(diclofenac sodium) Topical Gel
For topical use only
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CARDIOVASCULAR AND GASTROINTESTINAL RISK
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see WARNINGS AND PRECAUTIONS].
- Voltaren® Gel (diclofenac sodium gel) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS].
- NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events [see WARNINGS AND PRECAUTIONS].
Voltaren® Gel (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative. The chemical name is 2-[ (2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2. It has the following structural formula:
Voltaren® Gel (diclofenac sodium gel) also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.
Last reviewed on RxList: 10/15/2009
This monograph has been modified to include the generic and brand name in many instances.
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