Diclofenac Epolamine

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

• Known hypersensitivity to diclofenac or any components of the drug product
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Use in the setting of coronary artery bypass graft (CABG) surgery
• Use on non-intact or damaged skin

Adverse Reactions

• Cardiovascular thrombotic events
• Gastrointestinal bleeding, ulceration, and perforation
• Hepatotoxicity
• Hypertension
• Heart failure and edema
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Serious skin reactions
• Hematologic toxicity

General Guidance

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

Pregnancy

• Use of NSAIDs, including diclofenac epolamine topical system 1.3%, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
• Limit dose and duration of use between 20 and 30 weeks of gestation, and avoid use at 30 weeks of gestation and later in pregnancy

Nursing Mothers

Pediatric Use

• Safety and effectiveness established in pediatric patients 6 years and older
• Not investigated in pediatric patients less than 6 years old

Geriatric Use

• Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
• Start dosing at the low end of the dosing range, and monitor patients for adverse effects