Tacrolimus ointment

PROTOPIC

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What it isTopical calcineurin inhibitor that suppresses T-cell inflammation; moderate to severe atopic dermatitis.

Why this oneMore potent than pimecrolimus, it is the stronger steroid-sparing choice for face, eyelids, and folds.

What limits itBurning often ends the trial; avoid active infection and excessive UV exposure, and discuss the boxed malignancy warning.

FDA label

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BOXED WARNING Long-term safety of topical calcineurin inhibitors not established; rare cases of malignancy (skin, lymphoma) reported. Avoid continuous long-term use; limit application to areas of involvement. Not indicated for children under 2 years; only 0.03% is indicated for children 2-15 years.

FDA dosing	Population	Start	Target	Max
Moderate to severe atopic dermatitis (second-line, short-term/intermittent)	Adults (0.03% or 0.1%)	Apply thin layer BID	Thin layer BID to affected skin	Apply BID
Moderate to severe atopic dermatitis (second-line, short-term/intermittent)	Children 2-15 y (0.03% only)	Apply thin layer BID	Thin layer BID to affected skin	Apply BID

Renal No adjustment needed (dose adjustment not expected to be needed)

Hepatic No adjustment needed (dose adjustment not expected to be needed)

Continuous long-term use should be avoided; limit to areas of atopic dermatitis involvement

Instructions

Apply a thin layer to affected skin twice daily; rub in gently and completely
Stop use when signs and symptoms resolve; re-examine if no improvement within 6 weeks
Do not use with occlusive dressings
Minimize/avoid natural or artificial sunlight
Avoid eyes and mouth; wash hands after application (if not treating hands)
Not for immunocompromised patients; avoid on pre-malignant/malignant skin

Cautions

Local skin burning, stinging, pruritus
Bacterial and viral skin infections (resolve before treatment; risk of varicella zoster, herpes simplex, eczema herpeticum)
Lymphadenopathy — investigate etiology
Sun exposure — minimize/avoid
Not studied in immunocompromised patients or generalized erythroderma
Rare post-marketing acute renal failure; caution in patients predisposed to renal impairment

Adverse reactions

Skin burning
Pruritus
Flu-like symptoms
Skin erythema
Headache
Skin infection

Pregnancy Pregnancy Category C — use only if potential benefit justifies potential risk to the fetus

Lactation Tacrolimus excreted in human milk; decide whether to discontinue nursing or drug

NO BOXED WARNINGS

Classes and tags

Clinical profile

Direct muscarinic antagonism0 / 4

Mechanism of action: Tacrolimus ointment ballicule

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