Protopic (Tacrolimus (Topical))
Also sold as: Protopic, Taclonex (combination), Tacromus, Topi-Tak, Tacroz
Pregnancy
Cat C
Lactation
Caution
Schedule
H
Forms
Ointment 0.03% (paediatric — 2–15 years) +1
Indications
- Moderate-to-severe atopic dermatitis (eczema) — steroid-sparing (second-line when topical steroids inadequate or cause adverse effects)
- Facial and flexural eczema (where topical steroids cause atrophy)
- Eyelid eczema (steroid-free alternative — avoids glaucoma/cataract risk)
- Vitiligo (off-label — facial vitiligo; adjunct to phototherapy)
Adult Dosing
Atopic dermatitis (0.1%)
Apply thin layer to affected skin BD until resolution, then taper to OD or twice weekly (proactive maintenance)
May cause stinging/burning on first application — improves with continued use. Do not use under occlusion. Ideal for face, neck, eyelids where steroids cause problems.
Pediatric Dosing
NOT recommended under 2 years. 0.03% is the only approved strength in children aged 2–15.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| Any CrCl | Topical use — negligible systemic absorption at recommended doses; no adjustment |
Hepatic Adjustment
Severe hepatic disease may increase systemic tacrolimus levels if large areas treated — use cautiously
Pregnancy & Lactation
Pregnancy: Category C
Limited data — animal studies show fetal harm with systemic tacrolimus. Topical: systemic absorption is very low. Avoid in pregnancy if possible; small area facial use where steroid harm is greater may be acceptable.
Lactation: Caution
Avoid application to breast/nipple areas. Small area facial use: systemic absorption minimal — considered low risk, but data limited.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Strong CYP3A4 inhibitors (erythromycin, ketoconazole, itraconazole, fluconazole) | May increase systemic tacrolimus absorption if used on large areas — use with caution in extensive skin disease | Moderate |
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Side Effects
Common
- Skin burning and stinging (application site — first few applications; usually settles within 1 week)
- Pruritus/itch (application site)
- Alcohol intolerance — facial flushing with alcohol (warn patient)
- Folliculitis
- Herpes simplex reactivation at treatment site (if recurrent HSV history)
Serious / Discontinue If
- Lymphoma and malignancy concern (theoretical — FDA black box warning 2006 based on systemic immunosuppressant class effect; however, epidemiological studies do NOT show increased skin cancer or lymphoma with topical TCI; warning remains controversial)
- Herpes simplex/zoster reactivation (manage with antiviral)
- Eczema herpeticum (Kaposi varicelliform eruption — withhold TCI if eczema herpeticum suspected)
Contraindications
- Children < 2 years
- Active skin infections at treatment site
- Immunodeficiency conditions (HIV — use with caution; other immunodeficiencies)
- Netherton syndrome (increased absorption)
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Protopic 0.1% ointment | Astellas/Leo Pharma India | 30g ₹985 |
| Tacroz 0.1% ointment | Glenmark | 30g ₹785 |
| Tacromus 0.1% | Cipla | 30g ₹865 |
Monitoring Required
- Skin response (clearance of eczema, Investigator Global Assessment)
- Infection signs at treatment site
- Herpes simplex reactivation
- Duration of use (review at 3–6 months)
- Alcohol intolerance awareness
Patient Counseling Points
- Burning and stinging after applying is normal for the first few days — it usually gets much better within a week
- Apply a thin layer to the exact areas of eczema — not to normal skin
- ⚠️ If you have a cold sore, do NOT apply in that area — can spread the virus
- Use sunscreen on treated areas (tacrolimus may increase UV sensitivity)
- Avoid alcohol on the treated area — causes uncomfortable flushing
- Use twice weekly as maintenance even when skin looks clear (proactive therapy reduces flares significantly)
- Safe for face and eyelids where steroid creams would cause problems (thinning, eye pressure)
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Clinically reviewed by: Dr. Padmavathi Rao, MD (Dermatology), Senior Consultant Dermatologist
Last reviewed: 2026-04-01
References
- NICE Atopic Eczema Guidelines 2023
- EADV Atopic Dermatitis Guidelines 2018
- BNF — Tacrolimus (Topical)
- Cochrane — Calcineurin Inhibitors for Eczema
- FDA TCI Black Box Warning Communication 2006