AZULFIN

Azulfin

Sulfasalazina




Composição - AZULFIN

Cada comprimido revestido gastrorresistente de AZULFIN contém 500 mg da sulfasalazina.


Modo de ação - AZULFIN

A sulfasalazina (AZULFIN) é utilizada nos tratamentos dos distúrbios intestinais inflamatórios e na artrite reumatóide1. Seu nome químico é ácido 5- [[p-(2-piridilsulfamoil) fenil]azo] salicílico. O seu modo de ação encontra-se ainda sob investigação. Entretanto pode ser relacionado com as propriedades imunossupressoras observadas em animais nos modelos in vitro, com a sua afinidade com o tecido2 conjuntivo e (ou) com a concentração relativamente elevada encontrada nos fluidos plasmáticos, no fígado3 e nas paredes intestinais, como demonstrado nos estudos auto-radiográficos em animais. A sulfasalazina (AZULFIN) tem sido descrita também como um excelente veículo por transportar seus principais metabólitos sulfapiridina e ácido 5-aminos-salicílico até o colo, onde tem sido reportada a ação local de ambos. Devido a seus metabólitos, os efeitos adversos, o tratamento e as precauções são similares aos relativos às sulfonamidas. Estudos clínicos recentes utilizando a administração retal de sulfasalazina e de seus metabólitos indicaram que a maior ação terapêutica se deve ao ácido 5-aminossalicílico.


Indicações - AZULFIN

Gastroenterologia: AZULFIN é indicado no tratamento da retocolite ulcerativa inespecífica; colite4 ulcerativa média ou moderada; como terapia adjuvante na colite4 ulcerativa severa; doença de Crohn. Reumatologia: AZULFIN é indicado no tratamento da artrite reumatóide1 e da espondilite anquilosante. AZULFIN em comprimidos revestidos gastrorresistentes é indicado particularmente aos pacientes que não podem tomar comprimidos simples devido à intolerância gastrintestinal.


Contra-indicações - AZULFIN

Hipersensibilidade a sulfasalazina, seus metabólitos, sulfonamidas ou salicilatos; em crianças abaixo de dois anos de idade; na obstrução urinária ou intestinal. Pacientes com porfíria não devem receber sulfonamidas, pois há relatos de que estas drogas podem precipitar um ataque agudo5. Gravidez6: Estudos de reprodução realizados em ratas e coelhas com doses acima de 6 vezes a dose em humanos não revelaram evidências de alterações na fertilidade ou danos ao feto. Entretanto não há estudos adequados e bem- controlados em mulheres grávidas. O produto só deve ser usado nesses casos se a avaliação médica concluir que é absolutamente necessário. Amamentação7: As sulfonamidas são excretadas no leite materno. No recém-nascido elas competem com a bilirrubina8 pelos sítios de ligação com as proteínas9 plasmáticas e podem causar icterícia10 nuclear. Não se recomenda o uso da sulfasalazina durante a amamentação7. Pediatria: Não foram estabelecidas a segurança e a eficácia da droga em crianças com idade inferior a dois anos. Geriatria: Nos idosos, a possível ocorrência de reações adversas severas exige observação e avaliação cuidadosa do estado geral do paciente e controle freqüente durante o tratamento.


Interações medicamentosas - AZULFIN

Foi relatada diminuição da absorção de ácido fólico e de digoxina quando administrada concomitantemente com sulfasalazina.


Reações adversas - AZULFIN

As reações adversas mais comuns associadas à sulfasalazina são anorexia11, cefaléia12, náuseas13, vômitos14, distensão abdominal e oligospermia aparentemente reversível. Estas reações ocorrem em cerca de um terço dos pacientes.


Posologia e modo de usar - AZULFIN

Doses usuais: Tratamento inicial: Iniciar com 3 a 4 g diários em doses divididas igualmente. Em alguns casos é mais prudente iniciar o tratamento com dosagem menor, por exemplo 1- 2 g diários, para diminuir efeitos gastrintestinais adversos. Se as doses diárias necessárias para alcançar os efeitos desejados excederem 4 g, deve-se considerar o risco aumentado de toxicidade. Tratamento de manutenção: 2 g diários.


Apresentação - AZULFIN

Caixa com 60 comprimidos revestidos gastrorresistentes.

Maiores informações à disposição da classe médica.


APSEN DO BRASIL Indústria Química e Farmacêutica Ltda.




AZULFIN - Laboratório

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