Generic Name and Formulations:
Diclofenac sodium 1.5%; topical soln.
Indications for PENNSAID:
To treat signs/symptoms of osteoarthritis of the knee(s).
Use lowest effective dose for shortest duration. Apply to clean, dry skin. Initially dispense 10 drops; spread evenly around front, back and sides of the knee; repeat until 40 drops have been applied and knee is completely covered with solution. Usual dose: 40 drops/knee 4 times daily. Wash hands. Wait until area is dry before skin-to skin contact or applying other topical products (eg, sunscreen, insect repellent, lotion, moisturizer, cosmetics, medications).
Aspirin allergy. Coronary artery bypass graft surgery.
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. Do not apply to open wounds, infections, inflammations, exfoliative dermatitis. Avoid eyes, mucous membranes, external heat and/or occlusive dressings, sunlight. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; 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 other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).
Application site reactions (eg, dry skin, contact dermatitis, pruritus, vesicles), GI upset; cardiovascular thrombotic events, GI ulcer/bleed, edema, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.
Soln 1.5% (YES); Pump 2% (NO)
Soln 1.5%—150mL; Pump 2%—112g
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