FLECTOR PATCH Rx
Generic Name and Formulations:
Diclofenac epolamine 180mg; per patch.
Indications for FLECTOR PATCH:
Topical treatment of acute pain due to minor strains, sprains, and contusions.
Use lowest effective dose for shortest duration. Apply 1 patch to clean, dry, intact skin on most painful area twice daily. May tape edges down if patch begins to peel off. Wash hands after application. Remove during bathing/showering.
Aspirin allergy. Coronary artery bypass graft surgery. Non-intact or damaged skin (eg, dermatitis, eczema, burns, wounds, lesions).
Risk of serious cardiovascular and gastrointestinal events.
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, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Avoid eyes, mucosa. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: 1st and 2nd trimester); (Cat.D: 3rd trimester; avoid). Nursing mothers.
NSAID (benzeneacetic acid deriv.).
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, ARBs, 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. Caution with hepatotoxic drugs (eg, acetaminophen, antibiotics, antiepileptics).
Application site reactions (eg, pruritus, dermatitis, burning), GI events (eg, nausea, dysgeusia, dyspepsia); cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, anemia.