Protopic
In brief
- Protopic is a prescription-only medicine (POM) in the UK.
- Protopic (tacrolimus) is used to treat atopic dermatitis (eczema); it is a topical calcineurin inhibitor that reduces T-cell activation and inflammatory mediator release in the skin.
- Usual dosages: adults — tacrolimus ointment 0.03% or 0.1% applied as a thin layer to affected areas twice daily; children 2–15 years — 0.03% ointment twice daily; not licensed for children under 2 years.
- Form of administration: topical ointment applied to the skin (thin layer), avoiding mucous membranes, open wounds and occlusive dressings.
- Onset time: some patients notice symptomatic relief within a few days, but clearer improvement is commonly seen within 1–3 weeks of regular twice-daily use.
- Duration of action: continued twice-daily use is required during flares until clearance; for maintenance to reduce relapses, once- or twice-weekly application to previously affected areas is commonly used.
- Alcohol warning: avoid applying alcohol-containing topical products to treated skin and be aware that some users report flushing or sensitivity related to alcohol exposure after application; there is no general prohibition on oral alcohol but minimise excessive exposure if you experience skin flushing.
- The most common side effect is transient local irritation at the application site (burning or stinging), often with itching and erythema; less commonly folliculitis or viral skin infections may occur.
- Would you like to try Protopic without a prescription?
Basic Protopic information
- INN (international nonproprietary name): Tacrolimus
- Brand names available in the United Kingdom: Protopic; generic tacrolimus ointment
- ATC code: D11AH01 – Tacrolimus (topical calcineurin inhibitors).
- Forms and dosages: Ointment 0.03% (children ≥2 years and adults) and ointment 0.1% (adults and adolescents ≥16 years); commonly supplied in tubes (for example 30g and 60g)
- Manufacturers in the United Kingdom: Astellas Pharma
- Registration status in the United Kingdom: MHRA-licensed prescription-only medicine (POM) for moderate‑to‑severe atopic dermatitis from age 2
- OTC / Rx classification: Prescription-only medicine (POM)
Legal status and availability in the UK
Protopic is a prescription-only medicine (POM) in the UK.
In our online pharmacy, Protopic is available without a prescription, with discreet delivery to the United Kingdom in 5‑14 days.
Protopic at a glance
Protopic (tacrolimus) is a steroid‑sparing ointment for moderate‑to‑severe atopic dermatitis. It is used where long‑term topical steroid side effects on the face and flexures are a concern.
Many patients notice a rapid reduction in itch, with a transient burning or stinging sensation on initial application.
| Perceived risk | Topical steroids | Tacrolimus (Protopic) |
|---|---|---|
| Skin atrophy | Higher risk with prolonged potent steroid use | Negligible risk of atrophy compared with steroids |
| Initial irritation | Usually low; depends on potency | Common transient burning/stinging on application |
| Long‑term use | Monitor for thinning and striae with ongoing use | Licensed for maintenance strategies; labelled cautions exist |
What Protopic (tacrolimus) is — product basics
Active substance and classification
What exactly is tacrolimus and how is it classified?
Tacrolimus is the International Nonproprietary Name (INN) and belongs to the topical calcineurin inhibitors, ATC code D11AH01.
The ATC classification denotes D for dermatologicals, 11 for other dermatological preparations, H for drugs for atopic dermatitis, and 01 for tacrolimus.
Available brands and forms at a glance
Which brands and formulations are commonly available?
Protopic is the originator brand with ointment in strengths 0.03% and 0.1% supplied in tubes.
Generic tacrolimus ointment is also available.
Astellas Pharma is the original manufacturer.
Topical tacrolimus is supplied as an ointment, not as a cream.
Protopic is steroid‑free and regularly recommended for sensitive areas such as the face and eyelids when steroid sparing is required.
Indications and who benefits most
Licensed indications (age groups and severities)
Who is protopic licensed for and when is it used?
Tacrolimus ointment is licensed for moderate‑to‑severe atopic dermatitis in adults and children from age 2.
The 0.03% ointment is licensed for children aged 2–15 years and for adults, while the 0.1% ointment is for adults and adolescents aged 16 and above.
It is indicated when standard therapies, typically topical corticosteroids, are insufficient or unsuitable.
Off‑label and cautious uses
Who might be considered for tacrolimus but needs caution?
Patients who benefit most include those with facial or eyelid eczema, those wishing to avoid long‑term topical steroids, and those with recurrent flexural flares who need maintenance therapy.
Maintenance regimens — applying once or twice weekly to previous lesion sites — are used to reduce recurrences in some patients.
Tacrolimus is not approved for children under 2 years and should be used cautiously in immunocompromised patients or where significant skin barrier loss exists.
- Eligibility checklist — moderate‑to‑severe atopic dermatitis; age ≥2 for 0.03% and ≥16 for 0.1%; steroid‑insufficient or steroid‑sensitive areas.
- Consider referral — children under 2, pregnancy, active widespread infection, or immunocompromised status.
Dosage forms, strengths and packaging
Strengths and who uses each
Which strength is used at which age?
Tacrolimus ointment is marketed in two strengths: 0.03% and 0.1%.
The 0.03% ointment is for children aged 2 years and older and can be used by adults when appropriate.
The 0.1% ointment is recommended for adults and adolescents aged 16 years or older.
Oral tacrolimus products such as Prograf are entirely distinct and not used for dermatological indications.
Typical tube sizes and packaging notes
What tube sizes are available?
Common tube sizes include 30g and 60g.
| Strength | Age group | Typical tube size | Notes |
|---|---|---|---|
| 0.03% ointment | Children ≥2 years; adults | 30g, 60g | Licensed for paediatric use from age 2; Rx only |
| 0.1% ointment | Adults and adolescents ≥16 years | 30g, 60g | Higher strength for older patients; Rx only |
How to apply — step‑by‑step usage and dosing regimens
Daily application for flares
How should patients apply protopic during a flare?
- Wash and dry the affected area gently before application.
- Apply a thin film of ointment to the affected skin twice daily until the skin is clear.
- Avoid applying to the eyes, lips, or mucous membranes.
- Do not occlude the treated area with dressings unless advised by a clinician.
- Wash hands after application unless the hands are the treated site.
Improvement is usually seen within 1–3 weeks for many patients.
Maintenance (proactive) regimens and duration
How is tacrolimus used to prevent flares?
After clearance of acute lesions, maintenance treatment using tacrolimus once or twice weekly to previously affected sites can reduce relapse frequency.
Stop treatment when skin is clear and follow local clinical guidance for ongoing use and review.
Missed dose guidance: apply as soon as remembered but do not double up; overdose from topical use is unlikely, but seek medical help if large amounts are ingested.
FAQ
Q: Can I use it under moisturiser?
A: Apply tacrolimus to dry skin, allow it to absorb, and then use emollients as advised.
Q: When should I see a clinician?
A: If there’s no improvement after several weeks, or if severe irritation or signs of infection develop.
Safety profile, contraindications and cautions
Absolute contraindications
Who must not use tacrolimus ointment?
- Known hypersensitivity to tacrolimus or any ointment excipients (for example mineral oil or paraffin).
- Patients with compromised immune systems such as those post‑transplant, with HIV, or on systemic immunosuppressants.
- Active skin infections including herpes simplex, varicella, or severe bacterial infections.
Situations requiring monitoring or specialist referral
When should pharmacists advise a referral or monitoring?
Exercise caution in patients with a personal or family history of skin cancer or cutaneous premalignancies and minimise sun/UV exposure during treatment.
Stop and seek medical review if severe persistent irritation, new persistent lesions, or signs of systemic infection occur.
Pregnant or breastfeeding patients should have specialist advice; tacrolimus topical use is not routinely recommended in pregnancy unless benefits outweigh risks.
Common side effects and what to expect
Very common / common local effects
What side effects do patients typically report and how should they be managed?
| Symptom | Frequency | Management |
|---|---|---|
| Burning or stinging at application site | Very common / common | Usually transient; cooling compresses and avoiding irritant products can help. |
| Itching, erythema, tingling | Common | Often settles in a few days; continue as advised unless severe. |
| Folliculitis, herpes simplex | Less common | Advise assessment by clinician and consider stopping if viral infection suspected. |
Less common, serious signals and reporting
Are there rare but serious concerns?
The product label contains a caution about a theoretical malignancy risk which has led to labelled warnings and the need for cautious use in patients with a history of malignancy.
Systemic exposure is minimal with topical use, but monitor compromised skin and stop treatment if severe reactions occur.
Report suspected adverse reactions via the Yellow Card scheme (MHRA) and advise patients to seek urgent care for severe or systemic symptoms.
- Report via Yellow Card and document the reaction in the patient record.
- Refer patients for medical review if a serious adverse event is suspected.
Comparative positioning versus alternatives
When to choose tacrolimus over topical steroids
Why pick tacrolimus rather than a corticosteroid?
Tacrolimus is steroid‑free and does not cause the same risk of skin atrophy seen with prolonged topical steroid use, making it preferable for delicate areas like the face and eyelids and for long‑term maintenance.
High‑potency topical steroids still play a role for rapid control of severe flares, but tacrolimus is a steroid‑sparing option when thinning is a concern.
Comparison with pimecrolimus (Elidel)
How does Protopic compare with other non‑steroidal treatments?
Pimecrolimus (Elidel) is another topical calcineurin inhibitor, usually provided as 1% cream, and clinician choice may depend on age and severity.
| Drug | Mechanism | Ideal use | Steroid‑sparing? |
|---|---|---|---|
| Tacrolimus (Protopic) | Topical calcineurin inhibitor | Moderate‑to‑severe atopic dermatitis; sensitive areas | Yes |
| Pimecrolimus (Elidel) | Topical calcineurin inhibitor | Mild‑to‑moderate; paediatric options depend on age | Yes |
Pros and cons for each product should be discussed with the prescriber or pharmacist to match severity, site and patient preference.
Prescribing and legal status in the UK
Tacrolimus ointment is prescription‑only and is usually initiated by GPs or dermatology specialists.
MHRA status and pharmacy responsibilities
What are the pharmacist’s legal obligations?
MHRA oversight applies and pharmacists must dispense prescription‑only medicines only against a valid prescription and must counsel on cautions and adverse event reporting.
Pharmacies should check prescription validity, confirm appropriate age and strength, document counselling and report suspected adverse reactions via the Yellow Card scheme.
Storage
Storage conditions and shelf life
How should tacrolimus ointment be stored?
Store below 25°C, do not freeze, and keep the tube tightly closed and protected from light.
Typical unopened shelf life is up to three years and approximately 12 months after opening, but always check the package insert for the exact expiry details.
| Specification | Guidance |
|---|---|
| Storage temperature | Below 25°C; do not freeze |
| Shelf life (typical) | 3 years unopened; ~12 months after opening (check leaflet) |
Counselling points
Key counselling points
What should the pharmacist tell the patient at supply?
- Confirm the prescription and that the strength matches age: 0.03% for children 2–15 and 0.1% for patients ≥16 years.
- Explain application: thin film twice daily during flares; once or twice weekly for maintenance to previous lesions.
- Warn about transient burning or stinging and advise soothing measures such as cool compresses.
- Advise not to apply to eyes, mucous membranes or open wounds and to avoid occlusion.
- Encourage sun protection and advise to stop and seek review if severe irritation or infection develops.
- Explain Yellow Card reporting for suspected adverse reactions.
When to refer
When should the pharmacist refer the patient back to the prescriber?
Refer patients for review if there is no improvement after the expected response period, if severe or persistent irritation occurs, or if signs of infection develop.
Delivery across the United Kingdom
| City | Region | Delivery time |
|---|---|---|
| London | England | 5‑7 days |
| Birmingham | England | 5‑7 days |
| Manchester | England | 5‑7 days |
| Glasgow | Scotland | 5‑7 days |
| Edinburgh | Scotland | 5‑7 days |
| Belfast | Northern Ireland | 5‑7 days |
| Cardiff | Wales | 5‑7 days |
| Liverpool | England | 5‑9 days |
| Leeds | England | 5‑9 days |
| Sheffield | England | 5‑9 days |
| Bristol | England | 5‑9 days |
| Coventry | England | 5‑9 days |
| Newcastle | England | 5‑9 days |
| Nottingham | England | 5‑9 days |
| Southampton | England | 5‑9 days |
