Azi



Azi®
azitromicina diidratada

FORMAS FARMACÊUTICAS E APRESENTAÇÕES:
Azi® comprimidos revestidos de 1 g: caixas contendo 1 comprimido.
USO ADULTO
USO ORAL


COMPOSIÇÃO:
Cada comprimido revestido de 1 g contém:
azitromicina (na forma diidratada) ……………………………………………… 1 g
excipiente* q.s.p. ……………………………………………………….1 comp. rev.
* (celulose microcristalina, fosfato de cálcio dibásico, amido, croscarmelose
sódica, óleo vegetal hidrogenado, estearato de magnésio, dióxido de titânio,
hidroxipropilmetilcelulose + polietilenoglicol, etilcelulose).

INFORMAÇÕES AO PACIENTE
Ação esperada do medicamento: Azi® pertence a classe de
medicamentos chamados antibióticos. Sua substância ativa, a azitromicina,
é um antibiótico capaz de eliminar uma ampla variedade de germes
responsáveis por diversos tipos de infecções.
Cuidados de armazenamento: Manter à temperatura ambiente (15ºC e
30ºC). Proteger da luz e manter em lugar seco.
Prazo de validade: O número de lote e as datas de fabricação e validade
estão impressos no cartucho do medicamento. Não use o medicamento com
o prazo de validade vencido. Antes de usar, observe o aspecto do
medicamento.



Gravidez e lactação: Azi® não deve ser usado por mulheres grávidas sem
orientação do médico ou do cirurgião dentista. Azi® somente deverá ser
utilizado na gravidez se houver plena necessidade.
Não use Azi® durante a amamentação sem orientação médica. Avise ao seu
médico ou cirurgião dentista se você está amamentando ou se vai iniciar a
amamentação durante o uso deste medicamento.
Informar ao médico a ocorrência de gravidez na vigência do tratamento ou
após seu término. Informar ao médico se está amamentando.
Cuidados de administração: Azi® comprimido revestido não deve ser
mastigado ou triturado. Siga as orientações do seu médico, respeitando
sempre os horários, as doses e a duração do tratamento.
Interrupção do tratamento: Não interromper o tratamento sem o
conhecimento do seu médico.
Reações adversas: Informe ao seu médico o aparecimento de reações
desagradáveis, principalmente nos casos de manifestações cutâneas. Ver
item REAÇÕES ADVERSAS em informações técnicas.
TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS
CRIANÇAS.
Ingestão concomitante com outras substâncias: Azi® comprimidos
revestidos podem ser administrados a qualquer hora do dia, inclusive às
refeições. Ver item INTERAÇÕES MEDICAMENTOSAS nas informações
técnicas.
Contra-indicações e precauções: Informe ao seu médico sobre qualquer
medicamento que esteja usando, antes do início ou durante o tratamento.
Azi® é contra indicado em indivíduos com história de hipersensibilidade à
azitromicina, eritromicina, a qualquer antibiótico macrolídeo (classe de
antibióticos a qual pertence a azitromicina), cetolídeo ou a qualquer
componente da fórmula.
Apesar de raro, com o uso da azitromicina você pode desenvolver reações
alérgicas graves como angioedema (inchaço associado à urticária,
popularmente conhecido como reação alérgica, que geralmente ocorre com
lesões vermelhas na pele e coceira) e anafilaxia (reação alérgica séria),
raramente fatal.
Se você tiver algum problema grave de fígado, Azi® deve ser utilizado com
cuidado.
Não utilize Azi® juntamente com derivados do ergô (fungo denominado
esporão de centeio que produz alcalóides como ergotamina), pois


teoricamente pode ocorrer o ergotismo (intoxicação produzida por esses
derivados que se manifesta através dos seguintes sintomas: convulsões,
queda de pressão, coma e outros).
Fique atento para o aparecimento de qualquer outra infecção. Como
qualquer outro antibiótico, pode ocorrer o crescimento de organismos não
suscetíveis à Azitromicina (ou seja, contra os quais a azitromicina não age),
incluindo fungos.
Foram observados repolarização cardíaca e intervalo QT prolongados
(alterações no ritmo cardíaco), risco de desenvolvimento de arritmia
cardíaca e torsade de pointes (alterações no ritmo do coração) nos
tratamentos com outros macrolídeos. Um efeito semelhante com
azitromicina não pode ser completamente excluído em pacientes sob risco
aumentado
de
repolarização
cardíaca
prolongada
(vide
“Reações
Adversas”).
Não há evidências de que Azi® possa afetar a sua habilidade de dirigir ou
operar máquinas.
Só utilize Azi® pela via de administração indicada, ou seja, pela via oral.
NÃO USE MEDICAMENTO SEM O CONHECIMENTO DO SEU MÉDICO,
PODE SER PERIGOSO PARA A SAÚDE.

INFORMAÇÕES TÉCNICAS
Características: a azitromicina é o primeiro antibiótico de uma nova classe
de substâncias denominadas “azalídeos”. Os membros deste grupo são
derivados dos macrolídeos, através da inclusão de um átomo de nitrogênio
no anel lactâmico da eritromicina A.
Mecanismo de ação: a azitromicina atua inibição da síntese protéica
bacteriana através de ligação com a subunidade ribossomal 50S, desta
forma, impedindo a translocação peptídica.
Microbiologia: a azitromicina é ativa contra um grande número de
bactérias Gram positivas e Gram negativas. A produção de betalactamases
não tem efeito sobre a atividade antibacteriana da azitromicina.
Bactérias
Aeróbicas
Gram-positivas:
Staphylococcus
aureus,
Streptococcus pyogenes (estreptococos beta hemolíticos do grupo A),
Streptococcus pneumoniae, estreptococos alfa hemolíticos (grupo viridans),
outros estreptococos e Corynebacterium diphteriae. A azitromicina
demonstra resistência cruzada contra cepas Gram positivas resistentes à
eritromicina, incluindo Streptococcus faecalis (enterococos) e a maioria das
cepas de estafilococos meticilino resistentes.


Bactérias
Aeróbicas
Gram-negativas:
Haemophilus
influenzae,
Haemophilus parainfluenzae, Moraxella catarrhalis, Acinetobacter sp.,
Yersinia sp., Legionella pneumophila, Bordetella pertussis, Bordetella
parapertussis,
Shigella
sp.,
Pasteurella
sp.,
Vibrio
cholerae
e
parahaemolyticus, Pleisiomonas shigelloides. A atividade contra Escherichia
coli, Salmonella enteritidis, Salmonella typhi, Enterobacter sp., Aeromonas
hydrophila e Klebsiella sp., é variável e testes de susceptibilidade deverão
ser realizados. Proteus sp., Serratia sp., Morganella sp., e Pseudomonas
aeruginosa são freqüentemente resistentes.
Bactérias Anaeróbicas: Bacteroides fragilis e Bacteroides sp., Clostridium
perfringens, Peptococcus sp. e Peptostreptococcus sp., Fusobacterium
necrophorum e Propionibacterium acnes.
Em doenças sexualmente transmissíveis, a azitromicina é muito ativa contra
Chlamydia trachomatis e também demonstra boa atividade contra
Treponema pallidum, Neisseria gonorrhoeae e Haemophillus ducreyi.
Outros microrganismos: Borrelia burgdorferi (agente da doença de
Lyme). Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma
hominis,
Ureaplasma
urealyticum,
Campylobacter
sp
e
Listeria
monocytogenes. Patógenos oportunistas associados a infecções
causadas pelo vírus HIV: complexo Mycobacterium avium intracelulare,
Pneumocystis carinii e Toxoplasma gondii.
Farmacocinética geral:
Azithromycin given orally is rapidly absorbed and about 40% bioavailable. Absorption
from capsules, but not tablets or suspension, is reduced by food. Peak plasma
concentrations occur 2 to 3 hours after an oral dose and 1 to 2 hours after intravenous
dosage. However, azithromycin is extensively distributed into the tissues, and tissue
concentrations subsequently remain much higher than those in the blood; in contrast to
most other antibacterials, plasma concentrations are therefore of little value as a guide to
efficacy. High concentrations are taken up into white blood cells. There is little diffusion
into the CSF when the meninges are not inflamed. Data from animal studies indicate that
azithromycin crosses the placenta. Small amounts of azithromycin are demethylated in the
liver, and it is excreted in bile mainly as unchanged drug and a number of inactive
metabolites have also been detected. About 6% of an oral dose (representing about 20%
of the amount in the systemic circulation) is excreted in the urine. The terminal
elimination half-life is about 68 hours.
Após administração oral em seres humanos, a azitromicina é rapidamente
absorvida pela mucosa gastro entérica distribuindo se amplamente pelo
organismo em nível intra e extracelular. Sua biodisponibilidade é de
aproximadamente 37%.
O tempo necessário para atingir os picos de concentração plasmática é de
2 3 horas.
A meia vida plasmática é de 2 a 4 dias correlacionando se adequadamente
com a meia vida de eliminação tecidual.


Em estudos farmacológicos, têm sido observadas concentrações elevadas
de azitromicina nos fagócitos. Assim sendo, a concentração de azitromicina
resulta muito elevada nos locais de infecção.
A ligação protéica no plasma varia de 51%, em uma concentração
plasmática de 0,02 g/ml, até 7%, em uma concentração plasmática de 2
g/ml.
Sendo eliminada predominantemente por via hepática sob forma inalterada,
concentrações muito elevadas de azitromicina, acompanhadas por 10
metabólitos, têm sido encontradas na bile.

INDICAÇÕES
Azi® é indicado no tratamento das infecções causadas por organismos
susceptíveis, em infecções do trato respiratório superior e do ouvido, tais
como otite média, sinusite, rinossinusite, rinite, tonsilite, laringite e
faringotraqueíte; em infecções do trato respiratório inferior incluindo
tráqueobronquite, bronquite, broncopneumonia e pneumonia. Pode também
ser utilizada em infecções da pele e tecidos moles tais como abscessos,
furúnculos, flegmões, úlceras infectadas, quando causadas por organismos
sensíveis a azitromicina.
Azi® é indicado no tratamento das doenças sexualmente transmissíveis
(DST), no homem e na mulher.
Azi® é indicado no tratamento das infecções genitais, do tipo uretrites e
cervicites não complicadas, devido a Chlamydia trachomatis, Mycoplasma
hominis, Ureaplasma urealyticum, Neisseria gonorrhoeae sem resistências
múltiplas, devendo ser excluídas infecções concomitantes pelo Treponema
pallidum.
CONTRA-INDICAÇÕES
O uso de Azi® é contra indicado a indivíduos com história de
hipersensibilidade a azitromicina ou a qualquer outro antibiótico do grupo
dos macrolídeos, ou ainda a qualquer componente da fórmula.
PRECAUÇÕES E ADVERTÊNCIAS
Da mesma forma como ocorre com a eritromicina e outros macrolídeos, e
diferentemente dos antibióticos betalactâmicos, raramente têm sido
relatadas reações do tipo alérgico graves, como anafilaxia e angioedema.
Como ocorre com qualquer antibiótico, é fundamental a observação
constante de sinais indicativos de proliferação de organismos não sensíveis,
incluindo fungos.
Em pacientes com insuficiência hepática de grau leve (classe A) a moderada
(classe B), não existem evidências de modificação acentuada na
farmacocinética plasmática da azitromicina em comparação com indivíduos
com função hepática normal. Nesses pacientes, a concentração de
azitromicina na urina pode estar aumentada como compensação da redução
do clearance hepático.
Assim, não são recomendados ajustes de dose nos indivíduos com
insuficiência hepática de grau leve a moderado. Entretanto, sendo o fígado
a sua principal via de excreção, a azitromicina deverá ser utilizada
cuidadosamente em pacientes com disfunção hepática grave.
Em pacientes com insuficiência renal leve (clearance de creatinina > 40
ml/min.), não é necessário ajuste das doses do antibiótico, porém, não
existem relatos sobre o uso da azitromicina em pacientes com insuficiência
renal mais grave; portanto, são necessárias precauções máximas antes de
prescrever o produto a estes pacientes.
Nos pacientes recebendo derivados do ergô, os sinais de ergotismo têm sido
aumentados pela administração concomitante de alguns antibióticos do
grupo dos macrolídeos. Não há dados relativos à possibilidade de interação
entre a azitromicina e os derivados do ergô. No entanto, pela eventual
possibilidade teórica de ergotismo, a azitromicina e os derivados do ergô
não devem ser administrados em associação.
Efeitos sobre a habilidade de dirigir veículos e/ou operar máquinas
- Não existem quaisquer evidências que a azitromicina possa afetar a
capacidade do paciente para dirigir veículos ou operar máquinas perigosas.
Gravidez e lactação - Estudos sobre a reprodução em animais
demonstraram que a azitromicina atravessa a barreira placentária, porém
não revelaram evidências de lesões ao feto. Não existem dados sobre a
excreção no leite materno. Não foi estabelecida a segurança do uso da
azitromicina na gravidez e lactação, portanto, esta substância deverá ser
utilizada nestas pacientes somente quando outras alternativas não forem
disponíveis.
INTERAÇÕES MEDICAMENTOSAS
Teofilina - não houve evidência de qualquer interação farmacocinética
quando a azitromicina e a teofilina foram administradas concomitantemente
a voluntários sadios.
Varfarina - em estudos de interação farmacocinética a azitromicina não
alterou o efeito anticoagulante de uma dose única de 15 mg de varfarina


administrada a voluntários sadios. Nos casos em que a azitromicina e a
varfarina forem administradas em concomitância, deverá ser realizada a
monitorização rotineira do tempo de protrombina.
Ergô - devido à possibilidade teórica de ergotismo, é contra indicado o uso
concomitante da azitromicina com os derivados do ergô.
Carbamazepina - em estudo de interação farmacocinética, em voluntários
sadios, não foram observados efeitos significativos nos níveis plasmáticos
dessa substância ou de seus metabólitos ativos em pacientes que
receberam concomitantemente a azitromicina.
Digoxina - tem sido relatado que alguns antibióticos macrolídeos podem
prejudicar o metabolismo da digoxina, no intestino. Em pacientes que
estejam recebendo azitromicina (ou qualquer antibiótico azalídeo) e
digoxina em concomitância, deve ser considerada a possibilidade de
aumento dos níveis do cardiotônico.
Ciclosporina
-
na
ausência
de
dados
conclusivos
de
estudos
farmacocinéticos ou dados clínicos investigando a interação potencial entre
a azitromicina e a ciclosporina, devem ser tomadas precauções quando
utilizam se estas substâncias em concomitância. Caso isto se torne
necessário, devem ser monitorizados os níveis de ciclosporina e a dose
deverá ser ajustada em conformidade.
Antiácidos - um estudo sobre farmacocinética avaliou os efeitos da
administração simultânea da azitromicina e antiácidos, não tendo sido
observado qualquer efeito sobre a biodisponibilidade total, embora tenha
havido redução de até 30% no pico da concentração plasmática do
antibiótico. Azitromicina e antiácidos não deverão ser administrados
simultaneamente.
Cimetidina - em um estudo farmacocinético para avaliar os efeitos de uma
dose única de cimetidina, administrada duas horas antes da azitromicina,
não foram observadas quaisquer alterações.
Zidovudina - em um estudo preliminar para avaliar a farmacocinética e
tolerabilidade da azitromicina, pacientes HIV positivos tratados com a
zidovudina receberam 1 g por semana de azitromicina durante cinco
semanas. Não foram observados efeitos estatisticamente significativos nos
parâmetros farmacocinéticos da zidovudina e de seu metabólito
glicorunídeo. A única diferença estatisticamente significante observada foi
uma redução do tempo para atingir a concentração máxima da azitromicina.
Metilprednisolona - em um estudo em voluntários sadios, a azitromicina
não provocou qualquer efeito significante na farmacocinética da
metilprednisolona.
Terfenadina - a azitromicina não afetou a farmacocinética da terfenadina,
quando administrada na dose recomendada de 60 mg a cada 12 horas.



REAÇÕES ADVERSAS / COLATERAIS e ALTERAÇÕES de EXAMES
LABORATORIAIS
A azitromicina é bem tolerada, apresentando baixa incidência de efeitos
colaterais.
Gastrintestinal – anorexia, náusea, vômito/diarréia (raramente resultando
em desidratação), fezes amolecidas, dispepsia, desconforto abdominal
(dor/cólica), constipação, flatulência, colite pseudomembranosa e raros
relatos de descoloração da língua.
Sentidos Especiais - tem sido relatada disfunção auditiva com o uso de
antibióticos macrolídeos. Disfunções auditivas, incluindo perda de audição,
surdez e/ou tinito (ruído auditivo) foram relatados por pacientes recebendo
azitromicina. Muitos desses eventos foram associados ao uso prolongado de
altas doses em estudos de investigação. Nos casos onde informações de
acompanhamento estavam disponíveis, foi observado que a maioria desses
eventos foi reversível. Casos raros de distúrbios do paladar foram relatados.
Geniturinário – nefrite intersticial e disfunção renal aguda.
Hematopoiético - trombocitopenia.
Hepatobiliar - foram relatadas disfunção hepática incluindo hepatite e
icterícia colestática, assim como casos raros de necrose hepática e
insuficiência hepática, raramente resultando em óbito. Contudo, a relação
causal não foi estabelecida.
Musculoesquelético - artralgia.
Psiquiátrico - reação agressiva, nervosismo, agitação e ansiedade.
Reprodutivo - vaginite.
Sistema Nervoso Central e Periférico ­ tontura, vertigem, convulsões
(assim como com outros macrolídeos), cefaléia, sonolência, parestesias e
hiperatividade.
Sistema Retículo-Endotelial e Série Branca - episódios transitórios de
leve redução na contagem de neutrófilos têm sido ocasionalmente
observados nos estudos clínicos, embora uma relação causal com a
azitromicina não tenha sido estabelecida.
Pele
e
Anexos
-
reações
alérgicas
incluindo
prurido,
rash,
fotossensibilidade, edema, urticária e angioedema. Ocorreram raros casos
de reações dermatológicas sérias incluindo eritema multiforme, síndrome de
Stevens Johnson e necrólise tóxica epidermal.


Cardiovascular - palpitações e arritmias incluindo taquicardia ventricular
(como ocorre com os demais macrolídeos) têm sido relatadas embora a
relação causal com a azitromicina não tenha sido estabelecida.
Geral – foi relatada astenia embora a relação causal não tenha sido
estabelecida, monilíase e anafilaxia (raramente fatal) (vide "Advertências e
Precauções").
POSOLOGIA e ADMINISTRAÇÃO
Azi® deve ser administrado em dose única diária.
Não foi observada redução significante na biodisponibilidade quando a
azitromicina comprimidos revestidos ou suspensão oral foram administrados
concomitantemente com uma refeição rica em gorduras, podendo assim ser
administrados a qualquer hora do dia, inclusive às refeições.
USO EM ADULTOS: para o tratamento das doenças sexualmente
transmissíveis (DST) causadas por Chlamydia trachomatis, Neisseria
gonorrhoeae, Mycoplasma hominis, Ureaplasma urealyticum intracellulare,
Haemophilus ducreyi, Azi® deve ser administrado em dose oral única de 1g.

SUPERDOSAGEM
Até o momento não existem informes sobre superdosagem. Caso ocorra, a
lavagem gástrica e as medidas gerais de suporte deverão ser instituídas.
PACIENTES IDOSOS
Não há necessidade de ajuste posológico.

VENDA SOB PRESCRIÇÃO MÉDICA

Reg. MS: nº 1.3569.0011
Farm. Responsável: Carlos Alberto F. de Moraes
CRF SP nº 14.546



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Rua Com. Carlo Mário Gardano, 450 ­ S. B. do Campo / SP ­ CEP. 09720
470
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Atendimento ao Consumidor: 0800 191222
Cx. Postal 3 ­ Hortolândia / SP ­ CEP. 13186 481
sac.sigma@sigmapharma.com.br
SIGMA PHARMA LTDA.
Rod. SP 101, Km 08 ­ Hortolândia / SP ­ CEP. 13186 481
CNPJ: 00.923.140/0001 31 ­ Ind. Brasileira


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