What is the recommended concentration of diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) gel for adults?

Recommended Concentration of Diclofenac Gel for Adults

For adults, diclofenac sodium 3% gel is the recommended concentration for treating actinic keratosis, while diclofenac sodium 1% gel is the recommended concentration for pain management applications. 1

Diclofenac Gel Concentrations by Indication

For Actinic Keratosis Treatment

• 3% diclofenac sodium gel formulated with 2.5% hyaluronic acid 2, 1
  • Applied twice daily for 60-90 days
  • Achieves 70% clearance of target lesions compared to 44% with vehicle alone
  • Causes less intense local skin reactions than alternative treatments

For Pain Management

• 1% diclofenac sodium gel for musculoskeletal pain 3
  • FDA-approved commercial preparation
  • Significantly lower systemic exposure compared to oral diclofenac
  • Applied 4 times daily to affected area

Efficacy and Safety Considerations

Systemic Absorption

• Topical 1% diclofenac gel has 5-17 fold lower systemic exposure compared to oral diclofenac 3
• The extent of absorption depends more on:
  • Surface area of application
  • Frequency of application
  • Vehicle formulation
  • Less on the concentration of the active ingredient 1, 3

Safety Profile

• Main side effects of diclofenac gel include:
  • Pruritus (41%) and rash (40%) with 3% formulation 1
  • Application site reactions (mild) 3
• Higher concentrations (5-10%) used in compounded preparations may lead to increased systemic absorption and potential adverse effects 4

Important Clinical Considerations

Formulation Matters

• The presence of hyaluronic acid in the 3% gel enhances drug delivery to the target tissue for actinic keratosis treatment 1
• Different gel bases affect permeability and absorption rates 4

Application Guidelines

• For pain management: Apply to affected area 4 times daily 3
• For actinic keratosis: Apply twice daily for 60-90 days 1, 5
• Extending treatment beyond 90 days provides minimal additional benefit for actinic keratosis 1

Caution with Compounded Preparations

• Compounded diclofenac gels often range from 1% to 10% (or higher) 4
• Higher concentrations (>3%) have not been thoroughly evaluated for safety
• Increased concentration may lead to higher systemic exposure and potential adverse effects 4

While compounded preparations with concentrations of 5-10% exist, they lack the same level of safety data as the FDA-approved 1% (for pain) and 3% (for actinic keratosis) formulations. For maximum safety and efficacy, clinicians should use the FDA-approved concentrations appropriate for the specific indication.