Monograph Details
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Dermatological Disorders
> Miscellaneous dermatological conditions
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PROTOPIC |
| Manufacturer |
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Astellas Pharma US, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Immunomodulator. |
| Generic Name |
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Tacrolimus 0.03%, 0.1%; oint. |
| Indications |
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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 |
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<2 years: not recommended. 2–15 years: use 0.03% strength. ≥16 years: use either strength. Apply to affected areas twice daily. Do not occlude or apply to wet skin. |
| Precautions |
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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 |
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Caution with CYP3A4 inhibitors in widespread and/or erythrodermic disease. |
| Adverse Reactions |
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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). |
| How Supplied |
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Oint—30g, 60g, 100g |
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