fenoprofen (Rx)

Brand and Other Names:Nalfon
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 200mg
  • 400mg

tablets

  • 600mg

Pain

200 mg PO q4-6hr; not to exceed 3200 mg/day

Rheumatoid Arthritis

300-600 mg PO q6-8hr

Maximum recommended dose is 3200 mg/day

Osteoarthritis

300-600 mg PO q6-8hr

Maximum recommended dose is 3200 mg/day

Renal Impairment

Advanced renal disease: Not recommended

Administration

Take with food or 8-12 oz water to avoid GI effects

Other Indications

Off-label: vascular headache, gout

<12 years: Safety and efficacy not established

Pain

200 mg PO q4-6hr; not to exceed 3200 mg/day

Rheumatoid Arthritis, Osteoarthritis

300-600 mg PO q6-8hr

Maximum recommended dose is 3200 mg/day

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Interactions

Interaction Checker

and fenoprofen

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Dyspepsia (10.3%)

            Somnolence

            Increased LFT

            1-10%

            Abdominal pain

            Anemia

            Diarrhea

            Dizziness

            Edema

            Headache

            Constipation

            Confusion

            Tremor

            Sweating

            Tinnitus

            Blurred vision

            Palpitations

            Nervousness

            Fatigue

            Rash

            Nausea

            Vomiting

            GI bleeding, ulceration, perforation

            Frequency Not Defined

            Insomnia

            Asthenia

            Paresthesia

            Muscle weakness

            Decreased hearing

            Purpura, bruising, hemorrhage

            Thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, pancytopenia, slight decreases in hemoglobin concentration & hematocrit

            Dysuria, cystitis, hematuria

            Nephrotic syndrome, renal failure, oliguria, anuria, azotemia, allergic nephritis, nephrosis, papillary necrosis

            Jaundice

            Cholestatic hepatitis

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use & without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Absolute: ASA allergy

            Relative: bleeding disorders, duodenal/gastric/peptic ulcer, renal impairment, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

            Cautions

            Use caution in asthma (bronchial), cardiac disease, CHF, hepatic impairment, HTN

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

            Heart Failure (HF) risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
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            Pregnancy & Lactation

            Pregnancy

            Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

            In animal reproduction studies, embryo-fetal lethality and skeletal abnormalities were noted in offspring of pregnant rabbits following oral administration of fenoprofen during organogenesis at 0.6 times the maximum human daily dose of 3200 mg/day

            However, there were no major malformations noted following oral administration of fenoprofen calcium to pregnant rats and rabbits during organogenesis at exposures up to 0.3 and 0.6 times the maximum human daily dose of 3200 mg/day

            Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization

            In animal studies, administration of prostaglandin synthesis inhibitors such as fenoprofen, resulted in increased pre- and post-implantation loss

            Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

            Fetal toxicity

            • NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
            • Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
            • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice
            • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of the fetal ductus arteriosus
            • Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy

            Labor or Delivery

            • There are no studies on the effects of NALFON during labor or delivery; in animal studies, NSAIDS, including fenoprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase incidence of stillbirth

            Reproductive potential

            • Females
              • Based on mechanism of action, the use of prostaglandin mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
              • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
              • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, in women who have difficulties conceiving or who are undergoing investigation of infertility

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

            May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation. These effects may contribute to its anti-inflammatory activity

            Pharmacokinetics

            Onset: 2-4hr

            Duration: 4-6 hr

            Peak Plasma Time: 2 hr

            Peak Plasma Concentration: 50 mcg/mL

            Protein Bound: 99% (albumin)

            Metabolism: Liver

            Metabolites: 4'-hydroxyfenoprofen, glucuronic acid conjugates

            Enzymes inhibited: cyclooxygenase-1 (COX-1) & -2 (COX-2), prostaglandin synthesis

            Half-life: 2.5-3 hr

            Clearance: within 24 hr

            Excretion: urine (primarily); feces

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.