VOLTAREN GEL Rx
Generic Name and Formulations:
Diclofenac sodium 1%; gel.
Indications for VOLTAREN GEL:
Relief of the pain of osteoarthritis of joints amenable to topical treatment (eg, knees, hands).
Use lowest effective dose for shortest duration. Use dosing card to apply gel. Lower extremities (eg, knees, ankles, feet): Apply 4g to the affected area 4 times daily; max: 16g/day. Upper extremities (eg, elbows, wrists, hands): Apply 2g to the affected area 4 times daily; max: 8g/day. Total max dose over all affected joints: 32g/day. Do not wash treated hands for at least 1hr after application. Wait at least 10 minutes after application before getting dressed. Use on spine, hip, or shoulder has not been evaluated.
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 topical products and medications (eg, sunscreens, cosmetics, lotions, moisturizers, insect repellents). 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 (dermatitis, pruritus, erythema, paresthesia, dryness, vesicles, irritation); cardiovascular thrombotic events, GI ulcer/bleed, edema, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.