Flector Patch(diclofenac epolamine topical patch)1.3%
FLECTOR PATCH Rx
Generic Name and Formulations:
Diclofenac epolamine 180mg; per patch.
Company:
Pfizer Inc.
Indications for FLECTOR PATCH:
Topical treatment of acute pain due to minor strains, sprains, and contusions.
Adult:
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.
Children:
Not established.
Contraindications:
Aspirin allergy. Coronary artery bypass graft surgery. Non-intact or damaged skin (eg, dermatitis, eczema, burns, wounds, lesions).
Boxed Warning:
Risk of serious cardiovascular and gastrointestinal events.
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, 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.
Pharmacological Class:
NSAID (benzeneacetic acid deriv.).
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, 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).
Adverse Reactions:
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.
Generic Availability:
NO
How Supplied:
Patch—30 |
