Indications
1. INDICATIONS & USAGE Xiclo™ Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.
Contraindications
4. CONTRAINDICATIONS Xiclo™ Transdermal Patch is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. History of asthma, uticaria, or allergic-type reactions after absorbing non-steroidal anti-inflammatory drugs (NSAIDs) should also be considered.
Warnings and precautions
5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS
5.1Risk of Serious Cardiovascular and Gastrointestinal Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause an increased risk of serious cardiovascular (CV) 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. NSAIDs, including diclofenac, can lead to new onset of hypertension, or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Avoid the use of diclofenac external in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac external is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Avoid using NSAIDs within 14 days following coronary artery bypass graft (CABG) surgery.