Protopic 0.03% Ointment

Brand LEO
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Dr. Mohd Izzat Amir Bin Awang
Reviewed byDr. Mohd Izzat Amir Bin AwangDoctor of Medicine (MD), University of Mansoura - Manchester
Dr. Adeline Carol Peters
Written byDr. Adeline Carol PetersBachelor of Medicine and Bachelor of Surgery (MBBS) — Manipal Academy of Higher Education (MAHE)

Last updated:

Overview

Protopic 0.03% Ointment contains Tacrolimus (as tacrolimus monohydrate) 0.03% w/w and is presented as an ointment. It is supplied in a pack size of 10g.

It is classified as a non-prescription medicine, so no prescription is needed to order it. Under Malaysian rules for medicine information, this page carries product, safety and handling information only.

You can consult a doctor or pharmacist online on DoctorOnCall about this product before or after you order. Every order is checked by a registered pharmacist before it is delivered. Always read the label and the leaflet supplied with the pack.

Directions for Use

Apply a thin layer of Protopic 0.03% Ointment to the affected areas of skin twice daily as directed by your doctor, gently rubbing it in until fully absorbed, and continue until the skin clears; your doctor may then advise reducing to a maintenance regimen, and hands should be washed after application unless the hands themselves are the treated area.

Dosage

The typical dose for children aged 2 to 15 years, and for adults using the lower-strength maintenance regimen, is a thin layer of Protopic 0.03% Ointment applied twice daily to affected areas until clearance, with your doctor guiding any adjustment for maintenance therapy; do not apply more often or in a thicker layer than prescribed.

Storage Instructions

Store Protopic 0.03% Ointment below 25°C to 30°C in a dry place away from direct sunlight, and keep it out of the sight and reach of children when not being applied by a caregiver.

Side Effects

  • Headache
  • Nausea or vomiting
  • Increased blood sugar levels
  • Risk of infections
  • Tremors or shakiness
  • High blood pressure
  • Fatigue or weakness
  • Skin irritation (with topical use)

Contraindications

  • Known hypersensitivity to tacrolimus or any other ingredient in the ointment
  • Use on skin with an active, untreated bacterial, viral, or fungal infection
  • Children under 2 years of age, unless specifically directed by a paediatrician
  • Use under occlusive dressings or bandages unless specifically advised by your doctor
  • Conditions associated with a weakened immune system, or Netherton’s syndrome, without specific doctor approval, due to increased systemic absorption risk

Drug / Food Interactions

  • Alcohol may cause facial flushing or skin warmth in adult users when combined with Protopic 0.03% Ointment
  • Concurrent use of other topical treatments on the same area should only be done under medical advice
  • Phototherapy (UV light treatment) is not recommended while using tacrolimus, as combined use may increase skin cancer risk
  • Live vaccines should be discussed with your doctor before administration during treatment

Quick Tips

  • Apply only a thin layer — more product does not improve results and may increase side effects
  • Protect treated skin from strong sun exposure with sunscreen or protective clothing, as tacrolimus can increase photosensitivity
  • Avoid occlusive dressings or bandages over treated skin unless directed by your doctor
  • Do not apply to skin with active infection until it has been treated and cleared
  • Attend follow-up appointments, especially for children, so your doctor can monitor growth and skin response over time
  • Caregivers should wash their hands after applying the ointment to a child unless their own hands are the treated area

Ingredients / Active Ingredients

  • Tacrolimus (as tacrolimus monohydrate) 0.03% w/w
  • White soft paraffin
  • Paraffin oil
  • Propylene carbonate and other standard ointment excipients

Safety Advice

Pregnancy

Use With Care

This medicine should be used cautiously during pregnancy. Monitoring may be required.

Breastfeeding

Not Advisable

Generally not recommended while breastfeeding.

Kidney

Use With Care

Use cautiously. Dose adjustment or monitoring may be required.

Liver

Use With Care

Use cautiously. Liver function monitoring may be required.

Alcohol

Not Advisable

It is not advisable to consume alcohol while taking this medicine.

Driving

Not Advisable

It is not advisable to drive if you experience side effects from this medicine.

Relevant Information

Protopic 0.03% Ointment is the lower-strength option specifically studied and approved for children aged 2 years and above with moderate-to-severe eczema, and is also used in adults as a gentler maintenance treatment or for milder disease. Because it is a prescription immunomodulator used partly in a paediatric population, ongoing doctor follow-up — including monitoring of the child’s overall development — is an important part of safe treatment, and DoctorOnCall’s doctors remain available for review through further online consultations as needed.

Frequently Asked Questions

Product Specifications

BrandLEO
ClassificationNon-prescription
Ingredients / Active IngredientsTacrolimus
Weight10g
Shelf LifeProtopic 0.03% Ointment is generally stable for around 2 to 3 years from the date of manufacture when unopened, so always check the expiry date printed on the tube or carton before use.

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Important Medical Information

💊 Recommended Dosage:

The typical dose for children aged 2 to 15 years, and for adults using the lower-strength maintenance regimen, is a thin layer of Protopic 0.03% Ointment applied twice daily to affected areas until clearance, with your doctor guiding any adjustment for maintenance therapy; do not apply more often or in a thicker layer than prescribed.

🛑 Contraindications (Do not use if):
  • Known hypersensitivity to tacrolimus or any other ingredient in the ointment
  • Use on skin with an active, untreated bacterial, viral, or fungal infection
  • Children under 2 years of age, unless specifically directed by a paediatrician
  • Use under occlusive dressings or bandages unless specifically advised by your doctor
  • Conditions associated with a weakened immune system, or Netherton’s syndrome, without specific doctor approval, due to increased systemic absorption risk
If you are unsure, please chat with us or consult your doctor.
⚠️ Common Side Effects:
  • Headache
  • Nausea or vomiting
  • Increased blood sugar levels
  • Risk of infections
  • Tremors or shakiness
  • High blood pressure
  • Fatigue or weakness
  • Skin irritation (with topical use)
Stop taking this medication immediately and consult your doctor if you experience severe allergic reactions or side effects.
IMPORTANT: Unsure? Chat with our pharmacists (Mon - Sat, 9:00am - 6:00pm) before buying.