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Diclofenac Sodium

DICLOFENAC SODIUM TOPICAL

Manufacturer: REMEDYREPACK INC.

Score: 144.0

Quick Summary

Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) used for the topical treatment of actinic keratoses (AK). It works by reducing inflammation and relieving pain. However, it has several important safety considerations, including the risk of serious cardiovascular and gastrointestinal events, and contraindications such as known hypersensitivity to diclofenac or any components of the drug product. The recommended dose is 0.5 g of gel applied gently to lesion areas twice daily, with a recommended duration of therapy from 60 days to 90 days. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring and dose adjustments as needed.

Key Clinical Findings and Indications

  • Diclofenac sodium topical gel is used for the topical treatment of actinic keratoses (AK)
  • The mechanism of action of diclofenac sodium in the treatment of AK is unknown
  • The pharmacodynamics of diclofenac sodium topical gel in the treatment of AK has not been assessed

Important Safety Information

Warning

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Contraindications

  • With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
  • With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs
  • Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds
  • In the setting of coronary bypass graft (CABG) surgery

Adverse Reactions

  • Anaphylactic Reactions
  • Exacerbation of Asthma Related to Aspirin Sensitivity
  • Serious Skin Reactions
  • Cardiovascular Thrombotic Events
  • GI Bleeding, Ulceration and Perforation

Dosing Recommendations

General Guidance

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

Actinic keratoses (AK)

Adult Dose

0.5 g of gel applied gently to lesion areas twice daily

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

  • Use of NSAIDs, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
  • Limit dose and duration of diclofenac sodium topical gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium topical gel use at about 30 weeks of gestation and later in pregnancy

Nursing Mothers

  • No information available

Pediatric Use

  • Actinic keratoses is not a condition seen within the pediatric population
  • Diclofenac sodium topical gel should not be used by children

Geriatric Use

  • Elderly patients, compared to younger 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

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