Fenoprofen Calcium

Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Molecular Formula: C₃₀H₂₆CaO₆•2H₂O
CAS Number: 53746-45-5
Brands: Nalfon

• Cardiovascular Risk


• 
  

  Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).^{137 b} Risk may increase with duration of use.^{137 b} Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.^{100 137 b} (See Cardiovascular Effects under Cautions.)

  
  


• 
  

  Contraindicated for the treatment of pain in the setting of CABG surgery.^{100 137 b}

  
  

• GI Risk


• 
  

  Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).^{137 b} Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.^{137 b} Geriatric individuals are at greater risk for serious GI events.^{100 137 b} (See GI Effects under Cautions.)

  
  

Introduction

Prototypical NSAIA;^{100 b} propionic acid derivative;^b structurally and pharmacologically related to flurbiprofen, ibuprofen, ketoprofen, and naproxen.^{b d}

Uses for Fenoprofen Calcium

Consider potential benefits and risks of fenoprofen therapy as well as alternative therapies before initiating therapy with the drug.^{100 137 b} Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.^{100 137 b}

Pain

Relief of mild to moderate pain in adults.^{100 b}

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.^{100 b d}

Has been used in the symptomatic treatment of juvenile rheumatoid arthritis†.^{b c}

Also has been used with some success in the treatment of ankylosing spondylitis† and acute gouty arthritis†.^{b d}

Fenoprofen Calcium Dosage and Administration

General

• 
  

  Consider potential benefits and risks of fenoprofen therapy as well as alternative therapies before initiating therapy with the drug.^{100 137 b}

  
  

Administration

Oral Administration

Administer orally.^{100 b}

Administration with meals, milk, or antacids may minimize adverse GI effects.^{100 b d}

Dosage

Available as fenoprofen calcium; dosage expressed in terms of fenoprofen.^{100 b}

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.^{100 137 b} Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.^{100 137 b}

Adults

Pain

Oral

For mild to moderate pain, 200 mg every 4–6 hours as needed.^{100 b}

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 300–600 mg 3 or 4 times daily.^{100 b d} Adjust dose and frequency as necessary based on severity of symptoms and clinical response (maximum 3.2 g daily).^{100 b}

Patients with rheumatoid arthritis may require higher dosages than those with osteoarthritis.^{100 b}

Symptomatic improvement usually begins in a few days, but an additional 2–3 weeks may be needed to determine response.^{100 b}

Prescribing Limits

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 3.2 g daily.^{100 b}

Special Populations

Renal Impairment

No dosage adjustments recommended.¹⁰⁰

Use not recommended in patients with advanced renal disease.¹⁰⁰

Hepatic Impairment

No dosage adjustments recommended.

Cautions for Fenoprofen Calcium

Contraindications

• 
  

  Known hypersensitivity to fenoprofen or any ingredient in the formulation.^{100 d}

  
  


• 
  

  History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.^{100 137 d}

  
  


• 
  

  Treatment of perioperative pain in the setting of CABG surgery.^{100 137}

  
  


• 
  

  History of significant renal impairment.¹⁰⁰

  
  

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.¹³⁸ Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.^{141 142 143} Information not available on risk associated with fenoprofen at this time.^{141 142 143}

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.^{100 137}

Peripheral edema, palpitations, tachycardia (including supraventricular tachycardia), atrial fibrillation, and ECG changes reported.^{100 b}

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).¹³⁸

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.^{100 137 138} (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.^{100 137} Use with caution in patients with hypertension; monitor BP.^{100 137} Impaired response to certain diuretics may occur.^{100 137} (See Specific Drugs under Interactions.)

Fluid retention and edema reported.^{100 137} Caution in patients with fluid retention or heart failure.^{100 137}

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;^{100 104 105 108} 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.^{100 124 127 134}

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;^{107 124 125 126} alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)^{107 124 125} or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).¹²⁵

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.^{100 137}

Potential for overt renal decompensation.^{100 137} Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.^{100 137 140} (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.^{100 137}

Immediate medical intervention and discontinuance for anaphylaxis.^{100 137}

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.^{100 137 d}

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.^{100 137} Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).^{100 137}

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.¹⁰⁰

Elevations of serum ALT or AST reported.¹⁰⁰

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.¹⁰⁰ Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.¹⁰⁰

Hematologic Effects

Anemia reported rarely.^{100 137} Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.^{100 137 d}

May inhibit platelet aggregation and prolong bleeding time.^{100 137 d}

CNS Effects

Drowsiness and dizziness reported; may impair ability to perform activities requiring mental alertness.^{100 b}

Ocular Effects

Adverse ocular effects reported in patients receiving NSAIA therapy; ophthalmologic evaluation recommended if visual disturbances occur.^{100 b}

Otic Effects

Safety not established in patients with hearing impairment; auditory function tests should be performed periodically in these patients during prolonged therapy.^{100 b}

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.¹⁰⁰

May mask certain signs of infection.^b

Obtain CBC and chemistry profile periodically during long-term use.¹⁰⁰

Specific Populations

Pregnancy

Category C.¹⁰⁰ Avoid use in third trimester because of possible premature closure of the ductus arteriosus.¹⁰⁰

Lactation

Fenoprofen is distributed into milk.^{b d} Discontinue nursing or the drug.^{100 b}

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹⁰⁰

Geriatric Use

Use with caution in patients ≥65 years of age.¹⁰⁰ Geriatric patients appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.^{100 b} Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.^{100 b}

Renal Impairment

Has not been evaluated in patients with severe renal impairment.^{100 b} Use not recommended in patients with advanced renal disease.^{100 b}

Common Adverse Effects

Dyspepsia,^{100 d} nausea,^{100 d} constipation,^{100 d} headache,¹⁰⁰ somnolence,¹⁰⁰ dizziness,¹⁰⁰ nervousness,¹⁰⁰ asthenia,¹⁰⁰ and peripheral edema.¹⁰⁰

Interactions for Fenoprofen Calcium

Protein-bound Drugs

Possible pharmacokinetic interaction; potential for fenoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).^{100 b d} Observe for adverse effects if used with other protein-bound drugs.^{100 b}

Specific Drugs

Drug	Interaction	Comments
ACE inhibitors	Reduced BP response to ACE inhibitor possible 100 137 144 Possible deterioration of renal function in individuals with renal impairment144	Monitor BP100 144 b
Angiotensin II receptor antagonists	Reduced BP response to angiotensin II receptor antagonist possible144 Possible deterioration of renal function in individuals with renal impairment144	Monitor BP144 b
Antacids (aluminum- and magnesium-containing)	Did not affect fenoprofen absorption in one study; other antacids not evaluated for possible interactionsa b d
Anticoagulants (e.g., warfarin)	Possible bleeding complications100 137 144	Caution and careful monitoring advised100 144 b
Aspirin	Increased risk of GI ulceration or other complications 100 137 Possible decreased plasma concentrations and half-life of fenoprofen100 b d No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs 100 138	Concomitant use generally not recommended100 d
Diuretics (furosemide and thiazides)	Reduced natriuretic effects100 137	Monitor for diuretic efficacy and renal failure100 137
Lithium	Increased plasma lithium concentrations100 137	Monitor for lithium toxicity 100 137
Methotrexate	Possible toxicity associated with increased plasma methotrexate concentrations during concomitant NSAIA use100 b	Caution advised100 b
Phenobarbital	Possible decreased plasma concentrations and plasma half-life of fenoprofen100 b d	Dosage adjustment may be necessary when phenobarbital is initiated or discontinued100 b d

Fenoprofen Calcium Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.^{100 b d} Peak plasma concentrations usually attained within 2 hours.^{100 b}

Onset

Onset of analgesic activity reportedly occurs within 15–30 minutes following oral administration.^b

Duration

Duration of analgesic activity: 4–6 hours.^b

Food

Food delays and diminishes peak plasma fenoprofen concentrations.^{100 a b d}

Distribution

Extent

Distributed into milk;^{b d} does not appear to cross the placenta.^{b d}

Plasma Protein Binding

Approximately 99% (mainly to albumin).^{100 b d}

Elimination

Metabolism

Extensively metabolized in the liver.^{b d} Fenoprofen's major metabolite, 4′-hydroxyfenoprofen, probably is inactive.^b

Elimination Route

Eliminated principally in urine as unchanged drug (2–5%), 4′-hydroxyfenoprofen (2–5%), their glucuronide or other conjugates (90%), and unidentified conjugates (2–5%).^{100 b d}

Half-life

2.5–3 hours.^{100 b d}

Special Populations

Not substantially removed by hemodialysis or peritoneal dialysis.¹⁰⁰

Stability

Storage

Oral

Capsules and Tablets

Tight containers at 20–25°C.¹⁰⁰

ActionsActions

• 
  

  Inhibits cyclooxygenase-1 (COX-1) and COX-2.^{118 119 120 121 122 123 b}

  
  


• 
  

  Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.^{100 118 119 120 121 122 123 b d}

  
  

Advice to Patients

• 
  

  Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.^{100 137}

  
  


• 
  

  Risk of serious cardiovascular events with long-term use.^{100 b} Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.^{100 b}

  
  


• 
  

  Risk of GI bleeding and ulceration.^{100 111 115 b} Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.^{100 b}

  
  


• 
  

  Risk of serious skin reactions.^{100 b} Importance of discontinuing fenoprofen calcium and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.^{100 b}

  
  


• 
  

  Risk of anaphylactoid and other sensitivity reactions.^{100 b} Importance of seeking immediate medical attention if an anaphylactic reaction occurs.^{100 b}

  
  


• 
  

  Risk of hepatotoxicity.^{100 b} Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.^{100 b}

  
  


• 
  

  Importance of notifying clinician if signs and symptoms of unexplained weight gain or edema develop.¹⁰⁰

  
  


• 
  

  Risk of dizziness and potential for drug to impair mental alertness; use caution when driving or operating machinery until effects on individual are known.^{100 b}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰ Importance of avoiding fenoprofen in late pregnancy (third trimester).^{100 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.¹⁰⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁰ (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

Fenoprofen Calcium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	200 mg (of fenoprofen)*	Nalfon	Pedinol
		300 mg (of fenoprofen)*	Fenoprofen Calcium Capsules	Par, Sandoz, Watson
			Nalfon	Pedinol
	Tablets, film-coated	600 mg (of fenoprofen)*	Fenoprofen Calcium Tablets	Mylan, Purepac, Teva

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.

Fenoprofen Calcium 600MG Tablets (MYLAN): 30/$33.99 or 90/$79.97

Nalfon 200MG Capsules (PEDINOL): 100/$91.99 or 300/$249.98

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 November 2007. 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.

References

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c. Brewer EJ, Giannini EH, Baum J et al. Aspirin and fenoprofen (Nalfon) in the treatment of juvenile rheumatoid arthritis results of the double blind-trial: a segment II study. J Rheumatol. 1982; 9: 123-8.

d. Brogden RN, Pinder RM, Speight TM et al. Fenoprofen: a review of its pharmacological properties and therapeutic efficacy in rheumatic diseases. Drugs. 1977; 13: 241-65.

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