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(diclofenac sodium) Topical Solution 1.5% w/w is for Topical Use Only.
WARNING: 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].
- PENNSAID (diclofenac sodium topical solution) is contraindicated in the perioperative 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].
PENNSAID (diclofenac sodium topical solution) is a clear, colorless to faintly pink-orange solution for topical application.
PENNSAID contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula:
Each 1 mL of solution contains 16.05 mg of diclofenac sodium. In addition, PENNSAID (diclofenac sodium topical solution) contains the following inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), propylene glycol, alcohol, glycerin and purified water.
What are the possible side effects of diclofenac topical (Pennsaid, Solaraze, Voltaren Topical)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.
Stop using this medicine and call your doctor at once if you have a serious side effect such as:
- chest pain, slurred speech, problems with vision or balance, and feeling weak or...
What are the precautions when taking diclofenac sodium topical solution (PENNSAID)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or to dimethyl sulfoxide, or to propylene glycol; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver...
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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