What are the patient instructions for using tacrolimus (FK506) 0.03% ointment?

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From the Guidelines

Tacrolimus 0.03% ointment should be applied as a thin layer to affected skin areas twice daily, typically in the morning and evening, until symptoms improve. When using tacrolimus 0.03% ointment, it is essential to follow proper patient instructions to ensure safe and effective treatment.

Key Instructions

  • Wash your hands before and after application unless your hands are being treated.
  • Apply the medication to clean, dry skin and gently rub it in completely.
  • Do not cover the treated area with bandages or other dressings unless directed by your doctor.
  • Avoid getting the ointment in your eyes, nose, or mouth.
  • You may experience temporary burning, stinging, or itching when first applying the medication, which typically subsides with continued use, as noted in studies 1.

Important Considerations

  • Minimize sun exposure on treated areas as tacrolimus may increase sensitivity to sunlight.
  • This medication works by suppressing the immune system locally to reduce inflammation and relieve symptoms of conditions like eczema or atopic dermatitis.
  • Improvement is usually seen within the first few weeks of treatment, but contact your doctor if symptoms worsen or show no improvement after 6 weeks.
  • Discontinue use and seek medical attention if you experience severe irritation or signs of allergic reaction. It is crucial to be aware of the potential side effects and contraindications, including the most common side effect of burning and itching, as well as the controversial lymphoma "black box" warning issued by the FDA 1. Additionally, tacrolimus is categorized as pregnancy category C and is found in human milk, making it not recommended for nursing mothers 1.

From the Research

Patient Instructions for Using Tacrolimus 0.03% Ointment

  • Apply the ointment twice daily, as instructed by the physician, to the affected areas of the skin [ 2 ].
  • The average amount applied per 2% of total body surface area (TBSA) should be around 0.54 ± 0.52 g [ 2 ].
  • It is essential to follow the prescription instructions carefully, as applying the ointment less frequently or in inappropriate amounts may result in limited efficacy [ 2 ].
  • Patients should be aware of potential side effects, including skin burning, itching, flu-like syndromes, and headache [ 3 ].
  • Severe skin infections and skin cancer cannot be ruled out as serious side effects, and patients should be monitored closely [ 3 ].

Important Considerations

  • Tacrolimus ointment is approved for use in patients aged at least two years, when topical corticosteroids fail [ 3 ].
  • The 0.1% strength of tacrolimus ointment seems to be slightly more active than the 0.03% strength in adults [ 3 ].
  • Tacrolimus ointment has been shown to be effective in treating atopic dermatitis, chronic actinic dermatitis, and stasis dermatitis [ 4, 5, 6 ].
  • Patients should be instructed to use the ointment as directed and to report any adverse events or concerns to their physician [ 2 ].

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

A case of chronic actinic dermatitis treated with topical tacrolimus.

The Journal of dermatological treatment, 2005

Research

Successful treatment of stasis dermatitis with topical tacrolimus.

VASA. Zeitschrift fur Gefasskrankheiten, 2004

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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