Safety and Efficacy of 1 Year of Tacrolimus Ointment Monotherapy in Adults With Atopic Dermatitis

Reitamo, Sakari; Wollenberg, Andreas; Schöpf, Erwin; Perrot, Jean; Marks, R.; Ruzicka, Thomas; Christophers, Enno; Kapp, Alexander; Lahfa, M.; Рубинс, Андрис; Jabłońska, Stefania; Rustin, M.H.A.

doi:10.1001/archderm.136.8.999

Cited by 350 publications

(286 citation statements)

References 23 publications

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“…When combined with ethanol, tacrolimus and pimecrolimus, cream and ointment, respectively, may cause erythematosus flushing even after consuming a small amount of beer or wine [6,[49][50][51]. Patients with vitiligo of the face, treated with topical tacrolimus or pimecrolimus, experienced itching and burning, followed by flushing erythematosus, 5-10 minutes after ingestion of alcoholic beverages.…”

Section: Disulfiram-like Reactions With Dermatological Preparationsmentioning

confidence: 99%

Alcohol-Medication Interactions: The Acetaldehyde Syndrome

Oliveira¹

2014

J Pharmacovigil

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Medications that inhibit aldehyde dehydrogenase when coadministered with alcohol produce accumulation of acetaldehyde. Acetaldehyde toxic effects are characterized by facial flushing, nausea, vomiting, tachycardia and hypotension, symptoms known as acetaldehyde syndrome, disulfiram-like reactions or antabuse effects. Severe and even fatal outcomes are reported. Besides the aversive drugs used in alcohol dependence disulfiram and cyanamide (carbimide), several other pharmaceutical agents are known to produce alcohol intolerance, such as certain anti-infectives, as cephalosporins, nitroimidazoles and furazolidone, dermatological preparations, as tacrolimus and pimecrolimus, as well as chlorpropamide and nilutamide. The reactions are also observed in some individuals after the simultaneous use of products containing alcohol and disulfiram-like reactions inducers. Depending on the pharmacological inducer, reactions may occur several days after treatment completion. Disulfiram-alcohol reaction includes moderate decrease in blood pressure, but severe life-threatening arterial hypotension and shock sometimes develop. Myocardial infarction secondary to disulfiram-alcohol reaction has been also reported. For severe hypotension resulting from a disulfiram-ethanol reaction, adrenaline or noradrenaline have been employed as the pressor agent of choice. Fomepizole, an alcohol dehydrogenase inhibitor, may be a safe and effective treatment of severe reactions. When medications that produce antabuse effects are prescribed or dispensed, patients should be instructed to avoid medicines and other products containing alcohol, such as syrups, fermented vinegar, sauces and lotions. It is essential that doctors, nurses and pharmacists instruct patients to avoid alcohol during treatment with aversive drugs and disulfiram-like reactions inducers. Likewise, even when scientific evidence is inconclusive, such instructions should be provided in leaflets, which are often the only source of information for patients and a guide for health professionals.

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Section: Disulfiram-like Reactions With Dermatological Preparationsmentioning

confidence: 99%

Alcohol-Medication Interactions: The Acetaldehyde Syndrome

Oliveira¹

2014

J Pharmacovigil

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“…Os resultados obtidos demonstraram diferenças significativas de redução de área acometida e escores de gravidade. Não houve perda da eficácia com o tempo de uso 31,32 .…”

Section: Eficácia Dos Inibidores De Calcineurinaunclassified

“…A freqüência de prurido no local da aplicação por vezes não superou os achados observados nos pacientes que utilizavam apenas o veículo. Entretanto, em comparação à corticoterapia, o ardor e o prurido observados foram maiores nos pacientes que utilizavam tacrolimo [26][27][28][29][30][31][32][33][34] .…”

Section: Efeitos Adversos Locaisunclassified

“…A foliculite, entretanto, foi observada com maior freqüência nos pacientes que utilizavam placebo quando comparados àqueles que utilizavam tacrolimo. Com relação à infecção estafilocócica, com o uso prolongado desses medicamentos houve redução do número de processos infecciosos ao longo do estudo [26][27][28][29][30][31][32][33][34] .…”

Section: Efeitos Adversos Locaisunclassified

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Calcineurin inhibitors in the treatment of allergic dermatitis

Castro

2006

J Pediatr (Rio J)

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Objective: To review the role of calcineurin inhibitors in the treatment of allergic dermatitis, focusing on mechanisms of action, efficacy and topical and systemic adverse effects.Sources: Articles written in English and published in MEDLINE using the following keywords: pimecrolimus, tacrolimus, calcineurin inhibitors. Original articles that presented controlled and open studies for assessing efficacy, tolerability and adverse effects were selected. Review articles and case series were also evaluated; the latter was only considered for assessing adverse effects. The official websites of the Food and Drug Administration and of manufacturers of calcineurin inhibitors were also used. Summary of the findings:The data showed that calcineurin inhibitors are efficient in the treatment of mild to severe atopic dermatitis, leading to improvement in symptoms, reduction in number of attacks and need of topical corticotherapy. Calcineurin inhibitors have good tolerability and few topical adverse effects. To date, there has been no evidence to support higher prevalence of neoplasia in patients using these drugs; however, an adequate pharmacovigilance system has been set up to assess this aspect. Conclusions:Calcineurin inhibitors, which are a new drug class in the treatment of allergic dermatitis, are efficient, well tolerated and have few adverse effects. Calcineurin inhibitors should always be used according to recommended guidelines, and patients should always be followed by the physician during and after their administration.J Pediatr (Rio J). 2006;82(5 Suppl):S166-72: Pimecrolimus, tacrolimus, calcineurin inhibitors. ResumoObjetivo: Revisar o papel dos inibidores da calcineurina no tratamento das dermatoses alérgicas, com ênfase nos mecanismos de ação, eficácia e efeitos adversos tópicos e sistêmicos.Fontes dos dados: Artigos de língua inglesa publicados na MEDLINE, considerando as palavras chave: pimecrolimus, tacrolimo, calcineurin inhibitors. Foram selecionados os artigos originais que apresentaram estudos controlados e estudos abertos para avaliação da eficácia, tolerabilidade e eventos adversos. Também foram avaliados artigos de revisão e relatos e série de casos, sendo estes últimos considerados apenas para avaliação de efeitos adversos. Foram consultados os sites oficiais da Food and Drug Administration e dos fabricantes de inibidores da calcineurina. Síntese dos dados:Os dados mostraram que inibidores de calcineurina são eficientes no tratamento da dermatite atópica leve a grave, levando a melhora dos sintomas, diminuição do número de crises e necessidade de corticoterapia tópica. Apresentam boa tolerabilidade e poucos efeitos adversos tópicos. Até o momento, não há evidências que sustentem a maior prevalência de neoplasias nos pacientes que utilizam esses medicamentos; entretanto, um adequado sistema de farmacovigilância está montado para avaliar esse aspecto.Conclusões: Os inibidores de calcineurina são uma nova classe de medicamentos para o tratamento das dermatoses alérgicas. São eficazes, tolerado...

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“…Protopico, 1 % Salbe durfte 2-mal täglich auf die befallenen Areale aufgetragen werden bis jeweils 1 Woche nach Abklingen des akuten Ekzems. Unterstützend durften die Patienten wirkstofffreie pflegende Externa verwenden [29]. Die Beurteilung der Krankheitsaktivität erfolgte mit Hilfe eines Summenscores, welcher aus der klinischen Symptomatik und der befallenen Hautareale berechnet wurde (EASI, ¹eczema area and severity indexª), sowie durch eine globale Beurteilung durch den Arzt (IGA, ¹investigator global assessmentª) [30].…”

Section: Tacrolimus (Protopic)unclassified

Behandlung des atopischen Ekzems mit topischen Calcineurininhibitoren

Luger¹

2003

Akt Dermatol

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ZusammenfassungIn den letzten Jahren hat es wie noch nie zuvor in der gesamten Medizin und damit auch in der Dermatologie derart spannende und viel versprechende Entwicklungen in der Therapie gegeben. Ein entscheidender Fortschritt im therapeutischen Arsenal bei der Behandlung des atopischen Ekzems stellen die neuen topischen Calcineurininhibitoren wie Tacrolimus und Pimecrolimus dar. Beide Therapeutika Tacrolimus Salbe (Protopic) und Pimecrolimus Creme (Elidel) sind für die Behandlung des atopischen Ekzems zugelassen. Seit Einführung der topischen Kortikosteroide vor mehr als 50 Jahren stellt dies die erste wirkliche Innovation in der topischen Therapie dar und füllt damit eine groûe therapeutische Lücke. Beide Substanzen sind entzündungshem-mend wirksam und insbesondere Pimecrolimus besitzt nur ein schwaches immunsuppressives Potenzial. Beide Lokaltherapeutika sind bis auf ein vor allem bei Protopic auftretendes kurzfristiges Brennen gut verträglich und auch bei langfristiger Anwendung frei von kortikosteroidtypischen Nebenwirkungen wie Hautatrophie. Die nach lokaler Anwendung mögliche systemische Exposition ist relativ gering und insbesondere bei Pimecrolimus konnten in keinem Fall potenziell toxische Konzentrationen im Blut gemessen werden. Sowohl Protopic Salbe als Elidel Creme haben sich in Kurzzeit-und Langzeitstudien als sehr wirkungsvoll bei der Behandlung des atopischen Ekzems von Kindern und Erwachsenen erwiesen. Im Allgemeinen kommt es innerhalb von wenigen Tagen zu einer deutlichen Besserung der klinischen Symptomatik wie Juckreiz und Ekzem. Erste Beobachtungen belegen auch eine gute Wirksamkeit von topischen Calcineurininhibitoren bei der Behandlung von anderen entzündli-chen Dermatosen. Inwieweit bei Patienten mit atopischen Ekzem eine prophylaktische Anwendung von Protopic oder Elidel und damit die Vermeidung eines chronischen Krankheitsverlaufes möglich ist, werden weitere klinische Studien zeigen. AbstractDuring the last years the enormous progress in the understanding of the complex pathomechanisms underlying immune-mediated and inflammatory skin diseases has allowed for the development of novel therapeutic strategies. Among several drugs and biologics being investigated for dermatological use currently calcineurin inhibitors such as tacrolimus and pimecrolimus appear to be the most promising. Recently topical preparations of both tacrolimus (Protopic) and pimecrolimus (Elidel) have been developed and are available for the treatment of atopic dermatitis. Since the introduction of topical corticosteroids more than 50 years ago these novel compounds are the first major development in the topical treatment of inflammatory skin diseases. Both drugs exert a potent antiinflammatory activity and the immunosuppressive potential of pimecrolimus in particular is minimal. Both compounds are well tolerated, do not cause skin atrophy and are safe during long-term application. Application site adverse events mainly consist of a transient sensation of burning which more frequently has been observed after the...

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Safety and Efficacy of 1 Year of Tacrolimus Ointment Monotherapy in Adults With Atopic Dermatitis

Cited by 350 publications

References 23 publications

Alcohol-Medication Interactions: The Acetaldehyde Syndrome

Alcohol-Medication Interactions: The Acetaldehyde Syndrome

Calcineurin inhibitors in the treatment of allergic dermatitis

Behandlung des atopischen Ekzems mit topischen Calcineurininhibitoren

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