Pharm

Tacrolimus Ointment

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Tacrolimus Ointment, Protopic, Elidel, Pimecrolimus

  • Indications
  1. Severe refractory Atopic Dermatitis
  • Pharmacokinetics
  1. Normal topical use causes <5 ng/ml serum concentration
    1. Greater absorption in severely damaged skin
  2. Factors increasing serum concentrations
    1. Higher doses or greater surface area of application
    2. Inflamed skin
  • Mechanism
  1. Macrolide with similar activity to Cyclosporine
  2. Specifically binds T Cell receptors
    1. Inhibits cytokine production
    2. Inhibits IgE sensitivity
  • Precautions
  1. Increased risk of skin malignancy and Lymphoma
    1. FDA black box warning has been added
  2. Do not use for extended periods of time
  3. Use only in refractory Eczema
  • Preparations
  1. Pimecrolimus (Elidel)
  2. Tacrolimus (Protopic)
  • Dosing
  • Tracolimus
  1. Children over age 2 years: Apply 0.03% ointment bid
  2. Adults: Apply 0.03% or 0.1% ointment bid
  • Adverse Effects
  1. Local irritation (transient <1 week)
    1. Burning
    2. Erythema
    3. Pruritus
  2. Less common adverse effects
    1. Skin Tingling
    2. Acne
    3. Hyperesthesia
    4. Alcohol intolerance
  3. Immunosuppression related adverse effects
    1. Varicella zoster increased Incidence
    2. Eczema herpeticum
  4. Increased malignancy risk in mice (see precautions)
    1. Skin cancer
    2. Lymphoma
  • Precautions
  1. Protect treated areas from direct sunlight
  2. Systemic Tacrolimus associated with skin cancer
    1. Non-Melanoma skin cancer
  • Advantages
  1. Very effective in refractory atopic cases
  2. Unlike Corticosteroids, does not cause skin atrophy
    1. May be useful on face and neck
  • Disadvantages
  1. Expensive (costs per Red Book)
    1. Tacrolimus Ointment (0.03 or 0.1%): $60 per 30 grams
  2. Risk of malignancy (see prcautions)
    1. Skin cancer
    2. Lymphoma