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tacrolimus (topical)

(ta-kroe-li-mus) ,


(trade name)


Therapeutic: immunosuppressants
Pregnancy Category: C


Moderate to severe atopic dermatitis in non-immunocompromised patients who do not respond to or cannot tolerate conventional therapies.


Inhibits T-lymphocyte activation.

Therapeutic effects

Improvement in signs/symptoms of atopic dermatitis.


Absorption: Minimal following topical use.
Distribution: Crosses the placenta and enters breast milk.
Protein Binding: 99%.
Metabolism and Excretion: 99% metabolized by the liver; <1% excreted unchanged in the urine.
Half-life: Healthy volunteers—21.2 hr.

Time/action profile (immunosuppression)

Topical†unknown1–2 wkunknown
†Improvement in atopic dermatitis


Contraindicated in: Hypersensitivity to tacrolimus or any component of the ointment; Weakened/compromised immune system; Malignant or pre-malignant skin conditions; Lactation: Breastfeeding should be avoided; Pediatric: Children <2 yr (safety not established).
Use Cautiously in: Exposure to sunlight/UV light (may ↑risk of malignant skin changes); Superficial skin infections; Obstetric: Hyperkalemia and renal impairment may occur in the newborn; use only if benefit to mother justifies risk to the fetus.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • sinusitis


  • cough
  • pharyngitis


  • erythema (most frequent)
  • pruritis (most frequent)
  • skin infection (most frequent)
  • acne
  • folliculitis
  • rash


  • burning


  • back pain
  • myalgia


  • flu-like symptoms (most frequent)
  • fever
  • ↑ risk of lymphoma/skin cancer


Noted primarily for PO and IV use, but should be considered for topical use

Drug-Drug interaction

Risk of nephrotoxicity is ↑ by concurrent use of aminoglycosides, amphotericin B, cisplatin, or cyclosporine (allow 24 hr to pass after stopping cyclosporine before starting tacrolimus).Concurrent use of potassium-sparing diuretics, ACE inhibitors, or angiotensin II receptor antagonists ↑ risk of hyperkalemia.The following drugs ↑ tacrolimus blood levels: azoleantifungals, bromocriptine, calcium channel blockers, chloramphenicol, cimetidine, clarithromycin, cyclosporine, danazol, erythromycin, lansoprazole, magnesium/aluminum hydroxidemethylprednisolone, omeprazole, nefazodone, metoclopramide, protease inhibitors, and voriconazole.Phenobarbital, phenytoin, caspofungin, sirolimuscarbamazepine, and rifamycins may ↓ tacrolimus blood levels.Vaccinations may be less effective if given concurrently with tacrolimus (avoid use of live-virus vaccines).Concomitant use with astragalus, echinacea, and melatonin may interfere with immunosuppression.St. John's wort may ↓ tacrolimus blood levels.


Topical (Adults) Apply 0.03% or 0.1% ointment twice daily. Discontinue when signs/symptoms of atopic dermatitis resolve.
Topical (Children ≥2–15 yr) Apply 0.03% ointment twice daily. Discontinue when signs/symptoms of atopic dermatitis resolve.


Ointment: 0.03%, 0.1%

Nursing implications

Nursing assessment

  • Atopic Dermatitis: Assess skin lesions prior to and periodically during therapy.
    • Use only for short time, not continuously, and in the minimum dose possible to decrease risk of developing skin cancer.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)


  • Do not use continuously for a long time.
  • Topical: Wash their hands before applying. Apply a thin layer of ointment twice daily to affected skin. Use smallest amount of ointment needed to control the signs and symptoms of eczema. Do not cover treated area with bandages, dressings or wraps. If not treating areas on hands, wash hands with soap and water after applying to remove any ointment on the hands.

Patient/Family Teaching

  • Instruct apply ointment as directed. Advise patient to read the Medication Guide prior to starting and with each Rx renewal; new information may be available.
  • Advise patient not to bathe, shower, or swim right after applying; may wash off ointment. May use moisturizers with ointment. Instruct patient to check with health care professional first about products to use. If moisturizers are used, apply them after application of ointment.
  • Advise patient to contact health care professional if their symptoms do not improve after 6 wk of treatment, if their symptoms get worse, or they develop a skin infection.
    • Instruct patient to use ointment only on areas of skin with atopic dermatitis.
    • Advise patient to stop using the ointment when the signs/symptoms of atopic dermatitis (itching, rash, redness) go away.
    • Advise patient to limit sun exposure during therapy.
    • Advise patient of the risk of using topical tacrolimus during pregnancy.
    • Inform patient of the risk of lymphoma or skin cancer with topical tacrolimus therapy.

Evaluation/Desired Outcomes

  • Management of atopic dermatitis.


A trademark for the drug tacrolimus.


A brand name for TACROLIMUS.
References in periodicals archive ?
The Astellas dermatology portfolio comprises prescription and over-the-counter products, including established and strong brands such as Protopic for eczema, LocoidA and Locobase for skin care and Zineryt for acne.
But though the protopic cream helped his symptoms, the cycle of itch and scratch remained.
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Our study forecasts sales of 28 products, including these brands: -- Humira -- Enbrel -- Stelara -- Cubicin -- Zyvox -- Claravis -- Epiduo -- Bepanthen -- Protopic
Women who are pregnant or plan to become pregnant should check with their physicians before using Protopic, which should be avoided during breast-feeding, the Food and Drug Administration said in a statement announcing the approval.
That investigation also forecasts sales of 23 leading and recently launched drugs, including Cubicin, Zyvox, Humira, Enbrel, Stelara, Claravis, Epiduo and Protopic.
The patent expiry of marketed products such as Protopic and Elidel by 2012 - 2015 would allow the further entry of generic products at cheaper prices reducing market growth as well as the market size.
She will be responsible for the coordination of meetings for Astellas' Protopic and Amevive products, as well as all Smith & Nephew products.
PROTOPIC ointment (tacrolimus monohydrate) is already licensed to treat moderate and severe eczema (atopic dermatitis), often involving the treatment of flares as and when they occur.
The manufacturers of Elidel and Protopic have agreed to conduct research to determine if there is a risk of cancer in humans, the FDA said in a Talk Paper.