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PROTOPIC
Miscellaneous dermatological conditions
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Drug Name:

PROTOPIC Rx

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

Company:
Astellas Pharma US, Inc.

Therapeutic Use:

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. Reevaluate 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

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