Generic Name and Formulations:
Tacrolimus 0.03%, 0.1%; oint.
Astellas Pharma US, Inc.
Indications for PROTOPIC:
Second-line therapy: for short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised patients when other topical therapies are inadvisable or ineffective.
Adults and Children:
<2yrs: not recommended. 2–15yrs: use 0.03% strength. ≥16yrs: use either strength. Apply to affected areas twice daily. Do not occlude or apply to wet skin.
Clear infection at treatment site first if present. Netherton's syndrome, generalized erythroderma, malignant or pre-malignant skin conditions: not recommended. Varicella zoster. Herpes simplex. Eczema herpeticum. Consider discontinuing if lymphadenopathy of unknown etiology or acute infectious mononucleosis develops. Avoid sun, UV light. Reevaluate if no improvement after 6 weeks. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Caution with CYP3A4 inhibitors in widespread and/or erythrodermic disease.
Local reactions (eg, burning, pruritus, rash, folliculitis, acne, tingling, hyperesthesia, cysts), headache, flu symptoms, sinusitis, alcohol intolerance, back pain, varicella or herpes zoster, dyspepsia, myalgia; rare: malignancy (eg, skin, lymphoma).
Oint—30g, 60g, 100g