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Protopic Generic Name & Formulations
Legal Class
Rx
General Description
Tacrolimus 0.03%, 0.1%; oint.
Pharmacological Class
Immunomodulator.
How Supplied
Oint—30g, 60g, 100g
Manufacturer
Generic Availability
YES
Protopic Indications
Indications
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.
Protopic Dosage and Administration
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.
Protopic Contraindications
Not Applicable
Protopic Boxed Warnings
Boxed Warning
Long-term safety of topical calcineurin inhibitors has not been established.
Protopic Warnings/Precautions
Warnings/Precautions
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.
Protopic Pharmacokinetics
See Literature
Protopic Interactions
Interactions
Caution with CYP3A4 inhibitors in widespread and/or erythrodermic disease.
Protopic Adverse Reactions
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).
Protopic Clinical Trials
See Literature
Protopic Note
Not Applicable
Protopic Patient Counseling
See Literature
