Arthritis/rheumatic disorders:
Indications for: FELDENE
Osteoarthritis. Rheumatoid arthritis.
Clinical Trials:
The effectiveness of Feldene has been established for both acute exacerbations and long term management of rheumatoid arthritis and osteoarthritis in controlled clinical trials.
The therapeutic effects of Feldene are seen early in the treatment of both RA and osteoarthritis with a progressive increase in response over 8-12 weeks. Efficacy was measured by pain relief and, when present, a reduction in inflammation.
Doses of Feldene 20mg/day were observed to have a therapeutic effect comparable to therapeutic doses of aspirin, with a lower incidence of minor GI effects and tinnitus.
Feldene has been administered concomitantly with fixed doses of gold and corticosteroids. The existence of a “steroid sparing” effect has not been adequately studied to date.
Adult Dosage:
Use lowest effective dose for shortest duration. 20mg daily. May give in 2 divided doses.
Children Dosage:
Not established.
FELDENE Contraindications:
Aspirin allergy. Coronary artery bypass graft surgery.
Boxed Warning:
Risk of serious cardiovascular and gastrointestinal events.
FELDENE Warnings/Precautions:
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. CYP2C9 poor metabolizers. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.
FELDENE Classification:
NSAID (oxicam).
FELDENE Interactions:
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May potentiate other highly protein-bound drugs.
Adverse Reactions:
Nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia/blood dyscrasias.
Drug Elimination:
Plasma half-life is ~50 hours. Prolonged half-life results in the maintenance of stable plasma concentrations throughout the day on once daily doses and significant accumulation upon multiple dosing. Most patients approximate steady state plasma levels within 7 to 12 days.
Renal, fecal excretion.
Generic Drug Availability:
YES
How Supplied:
Caps—100
