Protopic Ointment – Comprehensive Product Description | Buy Tacrolimus Ointment Online from EZ Chemist Pharmacy

What is Protopic Ointment used for?
Protopic Ointment, containing tacrolimus, is a topical calcineurin inhibitor used to treat moderate to severe atopic dermatitis (eczema) in adults and children when other treatments are ineffective or unsuitable. It helps reduce inflammation, redness, and itching of the skin.

Product Name:
Protopic Ointment

Generic Name:
Tacrolimus

Other Common Names:
Tacrolimus topical ointment

FK506 ointment

Tacrolimus skin cream (generic version)

Protopic 0.03% and Protopic 0.1%

Drug Classification:
Category Details
Therapeutic Class Dermatological Agent
Pharmacologic Class Calcineurin Inhibitor
Drug Schedule Prescription Only
ATC Code D11AH01

Active Ingredient:
Tacrolimus monohydrate

Available concentrations:

Protopic 0.03% (typically used for children 2–15 years)

Protopic 0.1% (used for adults and adolescents over 16)

Mechanism of Action:
Tacrolimus is a macrolide immunosuppressant that acts by inhibiting calcineurin, a calcium-dependent phosphatase.
By blocking calcineurin in T-lymphocytes, tacrolimus suppresses the transcription of pro-inflammatory cytokines such as IL-2, IL-3, IL-4, TNF-alpha, and IFN-gamma.

This leads to a reduction in skin inflammation, redness, and itching in atopic dermatitis without causing skin thinning, unlike corticosteroids.

Indications and Uses:
Approved Uses:
Atopic Dermatitis (Eczema):

Adults and adolescents (≥16 years): Protopic 0.1%

Children (2–15 years): Protopic 0.03%

Used for:

Moderate to severe eczema unresponsive to corticosteroids

Maintenance treatment to prevent flares (intermittent use)

Dosage and Administration:
Age Group Formulation Usage
Adults/Teens ≥16 Protopic 0.1% Apply thin layer to affected areas twice daily until lesions resolve. Maintenance use may be twice weekly.
Children 2–15 years Protopic 0.03% Apply twice daily for up to 3 weeks, then as directed. Maintenance as twice weekly.

How to Apply:

Apply a thin layer to affected skin only.

Do not cover with occlusive dressings.

Wash hands after application unless hands are being treated.

Avoid contact with eyes, nose, or mouth.

Important Instructions:
Do not apply to broken/infected skin.

Avoid sunlight or UV therapy; use sunscreen or protective clothing.

Do not use for more than 6 weeks without reevaluation by a physician.

Avoid use in children under 2 years.

Side Effects:
Common (≥10%) Less Common Rare but Serious
Burning/stinging Itching Skin infections (herpes, folliculitis)
Redness Acne or rosacea Lymphoma or skin cancer (long-term theoretical risk, not proven clinically)
Tingling Flu-like symptoms Hypersensitivity reactions
Contraindications:
Hypersensitivity to tacrolimus or any component of the formulation

Use on immunocompromised patients (caution advised)

Do not use in pregnancy unless absolutely necessary (Category C)

Drug Interactions:
Interacting Substance Effect
Other immunosuppressants Additive immunosuppression (use caution)
UV therapy / phototherapy Increases photosensitivity and cancer risk
CYP3A4 inhibitors (oral) May affect systemic exposure in rare cases if absorbed, though minimal

Note: Topical absorption is low; systemic drug interactions are rare but possible with large surface area applications.

Use in Special Populations:
Pregnancy: Category C; use only if clearly needed

Lactation: Unknown if excreted in breast milk; avoid applying to chest

Children (2–15): Safe for short-term use of 0.03%

Infants (<2 years): Not recommended due to immature immune system

Storage and Handling:
Store at 20–25°C (68–77°F)

Do not refrigerate or freeze

Keep tube tightly closed and out of reach of children

Frequently Asked Questions (FAQs) – Protopic Ointment
Q1. What is Protopic used for?
Protopic is used to treat moderate to severe atopic dermatitis (eczema) in patients who are unresponsive or intolerant to corticosteroids.

Q2. Is Protopic a steroid?
No, Protopic is a non-steroidal topical immunomodulator, specifically a calcineurin inhibitor.

Q3. How long does it take for Protopic to work?
Many patients notice improvement within 1 week. Maximum effect may take 2–3 weeks.

Q4. Can I use Protopic with moisturizers or other creams?
Yes, but apply moisturizers after Protopic (with a 30-minute gap). Avoid using other topical medications at the same time unless prescribed.

Q5. Is it safe to use Protopic long-term?
Short-term use is considered safe. For long-term maintenance, twice-weekly application has been found effective and safe under medical supervision.