Generic Name and Formulations:
Tacrolimus 0.03%, 0.1%; oint.

Company:
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.

Warnings/Precautions:
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. Reeva luate if no improvement after 6 weeks. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Caution with CYP3A4 inhibitors in widespread and/or erythrodermic disease.

Pharmacological Class:
Immunomodulator.

Adverse Reactions:
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).

Generic Availability:
YES

How Supplied:
Oint—30g, 60g, 100g