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Pronunciation |
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(fen
oh PROE
fen) |

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U.S. Brand
Names |
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Nalfon® |

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Generic
Available |
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Yes |

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Synonyms |
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Fenoprofen Calcium |

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

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Use |
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Symptomatic treatment of acute and chronic rheumatoid arthritis and
osteoarthritis; relief of mild to moderate pain |

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Pregnancy Risk
Factor |
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B (D in 3rd trimester or near delivery) |

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Contraindications |
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Known hypersensitivity to fenoprofen or other NSAIDs |

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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, or
those receiving anticoagulants |

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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, aseptic meningitis, mental depression, drowsiness,
insomnia, 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 acute renal failure, vomiting, drowsiness,
leukocytosis
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. |

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Drug
Interactions |
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Decreased effect with phenobarbital; ACE-inhibitor effects may be decreased
by concurrent therapy with NSAIDs
Increased effect/toxicity of phenytoin, sulfonamides, sulfonylureas
Increased toxicity with salicylates, oral anticoagulants
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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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Onset of effect: Begins in a few days
Absorption: Rapid (to 80%) from upper GI tract
Distribution: Does not cross the placenta
Protein binding: 99%
Metabolism: Extensively in the liver
Half-life: 2.5-3 hours
Time to peak serum concentration: Within 2 hours
Elimination: In urine 2% to 5% as unchanged drug; small amounts appear in
feces |

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Usual Dosage |
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Adults: Oral:
Mild to moderate pain: 200 mg every 4-6 hours as needed |

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Dietary
Considerations |
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May be administered with food to decrease GI distress |

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Monitoring
Parameters |
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Monitor CBC, liver enzymes; monitor urine output and BUN/serum creatinine in
patients receiving diuretics |

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Reference Range |
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Therapeutic: 20-65 mg/mL (SI: 82-268
mmol/L) |

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Test
Interactions |
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chloride (S),
sodium
(S)
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Mental Health: Effects
on Mental Status |
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Dizziness is common; may cause nervousness; rarely may 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 the clearance of lithium resulting in elevated serum
levels and potential toxicity; monitor serum lithium levels; use acetaminophen,
if possible, for pain |

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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. Pregnancy/breast-feeding
precautions: Inform prescriber if you are or intend to be pregnant.
Breast-feeding is not recommended. |

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Nursing
Implications |
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Monitor CBC, liver enzymes; monitor urine output and BUN/serum creatinine in
patients receiving diuretics |

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Dosage Forms |
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Capsule, as calcium: 200 mg, 300 mg
Tablet, as calcium: 600 mg |

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References |
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Appleby DH, "Fenoprofen (Nalfon®) Overdose," Drug
Intell Clin Pharm, 1981, 15(2):129-30.
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.
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.
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.
Kolodzik JM, Eilers MA, and Angelos MG,
"Nonsteroidal Anti-inflammatory Drugs and Coma: A Case Report of Fenoprofen Overdose,"
Ann Emerg Med, 1990, 19(4):378-81.
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.
Stotts JS, Fang ML, Dannaker CJ, et al,
"Fenoprofen-Induced Toxic Epidermal Necrolysis," J Am Acad Dermatol,
1988, 18(4 Pt 1):755-7.
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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