Diclofenac 3% Generic Name & Formulations
Diclofenac sodium 3%; gel; contains benzyl alcohol.
Diclofenac 3% Indications
Diclofenac 3% Dosage and Administration
Use lowest effective dose for shortest duration. Apply to lesions twice daily for 60–90 days. Use 0.5g (pea size amount) on each 5cm×5cm lesion site.
Diclofenac 3% Contraindications
Aspirin allergy. Use on damaged skin. Coronary artery bypass graft surgery.
Diclofenac 3% Boxed Warnings
Risk of serious cardiovascular and gastrointestinal events.
Diclofenac 3% 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. Preexisting 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 (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.
Diclofenac 3% Pharmacokinetics
Diclofenac 3% 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 other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).
Diclofenac 3% Adverse Reactions
Application site reactions (eg, dry skin, contact dermatitis, exfoliation, rash, pruritus), GI upset; cardiovascular thrombotic events, GI ulcer/bleed, edema, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, SJS, TEN), DRESS (discontinue if occurs), anemia.
Diclofenac 3% Clinical Trials
Diclofenac 3% Note
Formerly known under the brand name Solaraze.
Diclofenac 3% Patient Counseling