Ethamolin®
oleato de monoetanolamina
Forma farmacêutica e apresentação
Solução aquosa ­ Embalagem contendo 6 ampolas com 2 ml
USO ADULTO
USO INTRAVENOSO
Composição
Cada ampola contém:
oleato de monoetanolamina………………………………………………………………. 100 mg;
excipiente q.s.p…………………………………………………………………………………..2 ml
(álcool benzílico e água para injetáveis)
INFORMAÇÕES AO PACIENTE

Como este medicamento funciona?
Ethamolin® funciona na eliminação de pequenas varizes.

Por que este medicamento foi indicado?
Ethamolin® é indicado para o tratamento da esclerose de pequenas varizes sem
insuficiência valvular, bem como das varizes residuais, após cirurgia.

Quando não devo usar este medicamento?
Contra-indicações
Ethamolin® não deve ser administrado nas situações a seguir:
· Varizes volumosas, com insuficiência ostial e valvular
· Infecções agudas
· Estados de hipersensibilidade
· Doenças sistêmicas graves


· Arteriopatias oclusivas
· Trombose venosa profunda
· Pacientes senis ou não-cooperativos
· Gestação (1º e 3º trimestres) e aleitamento
· Úlcera de estase
· Flebite aguda
· Edema
grave
· Hipersensibilidade a qualquer componente da fórmula

Advertências
· Este medicamento só poderá ser aplicado por seu médico.
· A via submucosa não é recomendada.
· Informe seu médico do aparecimento de febre e equimose no local da
injeção.
· Informe seu médico se você é diabético, tem hipertireoidismo, doença
hepática ou doença cardiorespiratória.
· É aconselhável a observação de intervalos de sete dias entre as sessões.
· Não há necessidade de ficar em repouso entre as sessões. O paciente
deve prosseguir com suas atividades diárias habituais.
Precauções
· Para evitar complicações, não é conveniente aplicar grandes volumes de
Ethamolin® de uma só vez, por isso o tratamento deve ser feito por
sessões.
· Em pacientes com disfunção hepática e doença cardiorrespiratória
concomitante é recomendado monitoramento cuidadoso e redução da dose
total por sessão.
· Evitar o extravasamento da injeção.
Interações medicamentosas
Não são conhecidas interações relevantes.



Não há contra-indicação relativa a faixas etárias.
Informe seu médico do aparecimento de reações indesejáveis.
Informe seu médico se você está fazendo uso de algum outro medicamento.
Não use medicamento sem o conhecimento de seu médico. Pode ser
perigoso para a sua saúde.

Como devo usar este medicamento?
Aspecto físico
Líquido límpido, amarelado, que espuma com agitação.

Posologia
A dose usual é de 1,5 a 5 ml por veia a ser esclerosada, dividida em três ou quatro
porções.
A dose máxima por sessão de tratamento não pode exceder 20 ml.
Siga a orientação de seu médico, respeitando sempre os horários, as doses
e a duração do tratamento.
Não interrompa o tratamento sem o conhecimento de seu médico.
Não use o medicamento com prazo de validade vencido. Antes de usar
observe o aspecto do medicamento.

Que males este medicamento pode causar?
Reações adversas
Uma vez observados criteriosamente os procedimentos da técnica de aplicação,
assim como as contra-indicações e precauções, não é de se prever a ocorrência
de efeitos colaterais significativos. A freqüência relatada de complicações/eventos
adversos por sessão é aproximadamente 13%. As reações adversas mais comuns
são:
· Derrame
pleural/infiltrados
· Úlcera
esofagiana


· Febre
· Dor
retroesternal
· Estenose
esofagiana
· Pneumonia
· Reações
alérgicas
Em alguns casos foram relatadas reações adversas raras. Em um deles, duas
pacientes apresentaram insuficiência renal aguda com recuperação completa,
após a utilização de 15 a 20 ml de Ethamolin®. Em outro relato de apenas um caso
ocorreu coagulação intravascular disseminada. E em um paciente pediátrico oito
horas após a escleroterapia com Ethamolin®, ocorreu paralisia medular devido a
oclusão da artéria espinhal anterior.
Dependendo do estado clínico do paciente e da dose utilizada, parece haver
correlação com a ocorrência das seguintes reações locais:
· Esofagite, ruptura esofagiana, descolamento da mucosa esofagiana que
recobre o vaso no qual foi injetada a medicação, ulceração, estenose,
necrose, abscesso peri-esofagiano e perfuração.
Em pacientes com varizes esofagianas foi observada bacteremia após a injeção
de Ethamolin®.
Complicações de ulceração, necrose e perfuração esofagiana tardia parecem
ocorrer mais freqüentemente quando Ethamolin® é administrado por via
submucosa.

O que fazer se alguém usar uma grande quantidade deste medicamento de
uma só vez?
Foi relatado grave choque anafilático após a aplicação de um volume muito acima
do volume normal em paciente com predisposição alérgica conhecida. Neste caso,
o médico pode aplicar 0,25 ml de uma solução de 1:1.000 de epinefrina (0,25 mg)
e as reações alérgicas devem ser controladas com anti-histamínicos.
Na escleroterapia de varizes esofagianas a superdosagem pode resultar em grave
necrose intramural do esôfago, podendo haver evolução fatal.



Onde e como devo guardar este medicamento?
Cuidados de conservação
Ethamolin® deve ser conservado em temperatura ambiente (entre 15ºC e 30° C),
em sua embalagem original e protegido da luz.
Prazo de validade
36 meses após a data de fabricação impressa no cartucho.
Não use medicamentos com prazo da validade vencido.

TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS
CRIANÇAS.

INFORMAÇÕES TÉCNICAS AOS PROFISSIONAIS DE SAÚDE

Características farmacológicas
O oleato de monoetanolamina atua primariamente por irritação da camada íntima
endotelial da veia e produz uma resposta inflamatória estéril dose-relacionada. Isto
resulta em fibrose da parede do vaso e possível oclusão da veia. A substância
também se difunde rapidamente através da parede venosa e produz uma reação
inflamatória extravascular dose-relacionada. O ácido oleico, componente do
Ethamolin®, é responsável pela resposta inflamatória e pode, também, ativar a
coagulação in vivo pela liberação do fator tisular e ativação do fator de Hageman.
A etanolamina, outro componente do Ethamolin® , contudo, pode inibir a formação
do coágulo de fibrina por sua ação quelante de cálcio; portanto, uma ação pró-
coagulante do Ethamolin® não pôde ser demonstrada. Após a administração,
Ethamolin® desaparece, em cinco minutos, do local da injeção, via sistema venoso
portal. Caso volumes superiores a 20 ml sejam injetados, alguma proporção do
Ethamolin® seguirá pelo sistema Ázigos através das veias periesofagianas. Em


estudos de autopsia em humanos foi demonstrado que quatro dias após a
administração, ocorreu infiltração neutrofílica da parede esofagiana e hemorragia
em seis dias. Tecido de granulação foi observado em 10 dias, trombos vermelhos
obliterando os vasos varicosos em 20 dias e esclerose das varizes em dois meses
e meio. A seqüência destes eventos sugere que a esclerose das varizes
esofagianas seja um efeito mais tardio, que imediato, da medicação.
A dose letal mínima do Ethamolin® para injeção intravenosa em coelhos é 130
mg/kg. Ethamolin® injetado por via intracardíaca (no átrio direito), em cães, na
dose de 1 ml/kg ao longo de um minuto, leva a aumento do volume hídrico
extravascular pulmonar.
A dose máxima recomendada em humanos é 20 ml, ou 0.4 ml/kg para um
paciente de 50 kg. A concentração de Ethamolin® que alcança os pulmões em
pacientes humanos tratados é menor que aquela encontrada em estudos com
cães, mas derrames pleurais, edema pulmonar, infiltrados pulmonares e
pneumonite foram relatados em estudos clínicos e a redução da dose total por
sessão de esclerose, especialmente naqueles com doença cardiopulmonar
concomitante, é recomendada (ver Advertências).
Resultados de eficácia

Um estudo¹ com 25 pacientes portadores de malformação venosa craniofacial
concluiu que a escleroterapia percutânea com oleato de etanolamina é segura e
efetiva no tratamento de malformações craniofaciais.
Um estudo² retrospectivo revisou os resultados de escleroterapia com diversos
esclerosantes para tratamento de lesões congênitas da cabeça e pescoço. Dentre
eles, a escleroterapia percutânea com oleato de etanolamina foi usada em 29
pacientes com malformação venosa. A escleroterapia com todos os esclerosantes
analisados no estudo, inclusive o oleato de etanolamina, foi segura e efetiva no
tratamento primário das lesões congênitas da cabeça e pescoço.
Em outro estudo³ a escleroterapia com etanolamina 5% foi usada no tratamento
de 63 espermatoceles em 58 pacientes. Os dados revelaram que 60% das
espermatoceles resolveram completamente, 33% parcialmente e 7% falharam.
Houve recorrência em quatro pacientes com mais de um ano após o tratamento
com sucesso.


1- Choi YH et al. Craniofacial cavernous venous malformations: percutaneous sclerotherapy
with use of ethanolamine oleate. J Vasc Interv Radiol;13 (5):475-82,2002.
2- Kim KH et al. Sclerotherapy for congenital lesions in the head and neck. Otolaryngol Head
Neck Surg; 131(3):307-16,2004.
3- Tammela TL et al. Ethanolamine oleate sclerotherapy for hydroceles and espermatoceles:
a survey of 158 patients with ultrasound followup. J Urol;147 (6):1551-3, 1992.


Indicações
Ethamolin® está indicado para o tratamento da esclerose (obliteração) das
pequenas varizes sem insuficiência valvular bem como das varizes residuais, após
cirurgia.

Contra-indicações
· Veias varicosas volumosas, com insuficiência ostial e valvular
· Infecções agudas
· Estados de hipersensibilidade
· Doenças sistêmicas graves
· Arteriopatias oclusivas
· Trombose venosa profunda
· Pacientes senis ou não-cooperativos
· Gestação (1º e 3º trimestres) e aleitamento
· Úlcera de estase
· Flebite aguda
· Edema
grave
· Hipersensibilidade a qualquer componente da fórmula
Modo de usar
É aconselhável a diluição do produto em água destilada ou soluto glicosado a
50%, a fim de obter-se soluções de 25% e 5% (a solução a 5% é geralmente
satisfatória para a esclerose de varículas ou teleangiectasias), ou seja, diluindo a
solução original de Ethamolin® em um volume 4 a 20 vezes maior.


Seringas de 3 ml e agulhas de 0,3 mm de diâmetro interno são adequadas tanto
para as veias varicosas de médio calibre como para as varicosidades ou
teleangiectasias.
Embora a técnica varie conforme os autores, aconselha-se como procedimentos
gerais:
1. Preparar a seringa com 1 ml da solução mais espuma (obtida pela aspiração de
ar com a agulha para baixo) e ar (aspirado com a agulha para cima), conforme
técnica de Orbach.
2. Com o paciente preferencialmente deitado e com a pele do local mantida sob
tensão (entre dois dedos), puncionar a veia suavemente, bastando quase sempre
introduzir a extremidade da agulha.
3. Injetar pequena quantidade de ar para permitir contato direto da solução com o
lúmen da veia.
4. Injetar a espuma lentamente, observando a sua progressão.
Para as teleangiectasias é em geral suficiente apenas o uso da espuma. Para
veias maiores, injetar um pouco da solução.
5. Repetir o procedimento até, no máximo, cinco ou seis picadas úteis, em veias
da mesma região.
6. Logo após a injeção, é aconselhável enfaixar o local, interpondo placa de
espuma após as primeiras voltas sobre o local da picada. Atentar para que a
tensão da atadura – que deve ser mantida por 24 ou 36 horas – não seja
exagerada, a fim de evitar edema distal.
Para obliterar a veia, as injeções devem ser feitas na hora do episódio de
sangramento agudo e então após uma semana, seis semanas, três meses e seis
meses, conforme indicação médica. Mas o tratamento pode ser repetido a
intervalos semanais, até a oclusão completa dos vasos.
Posologia
A dose usual é de 1,5 a 5 ml por veia a ser esclerosada, divididos em três ou
quatro porções.
A dose máxima por sessão de tratamento não pode exceder 20 ml.



Advertências
· Medicamentos parenterais devem ser inspecionados visualmente para
buscar partículas e descolorações ANTES de qualquer administração,
sempre que a solução ou embalagem permitirem.
· O tratamento esclerosante com Ethamolin® só deve ser realizado em
varizes pequenas e/ou em varículas, e desde que não exista insuficiência
valvular, caso em que a terapia, além de ineficiente, poderá resultar em
flebite, com formação de trombos extensos.
· A dosagem individual total em cada veia não deve ultrapassar 6 ml.
· É aconselhável a observação de intervalos de sete dias entre as sessões.
· O aparecimento de bolha de enfisema subcutâneo ao injetar o ar indica má
posição da agulha.
· A injeção deve ser interrompida diante de qualquer manifestação dolorosa
(é admissível apenas sensação de ardor ao término do procedimento), que
pode resultar de injeção rápida ou fora da veia, agulha excessivamente
calibrosa ou solução muito concentrada.
· O paciente não deve ficar em repouso entre as sessões, devendo, pelo
contrário, ser encorajado a levar vida ativa normal.
· Evitar o extravasamento da injeção.
· Em pacientes com doença cardiorrespiratória concomitante é recomendado
monitoramento cuidadoso e redução da dose total por sessão.
· Deve-se ter precaução nos casos de diabete ou hipertireoidismo.
· Cuidados especiais são necessários para evitar pneumonia por aspiração
quando estiver tratando varizes esofagianas.
· O médico deve ter em mente que necrose intensa pode resultar da injeção
direta de agentes esclerosantes, especialmente se volumes excessivos
forem usados. Pelo menos um caso fatal de necrose esofagiana extensa e
morte foi relatado.
· A medicação deve ser administrada por médicos que estejam familiarizados
com uma técnica aceitável de administração.


· Pacientes com hepatopatia, em classe funcional C, são mais propensos a
ter ulceração esofagiana que aqueles em classe funcional A e B.
· Complicações da ulceração, necrose e perfuração esofagiana tardia
parecem ocorrer mais freqüentemente quando Ethamolin® é administrado
por via submucosa. Esta via de administração não é recomendada.
· Na gravidez e lactação não há conhecimento se o oleato de etanolamina
pode causar dano fetal quando administrado a mulheres grávidas ou se
pode ter efeito na capacidade reprodutiva. Portanto, Ethamolin® somente
deve ser administrado em gestantes quando os benefícios claramente
superarem os riscos. Não se tem conhecimento se a droga é secretada no
leite materno; por este motivo, deve-se ter precaução quando o produto for
administrado a lactantes.
· Morte decorrente de pneumonia por aspiração ocorreu em pacientes idosos
que se submeteram a escleroterapia de varizes esofagianas com
Ethamolin®. Este evento adverso parece relacionar-se mais com o
procedimento que com o medicamento, mas a broncoaspiração de sangue
ou do conteúdo gástrico não é incomum em pacientes com hemorragia
digestiva por varizes esofagianas. Precauções especiais devem ser
tomadas para prevenir esta ocorrência, especialmente em pacientes idosos
e naqueles criticamente enfermos.
Uso em idosos, crianças e outros grupos de risco
Pacientes idosos
Não existe a necessidade de ajuste da dose em pacientes idosos.
Pacientes com doença cardiorrespiratória
Nestes casos, recomenda-se monitoramento cuidadoso e redução da dose total
por sessão.
Uso pediátrico


A segurança e efetividade do Ethamolin® ,em pacientes pediátricos ainda não foi
determinada.
Interações medicamentosas
Não são conhecidas interações relevantes.
Reações adversas
Uma vez observados criteriosamente os procedimentos da técnica de aplicação,
assim como as contra-indicações e precauções, não se espera que ocorram
efeitos colaterais significativos.
As reações adversas estão relacionadas na tabela de acordo com a freqüência do
CIOMS: (Council for International Organizations of Medical Sciences).
Muito comum
10 %
Comum
1% e < 10 %
Incomum
0,1% e < 1 %
Rara
0,01% e < 0,1 %
Muito rara
< 0,01 %

Sistema Corporal
Reação adversa
Gastrointestinal
Muito Comum
Úlcera esofagiana, estenose
esofagiana
Incomum
Esofagite, ruptura esofagiana,
descolamento da mucosa
esofagiana que recobre o vaso
no qual foi injetada a
medicação, ulceração,
estenose, necrose, abscesso
peri-esofagiano e perfuração
Nervoso


Incomum Paralisia
medular
Respiratório
Muito comum
Pneumonia,
derrame
pleural/infiltrados, dor
retroesternal
Imunológico
Muito comum
Reações alérgicas
Urinário
Rara
Insuficiência renal aguda
Vascular
Rara Coagulação
intravascular
disseminada
Geral
Muito comum
Febre
* Dependendo do estado clínico do paciente e da dose utilizada.
Em pacientes com varizes esofagianas foi observada bacteremia após a
injeção de Ethamolin®.
Complicações de ulceração, necrose e perfuração esofagiana tardia
parecem ocorrer mais freqüentemente quando Ethamolin® é administrado
por via submucosa.
Foi relatado grave choque anafilático após a aplicação de um volume muito acima
do volume normal em paciente com predisposição alérgica conhecida. Neste caso,
o médico pode aplicar 0,25ml de uma solução de 1:1.000 de epinefrina (0,25mg) e
as reações alérgicas devem ser controladas com anti-histamínicos.
Na escleroterapia de varizes esofagianas, a superdosagem pode resultar em
grave necrose intramural do esôfago, o que pode levar a evolução fatal.

Superdosagem
Foi relatado grave choque anafilático após a aplicação de um volume muito acima
do volume normal em paciente com predisposição alérgica conhecida. Neste caso,


o médico pode aplicar 0,25 ml de uma solução de 1:1.000 de epinefrina (0,25 mg)
e as reações alérgicas devem ser controladas com anti-histamínicos.
Na escleroterapia de varizes esofagianas a superdosagem pode resultar em grave
necrose intramural do esôfago, podendo haver evolução fatal.

Armazenagem
Ethamolin® deve ser conservado em temperatura ambiente (entre 15ºC e 30ºC),
em sua embalagem original e protegido da luz.
VENDA SOB PRESCRIÇÃO MÉDICA.

Número de lote, data de fabricação e prazo de validade: vide cartucho
MS: 1.4916.0002
Farm. Resp.: Dra. Márcia Weiss I. Campos – CRF-RJ nº 4499
Fabricado e distribuído por:
Zest Farmacêutica Ltda
Rua Viúva Cláudio, 300 ­ Rio de Janeiro ­ RJ
CEP: 20970-032
Indústria Brasileira
CNPJ: 03.557.772/0001-17
SAC: 0800-250110


Mais Bulas de Medicamentos


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