Diclofenac Sodium Prescribing Information
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use[see Warnings and Precautions ].
- Diclofenac sodiumis contraindicated in the setting of coronary artery bypass graft (CABG) surgery[see Contraindications and Warnings and Precautions ].
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events[see Warnings and Precautions ].
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratosis (AK).
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
Apply diclofenac sodium topical gel gently to lesion areas twice daily to adequately cover each lesion. Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered.
Avoid contact of diclofenac sodium topical gel with eyes and mucous membranes.
Topical gel, 3%. Each gram of diclofenac sodium topical gel contains 30 mg of diclofenac sodium USP, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium topical gel is supplied in 100 g tubes.
Diclofenac sodium topical gel is contraindicated in the following patients:
- With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions and Description ]
- With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ]
- Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions ]
- In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions ]