Fenoprofen Calcium
Pronouncation: (FEN-oh-PROE-fen KAL-si-um)Class: NSAID
Trade Names:
Fenoprofen
- Tablets 600 mg
Trade Names:
Nalfon
- Capsules 200 mg
- Capsules 300 mg
Pharmacology
Feedback for Fenoprofen Calcium
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Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
Pharmacokinetics
Absorption
T max is 2 h; C max is 50 mcg/mL.
Distribution
Fenoprofen is about 99% protein bound.
Metabolism
Major urinary metabolites are fenoprofen glucuronide and 4′-hydroxyfenoprofen glucuronide.
Elimination
The t ½ is 3 h; about 90% is renally eliminated.
Indications and Usage
Symptomatic relief for rheumatoid arthritis, osteoarthritis, and mild to moderate pain.
Unlabeled Uses
Selected NSAIDs have been used in the treatment of juvenile rheumatoid arthritis, symptomatic treatment of sunburn, and for various migraine headaches.
Contraindications
History of significantly impaired renal function; patients with known hypersensitivity to any component of the product; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Dosage and Administration
Rheumatoid Arthritis/OsteoarthritisPO 300 to 600 mg 3 to 4 times daily; do not exceed 3.2 g/day.
Mild/Moderate PainPO 200 mg every 4 to 6 h as needed.
General Advice
- Administer without regard to meals, but administer with food or milk if GI upset occurs.
Storage/Stability
Store tablets and capsules at controlled room temperature (68° to 77°F).
Drug Interactions
Aminoglycosides (eg, gentamicin)Plasma aminoglycoside levels may be elevated.
Angiotensin-converting enzyme (ACE) inhibitorsAntihypertensive effect of ACE inhibitors may be diminished.
AnticoagulantsCoadministration may prolong PT.
AspirinFenoprofen Cl may be increased; coadministration is not recommended.
DiureticsPatients treated with fenoprofen may be resistant to the effects of loop diuretics and thiazides.
Hydantoins, sulfonamides, sulfonylureasFenoprofen may displace these drugs from their binding site.
LithiumRenal Cl of lithium may be reduced and plasma levels may be elevated, which may increase the risk of lithium toxicity.
MethotrexateMay increase methotrexate levels.
PhenobarbitalMay decrease fenoprofen t ½ . Dosage adjustments of fenoprofen may be required if phenobarbital is added or withdrawn.
SSRIs (eg, fluoxetine)The risk of GI effects may be increased.
Laboratory Test Interactions
False elevation in free and total serum T 3 as measured by Amerlex-M kit.
Adverse Reactions
Cardiovascular
Palpitations (3%).
CNS
Headache, somnolence (9%); dizziness (7%); nervousness (6%); asthenia (5%); fatigue, tremor (2%); confusion (1%).
Dermatologic
Increased sweating (5%); pruritus, rash (4%).
EENT
Tinnitus (5%); blurred vision, decreased hearing (2%); nasopharyngitis (1%).
GI
Dyspepsia (10%); nausea (8%); constipation (7%); vomiting (3%); abdominal pain, diarrhea (2%).
Respiratory
Dyspnea (3%); upper respiratory tract infection (2%).
Miscellaneous
Peripheral edema (5%).
Precautions
WarningsNSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Fenoprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events. |
MonitorFollow chronically treated patients for signs and symptoms of GI tract ulceration and bleeding. Monitor CBC, chemistry profile, and LFTs periodically during long-term therapy. Monitor renal function in patients with compromised kidney function. Monitor Hgb or Hct in patients with any signs or symptoms of anemia. Perform eye examinations if patient experiences visual disturbances. Closely monitor BP during the initiation of treatment and throughout the course of therapy. Carefully monitor patients who may be adversely affected by alterations in platelet function (eg, patients with coagulation disorders or receiving anticoagulant therapy). Monitor auditory function periodically during prolonged therapy. |
Pregnancy
Category C . Avoid in late pregnancy.
Lactation
Undetermined.
Children
Safety and efficacy not established.
Elderly
Use with caution.
Hypersensitivity
Do not use in aspirin-sensitive individuals because of possible cross-sensitivity.
Renal Function
Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia, and renal papillary necrosis may occur. Contraindicated in patients with a history of significantly impaired renal function
Hepatic Function
Use with caution. Discontinue if any significant liver abnormalities occur.
Anaphylactoid reactions
Do not administer to patients with aspirin triad, which typically occurs in patients with asthma who experience rhinitis with or with nasal polyps, or who exhibit severe, potentially fatal, bronchospasm after taking aspirin or other NSAIDs.
Asthma
Patients with asthma may have aspirin-sensitive asthma, which may be associated with severe and sometimes fatal bronchospasm. Fenoprofen should not be administered to patients with this type of aspirin-sensitivity because of possible cross-reactivity.
Bleeding
May decrease platelet aggregation.
Hypertension
New hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events, may occur.
Peripheral edema
Has been observed. Use with caution in patients with hypertension or compromised cardiac function.
Skin reactions
Serious and sometimes fatal skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur.
Overdosage
Symptoms
Abdominal pain, acute renal failure, ataxia, confusion, dizziness, drowsiness, dyspepsia, headache, hyperpyrexia, hypotension, metabolic acidosis, nausea, respiratory depression, tachycardia, tinnitus, tremor, vomiting.
Patient Information
- Advise patient to review Medication Guide before using the first time and with each refill.
- Advise patient that dose is individualized based upon condition being treated, severity of symptoms, and response to therapy.
- Instruct patient to take prescribed dose without regard to meals but to take with food if stomach upset occurs.
- Caution patient not to change the dose or stop taking unless advised by health care provider. Advise patient to notify health care provider if medication does not adequately control pain or arthritis symptoms.
- Caution patient to avoid smoking, alcohol, and self-administration of aspirin-containing medications while taking fenoprofen.
- Advise patient that if a dose is missed, to take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
- Advise patient to seek emergency medical assistance if any of the following occur: shortness of breath or trouble breathing, chest pain, weakness in one part or one side of body, slurred speech, swelling of the face or throat.
- Advise patient to discontinue drug and immediately notify health care provider if any of the following occur: persistent or recurrent GI upset or stomach pain, skin rash or itching, vomiting blood, bloody or black stools, rapid weight gain or swelling, changes in urine patterns, joint pain, fever, bleeding or unusual bruising, unexplained tiredness or fatigue, intestinal flu-like symptoms, yellowing of the skin or eyes, visual changes.
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More Fenoprofen Calcium resources:
Fenoprofen - Includes detailed dosage instructions.
Fenoprofen Calcium Drug Interactions
Pain, Rheumatoid Arthritis, Osteoarthritis, Gout -- Acute
