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Pronunciation |
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(kee
toe PROE
fen) |

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U.S. Brand
Names |
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Actron®[OTC]; Orudis®;
Orudis® KT [OTC]; Oruvail® |

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Generic
Available |
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No |

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Canadian Brand
Names |
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Apo®-Keto; Apo®-Keto-E;
Novo-Keto-EC; Nu-Ketoprofen; Nu-Ketoprofen-E; Orafen; PMS-Ketoprofen;
Rhodis™; Rhodis-EC™ |

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Pharmacological Index |
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Nonsteroidal Anti-Inflammatory Agent (NSAID) |

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Use |
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Dental: Management of pain and swelling
Medical: Acute and long-term treatment of rheumatoid arthritis and
osteoarthritis; primary dysmenorrhea; mild to moderate pain
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Pregnancy Risk
Factor |
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B (D in 3rd trimester) |

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Contraindications |
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Known hypersensitivity to ketoprofen or other
NSAIDs/aspirin |

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Warnings/Precautions |
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Use with caution in patients with congestive heart failure, dehydration,
hypertension, decreased renal or hepatic function, history of GI disease
(bleeding or ulcers), or those receiving anticoagulants; safety and efficacy in
children <6 months of age have not yet been established |

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Adverse
Reactions |
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>10%:
Central nervous system: Dizziness
Dermatologic: Rash
Gastrointestinal: Abdominal cramps, heartburn, indigestion, nausea
1% to 10%:
Central nervous system: Headache, nervousness
Dermatologic: Itching
Endocrine & metabolic: Fluid retention
Gastrointestinal: Vomiting
Otic: Tinnitus
<1%: Congestive heart failure, hypertension, arrhythmias, tachycardia,
confusion, hallucinations, mental depression, drowsiness, insomnia, aseptic
meningitis, urticaria, erythema multiforme, toxic epidermal necrolysis,
Stevens-Johnson syndrome, angioedema, polydipsia, hot flashes, gastritis, GI
ulceration, cystitis, polyuria, agranulocytosis, anemia, hemolytic anemia, bone
marrow suppression, leukopenia, thrombocytopenia, hepatitis, peripheral
neuropathy, toxic amblyopia, blurred vision, conjunctivitis, dry eyes, decreased
hearing, acute renal failure, allergic rhinitis, shortness of breath, epistaxis
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Overdosage/Toxicology |
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Symptoms of overdose include apnea, metabolic acidosis, coma, and nystagmus;
leukocytosis, renal failure
Management of a nonsteroidal anti-inflammatory drug (NSAID) intoxication is
primarily supportive and symptomatic. Fluid therapy is commonly effective in
managing the hypotension that may occur following an acute NSAID overdose,
except when this is due to an acute blood loss. Seizures tend to be very
short-lived and often do not require drug treatment. Although, recurrent
seizures should be treated with I.V. diazepam. Since many of the NSAIDs undergo
enterohepatic cycling, multiple doses of charcoal may be needed to reduce the
potential for delayed toxicities. |

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Drug
Interactions |
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CYP2C and 2C9 enzyme inhibitor
Increased effect/toxicity with probenecid, lithium
Increased toxicity of methotrexate |

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Mechanism of
Action |
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Inhibits prostaglandin synthesis by decreasing the activity of the enzyme,
cyclo-oxygenase, which results in decreased formation of prostaglandin
precursors |

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Pharmacodynamics/Kinetics |
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Peak levels in 1-2 hours
Absorption: Almost completely
Metabolism: In the liver
Half-life: 1-4 hours
Time to peak serum concentration: 0.5-2 hours
Elimination: Renal excretion (60% to 75%), primarily as glucuronide
conjugates |

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Usual Dosage |
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Oral:
Children >12 years and Adults:
Rheumatoid arthritis or osteoarthritis: 50-75 mg 3-4 times/day up to a
maximum of 300 mg/day
Mild to moderate pain: 25-50 mg every 6-8 hours up to a maximum of 300 mg/day
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Dietary
Considerations |
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In order to minimize gastrointestinal effects, ketoprofen can be prescribed
to be taken with food or milk; although food affects the bioavailability of
ketoprofen, analgesic efficacy is not significantly diminished; food slows rate
of absorption resulting in delayed and reduced peak serum
concentrations |

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Test
Interactions |
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chloride (S),
sodium (S),
bleeding
time
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Mental Health: Effects
on Mental Status |
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Dizziness is common; may cause nervousness; may rarely cause insomnia,
confusion, depression, or hallucinations |

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Mental Health:
Effects on Psychiatric
Treatment |
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May rarely cause agranulocytosis; use caution with clozapine and
carbamazepine; may decrease lithium clearance resulting in an increase in serum
lithium levels and potential lithium toxicity; monitor serum lithium
levels |

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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |

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Dental Health:
Effects on Dental Treatment |
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NSAID formulations are known to reversibly decrease platelet aggregation via
mechanisms different than observed with aspirin. The dentist should be aware of
the potential of abnormal coagulation. Caution should also be exercised in the
use of NSAIDs in patients already on anticoagulant therapy with drugs such as
warfarin (Coumadin®). |

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Patient
Information |
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Take this medication exactly as directed; do not increase dose without
consulting prescriber. Do not crush tablets or break capsules. Take with food or
milk to reduce GI distress. Maintain adequate fluid intake (2-3 L/day of fluids
unless instructed to restrict fluid intake). Do not use alcohol, aspirin, or
aspirin-containing medication, and all other anti-inflammatory medications
without consulting prescriber. You may experience drowsiness, dizziness,
nervousness, or headache (use caution when driving or engaging in tasks
requiring alertness until response to drug is known); anorexia, nausea,
vomiting, or heartburn (frequent small meals, frequent mouth care, sucking
lozenges, or chewing gum may help); fluid retention (weigh yourself weekly and
report unusual (3-5 lb/week) weight gain). GI bleeding, ulceration, or
perforation can occur with or without pain; discontinue medication and contact
prescriber if persistent abdominal pain or cramping, or blood in stool occurs.
Report breathlessness, difficulty breathing, or unusual cough; chest pain, rapid
heartbeat, palpitations; unusual bruising/bleeding; blood in urine, stool,
mouth, or vomitus; swollen extremities; skin rash or itching; acute fatigue; or
changes in hearing or ringing in ears. Breast-feeding precautions:
Consult prescriber if breast-feeding. |

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Nursing
Implications |
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Dose must be lowest recommended in renal insufficiency and hypoalbuminemia.
There are no clinical guidelines to predict which NSAID will give response in a
particular patient. Trials with each must be initiated until response
determined. Consider dose, patient convenience, and cost. |

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Dosage Forms |
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Capsule (Orudis®): 25 mg, 50 mg, 75 mg
Actron®, Orudis® KT [OTC]: 12.5
mg
Capsule, extended release (Oruvail®): 100 mg, 150 mg,
200 mg |

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References |
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Balevi B,
"Ketorolac Versus Ibuprofen: A Simple Cost-Efficacy Comparison for Dental Use,"
J Can Dent Assoc, 1994, 60(1):31-2.
Brooks PM and Day RO,
"Nonsteroidal Anti-inflammatory Drugs - Differences and Similarities," N Engl
J Med, 1991, 324(24):1716-25.
Clinch D, Banerjee AK, Ostick G,
"Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer," Age
Ageing, 1984, 13:120-3.
Clive DM, Stoff JS,
"Renal Syndromes Associated With Nonsteroidal Anti-inflammatory Drugs," N
Engl J Med, 1984, 310(9):563-72.
Cooper SA, "Ketoprofen in Oral Surgery Pain: A Review," J Clin
Pharmacol, 1988, 28(12 Suppl):S40-6.
Court H and Volans GN,
"Poisoning After Overdose With Nonsteroidal Anti-inflammatory Drugs," Adverse
Drug React Acute Poisoning Rev, 1984, 3(1):1-21.
"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.
Graham DY,
"Prevention of Gastroduodenal Injury Induced by Chronic Nonsteroidal Anti-inflammatory Drug Therapy,"
Gastroenterology, 1989, 96(2 Pt 2 Suppl):675-81.
Gurwitz JH, Avorn J, Ross-Degnan D, et al,
"Nonsteroidal Anti-Inflammatory Drug-Associated Azotemia in the Very Old,"
JAMA, 1990, 264(4):471-5.
Hawkey CJ, Karrasch JA, Szczepanski L, et al,
"Omeprazole Compared With Misoprostrol for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,"
N Engl J Med, 1998, 338(11):727-34.
Hersh EV,
"The Efficacy and Safety of Ketoprofen in Postsurgical Dental Pain,"
Compendium, 1991, 12(4):234.
Hoppmann RA, Peden JG, and Ober SK,
"Central Nervous System Side Effects of Nonsteroidal Anti-inflammatory Drugs. Aseptic Meningitis, Psychosis, and Cognitive Dysfunction,"
Arch Intern Med, 1991, 151(7):1309-13.
Pounder R, "Silent Peptic Ulceration: Deadly Silence or Golden Silence?"
Gastroenterology, 1989, 96(2 Pt 2 Suppl):626-31.
Smolinske SC, Hall AH, Vandenberg SA, et al,
"Toxic Effects of Nonsteroid Anti-inflammatory Drugs in Overdose. An Overview of Recent Evidence on Clinical Effects and Dose-Response Relationships,"
Drug Saf, 1990, 5(4):252-74.
Vale JA and Meredith TJ,
"Acute Poisoning Due to Nonsteroidal Anti-inflammatory Drugs," Med
Toxicol, 1986, 1(1):12-31.
Verbeeck RK,
"Pharmacokinetic Drug Interactions With Nonsteroidal Anti-inflammatory Drugs,"
Clin Pharmacokinet, 1990, 19(1):44-66.
Yeomans ND, Tulassay Z, Juhasz L, et al,
"A Comparison of Omeprazole With Ranitidine for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,"
N Engl J Med, 1998, 338(11):719-26. |

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