Diclofenac topical patch

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Undefined

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

Instructions

• Apply to intact skin only; do not apply to non-intact or damaged skin
• If edges peel, tape down or use a non-occlusive mesh netting sleeve
• Do not wear while bathing/showering; wash hands after handling; avoid eye contact
• Do not combine with an oral NSAID unless benefit outweighs risk
• Use lowest effective dose for shortest duration

Contraindications

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• In the setting of coronary artery bypass graft (CABG) surgery
• For use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds

Cautions

• Hepatotoxicity — discontinue if abnormal liver tests persist/worsen
• Hypertension; heart failure and edema
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Exacerbation of asthma related to aspirin sensitivity
• Serious skin reactions (exfoliative dermatitis, SJS, TEN, GBFDE)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
• Fetal toxicity (avoid at ≥30 weeks; limit 20–30 weeks gestation)
• Hematologic toxicity; masking of inflammation/fever
• Accidental exposure in children/pets from used systems

Adverse reactions

• Application site pruritus, dermatitis, burning
• Nausea, dysgeusia, dyspepsia
• Headache (pediatric), application site pruritus (pediatric)

Pregnancy Avoid use at about 30 weeks gestation and later (premature closure of fetal ductus arteriosus); limit dose/duration between about 20 and 30 weeks (oligohydramnios/neonatal renal impairment).

Lactation Small amounts of diclofenac present in human milk (topical exposure <1% of a 50 mg oral dose); consider benefits of breastfeeding with clinical need.