PARA EVITAR USO IMPRÓPRIO DO MEDICAMENTO, LEIA ESTA BULA COM
ATENÇÃO.

Penvir®
fanciclovir

Forma farmacêutica e apresentações:
Penvir® comprimidos revestidos 125 mg: caixa contendo 10 comprimidos.
Penvir® comprimidos revestidos 500 mg: caixa contendo 14 e 21 comprimidos.
Uso Oral
Uso Adulto
Composição:


Penvir® 125 mg
Penvir® 500 mg
fanciclovir
125 mg
500 mg
Excipiente* q.s.p.
1 comprimido revestido
1 comprimido revestido
*(lactose, amido, croscarmelose sódica, estearato de magnésio, hipromelose,
macrogol, etilcelulose, dióxido de titânio).
INFORMAÇÕES AO PACIENTE
Ação esperada do medicamento:
Penvir® é um medicamento utilizado no tratamento do Herpes simplex (tipos 1 e
2) e vírus da Varicella zoster.
Cuidados de armazenamento:
Manter à temperatura ambiente (15ºC a 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:
Este medicamento não deve ser utilizado em mulheres grávidas sem orientação
médica.
Informe seu médico a ocorrência de gravidez na vigência do tratamento ou após
seu término. Informar ao médico se estiver amamentando.
Cuidados de administração:
Siga a orientação 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 seu médico o aparecimento de reações desagradáveis, tais como dores
de cabeça e náuseas.
TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS
CRIANÇAS.
Ingestão concomitante com outras substâncias:
Informe ao seu médico sobre qualquer medicamento que esteja usando, antes
do início, ou durante o tratamento.
Contra-indicações e precauções:
Penvir® é contra indicado a pacientes com conhecida hipersensibilidade aos
componentes da fórmula e a fanciclovir.
Não é recomendado o uso de Penvir® em crianças.
NÃO TOME REMÉDIO SEM O CONHECIMENTO DE SEU MÉDICO. PODE SER
PERIGOSO PARA A SAÚDE.
INFORMAÇÕES TÉCNICAS
Penvir® contém como princípio ativo o fanciclovir, a forma oral de penciclovir.
Fanciclovir é rapidamente convertido in vivo em penciclovir, que tem atividade
demonstrada in vivo e in vitro contra os vírus do herpes em seres humanos,
inclusive o vírus Varicella zoster e o vírus do Herpes simplex tipo 1 e 2.
O efeito antivirótico de fanciclovir administrado por via oral foi demonstrado em
vários estudos com animais; este efeito é devido à conversão in vivo em
penciclovir. Penciclovir dirige se às células infectadas pelos vírus, onde é rápida e


eficientemente convertido em trifosfato (mediado via timidina quinase induzida
pelo vírus).
O trisfosfato de penciclovir permanece nas células infectadas por mais de 12
horas, onde inibe a reprodução de DNA virótico e tem uma meia vida de 9, 10 e
20 horas em células infectadas com o vírus Varicella zoster, vírus Herpes simplex
Tipo 1 e vírus Herpes simplex Tipo 2, respectivamente. Em células não infectadas
tratadas com penciclovir, as concetrações de trifosfato de penciclovir são apenas
escassamente detectáveis. Conseqüentemente, é improvável que células não
infecatadas sejam afetadas por concentrações terapêuticas de penciclovir.
Penciclovir demonstrou ter atividade contra uma cepa do vírus da Herpes simplex
recentemente isolada, resistente a aciclovir, que possui uma polimerase de DNA
alterada.
Farmacocinética:
Após administração oral, fanciclovir é rápido e extensivamente absorvido e
rapidamente convertido ao componente ativo, penciclovir. A biodisponibilidade de
penciclovir após administração oral de Penvir® é de 77%. O pico médio de
concentração plasmática de penciclovir, após uma dose oral de 125 mg e 250 mg
de fanciclovir, foi de 0,8 g/mL e 1,6 g/mL, respectivamente, e ocorreu em um
tempo médio de 45 minutos pós dose. As curvas de concentração plasmática x
tempo de penciclovior são semelhantes após dose única e doses repetidas. A
meia vida plasmática final de penciclovir após dose única e doses repetidas de
fanciclovir é de aproximadamente 2,0 horas. Não há acúmulo de penciclovir com
doses repetidas de fanciclovir. Penciclovir e seu precursor 6 desoxi tem baixa
ligação às proteínas plasmáticas (< 20%). Fanciclovir é eliminado principalmente
como penciclovir e seu precursor 6 desoxi, que são excretados sem alterações
pela urina. O penciclovir não foi detectado na urina.
A secreção tubular contribui para a eliminação renal do composto.
A infecção por Herpes zoster não complicada não altera significativamente a
farmacocinética de penciclovir, após administração oral de Penvir®.
INDICAÇÕES
Penvir® está indicado para tratamento:
- Herpes zoster agudo;
- Infecções por Herpes simplex: tratamento ou supressão do herpes genital
recorrente em pacientes imunocompetentes;
- Infecções por Herpes simplex: tratamento de infecções mucocutâneas
recorrentes em pacientes imunocompetentes.
CONTRA-INDICAÇÕES
Penvir® é contra indicado a pacientes que apresentem hipersensibilidade ao
fanciclovir e aos componentes da formulação e nos casos de hipersensibilidade
conhecida a penciclovir.
PRECAUÇÕES
Deve se dispensar atenção especial a pacientes com função renal comprometida,
já que um ajuste da dose é necessário.
Não são necessárias precauções especiais para pacientes com insuficiência
hepática ou idosos.
O herpes genital é uma doença sexualmente transmissível. O risco de
transmissão é aumentado durante episódios agudos. Os pacientes devem evitar
relações sexuais quando os sintomas estiverem agudos ou quando os sintomas
estiverem presentes, mesmo se o tratamento com um antivirótico já tiver sido
iniciado.
Embora estudos em animais não tenham demonstrado quaisquer efeitos
embriotóxicos ou teratogênicos com fanciclovir ou penciclovir, a segurança de
fanciclovir na gravidez humana não foi estabelecida. Assim, Penvir® não deve
ser usado durante a gravidez ou em mulheres que estejam amamentando, a
menos que os benefícios potenciais do tratamento compensem qualquer
possibilidade de risco. Estudos em ratos mostram que penciclovir é excretado
pelo leite de fêmeas lactantes recebendo fanciclovir por via oral. Não há
informações sobre a excreção pelo leite humano.
Os dados sobre a segurança e eficácia de fanciclovir em crianças são
insuficientes, portanto, o uso em crianças não é recomendado.
INTERAÇÕES MEDICAMENTOSAS
Nenhuma interação farmacocinética clinicamente significativa foi identificada.
A probenecida e outras drogas que afetam a fisiologia renal podem afetar os
níveis plasmáticos de penciclovir.
REAÇÕES ADVERSAS
O fanciclovir foi bem tolerado em estudos realizados no homem. Cefaléia e
náusea foram relatadas em estudos clínicos. Estas reações foram de natureza
leve a moderada e ocorreram com incidência similar em pacientes recebendo
tratamento com placebo.



POSOLOGIA E ADMINISTRAÇÃO
Herpes zoster
A dose recomendada é de 500 mg a cada 8 horas durante 7 dias. O tratamento
deve ser iniciado tão breve a Herpes zoster seja diagnosticada.
Infecções por Herpes simplex
Primeiro episódio de infecções por herpes genital: 250 mg três vezes ao
dia por cinco dias. Recomenda se que o tratamento seja iniciado o mais cedo
possível após o início das lesões.
Herpes genital recorrente: A dose recomendada é de 125 mg duas vezes ao
dia durante 5 dias. Recomenda se iniciar o tratamento ao primeiro sinal ou
sintoma do herpes genital. A eficácia de fanciclovir não foi estabelecida quando o
tratamento é iniciado após 6 horas do início dos sintomas ou lesões.
Supressão do herpes genital recorrente: A dose recomendada é de 250 mg
duas vezes ao dia durante 1 ano. A segurança e eficácia do tratamento com
fanciclovir por mais de 1 ano não foi estabelecida.
Pacientes infectados pelo HIV:
A dose recomendada é de 500 mg duas vezes ao dia durante 7 dias para o
tratamento de infecções orolabial recorrente ou Herpes simplex genital.

Pacientes com insuficiência renal:
Modificação da dose é habitualmente desnecessária em pacientes com discreta
alteração da função renal.
Em pacientes com comprometimento moderado a severo da função renal, a
freqüencia de administração deve ser diminuída proporcionalmente ao grau de
comprometimento avaliado pelo clearance de creatinina. As seguintes alterações
são recomendadas.
Clearance de
Indicação e Dose
creatinina
Ajuste da dose
Intervalo
de fanciclovir
(mL/min)
Herpes Zoster
> 60
500 mg
a cada 8 horas
500 mg a cada 8
40 a 59
500 mg
a cada 12 horas
horas
20 a 39
500 mg
a cada 24 horas
< 20
250 mg
a cada 24 horas


HD*
500 mg
Após cada diálise
40
125 mg
a cada 12 horas
Herpes
genital
recorrente
20 a 39
125 mg
a cada 24 horas
125 mg a cada 12
< 20
125 mg
a cada 24 horas
horas
HD*
125 mg
Após cada diálise
40
250 mg
a cada 12 horas
Supressão
do
Herpes
genital
20 a 39
125 mg
a cada 12 horas
recorrente
< 20
125 mg
a cada 24 horas
2505 mg a cada 12
horas
HD*
125 mg
Após cada diálise
Herpes genital ou
40
500 mg
a cada 12 horas
orolabial recorrente
em
pacientes
20 a 39
500 mg
a cada 24 horas
infectados pelo HIV
< 20
250 mg
a cada 24 horas
500 mg a cada 12
horas
HD*
250 mg
Após cada diálise
* Hemodiálise

Uso Pediátrico:
Atualmente, os dados sobre a segurança e eficácia de fanciclovir em crianças
com menos de 18 anos são insuficientes e, portanto, o seu uso em crianças não
é recomendado.

SUPERDOSAGEM
Não há relatos de superdosagem aguda com fanciclovir. Tratamento sintomático
e de suporte devem ser administrados, se apropriado. Insuficiência renal aguda
foi relatada raramente em pacientes com doença renal latente, onde a dose de
fanciclovir não foi apropriadamente reduzida para o nível da função renal.
Penciclovir pode ser eliminado por diálise e as concentrações plasmáticas são
reduzidas em aproximadamente 75% após hemodiálise por 4 horas.
Informações adicionais
Fanciclovir não tem efeitos significativos sobre a espermatogênese ou morfologia
e motilidade de espermatozóides no homem.
Em doses muito acima daquelas terapeuticamente usadas, observou se um
comprometimento da fertilidade em ratos machos sendo que tais efeitos não
foram observados em ratos fêmeas. Em um nível de dose de aproximadamente
50 vezes a dose terpêutica normal, houve um aumento na incidência de
adenocarcinoma mamário em fêmeas de rato.


Tal efeito foi observado em ratos machos ou em camundongos de ambos os
sexos. Além disso, fanciclovir não foi considerado genotóxico em uma ampla
bateria de tetes in vivo e in vitro, desenhados para detectar mutação genética,
danos cromossômicos e danos reparáveis no DNA.
Penciclovir, da mesma forma que outras drogas desta classe, demonstrou causar
dano cromossômico, mas não induziu a mutação genética em sistemas celulares
bacterianos ou de mamíferos, nem houve evidências de reparo aumentado do
DNA in vitro. Estes achados não são considerados como tendo significância
clínica.
PACIENTES IDOSOS
Não são necessários ajustes de dosagens, a menos que a função renal esteja
comprometida.
VENDA SOB PRESCRIÇÃO MÉDICA
Reg. M.S. Nº 1.0583.0214
Farm. Resp.: M. Geisa P. Lima e Silva CRF SP Nº 8.082
Fabricado pela EMS S/A
Rua Com. Carlo Mário Gardano, 450
São Bernardo do Campo/SP
C.N.P.J.: 57.507.378/0001 01
SAC: 0800 191222
www.ems.com.br
GERMED FARMACÊUTICA LTDA.
Rod. SP 101 ­ km 08 ­ Hortolândia/SP
CEP 13.186 481
C.N.P.J.: 45.992.062/0001 65
Indústria Brasileria
“Nº de Lote, Fabricação e Validade: vide cartucho.”


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    You {seem|appear} {to understand|to know|to grasp} {so much|a lot}
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    {Thanks|Many thanks|Thank you|Cheers|Appreciate it|Kudos}!|
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    {Pretty sure|Fairly certain} {he will|he’ll|he’s going to} {have a good|have a very good|have a great}
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    {Wow|Whoa|Incredible|Amazing}! This blog looks {exactly|just}
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    {Hi|Hello|Hi there|What’s up}, I {log on to|check|read} your {new
    stuff|blogs|blog} {regularly|like every week|daily|on a regular basis}.
    Your {story-telling|writing|humoristic} style is {awesome|witty}, keep {doing what you’re doing|up the good work|it up}!|
    I {simply|just} {could not|couldn’t} {leave|depart|go away} your {site|web site|website} {prior to|before}
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    enough to {drop|{leave|drop|{write|create}}|post} a {thought|{comment|{comment|leave a response}a response}} {:-P|:
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    {Hi there|Hello}, I enjoy reading {all of|through} your {article|post|article post}.
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    I {always|constantly|every time} spent my half an
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    I {always|for all time|all the time|constantly|every
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    site} post page to all my {friends|associates|contacts}, {because|since|as|for the reason that} if like to read it {then|after that|next|afterward} my {friends|links|contacts} will too.|
    My {coder|programmer|developer} is trying to {persuade|convince} me to
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    {Hello|Hi|Hello there|Hi there|Howdy|Good day}!
    I could have sworn I’ve {been to|visited} {this blog|this web
    site|this website|this site|your blog} before but after {browsing through|going through|looking
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    {Terrific|Great|Wonderful} {article|work}! {This is|That is} {the type of|the kind of} {information|info} {that are meant to|that are supposed to|that should} be shared
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    {Thank you|Thanks} =)|
    Heya {i’m|i am} for the first time here. I {came across|found} this
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    {Hi|Hello|Hi there|Hello there|Howdy|Greetings}, {I think|I believe|I do believe|I do think|There’s no doubt that} {your site|your website|your web
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    {I just|I simply|I merely} wanted to {give you a|provide you with a} quick heads up!
    {Other than that|Apart from that|Besides that|Aside from that}, {fantastic|wonderful|great|excellent} {blog|website|site}!|
    {A person|Someone|Somebody} {necessarily|essentially} {lend a hand|help|assist} to make {seriously|critically|significantly|severely}
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    {I’m|I am} {gonna|going to} {watch out|be careful} for
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    {I am|I’m} curious to find out what blog {system|platform}
    {you have been|you happen to be|you are|you’re} {working with|utilizing|using}?

    I’m {experiencing|having} some {minor|small} security {problems|issues} with my latest {site|website|blog} and {I would|I’d} like to find something more
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    {Hi|Hello}, Neat post. {There is|There’s} {a problem|an issue}
    {with your|together with your|along with your} {site|web site|website} in {internet|web} explorer,
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    {I’m|I am} not sure where {you are|you’re} getting your {info|information}, but {good|great} topic.

    I needs to spend some time learning {more|much more} or understanding more.
    Thanks for {great|wonderful|fantastic|magnificent|excellent} {information|info} I was looking for this {information|info} for my mission.|
    {Hi|Hello}, i think that i saw you visited my {blog|weblog|website|web site|site} {so|thus} i came to “return the favor”.{I am|I’m} {trying to|attempting to} find things to
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