Xiclofen: US FDA label indications

Label details

Brand name

Xiclofen

Generic name

Diclofenac Sodium, Methyl Salicylate

Manufacturer

ASCLEMED USA INC.

Route

Cutaneous

Product type

Human Prescription Drug

Substance

Diclofenac Sodium

Indications and usage (label excerpt)

1. ​INDICATIONS & USAGE Xiclofen TM Ointment 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.

Warnings (label excerpt)

5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS 5.1 Risk 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 sodium external in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium external is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Avoid using NSAID…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).

Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.