MODELO DE BULA
Tapazol®
tiamazol

IDENTIFICAÇÃO DO PRODUTO

· Forma farmacêutica e apresentações:
Comprimido 5 mg. Caixa com 50 e 100 comprimidos.
Comprimido 10 mg. Caixa com 50 e 100 comprimidos.

· Uso pediátrico ou adulto.
· Composição:
Comprimido
Cada comprimido de 5 mg contém:
Tiamazol ……………………………………………..
5 mg
Excipientes: lactose, talco, estearato de magnésio, amido.
Cada comprimido de 10 mg contém:
Tiamazol ……………………………………………..
10 mg
Excipientes: lactose, talco, estearato de magnésio, amido.

INFORMAÇÕES AO PACIENTE
· O tiamazol inibe a síntese dos hormônios tiroideanos, sendo assim eficaz
no tratamento do hipertiroidismo. A droga não inativa a tiroxina e a
triiodotironina que estejam armazenadas na tiróide ou estejam circulando no
sangue, nem interfere na eficácia de hormônios tiroideanos administrados por
via oral ou parenteral.
· Mantenha Tapazol® em temperatura ambiente (15 a 30ºC) e protegido da
luz.
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· Prazo de validade: 24 meses a partir da data de fabricação. Não utilize
medicamentos com a validade vencida.
· Informe seu médico a ocorrência de gravidez na vigência do tratamento
com Tapazol® ou após o seu término. Informe ao médico se está
amamentando. Este medicamento não deve ser utilizado por mulheres grávidas
sem orientação médica. Informe imediatamente seu médico em caso de
suspeita de gravidez.

· Siga a orientação do seu médico, respeitando sempre os horários, as doses
e a duração do tratamento com Tapazol®.
· Não interrompa o tratamento com Tapazol® sem o conhecimento do seu
médico. A doença e/ou seus sintomas poderão retornar.

· Informe seu médico o aparecimento de reações desagradáveis, tais como:
Febre, dor de garganta, redução ou perda de apetite, prurido, dor no quadrante
superior direito do abdômen, erupção cutânea, dor de cabeça e mal-estar geral.
· Todo medicamento deve ser mantido fora do alcance das crianças.

· Informe seu médico sobre qualquer medicamento que esteja usando, antes
do início, ou durante o tratamento com Tapazol®.
· Contra-indicações: Tapazol® não deve ser usado por pacientes com
hipersensibilidade aos componentes da fórmula e por mulheres que estejam
amamentando.

Precauções: (Veja item Precauções nas Informações Técnicas)

· Não tome remédio sem o conhecimento do seu médico. Pode ser
perigoso para a saúde.

INFORMAÇÕES TÉCNICAS
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· Características: O tiamazol (1-metilimidazol-2-tiol) é uma substância
cristalina branca, muito solúvel em água. Difere quimicamente das drogas do
grupo tiouracil por apresentar um anel de 5 elementos e não de 6. O peso
molecular é 114,16 e a fórmula molecular é C4H6N2S.
O tiamazol inibe a síntese dos hormônios tiroideanos, sendo assim eficaz no
tratamento do hipertiroidismo. A droga não inativa a tiroxina e a triiodotironina
que estejam armazenadas na tiróide ou estejam circulando no sangue, nem
interfere na eficácia de hormônios tiroideanos administrados por via oral ou
parenteral. As ações e o uso do tiamazol são similares ao propiltiouracil. Peso
por peso, a droga é pelo menos 10 vezes mais potente do que o propiltiouracil,
mas o tiamazol pode ser menos consistente na ação.
O tiamazol é rapidamente absorvido no trato gastrointestinal, sendo
rapidamente metabolizado, requerendo administração mais freqüente. O
tiamazol é excretado na urina. Em animais de laboratório, vários regimes que
suprimem continuamente a função tiroideana e, portanto, aumentam a
secreção do hormônio tirotrófico (TSH), resultam na hipertrofia da tiróide. Sob
tais condições, foi também relatado o aparecimento de neoplasias da tiróide e
da hipófise. Os regimes estudados incluem drogas antitiroideanas ou uma dieta
com deficiência de iodo, tiroidectomia subtotal, implantação de tumores
hipofisários autônomos secretores de hormônios tirotróficos e administração de
drogas bociogênicas.

· Indicações: Tiamazol é indicado no tratamento clínico do hipertiroidismo. O
tratamento a longo prazo pode levar à remissão da doença. O tiamazol poderá
ser usado para controlar o hipertiroidismo na preparação da tiroidectomia
subtotal ou terapia com iodo radioativo. O tiamazol é usado também quando a
tiroidectomia é contraindicada ou desaconselhada.

· Contra-indicações: O tiamazol é contra-indicado na presença de
hipersensibilidade à droga e a mulheres que estão amamentando, uma
vez que a droga é excretada no leite.
· Precauções e advertências: Gerais ­ A agranulocitose é potencialmente
uma reação adversa grave. Os pacientes devem ser orientados para comunicar
ao seu médico qualquer sintoma de agranulocitose, tais como febre ou dor de
garganta. Leucopenia, trombocitopenia e anemia aplástica (pancitopenia)
também podem ocorrer. A droga deve ser descontinuada na presença de
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agranulocitose, anemia aplástica (pancitopenia), hepatite ou dermatite
esfoliativa. A função da medula óssea deve ser monitorada.
Devido à similaridade de toxicidade hepática entre o tiamazol e o propiltiouracil,
deve ser dada atenção às reações hepáticas graves que têm ocorrido com
ambas as drogas. Raros relatos de hepatite fulminante, necrose hepática,
encefalopatia e morte têm sido reportados. Avaliação da função hepática deve
ser realizada quando aparecerem sintomas sugestivos de disfunção hepática,
tais como anorexia, prurido, dor no quadrante superior direito, etc. O tratamento
de ser imediatamente interrompido se houver evidência clinicamente
significativa de anormalidade hepática, incluindo os valores de transaminase
(TGO) hepática excedendo a três vezes o limite superior de variação normal.
Os pacientes que estão recebendo tiamazol devem ficar sob estrita vigilância e
devem ser orientados sobre a necessidade de relatar imediatamente qualquer
evidência de doença, particularmente dor de garganta, erupções cutâneas,
febre, dor de cabeça ou mal-estar geral. Em tais casos, devem ser feitas
contagens de leucócitos e contagens diferenciais para determinar se houve
desenvolvimento de agranulocitose. Devem ser tomados cuidados especiais
com pacientes que estão recebendo drogas que causam agranulocitose.
Cuidados com os dentes: os efeitos depressores dos agentes antitiroideanos
sobre a medula óssea pode resultar no aumento da incidência de infecção
microbiana, demora na cicatrização e sangramento gengival. Se ocorrer
leucopenia ou trombocitopenia, o tratamento dentário deve ser adiado até que
a contagem sangüínea tenha retornado ao normal, e os pacientes devem ser
orientados sobre como proceder uma higiene oral adequada, incluindo cuidado
no uso de escova de dentes, fio dental e palitos de dente.
Monitoração do paciente: devido ao tiamazol poder causar hipoprotrombinemia
e hemorragia, o tempo de protrombina deve ser monitorado durante a terapia
com a droga, especialmente antes da cirurgia (ver Precauções ­ Gerais). É
necessária monitoração periódica da função tiroideana e achados de níveis
elevados de TSH advertem uma diminuição na dosagem de tiamazol.
Carcinogênese, mutagênese, danos à fertilidade: em um estudo de dois anos,
tiamazol foi administrado a ratos nas doses de 0,5, 3 e 18 mg/kg/dia. Essas
doses foram de 0,3, 2 e 12 vezes a dose máxima de manutenção em humanos,
15 mg/dia (quando calculada em base de superfície corporal). Hiperplasia da
tiróide, adenoma e carcinoma desenvolveram em ratos tratados com as duas
doses mais altas. O significado clínico desses achados é desconhecido.
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Gravidez ­ O tiamazol pode causar dano fetal quando administrado a mulheres
grávidas. O tiamazol atravessa facilmente a barreira placentária e pode induzir
bócio e mesmo cretinismo no feto em desenvolvimento. Além disso, raros
casos de defeitos congênitos, como aplasia de pele, manifestada pelos defeitos
no couro cabeludo; atresia esofágica com fístula traqueoesofágica; e atresia
coanal com mamilos ausentes / hipoplásticos, têm ocorrido em crianças
nascidas de mães que receberam tiamazol durante a gravidez. Se o tiamazol
for usado durante a gravidez ou se a paciente engravidar durante o tratamento,
deve ser alertada quanto ao risco potencial ao feto.
Desde que os defeitos congênitos acima foram reportados em crianças
nascidas de pacientes tratadas com tiamazol, pode ser apropriado usar outros
agentes em mulheres grávidas necessitando de tratamento para
hipertireoidismo.
O tiamazol, usado criteriosamente, é uma droga eficaz no hipertireoidismo
complicado pela gravidez. Em muitas mulheres grávidas, a disfunção tiroideana
diminui à medida que a gravidez evolui; consequentemente, é possível uma
redução na dose. Em alguns casos, o uso de tiamazol poderá ser
descontinuado 2 ou 3 semanas antes do parto.
Este medicamento não deve ser utilizado por mulheres grávidas sem
orientação médica. Informe imediatamente seu médico em caso de suspeita de
gravidez.
Lactação ­ Pacientes pós-parto recebendo tiamazol não devem amamentar. A
droga é excretada no leite humano e é contra-indicada a mulheres que estão
amamentando.
Pediatria ­ Os agentes antitiroideanos são freqüentemente usados no
tratamento de hipertiroidismo em crianças. As crianças parecem responder aos
medicamentos antitiroideanos tão bem quanto os adultos. Os estudos
farmacocinéticos conduzidos em crianças também não revelaram qualquer
alteração específica da população pediátrica. Deve-se ter cautela na
interpretação dos resultados dos testes de função da tiróide em neonatos, uma
vez que as concentrações séricas dos hormônios tiroideanos são maiores após
o nascimento do que em crianças saudáveis ou adultos e começam a cair a
níveis normais na primeira semana de vida.
Geriatria (idosos) ­ Um estudo demonstrou que a agranulocitose é mais
comum em pacientes idosos do que em pacientes com 40 anos de idade ou em
pacientes tomando mais do que 40 mg de tiamazol por dia. Em um estudo
farmacocinético, nenhuma diferença significativa foi encontrada para pacientes
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geriátricos em alguns parâmetros farmacocinéticos (por exemplo, volume de
distribuição, volume de distribuição beta, volume de distribuição em estado de
equilíbrio, área sob a curva e clearance). O grau de absorção foi menor
(aproximadamente 1/3 dos indivíduos mais jovens) apesar de não haver dados
sobre a importância clínica desta informação.
Pacientes geriátricos com doença cardíaca severa devem receber agentes
antitiroideanos e/ou medicamentos bloqueadores beta-adrenérgicos, como o
propranolol, por 4 a 6 semanas antes do tratamento com radioiodo para ajudar
a reduzir possível exacerbação da doença cardíaca devido à tiroidite induzida
pela radiação. Drogas antitireóides devem ser descontinuadas pelo menos 3 a
4 dias antes do tratamento com radioiodo, sendo que o tratamento não deve
ser reiniciado antes de uma semana após o tratamento. Entretanto, um
medicamento bloqueador beta-adrenérgico pode ser usado durante todo o
período de tratamento, se necessário.

· Interações medicamentosas: Anticoagulantes (orais) ­ A atividade de
anticoagulantes pode ser potencializada pela atividade anti-vitamina K atribuída
ao tiamazol.
Agentes bloqueadores beta-adrenérgicos ­ Hipertiroidismo pode causar um
aumento no clearance dos beta-bloqueadores com uma alta razão de extração.
Uma redução na dose dos bloqueadores beta-adrenérgicos pode ser
necessária quando um paciente hipertiroideo torna-se eutiroideo.
Glicosídeos digitálicos ­ Os níveis séricos de digitálicos podem ser
aumentados quando pacientes hipertiroideos num regime estável de
glicosídeos digitálicos tornam-se eutiroideos; uma dosagem menor de
glicosídeos digitálicos pode ser requerida.
Teofilina ­ O clearance de teofilina pode diminuir quando pacientes
hipertiroideos num regime estável de teofilina tornam-se eutiroideos; uma dose
menor de teofilina pode ser necessária.

· Interferência em exames laboratoriais: Agentes antitiroideanos podem
diminuir a recaptação de I123, I131 e pertecnetato pela tiróide; a retirada do
agente antitiroideano 5 ou mais dias antes dos testes de captação de iodo
radioativo é necessária para prevenir interferência.
As concentrações séricas de alanina aminotransferase, fosfatase alcalina,
aspartato aminotransferase, bilirrubina e lactato desidrogenase e o tempo de
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protrombina podem estar diminuídos, podendo indicar hepatotoxicidade ou
estar associado com esplenomegalia.

· Reações adversas: As reações adversas de maior importância (muito
menos comuns que as de menor importância) incluem a inibição da
mielopoiese (agranulocitose, granulocitopenia e trombocitopenia), anemia
aplástica, febre medicamentosa, síndrome semelhante ao lúpus, síndrome
insulino-auto-imune (que pode resultar em coma hipoglicêmico), hepatite
(icterícia pode persistir por várias semanas após a interrupção da droga),
periartrite e hipoprotrombinemia. Nefrite é muito rara.
Reações adversas de menor importância incluem erupção cutânea,
urticária, náusea, vômito, dor epigástrica, artralgia, parestesia, perda do
paladar, perda anormal do cabelo, mialgia, dor de cabeça, prurido,
sonolência, neurite, edema, vertigem, pigmentação da pele, icterícia,
sialadenopatia e linfadenopatia.
Deve ser notado que cerca de 10% dos pacientes com hipertiroidismo não
tratados apresentam leucopenia (contagem de leucócitos de menos de
4000/mm3), freqüentemente com granulocitopenia relativa.

· Posologia:
Tiamazol é administrado por via oral, em dose única diária ou em 3 doses
iguais a intervalos de aproximadamente 8 horas.
Adultos: a dose diária inicial é de 15 mg para o hipertiroidismo leve, 30 a 40 mg
para o hipertiroidismo moderadamente grave e 60 mg para o hipertireoidismo
grave. A dose de manutenção é de 5 a 15 mg/dia.
Crianças: inicialmente, a dose diária é de 0,4 mg/kg de peso corporal. A dose
de manutenção é de aproximadamente a metade da dose inicial.
· Superdosagem:
Sintomas: Os sintomas podem incluir náusea, vômito, dor epigástrica, dor de
cabeça, febre, dor articular, prurido e edema. A anemia aplástica (pancitopenia)
ou agranulocitose pode ser manifestada em horas ou dias. As reações menos
freqüentes são hepatite, síndrome nefrótica, dermatite esfoliativa, neuropatias e
estimulação ou depressão do SNC. Apesar de não estar bem estudado, a
agranulocitose induzida pelo tiamazol geralmente é associada com doses de
40mg ou mais em pacientes com mais de 40 anos de idade. Não há informação
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disponível sobre a dose letal média da droga ou da concentração de tiamazol
nos fluidos orgânicos relacionados com toxicidade e/ou morte.
Tratamento: Ao tratar uma superdosagem, considerar a possibilidade de
superdoses de múltiplas drogas, interação entre drogas e de cinéticas pouco
comuns de drogas no paciente.
Proteger a passagem de ar para o paciente e manter ventilação e perfusão.
Meticulosamente monitorar e manter dentro de limites aceitáveis os sinais vitais
do paciente, gasometria sangüínea, eletrólitos séricos, etc. A função da medula
óssea deve ser monitorada. A absorção de drogas pelo trato gastrointestinal
pode ser diminuída administrando carvão ativado, que em muitos casos é mais
eficaz que a êmese ou a lavagem; considerar o carvão ativado ao invés de ou
em adição ao esvaziamento gástrico. Doses repetidas de carvão ativado
podem acelerar a eliminação de algumas drogas que foram absorvidas.
Proteger a passagem de ar para o paciente quando empregar o esvaziamento
gástrico ou carvão ativado.
Diurese forçada, diálise peritoneal, hemodiálise ou hemoperfusão com carvão
ativado não foram estabelecidos como métodos benéficos nos casos de
superdosagem com tiamazol.
· Pacientes idosos: Veja o item “geriatria” em “Precauções e advertências”.
Venda sob prescrição médica

Registro MS ­ 1.0974.0193
Farm. Resp.: Dr. Dante Alario Junior – CRF-SP nº 5143
Número do lote, data de fabricação e prazo de validade: vide cartucho/rótulo.
BIOLAB SANUS Farmacêutica Ltda.
Av. Paulo Ayres, 280 – Taboão da Serra ­ SP
CEP 06767-220 SAC 0800 724 6522
CNPJ 49.475.833/0001-06
Indústria Brasileira
Biolab Sanus
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    {Superb|Exceptional|Outstanding|Excellent} Blog!|
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    {I love|I really like|I enjoy|I like|Everyone loves} what you guys {are|are usually|tend to be} up too.

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    {My apologies|Apologies|Sorry} for {getting|being}
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    {Howdy|Hi there|Hi|Hey there|Hello|Hey} would you mind letting me
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    Thank you for the {auspicious|good} writeup.
    It in fact was a amusement account it. Look advanced to {far|more} added agreeable from you!
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    {Howdy|Hi there|Hey there|Hello|Hey} just wanted to give you a quick heads up.

    The {text|words} in your {content|post|article} seem to
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    The {style and design|design and style|layout|design} look great though!
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    {Kudos|Cheers|Many thanks|Thanks}|
    This is a topic {that is|that’s|which is} {close to|near
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    {Where|Exactly where} are your contact details though?|
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    {Hola|Hey there|Hi|Hello|Greetings}! I’ve been {following|reading} your {site|web site|website|weblog|blog} for {a long time|a while|some time} now and finally got
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    {I am|I’m} {extremely|really} {inspired|impressed} {with your|together with your|along with your} writing {talents|skills|abilities} {and also|as
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