What is the recommended use and dosage of diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) 10% ointment?

Diclofenac 10% Ointment: Recommended Use and Dosage

Diclofenac 10% ointment is not a standard FDA-approved formulation for topical use, and treatment should instead utilize the FDA-approved 3% diclofenac sodium gel formulation applied twice daily for 60-90 days for actinic keratosis. 1

Approved Diclofenac Formulations and Indications

• The FDA-approved diclofenac topical formulation for skin conditions is 3% diclofenac sodium in 2.5% hyaluronic acid gel, which is indicated for actinic keratosis (AK) 1
• Standard application is twice daily for 60-90 days as a field-based or lesion-directed treatment 1
• Diclofenac gel causes less intense local skin reactions than 5-fluorouracil (5-FU) or imiquimod 5% cream, making it more tolerable but potentially less effective 1

Efficacy for Actinic Keratosis

• Complete clearance rates with diclofenac 3% gel range from 19-50% after 90 days of treatment 1
• In comparative studies, diclofenac 3% gel showed 32% complete clearance versus 55.4% for 5-FU 0.5% in 10% salicylic acid 1
• Extending treatment from 90 to 180 days provides only an additional 5% complete clearance without significant changes in adverse effects 1

Application Instructions

• Apply to clean, dry skin 2
• Wash hands completely after application 2
• Wait until the treated area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, or other topical medications 2
• Avoid skin-to-skin contact between other people and the treated area until completely dry 2

Special Considerations by Treatment Site

• For actinic keratosis on the face and scalp: Apply twice daily for 60-90 days 1
• For forearm and hands: May require prolonged treatment due to thicker skin or hindrance to penetration by keratin in thicker AKs 1
• For below the knee: Use with caution due to potential healing issues, especially in elderly patients; consider less frequent application 1
• For lips: Diclofenac 3% gel has been shown effective for AK of the lip with a low incidence of irritation 3

Adverse Effects and Monitoring

• Local adverse effects include contact dermatitis, skin rash, dry skin, desquamation, pruritus, local pain, and paresthesia 4
• Adverse effects can be due to either diclofenac or the excipient but appear less intense than with topical fluorouracil 4
• For patients with poor healing sites such as the lower leg, treatment should be undertaken with caution and may need supervision 1

Combination Therapy

• The combination of diclofenac and cryosurgery is not recommended over cryosurgery alone 1
• Consider alternative treatments if diclofenac is ineffective, such as 5-FU, imiquimod, or photodynamic therapy 1

Important Cautions

• Do not apply to open wounds 2
• Avoid contact with eyes and mucous membranes 2
• Do not apply external heat and/or occlusive dressings to treated areas 2
• Do not use combination therapy with diclofenac topical solution and an oral NSAID unless the benefit outweighs the risk 2

While diclofenac 10% ointment specifically is not a standard formulation, the evidence supports using the FDA-approved 3% diclofenac sodium gel for actinic keratosis with the application guidelines provided above.