• Atopic dermatitis

Protopic Generic Name & Formulations

General Description

Tacrolimus 0.03%, 0.1%; oint.

Pharmacological Class


How Supplied

Oint—30g, 60g, 100g


Generic Availability


Protopic 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


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


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