Diclofenac 3% Generic Name & Formulations
Legal Class
Rx
General Description
Diclofenac sodium 3%; gel; contains benzyl alcohol.
Pharmacological Class
NSAID.
How Supplied
Contact supplier
Manufacturer
Diclofenac 3% Indications
Indications
Actinic keratoses.
Diclofenac 3% Dosage and Administration
Adult
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.
Children
Not recommended.
Diclofenac 3% Contraindications
Contraindications
Aspirin allergy. Use on damaged skin. Coronary artery bypass graft surgery.
Diclofenac 3% Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Diclofenac 3% Warnings/Precautions
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
Elimination
Renal.
Diclofenac 3% Interactions
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
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
See Literature
Diclofenac 3% Note
Notes
Formerly known under the brand name Solaraze.
Diclofenac 3% Patient Counseling
See Literature