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Ointment, tacrolimus

Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsuku-baensis. Each gram of ointment contains (w/w) either [Pg.239]

03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax. [Pg.239]

Handbook of Pharmaceutical Manufacturing Formulations Semisolid Products [Pg.240]


Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream) have fungicidal and antiinflammatory properties and can be used for the scalp or face. [Pg.212]

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. [Pg.214]

The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. Do not use tacrolimus ointment with occlusive dressings. [Pg.2067]

Absorption/Distribution - In atopic dermatitis patients, tacrolimus is absorbed after topical application of 0.1% tacrolimus ointment. [Pg.2067]

Infected atopic dermatitis Before commencing treatment with tacrolimus ointment, clear clinical infections at treatment sites. [Pg.2068]

WraZ/nfecf/on. Treatment with tacrolimus ointment may be associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. [Pg.2068]

Lymphadenopathy Patients who receive tacrolimus ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, consider discontinuation of tacrolimus ointment. Monitor patients who develop lymphadenopathy to ensure that the lymphadenopathy resolves. [Pg.2068]

Other skin disorders The use of tacrolimus ointment in patients with Netherton syndrome is not recommended because of the potential for increased systemic absorption of tacrolimus. The safety of tacrolimus ointment has not been established in patients with generalized erythroderma. [Pg.2068]

Because of the effectiveness of systemic tacrolimus in some dermatologic diseases, a topical preparation is now available. Tacrolimus ointment is currently used in the therapy of atopic dermatitis and psoriasis. [Pg.1191]

Beck LA. The efficacy and safety of tacrolimus ointment a clinical review. J Am, Acad Dermatol. 2005 53 (suppl 2) S165-S170. [Pg.602]

Ruzicka, T., Bieber, T., Schopf, E. et al. A short-term trial of tacrolimus ointment for atopic dermatitis. European tacrolimus multicenter atopic dermatitis study group. N. Engl. J. Med. 1998 339 1788-89. [Pg.153]

Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus... [Pg.199]

Joseph MA, Kaufman HE, Insler M.Topical tacrolimus ointment for treatment of refractory anterior segment inflammatory disorders. Cornea 2005 24 417-420. [Pg.573]

Lubbe J, Pournaras CC, Saurat JH. Eczema herpeticum during treatment of atopic dermatitis with 0.1% tacrolimus ointment. Dermatology 2000 201(3) 249-51. [Pg.2834]

Soter NA, Fleischer AB Jr, Webster GF, Monroe E, Lawrence I. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients part II, safety. J Am Acad Dermatol 2001 44(Suppl 1) S39 6. [Pg.2834]

Jablonska S, Rustin M. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol 2000 136(8) 999-1006. [Pg.2834]

In children 0.1% tacrolimus ointment has been used daily without major adverse effects. [Pg.3283]

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. [Pg.3285]

In 631 adult patients with moderate to severe atopic dermatitis enrolled in a randomized, double-blind, multicenter comparison of tacrolimus (0.03% or 0.1%) with a vehicle applied twice-daily for 12 weeks, the most common adverse events were skin burning, erythema, and pruritus (83). Others were flu-like symptoms and headache. Withdrawal was required in 50 patients because of adverse events, twice as many as in the vehicle group. There was pruritus in 30 patients, skin burning in 19, skin erythema in 12, and skin infections in two. Skin burning and pruritus have consistently been observed with tacrolimus ointment, typically during the first days of treatment, reducing in incidence within the first week they tend to be mild or moderate. [Pg.3285]

In a randomized, double-blind, placebo-controlled study at 23 centers in the USA, children with moderate to severe atopic dermatitis applied the vehicle, tacrolimus ointment 0.03%, or tacrolimus ointment 0.1% for 12 weeks (94). Burning and pruritus were the main adverse effects. Varicella infection and vesiculobullous rashes on non-application areas occurred, but with a low incidence (below 5%). Since they occurred in those who used tacrolimus 0.03%, it is likely that they were random events rather than drug-related. Regardless of dose, there were some age-related differences in the incidence of individual adverse events. For example, otitis media was more common in younger children (2-6 years). Tacrolimus ointment had no age-selective effect that was not also observed with the vehicle. Each of the adverse events resolved without sequelae. [Pg.3286]

Yoshida H, Tamura S, Toyoda T, et al. In vitro release of tacrolimus from tacrolimus ointment and its speculated mechanism. Int Pharm 2004 270(1-2) 55-64. [Pg.623]

Reitamo S, Rissanen C, Paul C, et al. Tacrolimus ointment does not affect collagen synthesis results of a single-center randomized trial. J Invest Dermatol 1998 111 396-398. [Pg.1791]

Boguniewicz M, Fiedler VC, Raimer S, et al. A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children Pediatric tacrolimus study group. J Allergy Clin Immunol 1998 102(4 Pt l) 637-644. [Pg.1791]

Very recently topical tacrolimus (ointment) has been shown to be a very effective therapy for the treatment of moderate to severe atopic dermatitis, making it the first true alternative to steroids for treating this widespread disease. It seems... [Pg.425]

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... [Pg.435]

Large-scale, multicenter, double-blind comparative studies have also been conducted in the United States and Europe. Hanifin et al. [121] and the Tacrolimus Ointment Study Group reported the results focused on the efficacy of tacrolimus... [Pg.437]

With respect to safety in a total of 631 adult patients who applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks, a sensation of skin burning was observed more often in the tacrolimus ointment groups than in the vehicle group (25% vs. 45% and 57%, vehicle vs. 0.03% and 0.1%, respectively). These application site adverse events were generally of short duration and their prevalence decreased after a few days of treatment. No clinically meaningful... [Pg.438]

Fig. 4. Change from baseline to end of treatment (least squares mean + SE) for individual signs of atopic dermatitis. Vehicle (shaded bars), 0.03% tacrolimus ointment (open bars), and 0.1% tacrolimus ointment (solid bars)., significantly greater improvement compared with vehicle group (P < 0.001) O, significantly greater improvement for the 0.1% concentration compared with the 0.03% concentration of tacrolimus ointment (P = 0.05). (Reprinted with permission from Hanifin et al. [121], Fig. 3, p. S33.)... Fig. 4. Change from baseline to end of treatment (least squares mean + SE) for individual signs of atopic dermatitis. Vehicle (shaded bars), 0.03% tacrolimus ointment (open bars), and 0.1% tacrolimus ointment (solid bars)., significantly greater improvement compared with vehicle group (P < 0.001) O, significantly greater improvement for the 0.1% concentration compared with the 0.03% concentration of tacrolimus ointment (P = 0.05). (Reprinted with permission from Hanifin et al. [121], Fig. 3, p. S33.)...
Pallet et al. [125] reported the safety and eiificacy of tacrolimus ointment for the treatment of 351 children ages 2-15 years with moderate to severe atopic dermatitis in a randomized, double-blind, vehicle controlled study. Patients were allowed to treat up to 100% BSA twice daily for 12 weeks with either 0.03%,... [Pg.439]

Drake et al. [122], using a validated quality-of-life (QOL) measurement instrument, assessed changes in QOL for all three U.S. phase 3 studies mentioned above. In that assessment, tacrolimus ointment therapy with either 0.1% or 0.03% was associated with a statistically significantly greater QOL improvement than placebo treatment in adults, children, and toddlers. As illustrated in Fig. 6, the patients preference for continuing on the study therapy supports the QOL benefits of tacrolimus ointment for atopic dermatitis from the patients perspectives. [Pg.440]


See other pages where Ointment, tacrolimus is mentioned: [Pg.463]    [Pg.153]    [Pg.239]    [Pg.435]    [Pg.436]    [Pg.436]    [Pg.436]    [Pg.436]    [Pg.437]    [Pg.437]    [Pg.438]    [Pg.439]    [Pg.440]   
See also in sourсe #XX -- [ Pg.239 ]

See also in sourсe #XX -- [ Pg.228 , Pg.234 ]

See also in sourсe #XX -- [ Pg.596 ]




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