoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs.52 78 Observe for adverse effects.209 210 211
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
ACE inhibitors | Reduced BP response to the ACE inhibitor1 | Monitor BP1 |
Angiotensin II receptor antagonists | Reduced BP response to the angiotensin II receptor antagonist291 | Monitor BP291 |
Antacids (magnesium- or aluminum-containing) | Conventional capsules: Pharmacokinetic interaction unlikely1 | |
Anticoagulants (warfarin) | Possible bleeding complications1 Increased PT reported 240 | Caution advised 1 |
Aspirin | Decreased ketoprofen protein binding1 52 Increased risk of GI ulceration or other complications 1 No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs284 | Concomitant use not recommended1 Clinical importance of pharmacokinetic changes unknown1 |
Digoxin | Pharmacokinetic interaction unlikely1 | |
Diuretics (furosemide, thiazides) | Reduced natriuretic effects1 | Monitor for diuretic efficacy and renal failure1 |
Lithium | Increased plasma lithium concentrations1 209 229 | Monitor for lithium toxicity1 209 229 |
Methotrexate | Possible increased and prolonged blood concentrations of methotrexate1 24 210 216 217 218 219 221 231 | Use with caution1 |
Probenecid | Decreased clearance of ketoprofen and/or its conjugates78 | Concomitant use not recommended1 |
Salicylates | Possible altered elimination of ketoprofen; no change in the pharmacokinetics of salicylate52 | Clinical importance unknown52 |
Thrombolytic agents (streptokinase) | Possible bleeding complications39 | Use with caution39 |
Ketoprofen Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration; bioavailability is about 90%.1 Peak plasma concentration usually attained within 0.5–2 hours (conventional capsules) or 6–7 hours (extended-release capsules).1 58 60 61 62 64 66 69 71
Food
Food delays time to peak plasma concentration by <1 hour or about 2 hours following administration as conventional capsules or extended-release capsules, respectively.1
Distribution
Extent
Distributed into synovial fluid57 64 67 68 71 227 and the CNS.75
Not known whether ketoprofen is distributed into human milk.1
Plasma Protein Binding
>99% (mainly albumin).1 75
Elimination
Metabolism
Rapidly and extensively metabolized in the liver; active metabolites not identified.1 2 45 59
Elimination Route
Excreted principally in urine.1 57 59 60 61 62 70 72 80 228
Half-life
Conventional capsules: 2–4 hours.1
Extended-release capsules: 5.4 hours.1
Special Populations
Renal Impairment: Half-life (when given as conventional capsules) prolonged to about 3 hours in patients with mild renal impairment and to about 5–9 hours in patients with moderate to severe renal impairment.1
Stability
Storage
Oral
Conventional and Extended-release Capsules
Tight1 , light resistant containers2 at 25°C1 2 ; protect from direct light and excessive heat and humidity.1
ActionsActions
Inhibits cyclooxygenase-1 (COX-1) and COX-2.264 265 266 267 268 269 270
Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.1 31 34 42 43 205
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.1
Risk of serious cardiovascular events with long-term use.1
Risk of GI bleeding and ulceration.1 247 255
Risk of serious skin reactions.1 Risk of anaphylactoid and other sensitivity reactions.1
Risk of hepatotoxicity.1
Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.1
Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.1
Importance of discontinuing ketoprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.1 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.1
Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of avoiding ketoprofen in late pregnancy (third trimester).1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 50 mg* | Ketoprofen Capsules | Mylan, Teva |
75 mg* | Ketoprofen Capsules | Mylan, Teva | ||
Capsules, extended-release | 200 mg* | Ketoprofen Capsules extended-release | Mylan | |
Oruvail | Wyeth |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Ketoprofen 50MG Capsules (TEVA PHARMACEUTICALS USA): 90/$20.98 or 180/$31.98
Ketoprofen 75MG Capsules (TEVA PHARMACEUTICALS USA): 60/$14.99 or 180/$34.98
Ketoprofen CR 200MG 24-hr Capsules (MYLAN): 30/$89.99 or 90/$269.96
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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