Tacrolimus ointment

Tacrolimus ointment is a prescription medicine used to treat the symptoms of atopic dermatitis.

• Tacrolimus ointment is available under the following different brand names: Protopic

Adult and pediatric dosage

Ointment

• 0.03%
• 0.1%

Atopic Dermatitis

Adult dosage

• 0.03% or 0.1% ointment: Apply a thin layer to the affected area every 12 hours; discontinue treatment when symptoms have cleared; if no improvement within 6 weeks, reassess diagnosis

Pediatric dosage

• Children below 2 years: Not recommended
• Children between 2 to 15 years: 0.03% ointment: Apply a thin layer to the affected area every 12 hours
• Children above 15 years: Apply 0.03% or 0.1% ointment as a thin layer to the affected area every 12 hours; discontinue treatment when symptoms have cleared; if no improvement within 6 weeks, reassess diagnosis

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Tacrolimus ointment include:

• mild burning, stinging or itching,
• skin redness,
• acne,
• cold or flu symptoms: stuffy nose, sneezing, sore throat,
• headache, and
• feeling more sensitive to hot or cold temperatures.

Serious side effects of Tacrolimus ointment include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe stinging, burning, itching, or soreness at the injection site,
• swollen glands,
• redness or crusting around hair follicles, and
• signs of skin infection: redness, swelling, itching, or oozing.

Rare side effects of Tacrolimus ointment include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tacrolimus ointment has no noted severe interactions with any other drugs.
• Tacrolimus ointment has no noted serious interactions with any other drugs.
• Tacrolimus ointment has no noted moderate interactions with any other drugs.
• Tacrolimus ointment has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Children less than 2 years

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tacrolimus ointment?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tacrolimus ointment?”

Cautions

• Preferably use as second-line agents for short-term & intermittent treatment in unresponsive to, or intolerant of other treatments
• Do not use with occlusive dressings
• It May be associated with the development of lymphadenopathy
• Not for application in areas with active viral or bacterial infections
• Acute renal failure reported (rare)
• The potential risk of lymphoma and skin cancer
• Not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus (eg, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma, cutaneous graft vs host disease)

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.

Lactation

• Not known whether tacrolimus is distributed in milk following topical administration to the skin