"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(diclofenac epolamine) Patch
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].
- Flector Patch is contraindicated in the peri-operative 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].
Flector Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.
Diclofenac epolamine is a non-opioid analgesic chemically designated as 2-[(2,6- dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C20H24Cl2N2O3(molecular weight 411.3), an n-octanol/water partition coefficient of 8 at pH 8.5, and the following structure:
Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water.
What are the possible side effects of diclofenac transdermal (Flector Patch)?
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 short of...
What are the precautions when taking diclofenac epolamine topical patch (Flector Patch)?
Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain 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), recent heart bypass surgery (CABG).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestine problems (e.g.,...
Last reviewed on RxList: 4/11/2016
This monograph has been modified to include the generic and brand name in many instances.
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