Fenoprofen


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Rheumatoid arthritis; Osteoarthritis 300-600 mg 3-4 times/day. Max: 3.2 g/day. Mild to moderate pain 200 mg 4-6 hrly. Max: 3.2 g/day.
Dosage Details
Oral
Osteoarthritis, Rheumatoid arthritis
Adult: 300-600 mg 3-4 times daily. Max: 3.2 g/day.

Oral
Mild to moderate pain
Adult: 200 mg 4-6 hrly as needed. Max: 3.2 g/ day.
Renal Impairment
Severe: Contraindicated.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to aspirin or other NSAIDs, treatment of perioperative pain in the setting of CABG surgery. Severe renal impairment. 3rd trimester of pregnancy, and lactation.
Special Precautions
Patient w/ known CV disease or risk factors for CV disease, history of upper GI disease, low pretreatment of Hb concentration. Hepatic and mild to moderate renal impairment. Elderly (avoid chornic use).
Adverse Reactions
Dyspepsia, nausea, constipation, vomiting, abdominal pain, diarrhoea, headache, somnolence, dizziness, tremor, confusion, increased sweating, pruritus, rash, tinnitus, blurred vision, decreased hearing, palpitations, tachycardia, ECG changes, nervousness, asthenia, peripheral oedema, dyspnoea, dysuria, cystitis, haematuria, nephrotic syndrome, upper resp infection, nasopharyngitis. Elevations in BUN, serum creatinine, serum aminotransferase concentrations, LDH and alkaline phosphatase.
Potentially Fatal: Serious CV thrombotic events, MI, stroke, renal failure, bleeding, ulceration or perforation of stomach and intestines, jaundice, cholestatic hepatitis.
PO: C (FDA Pregnancy Category C if given prior to 30 weeks gestation.), D (FDA pregnancy Category D if given following 30 weeks gestation.

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Patient Counseling Information
May impair ability to perform activities requiring mental alertness or physical coordination (e.g. driving a motor vehicle, operating machinery).
MonitoringParameters
Monitor CBC, liver enzymes; monitor urine output and BUN/serum creatinine in patients receiving diuretics; BP in patients receiving antihypertensives; audiogram in patients w/ baseline hearing impairment.
Overdosage
Symptoms: Nonoliguric renal failure, hypotension, coma, metabolic acidosis, resp depression, proteinuria, tachycardia w/ ST-segment and T-wave abnormalities. Management: Empty the stomach by inducing emesis or by gastric lavage, followed by admin of activated charcoal. Supportive and symptomatic treatment including correction of fluid imbalance and admin of dopamine.
Drug Interactions
Increased risk of GI bleeding w/ anticoagulants, bisphosphonates, clopidogrel, oral corticosteroids, dabigatran, rivaroxaban, salicylates and SSRIs. May reduce antihypertensive effect of ACE inhibitors. Increased nephrotoxicity w/ ciclosporin. Decrease in plasma half-life w/ phenobarbital. May reduce the natriuretic effects of loop and thiazide diuretics. May increase toxicity of lithium and methotrexate. Increased risk of CNS stimulation and seizures w/ quinolones.
Food Interaction
Rate and extent of absorption may be reduced when taken w/ food. Increased risk of GI bleeding w/ alcohol.
Lab Interference
False elevations in both free and total serum triiodothyronine (T3) concentrations determined by the Amerlex-T® assay.
Action
Description: Fenoprofen, a propionic acid derivative, reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes resulting in decreased formation of prostaglandin precursors.
Onset: W/in 15-30 min.
Duration: 4-6 hr.
Pharmacokinetics:
Absorption: Rapidly and almost completely absorbed from the GI tract. Food may reduce the rate and extent of absorption. Bioavailability: Approx 85%. Time to peak plasma concentration: 1-2 hr.
Distribution: Distributed into breast milk. Plasma protein binding: 99%
Metabolism: Undegoes hepatic metabolism to 4'-hydroxyfenoprofen.
Excretion: Via urine (approx 90%) as glucuronide and glucuronide of hydroxylated fenoprofen and faeces (small amounts). Plasma half-life: Approx 3 hr.
Storage
Store between 20-25°C. Protect from light.
References
Anon. Fenoprofen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/05/2014.

Buckingham R (ed). Fenoprofen Calcium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/05/2014.

Fenoprofen Calcium Tablet, Film Coated (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 27/05/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Fenoprofen Calcium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 27/05/2014.

Wickersham RM. Fenoprofen Calcium. Facts and Comparisons [online]. St. Louis, MO. Wolters Kluwer Clinical Drug Information, Inc. https://www.wolterskluwercdi.com/facts-comparisons-online/. Accessed 27/05/2014.

Disclaimer: This information is independently developed by MIMS based on Fenoprofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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