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|Fenoprofen Calcium

Fenoprofen Calcium

Trade Names:
Fenoprofen
- Tablets 600 mg

Trade Names:
Nalfon
- Capsules 200 mg
- Capsules 300 mg

Mechanism of Action

Pharmacology

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Pharmacokinetics

Absorption

T _max is 2 hr; 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 hr; 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 peri-operative pain in the setting of coronary artery bypass graft surgery.

Dosage and Administration

PO 300 to 600 mg tid to qid; do not exceed 3.2 g/day.

PO 200 mg q 4 to 6 hr prn.

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

Plasma aminoglycoside levels may be elevated.

Antihypertensive effect of ACE inhibitors may be diminished.

Coadministration may prolong PT.

Fenoprofen Cl may be increased; coadministration is not recommended.

Patients treated with fenoprofen may be resistant to the effects of loop diuretics and thiazides.

Fenoprofen may displace these drugs from their binding site.

Renal Cl of lithium may be reduced and plasma levels may be elevated, which may increase the risk of lithium toxicity.

May increase methotrexate levels.

May decrease fenoprofen t _½ . Dosage adjustments of fenoprofen may be required if phenobarbital is added or withdrawn.

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

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

• Explain name, dose, action, potential benefits and adverse reactions, and risks of drug.
• Obtain patient history, including drug history and any known allergies.
• Advise patient to review Medication Guide for Nonsteroidal Anti-Inflammatory Drugs 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 on 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.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
• Caution patient not to take any prescription or OTC medications, dietary supplements, or herbal preparations unless advised by health care provider.
• Advise patient that follow-up examinations and lab tests may be required to monitor therapy and to keep appointments.