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Protopic

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Protopic (tacrolimus) is a topical calcineurin inhibitor used to treat moderate to severe atopic dermatitis. It helps adults and children who do not respond well to other therapies. The ointment works by calming the immune response in the skin to reduce redness, itching, and inflammation without using steroids.


Ingredient
Availability
In Stock
Delivery Time
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Active Ingredient(s)
Tacrolimus
Reference Brand
Protopic
Manufacturer
LEO Pharma
Product Form
Ointment
Regulatory Classification
Rx
Primary Category
Skin Treatment
Product Category
Dermatologicals, Other dermatological preparations, Agents for dermatitis
Pharmacological Class
Calcineurin inhibitors
Clinical Indications
Manufacturer Description
A steroid-free ointment used to treat moderate to severe atopic eczema when other treatments provide insufficient relief.
Mechanism of Action
Protopic (tacrolimus) works by suppressing the local immune response on the skin. It inhibits the production of inflammatory cytokines that cause the redness, itching, and swelling associated with eczema.
Route of Administration
Topical
Onset Time
1 week
Duration
Localized effect
Contraindications
Hypersensitivity to tacrolimus, Netherton's syndrome, Immunodeficient patients
Severe Adverse Events
Skin infections, Swollen lymph nodes, Rosacea-like dermatitis
Common Side Effects
Skin burning, Itching, Redness, Tingling
Uncommon Side Effects
Folliculitis, Acne, Increased sensitivity to alcohol on skin
Drug Interactions
Alcohol (causes skin flushing), Amesal
Pregnancy Safety Warnings
Not recommended during pregnancy unless essential.
Age Restrictions
2 years and older
Storage Guidelines
Store below 25°C.
Related Products
Elidel, Hydrocortisone, Eumovate

Protopic FAQ

Can I use Protopic on my face?

Facial application is generally avoided because the skin is thinner and more prone to irritation. Some dermatologists may prescribe a very low-dose regimen for specific facial eczema, but this should only be done under specialist supervision.

How long does an opened tube of Protopic remain effective?

After opening, the ointment should be used within three months. Discard any tube that shows a change in colour, texture, or odour, as potency may be compromised.

Will Protopic protect me from sunburn?

No. Tacrolimus can increase photosensitivity, so you should apply sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.

Is Protopic compatible with other topical eczema treatments?

It can be used sequentially with emollients and moisturisers. Combining it with other potent immunosuppressants (e.g., topical corticosteroids) is usually unnecessary and should be coordinated by a prescriber.

Do I need to wash my hands after applying Protopic?

Yes, wash your hands thoroughly after each application to avoid accidental transfer to the eyes or other uninvolved skin areas.

Can I travel with Protopic in my hand luggage?

Protopic is a prescription medication but not a controlled substance. Carry it in its original packaging with a copy of the prescription, and declare it if required by airline security.

Is there a risk of developing a systemic infection while using Protopic?

Because tacrolimus suppresses local immune activity, secondary skin infections can occur more readily. Promptly report signs of infection (increased redness, swelling, pus) to your clinician.

How does Protopic compare with topical steroids for eczema?

Both reduce inflammation, but Protopic does not cause skin thinning, which is a common side effect of prolonged steroid use. Choice of therapy depends on disease severity, skin location, and patient response.

Can pregnant women safely use Protopic?

Use during pregnancy is only recommended when the expected benefit outweighs potential risk to the fetus. Discuss the decision thoroughly with an obstetrician and dermatologist.

What should I do if I experience a burning sensation after application?

A mild burning sensation is common initially and often resolves within a few days. If the discomfort is severe or persists, contact your healthcare provider for possible dose adjustment or alternative therapy.

What is Protopic?

Protopic is a prescription-only (POM) topical medication marketed in the United Kingdom by Astellas Pharma. Its active ingredient is tacrolimus, a calcineurin inhibitor used to manage inflammatory skin conditions. Protopic is supplied as a tube-filled ointment in two strengths: 0.03 % and 0.1 % tacrolimus. The product is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the short-term and intermittent treatment of moderate to severe atopic dermatitis (eczema) when topical corticosteroids are inappropriate or ineffective.

How Protopic Works in the Body

Tacrolimus belongs to the class of immunomodulatory agents known as calcineurin inhibitors. By binding to the intracellular protein FKBP-12, tacrolimus forms a complex that blocks the enzyme calcineurin. This inhibition prevents the dephosphorylation and activation of the nuclear factor of activated T-cells (NF-AT), a key transcription factor for interleukin-2 (IL-2) and other cytokines that drive T-cell proliferation.

  • Result: Reduced activation of skin-resident T-cells, dampened release of inflammatory cytokines (IL-2, IL-4, IL-5, IFN-γ), and decreased recruitment of inflammatory cells to the epidermis.
  • Onset: Patients often notice a reduction in itching and erythema within a few days of consistent application.
  • Duration: The anti-inflammatory effect persists as long as the medication is applied; there is no systemic accumulation with normal topical use.

Conditions Treated by Protopic

Indication (MHRA-approved) Typical Patient Population
Moderate to severe atopic dermatitis (eczema) Children ≥ 2 years (0.03 % strength) and adults (0.1 % strength) who have not responded adequately to topical corticosteroids or for whom steroids are contraindicated.

Key points

  • Protopic is intended for short-term control of flare-ups and for intermittent maintenance to prevent recurrence.
  • The medication is not a first-line therapy for mild eczema, where emollients or low-potency steroids are usually sufficient.

Evidence-Based Off-Label Uses

Protopic’s tacrolimus component has been investigated for several dermatological conditions outside its approved label:

  • Vitiligo: Small randomized trials have shown modest repigmentation when tacrolimus ointment is combined with phototherapy. Off-label use requires specialist supervision.
  • Psoriasis (especially inverse psoriasis): Case series suggest benefit, but larger controlled studies are lacking.
  • Lichen planus: Limited evidence indicates improvement in oral and cutaneous lesions; use remains off-label.

Disclaimer: Off-label applications are not authorised by the MHRA. They should only be undertaken under the guidance of a qualified dermatologist, with a clear risk-benefit assessment.

Who Should Use Protopic? Contraindications and Precautions

Absolute Contraindications

  • Known hypersensitivity to tacrolimus, any excipients in the ointment, or to other macrolide immunosuppressants.
  • Presence of active cutaneous infections (bacterial, viral, fungal) at the intended application site.

Relative Contraindications / Cautions

  • Pregnancy and lactation: Tacrolimus crosses the placenta and is excreted in breast milk. Use only if the potential benefit justifies the potential risk.
  • Immunocompromised patients: Systemic absorption may be higher; monitor for opportunistic infections.
  • Severe hepatic or renal impairment: May increase systemic exposure; dose adjustment is not standard for topical use but clinical judgment is required.
  • Children under 2 years: Safety and efficacy have not been established for the 0.03 % formulation.
  • Patients with a history of skin cancer or lymphoma: Long-term use should be approached cautiously, with regular dermatological review.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Burning or stinging sensation at the application site (often transient).
  • Itching, erythema, or mild dermatitis localized to the treated area.
  • Dryness or flaking of the skin.

These effects are usually mild and diminish with continued use or reduced frequency.

Serious Adverse Events

  • Secondary skin infections (e.g., impetigo, herpes simplex) requiring medical treatment.
  • Skin cancer (particularly cutaneous T-cell lymphoma) and melanoma: Long-term, extensive use has been associated with a theoretical increased risk; patients should undergo regular skin examinations.
  • Systemic tacrolimus toxicity (rare) manifesting as nephrotoxicity, neurotoxicity, or hypertension-typically only when large surface areas are treated for prolonged periods.

Drug Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin) could increase systemic tacrolimus levels if significant percutaneous absorption occurs. Caution is advised when patients are on systemic tacrolimus or other CYP3A4-metabolised drugs.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine) may reduce systemic exposure, though clinical relevance is minimal for topical use.

Food and Lifestyle Interactions

  • No specific food restrictions are required.
  • Sun exposure: Tacrolimus can cause photosensitivity; patients should use sunscreen and protective clothing when outdoors.
  • Driving or operating machinery: No impairment is expected, but patients experiencing severe burning or dizziness should exercise caution.

Safety tip: Patients should inform their healthcare provider of all concomitant medicines, including over-the-counter products and herbal supplements, before initiating Protopic.

How to Take Protopic

Standard Dosing Regimen

  • 0.03 % ointment (children ≥ 2 years): Apply a thin layer to the affected area twice daily (morning and evening) for up to 2 weeks.
  • 0.1 % ointment (adults and adolescents ≥ 16 years): Apply a thin layer twice daily for up to 2 weeks.
  • After the initial control phase, the frequency may be reduced to once daily or intermittent (e.g., twice weekly) for maintenance, depending on the clinician’s assessment.

Administration Tips

  • Tube use: Squeeze a small amount onto a clean fingertip; spread gently without rubbing.
  • Avoid occlusion (covering with dressings) unless directed, as it may increase absorption.
  • Do not apply to the face, genital area, or mucous membranes unless specifically instructed.

Missed Dose

  • If a dose is missed, apply it as soon as remembered unless the next scheduled dose is within a few hours; do not double the dose.

Overdose Management

  • Symptoms: Unusual systemic signs such as nausea, vomiting, tremor, or decreased urine output.
  • Action: Seek immediate medical attention; treatment is supportive, and severe cases may require intravenous hydration and monitoring of renal function.

Discontinuation

  • Abrupt cessation is generally safe, but if prolonged treatment has been used, tapering the frequency can minimise rebound inflammation.
  • Patients should schedule a follow-up appointment to reassess skin status after stopping.

Monitoring and Follow-Up

  • Initial review: Within 2-4 weeks of starting therapy to assess efficacy and tolerability.
  • Long-term monitoring: Periodic skin examinations (every 6-12 months) for signs of malignancy, especially when large body-surface areas are treated.
  • Laboratory tests: Not routinely required for topical use, but if systemic absorption is suspected (e.g., extensive application), serum tacrolimus levels and renal function may be checked.

Storage and Handling

  • Keep the tube tightly capped and store at 15 °C to 30 °C (room temperature).
  • Protect from direct sunlight and moisture.
  • Do not freeze.
  • Once opened, use within 3 months; discard any product that changes colour, consistency, or develops an off-odour.
  • Keep out of reach of children and pets.

Medication-Specific Glossary

Calcineurin
An enzyme in T-cells that activates NF-AT, leading to cytokine production; inhibition reduces immune activity.
Immunomodulator
A drug that alters the immune response, either enhancing or suppressing specific pathways.
Eczema (Atopic Dermatitis)
A chronic inflammatory skin disease characterised by itchy, red, and scaly patches.
Lymphoma
A type of cancer arising from lymphocytes; topical tacrolimus has a theoretical association with cutaneous T-cell lymphoma after prolonged use.
Photosensitivity
Increased skin reaction to ultraviolet light, potentially leading to sunburn or rash.

Medical Disclaimer

This article provides educational information about Protopic and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Protopic is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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