Adverse effects topical tacrolimus

The most common patient complaints with topical tacrolimus therapy are transient itching and burning at the site of application. Although no data support the practice, many clinicians recommend pretreatment with topical corticosteroids to prevent or reduce tacrolimus-induced burning and erythema. Systemic adverse effects of tacrolimus, while well documented with oral therapy, have not been observed in patients using the topical ointment for AD. Patients who receive long-term systemic immunosuppressants are prone to devel-... 

The topical immunomodulators tacrolimus (Protopic) and pimecrolimus (Elidel) inhibit calcineurin, which normally initiatives T-cell activation. These agents can be used on all parts of the body for prolonged periods without producing corticosteroid-induced adverse effects. Tacrolimus ointment 0.03% and 0.1% is applied twice daily the lower strength is preferred in children with moderate to severe atopic dermatitis. The most common adverse effect is transient itching and burning at the site of application. Pimecrolimus cream 1% is applied twice daily for mild to moderate atopic dermatitis in adults and children older than age 2. 

Tacrolimus, an immunosuppressant that inhibits T-cell activation, is a useful alternative in severe recalcitrant psoriasis. Although it is not FDA approved for this indication, patients have received oral doses of 0.05 mg/kg daily, with increases up to 0.15 mg/kg daily, depending on results. Adverse effects include diarrhea, nausea, paresthesias, hypertension, tremor, and insomnia. Methotrexate, an antimetabolite, is indicated for moderate to severe psoriasis. It is particularly beneficial for psoriatic arthritis. It is also indicated for patients refractory to topical or UV therapy. Methotrexate can he administered orally, subcutaneously, or intramuscularly. The starting dose is 7.5 to 15 mg per week, increased incrementally by 2.5 mg every 2 to 4 weeks until response maximal doses are approximately 25 mg/wk. Adverse effects include nausea, vomiting, mucosal ulceration, stomatitis, malaise, headache, macrocytic anemia, and hepatic and pulmonary toxicity. Nausea and macrocytic anemia can be ameliorated by giving oral fohc acid 1 to 5 mg/day. Methotrexate should be avoided in patients with active infections and in those with liver disease. It is contraindicated in pregnancy because it is teratogenic. 

The long-term safety of topical tacrolimus ointment 0.1% for 6-12 months has been assessed in 316 patients with atopic dermatitis (82). The most common adverse effects clearly attributed to tacrolimus were a local burning sensation (47%), pruritus (24%), and erythema (12%) the incidences fell with time. The observed incidence of infections did not exceed the expected incidence in patients with atopic dermatitis, and there were no effects on circulating cell-mediated immunity. 

Adverse effects include diarrhea, nausea, paresthesias, hypertension, tremor, and insomnia. Other toxicities with topical tacrolimus— including renal insufficiency and immunosuppression—have been rarely reported. ... 

Topical calcineurin inhibitors, including tacrolimus and pime-crolrmus, have added a new dimension to treatment of AD. Unlike corticosteroids, these agents offer a more long-term option, as they can be used on all parts of the body for prolonged periods without fear of corticosteroid-induced adverse effects. These agents form a complex that results in inhibition of calcineurin, which normally initiates T-cell activation. Through inhibition, the complex subdues the inflammatory component of AD (Table 97-3). ... 

Adverse effects of topical application of tacrolimus are rash, irritation, pain and paraes-thesia. 

Topical tacrolimus has been successfully developed as an ointment. An open trial in Japan as the first human experience highlighted the therapeutic potential of topical tacrolimus [33]. Three different concentrations of tacrolimus ointment (0.03%, 0.1%, and 0.3%) were evaluated. All concentrations provided excellent clinical improvements with minimal adverse effects, primarily local burning and pruritus. The benefits were most profound on the face and neck, areas traditionally most difficult to control due to restrictions on the use of topical steroids due to side effects such as skin atrophy and telangiectasia formation. Following these initially promising results, a large number of clinical trials have been conducted to further establish the clinical efficacy and safety of topically applied tacrolimus. These trials have been conducted in Japan [118-120], North America [121-125], and Europe [126-128]. To date, more than 8000 patients in 28 clinical studies... 

Tacrolimus ointment is the first topical, nonsteroidal, effective and safe immunomodulatory agent to offer the potency of a corticosteroid without its attendant adverse effects. It truly represents the first therapeutic advance in the treatment of atopic dermatitis since the introduction of topical steroids more than 40 years ago [105, 129]. 

Skill Pimecrolimus and tacrolimus can be used for prolonged periods, avoiding the adverse effects that are related to long-term use of topical glucocorticoids. Although atrophy, telangiectasia, and tachyphylaxis have not been described, topical tacrolimus... 

Facial flushing should be recognized as an adverse effect of topical calcineurin inhibitors, both pimecrohmus and tacrolimus, independently from the skin disease. 

Topical calcineurin inhibitors are also used to treat atopic dermatitis and include pimecrolimus (Elidel) and tacrolimus (Protopic).Treatment effects are seen in 1 to 3 weeks. Adverse reactions most commonly include burning. Although a causal relation has not been established, rare skin malignancy and lymphoma have been reported. 

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