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.
Long-term safety of topical calcineurin inhibitors has not been established.
Avoid continuous long-term use in any age group. Clear infection at treatment site first if present. Netherton's syndrome, generalized erythroderma, malignant or pre-malignant skin conditions: not recommended. Immunocompromised. 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
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