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Calcineurin Inhibitor (Topical) Pregnancy: US Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; the cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pimecrolimus

Brand names: Elidel

Pimecrolimus is a topical calcineurin inhibitor cream used as a second-line treatment for mild-to-moderate atopic dermatitis (eczema), including on the face and skin folds.

Adult dose

Dose: Apply a thin layer of pimecrolimus cream 1% to the affected skin (each gram of cream contains 10 mg of pimecrolimus)
Route: Topical (cream, 1%)
Frequency: Twice daily
Stop using when signs and symptoms (e.g. itch, rash and redness) resolve; the patient should be instructed on what actions to take if symptoms recur. If signs and symptoms persist beyond 6 weeks, the patient should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis. Continuous long-term use should be avoided and application should be limited to areas of involvement with atopic dermatitis. The safety of the cream under occlusion, which may promote systemic exposure, has not been evaluated — avoid use with occlusive dressings. Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications; avoid treatment on malignant or pre-malignant skin conditions; should not be used in patients with Netherton's Syndrome or skin diseases with a potential for increased systemic absorption. Paediatric: not indicated for use in children less than 2 years of age; the long-term safety and effects on the developing immune system are unknown. No numeric per-kg or per-age paediatric dose is stated in the source (the same 'thin layer twice daily' topical application was used in trials of subjects 2-17 years) — verify paediatric use against a children's formulary. Not from a UK SPC — UK product information may differ.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • History of hypersensitivity to pimecrolimus or to any of the components of the cream

Side effects

  • Application site burning
  • Headache
  • Nasopharyngitis
  • Cough
  • Influenza, pyrexia and viral infection

Interactions

  • Potential interactions with other drugs, including immunisations, have not been systematically evaluated; systemic drug interactions are not expected because of low blood levels after topical application, but cannot be ruled out
  • Concomitant administration of known CYP3A inhibitors in patients with widespread and/or erythrodermic disease should be done with caution — e.g. erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine

Clinical monograph

How it works

It is a calcineurin inhibitor that blocks T-lymphocyte activation and the production of inflammatory cytokines, reducing the inflammation of atopic eczema without causing skin atrophy.

Prescribing in practice

  • Advise effective sun protection and avoidance of UV light, and counsel that it is applied to affected areas only as a corticosteroid-sparing option, not for continuous indefinite use.
  • A transient burning, warmth or stinging sensation on application is common in the first days of treatment.
  • It should not be applied to skin that is actively infected, and viral skin infections should be cleared before use.

Monitoring

Review eczema control and treated skin for infection, and reassess if there is no improvement after an adequate trial.

Counselling the patient

  • A short-lived burning or warm feeling when you first apply it is normal and usually settles.
  • Protect treated skin from strong sunlight and use sunscreen.
  • Do not apply it to broken or infected skin, such as cold sores.

Evidence & guidelines

Topical calcineurin inhibitors are recommended in NICE guidance as second-line options for atopic eczema not adequately controlled by, or where there are concerns about, topical corticosteroids.

Reference: NICE NG190; BAD Eczema Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.