Forexin 500 mg ciprofloxacina

Penicilina VK.

Forma de dosagem: comprimido.

Visão geral Efeitos secundários Dosagem Interações profissionais.

Penicilina-VK.

Comprimidos de potássio de penicilina V, USP.

250 mg (400,000 Unidades)

500 mg (800,000 unidades)

Para reduzir o desenvolvimento de bactérias resistentes aos fármacos e manter a eficácia da penicilina-VK e outros medicamentos antibacterianos, a penicilina-VK deve ser usada apenas para tratar ou prevenir infecções provadas ou fortemente suspeitas de serem causadas por bactérias.

Descrição da Penicilina VK.

A penicilina V é o análogo de fenoximetilo da penicilina G.

O pó de penicilina V é o sal de potássio da penicilina V.

Fórmula Molecular: C 16 H 17 O 5 KN 2 S Peso Molecular: 388,5.

Penicilina-VK (comprimidos de potássio V de potássio USP), para administração oral, contém 250 mg (400 000 unidades) ou 500 mg (800,000 unidades) de penicilina V de potássio. Além disso, cada comprimido contém os seguintes ingredientes inactivos: hidroxipropilmetilcelulose, estearato de magnésio, polietilenoglicol, povidona, talco e dióxido de titânio.

Penicilina VK - Farmacologia Clínica.

A penicilina V exerce uma ação bactericida contra microorganismos sensíveis à penicilina durante o estágio de multiplicação ativa. Atua através da inibição da biossíntese do mucopeptídeo da parede celular. Não é ativo contra a bactéria que produz a penicilinase, que inclui muitas cepas de estafilococos. A droga exerce alta atividade in vitro contra estafilococos (exceto estirpes produtoras de penicilinases), estreptococos (grupos A, C, G, H, L e M) e pneumococos. Outros organismos sensíveis in vitro à penicilina V são Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus moniliformis, Listeria monocytogenes, Leptospira e Neisseria gonorrhoeae. Treponema pallidum é extremamente sensível.

O sal de potássio da penicilina V tem a vantagem distinta sobre a penicilina G em resistência à inativação por ácido gástrico. Pode ser administrado com as refeições; no entanto, os níveis sanguíneos são ligeiramente superiores quando o medicamento é administrado com o estômago vazio. Os níveis médios de sangue são duas a cinco vezes superiores aos níveis seguindo a mesma dose de penicilina G oral e também mostram variações muito menores.

Uma vez absorvido, a penicilina V é cerca de 80% ligada à proteína do soro. Os níveis de tecido são mais elevados nos rins, com menores quantidades no fígado, pele e intestino. Pequenas quantidades são encontradas em todos os outros tecidos do corpo e no líquido cefalorraquidiano. A droga é excretada tão rapidamente quanto é absorvida em indivíduos com função renal normal; no entanto, a recuperação do fármaco da urina indica que apenas cerca de 25% da dose administrada é absorvida. Em neonatos, crianças pequenas e indivíduos com insuficiência renal, a excreção é consideravelmente adiada.

Indicações e uso para Penicilina VK.

Os comprimidos de potássio da penicilina V são indicados no tratamento de infecções de leve a moderadamente severas devido a microorganismos sensíveis à penicilina G. A terapia deve ser orientada por estudos bacteriológicos (incluindo testes de sensibilidade) e por resposta clínica.

NOTA: pneumonia grave, empiema, bacteremia, pericardite, meningite e artrite não devem ser tratados com penicilina V durante o estágio agudo. Procedimentos cirúrgicos indicados devem ser realizados.

As seguintes infecções geralmente responderão à dosagem adequada de penicilina V.

Infecções estreptocócicas (sem bacteremia). Infecções suaves a moderadas do trato respiratório superior, escarlatina e erisipela leve.

NOTA: Os estreptococos nos grupos A, C, G, H, L e M são muito sensíveis à penicilina. Outros grupos, incluindo o grupo D (enterococcus), são resistentes.

Infecções por pneumococos e ndash; Infecções ligeiras a moderadamente graves do trato respiratório.

Infecções por Staphylococcus & ndash; penicilina sensível ao G Infecções suaves da pele e tecidos moles.

NOTA: Os relatórios indicam um número crescente de cepas de estafilococos resistentes à penicilina G, enfatizando a necessidade de estudos de cultura e sensibilidade no tratamento de infecções por estafilococos suspeitas.

Fusospirochetose (gengivite Vincents e faringite) & ndash; As infecções moderadas ou moderadas da orofaringe geralmente respondem à terapia com penicilina oral.

NOTA: O atendimento odontológico necessário deve ser realizado em infecções envolvendo o tecido de gengiva.

Condições médicas em que a terapêutica oral com penicilina é indicada como profilaxia: para a prevenção da recorrência após febre reumática e / ou coreia: a profilaxia com penicilina oral de forma contínua provou ser efetiva na prevenção da recorrência dessas condições.

Embora não tenham sido realizados estudos de eficácia clínica controlada, a Penicilina V foi sugerida pela American Heart Association e pela American Dental Association para uso como um regime oral para profilaxia contra endocardite bacteriana em pacientes com doença cardíaca congênita ou reumática ou outro coração valvular adquirido doença quando submetidos a procedimentos dentários e procedimentos cirúrgicos do trato respiratório superior 1. A penicilina oral não deve ser utilizada em pacientes com risco particularmente alto de endocardite (por exemplo, aqueles com válvulas cardíacas próteses ou shunts pulmonares sistêmicos construídos cirurgicamente). A penicilina V não deve ser utilizada como profilaxia adjuvante para instrumentação ou cirurgia genitourinária, cirurgia do tracto intestinal inferior, sigmoidoscopia e parto. Uma vez que pode acontecer que os estreptococos alfa-hemolíticos relativamente resistentes à penicilina possam ser encontrados quando os pacientes estão recebendo penicilina oral contínua para prevenção secundária de febre reumática, podem ser escolhidos agentes profiláticos, além da penicilina, para esses pacientes e prescritos, além da sua profilaxia contínua de febre reumática regime.

NOTA: Ao selecionar antibióticos para a prevenção da endocardite bacteriana, o médico ou o dentista devem ler a declaração conjunta completa da American Heart Association e da American Dental Association 1.

Para reduzir o desenvolvimento de bactérias resistentes a fármacos e manter a eficácia da penicilina-VK e outros medicamentos antibacterianos, a penicilina-VK deve ser usada apenas para tratar ou prevenir infecções provadas ou fortemente suspeitas de serem causadas por bactérias suscetíveis. Quando a cultura e a informação sobre susceptibilidade estão disponíveis, elas devem ser consideradas na seleção ou modificação da terapia antibacteriana. Na ausência de tais dados, a epidemiologia local e os padrões de susceptibilidade podem contribuir para a seleção empírica da terapia.

Contra-indicações.

Uma reação de hipersensibilidade anterior a qualquer penicilina é uma contra-indicação.

AS REACÇÕES DE HIPERSENIDADE GRAVE E OCCASIONALMENTE FATAL (anafilática) foram relatadas em pacientes com terapia de penicilina. ESTAS REACÇÕES SÃO MAIS POSSÍVEIS DE OCORRIR EM INDIVÍDUOS COM UMA HISTÓRIA DE HIPERSENSIBILIDADE DE PENICILLINA E / OU UMA HISTÓRIA DE SENSIBILIDADE PARA ALGÉRÍGENOS MÚLTIPLOS. HAVI RELATÓRIOS DE INDIVÍDUOS COM UMA HISTÓRIA DE HIPERSENSIDADE PENICILLINA QUE TIVERAM EXPERIMENTADAS REACÇÕES GRAVE QUANDO TRATADO COM CEFALOSPORINAS. ANTES DE INICIAR A TERAPÊNCIA COM OS COMPRIMIDOS PENICILLIN V POTASSIUM, É DEVER FAZER UM INQUÉRITO CUIDADOSO SOBRE AS REAÇÕES ANTERIORES DE HIPERSENSIBILIDADE PARA PENICILLINS, CEFALOSPORINAS OU OUTROS ALERGENTES. SE UMA REACÇÃO ALÉRGICA OCORRER, AS TABRAS DE POTÁSSIO PENICILLIN V DEVEM SER DESCONTINUADAS E TERAPIA APROPRIADA INSTITUÍDA. REAÇÕES ANALFILÁTICAS GRAVES EXIGEM TRATAMENTO DE EMERGÊNCIA IMEDIATO COM EPINEPHRINE. OXIGÊNIO, ESTERÓIDES INTRAVENOSOS E GESTÃO DE ÁGUA, INCLUINDO A INTOLAÇÃO, DEVEM SER ADMINISTRADOS COMO INDICADO.

A diarreia associada ao Clostridium difficile (DCAD) foi relatada com o uso de quase todos os agentes antibacterianos, incluindo a penicilina, e pode variar de gravidade de diarréia leve a colite fatal. O tratamento com agentes antibacterianos altera a flora normal do cólon levando ao crescimento excessivo de C. difficile.

C. difficile produz toxinas A e B que contribuem para o desenvolvimento de CDAD. As cepas de C. difficile causadas por hipertoxina causam aumento da morbidade e mortalidade, uma vez que estas infecções podem ser refratárias à terapia antimicrobiana e podem requerer colectomia. O CDAD deve ser considerado em todos os pacientes que apresentam diarréia após o uso de antibióticos. É necessária uma história médica cuidadosa, uma vez que o CDAD ocorreu durante dois meses após a administração de agentes antibacterianos.

Se CDAD for suspeitado ou confirmado, o uso contínuo de antibióticos não dirigido contra C. difficile pode precisar ser descontinuado. O gerenciamento adequado de fluidos e eletrólitos, suplementação de proteínas, tratamento antibiótico de C. difficile e avaliação cirúrgica deve ser instituído como indicado clinicamente.

Precauções.

A penicilina deve ser usada com precaução em indivíduos com histórias de alergias significativas e / ou asma.

A prescrição de penicilina-VK na ausência de uma infecção bacteriana comprovada ou fortemente suspeita ou uma indicação profilática é pouco provável para proporcionar benefícios ao paciente e aumenta o risco de desenvolvimento de bactérias resistentes a medicamentos.

A via oral de administração não deve ser invocada em pacientes com doença grave, ou com náuseas, vômitos, dilatação gástrica, cardiospasmo ou hipermotilidade intestinal.

Pacientes ocasionais não absorverão quantidades terapêuticas de penicilina administrada por via oral.

Nas infecções estreptocócicas, a terapia deve ser suficiente para eliminar o organismo (mínimo de 10 dias); caso contrário, as sequelas da doença estreptocócica podem ocorrer. As culturas devem ser tomadas após a conclusão do tratamento para determinar se os estreptococos foram erradicados.

O uso prolongado de antibióticos pode promover o crescimento excessivo de organismos não sensíveis, incluindo fungos. Se a superinfecção ocorrer, devem ser tomadas medidas apropriadas.

Informação para Pacientes.

Os pacientes devem ser avisados ​​de que os medicamentos antibacterianos, incluindo a penicilina-VK, só devem ser usados ​​para tratar infecções bacterianas. Eles não tratam infecções virais (por exemplo, o resfriado comum). Quando a penicilina-VK é prescrita para tratar uma infecção bacteriana, os pacientes devem ser informados de que, embora seja comum sentir-se melhor no início da terapia, a medicação deve ser tomada exatamente como indicado. Saltar as doses ou não completar o curso completo da terapia pode: (1) diminuir a eficácia do tratamento imediato e (2) aumentar a probabilidade de bactérias desenvolverem resistência e não serão tratáveis ​​pela penicilina-VK ou outros medicamentos antibacterianos na futuro.

A diarréia é um problema comum causado por antibióticos que geralmente termina quando o antibiótico é descontinuado. Às vezes, após o início do tratamento com antibióticos, os pacientes podem desenvolver fezes aquosas e sangrentas (com ou sem cãibras no estômago e febre) mesmo nos dois ou mais meses depois de ter tomado a última dose do antibiótico. Se isso ocorrer, os pacientes devem entrar em contato com o médico o mais rápido possível.

Reações adversas.

Embora a incidência de reações a penicilinas orais tenha sido relatada com muito menos frequência do que a terapia parenteral, deve-se lembrar que todos os graus de hipersensibilidade, incluindo anafilaxia fatal, foram relatados com penicilina oral.

As reações mais comuns à penicilina oral são náuseas, vômitos, distúrbios epigástricos, diarréia e língua peluda preta. As reações de hipersensibilidade relatadas são erupções cutâneas (dermatite maculopapular a esfoliativa), urticária e outras reações de doença sérica, edema laríngeo e anafilaxia.

A febre e a eosinofilia podem ser freqüentemente a única reação observada. A anemia hemolítica, leucopenia, trombocitopenia, neuropatia e nefropatia são reações infreqüentes e geralmente associadas a altas doses de penicilina parenteral.

Penicilina VK Dosagem e Administração.

A dose de penicilina V deve ser determinada de acordo com a sensibilidade dos microrganismos causadores e a gravidade da infecção e ajustada à resposta clínica do paciente.

As recomendações de dosagem usuais para adultos e crianças com 12 anos ou mais são as seguintes:

Infecções estreptocócicas - leve a moderadamente severas - do trato respiratório superior e incluindo escarlitas e erisipela: de 125 a 250 mg (200.000 a 400.000 unidades) a cada 6 a 8 horas durante 10 dias.

Infecções pneumocócicas - leve a moderadamente grave - do trato respiratório, incluindo otite média: 250 a 500 mg (400.000 a 800.000 unidades) a cada 6 horas até o paciente ter sido afebrável por pelo menos 2 dias.

Infecções estafilocócicas - infecções leves da pele e dos tecidos moles (cultura e testes sensíveis devem ser realizados): 250 a 500 mg (400.000 a 800.000 unidades) a cada 6 a 8 horas.

Fusospirochetose (infecção Vincents) da orofaringe. Infecções moderadas a moderadamente graves: 250 a 500 mg (400 000 a 800 000 unidades) a cada 6 a 8 horas.

Para a prevenção da recorrência após febre reumática e / ou coreia: 125 a 250 mg (200.000 a 400.000 unidades) duas vezes ao dia de forma contínua.

Para profilaxia contra endocardite bacteriana 1 em pacientes com cardiopatia congênita ou doença cardíaca valvular reumática ou outra adquirida quando submetidos a procedimentos dentários ou procedimentos cirúrgicos do trato respiratório superior: 2 gramas de penicilina V (1 grama para crianças menores de 60 libras) 1 hora antes do procedimento, e depois, 1 grama (500 mg para crianças com menos de 60 libras) 6 horas depois.

Como é fornecido o Penicillin VK.

Penicilina - Comprimidos VK (comprimidos de potássio V de potássio USP), 250 mg (400.000 unidades) são comprimidos brancos redondos, biconvexos, PVK 250 debossados ​​e pontaque de ponta em um lado e GG 949 no verso.

NDC 0781-1205-01. garrafas de 100.

NDC 0781-1205-10. garrafas de 1000.

Penicilina - Comprimidos VK (comprimidos de potássio V de potássio USP), 500 mg (800.000 unidades) são comprimidos brancos oblongos, biconvexos, PVK 500 debossados ​​de um lado e GG 950 no verso e pontaqueado em ambos os lados.

NDC 0781-1655-01. garrafas de 100.

NDC 0781-1655-10. garrafas de 1000.

Armazenar a 20 ° C; - 25 ° C (68 ° - 77 ° F) (ver temperatura controlada da sala USP).

Mantenha-se bem fechado. Dispense em um recipiente apertado, conforme definido na USP.

REFERÊNCIAS.

1. American Heart Association.1984. Prevenção da endocardite bacteriana. Circulação 70 (6): 1123A & ndash; 1127A.

Fabricado na Áustria pela Sandoz GmbH.

para Sandoz Inc., Princeton, NJ 08540.

mg Rótulo.

Pasta de penicilina com potássio.

Pasta de penicilina com potássio.

Mais sobre penicilina VK (penicilina e potássio)

Recursos do consumidor.

Recursos profissionais.

Guias de tratamento relacionados.

Tudo o que você precisa saber sobre antibióticos:

Status da droga.

Prescrição disponível apenas.

Categoria de Gravidez Nenhum risco comprovado em humanos.

Programação CSA Não é uma droga controlada.

Histórico de aprovação Histórico de medicamentos na FDA.

Penicillin VK Rating.

Drugs Mobile Apps.

A maneira mais fácil de pesquisar informações sobre drogas, identificar pílulas, verificar interações e configurar seus próprios registros de medicamentos pessoais. Disponível para dispositivos Android e iOS.

Sobre.

Termos & amp; Privacidade.

Inscreva-se para receber notificações por e-mail sempre que novos artigos forem publicados.

A droga fornece informações precisas e independentes em mais de 24 mil medicamentos prescritos, medicamentos sem receita médica e produtos naturais. Este material é fornecido apenas para fins educacionais e não se destina a aconselhamento médico, diagnóstico ou tratamento. Fontes de dados incluem Micromedex & reg; (atualizado em 2 de janeiro de 2018), Cerner Multum & trade; (atualizado em 3 de janeiro de 2018), Wolters Kluwer & trade; (atualizado em 3 de janeiro de 2018) e outros. Para ver fontes de conteúdo e atribuições, consulte nossa política editorial.

Cumprimos o padrão HONcode para informações de saúde confiáveis ​​- verifique aqui.

Ciprofloxacina 500mg Comprimidos revestidos por película.

Detalhes de contato da Accord Healthcare Limited.

Ingrediente ativo.

cloridrato de ciprofloxacina.

Categoria jurídica.

POM: medicamento de prescrição apenas.

Relatório de efeito secundário Medicamentos relacionados Mesmos ingredientes ativos Mesma empresa Bookmark Email.

Última atualização no eMC: 26 de fevereiro de 2018.

Mostrar tabela de conteúdos.

Ocultar tabela de conteúdos.

Esta informação destina-se a ser utilizada por profissionais de saúde.

Ciprofloxacina 500mg Comprimidos revestidos por película.

Cada comprimido de 500 mg de Ciprofloxacina contém 582,20 mg de cloridrato de ciprofloxacina equivalente a 500 mg de Ciprofloxacina (INN).

Para a lista completa de excipientes, veja a seção 6.1.

Os comprimidos de 500 mg de ciprofloxacina são brancos a esbranquiçados, forma de cápsula, biconvexos com borda chanfrada, comprimido revestido de película com inscrição 'CI' de um lado e planície do outro lado.

A ciprofloxacina é indicada para o tratamento das seguintes infecções (ver secções 4.4 e 5.1). Deve ser dada especial atenção às informações disponíveis sobre a resistência à ciprofloxacina antes de iniciar a terapia.

Deve ser considerada a orientação oficial sobre o uso adequado de agentes antibacterianos.

& # 8226; Infecções inferiores do aparelho respiratório devido a bactérias Gram-negativas.

- exacerbações da doença pulmonar obstrutiva crônica.

- infecções bronco-pulmonares em fibrose cística ou em bronquiectasias.

& # 8226; Otite média supurativa crônica.

& # 8226; Exacerbação aguda da sinusite crónica, especialmente se estas são causadas por bactérias Gram-negativas.

& # 8226; Infecções do trato urinário.

& # 8226; Infecções do trato genital.

- uretrite gonocócica e cervicite devido à susceptível Neisseria gonorrhoeae.

- epididio-orquite incluindo casos devido à susceptível Neisseria gonorrhoeae.

- doença inflamatória pélvica incluindo casos devido a Neisseria gonorrhoeae suscetível.

& # 8226; Infecções do trato gastrointestinal (por exemplo, diarréia dos viajantes)

& # 8226; Infecções da pele e dos tecidos moles causados ​​por bactérias Gram-negativas.

& # 8226; Otite externa maligna.

& # 8226; Infecções dos ossos e articulações.

& # 8226; Profilaxia de infecções invasivas por Neisseria meningitidis.

& # 8226; Antrax por inalação (profilaxia pós-exposição e tratamento curativo)

A ciprofloxacina pode ser utilizada no tratamento de pacientes neutropênicos com febre suspeita de ser causada por uma infecção bacteriana.

Crianças e adolescentes.

& # 8226; Infecções bronco-pulmonares na fibrose cística causadas por Pseudomonas aeruginosa.

& # 8226; Infecções do trato urinário complicadas e pielonefrite.

& # 8226; Antrax por inalação (profilaxia pós-exposição e tratamento curativo)

A ciprofloxacina também pode ser usada para tratar infecções graves em crianças e adolescentes quando isso é considerado necessário.

O tratamento deve ser iniciado apenas por médicos experientes no tratamento de fibrose cística e / ou infecções graves em crianças e adolescentes (ver secções 4.4 e 5.1).

A dosagem é determinada pela indicação, a gravidade e o local da infecção, a susceptibilidade à ciprofloxacina do (s) organismo (s) causador (s), a função renal do paciente e, em crianças e adolescentes, o peso corporal.

A duração do tratamento depende da gravidade da doença e do curso clínico e bacteriológico.

O tratamento de infecções devido a certas bactérias (por exemplo, Pseudomonas aeruginosa, Acinetobacter ou Staphylococci) pode requerer doses mais elevadas de ciprofloxacina e co-administração com outros agentes antibacterianos apropriados.

O tratamento de algumas infecções (por exemplo, doença inflamatória pélvica, infecções intra-abdominais, infecções em pacientes neutropênicos e infecções de ossos e articulações) pode exigir co-administração com outros agentes antibacterianos apropriados, dependendo dos patógenos envolvidos.

Dose diária em mg.

Duração total do tratamento (potencialmente incluindo o tratamento parenteral inicial com ciprofloxacina)

Infecções do trato respiratório inferior.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

Infecções do trato respiratório superior.

Exacerbação aguda de sinusite crônica.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

Otite média supurativa crônica.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

Otite externa maligna.

750 mg duas vezes ao dia.

28 dias até 3 meses.

Infecções do trato urinário (ver secção 4.4)

250 mg duas vezes ao dia para 500 mg duas vezes ao dia.

Em mulheres pré-menopáusicas, pode ser utilizada uma dose única de 500 mg.

Cistite complicada, pielonefrite não complicada.

500 mg duas vezes ao dia.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

pelo menos 10 dias, pode continuar por mais de 21 dias em algumas circunstâncias específicas (como abscessos)

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

2 a 4 semanas (aguda) a 4 a 6 semanas (crônica)

Infecções do trato genital.

Uretrite gonocócica e cervicite.

500 mg como uma dose única.

1 dia (dose única)

Epidídimo-orquite e doenças inflamatórias pélvicas.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

pelo menos 14 dias.

Infecções do trato gastrointestinal e infecções intra-abdominais.

Diarréia causada por agentes patogénicos bacterianos, incluindo Shigella spp. além de Shigella dysenteriae tipo 1 e tratamento empírico da diarréia dos viajantes graves.

500 mg duas vezes ao dia.

Diarréia causada por Shigella dysenteriae tipo 1.

500 mg duas vezes ao dia.

Diarréia causada por Vibrio cholerae.

500 mg duas vezes ao dia.

500 mg duas vezes ao dia.

Infecções intra-abdominais devido a bactérias Gram-negativas.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

Infecções da pele e tecidos moles.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

Infecções ósseas e articulares.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

max. de 3 meses.

Pacientes neutropênicos com febre suspeita de ser causada por uma infecção bacteriana.

A ciprofloxacina deve ser co-administrada com o (s) agente (s) antibacteriano (s) adequado (s) de acordo com a orientação oficial.

500 mg duas vezes ao dia para 750 mg duas vezes ao dia.

A terapia deve ser continuada durante todo o período de neutropenia.

Profilaxia de infecções invasivas por Neisseria meningitidis.

500 mg como uma dose única.

1 dia (dose única)

Profilaxia pós-exposição ao antraz por inalação e tratamento curativo para pessoas capazes de receber tratamento por via oral quando clinicamente apropriado.

A administração de medicamentos deve começar o mais rápido possível após exposição suspeita ou confirmada.

500 mg duas vezes ao dia.

60 dias após a confirmação da exposição a Bacillus anthracis.

Dose diária em mg.

Duração total do tratamento (potencialmente incluindo o tratamento parenteral inicial com ciprofloxacina)

20 mg / kg de peso corporal duas vezes ao dia com um máximo de 750 mg por dose.

Infecções do trato urinário complicadas e pielonefrite.

10 mg / kg de peso corporal duas vezes ao dia para 20 mg / kg de peso corporal duas vezes ao dia com um máximo de 750 mg por dose.

Profilaxia pós-exposição ao antraz por inalação e tratamento curativo para pessoas capazes de receber tratamento por via oral quando clinicamente apropriado. A administração de medicamentos deve começar o mais rápido possível após exposição suspeita ou confirmada.

10 mg / kg de peso corporal duas vezes ao dia para 15 mg / kg de peso corporal duas vezes ao dia com um máximo de 500 mg por dose.

60 dias após a confirmação da exposição a Bacillus anthracis.

Outras infecções graves.

20 mg / kg de peso corporal duas vezes ao dia com um máximo de 750 mg por dose.

De acordo com o tipo de infecções.

Os pacientes idosos devem receber uma dose selecionada de acordo com a gravidade da infecção e a depuração da creatinina do paciente.

Pacientes com insuficiência renal e hepática.

Recomendadas doses iniciais e de manutenção para pacientes com insuficiência renal:

Veja a Dosagem Geral.

250-500 mg a cada 12 h.

250-500 mg a cada 24 h.

Pacientes em hemodiálise.

250-500 mg a cada 24 h.

Pacientes em diálise peritoneal.

250-500 mg a cada 24 h.

Em pacientes com insuficiência hepática, não é necessário ajustar a dose.

A dosagem em crianças com insuficiência renal e / ou função hepática não foi estudada.

Modo de administração.

Os comprimidos devem ser engolidos sem necessidade de fluido. Eles podem ser independentes das refeições. Se for tomado com o estômago vazio, a substância activa é absorvida mais rapidamente. Os comprimidos de ciprofloxacina não devem ser tomados com produtos lácteos (por exemplo, leite, iogurte) ou suco de fruta fortificado com mineral (por exemplo suco de laranja fortificado com cálcio) (ver secção 4.5).

Em casos graves ou se o paciente não é capaz de tomar comprimidos (por exemplo, pacientes em nutrição enteral), recomenda-se que comece a terapia com ciprofloxacina intravenosa até que seja possível mudar a administração oral.

Hipersensibilidade à substância activa, a outras quinolonas ou a qualquer dos excipientes (ver secção 6.1).

Administração concomitante de ciprofloxacina e tizanidina (ver secção 4.5).

Infecções por Streptococcus (incluindo Streptococcus pneumoniae)

A ciprofloxacina não é recomendada para o tratamento de infecções por estreptococos devido a eficácia inadequada.

Infecções graves e infecções mistas com patógenos Gram-positivos e anaeróbios.

A monoterapia com ciprofloxacina não é adequada para o tratamento de infecções graves e infecções que possam ser devidas a patógenos Gram-positivos ou anaeróbios. Em tais infecções, a ciprofloxacina deve ser co-administrada com outros agentes antibacterianos adequados.

Infecções do trato genital.

Uretrite gonocócica, cervicite, epididoma-orquite e doenças inflamatórias pélvicas podem ser causadas por isolados de Neisseria gonorrhoeae resistentes a fluoroquinolonas.

Portanto, a ciprofloxacina deve ser administrada para o tratamento da uretrite gonocócica ou cervicite somente se a Neisseria gonorrhoeae resistente à ciprofloxacina puder ser excluída.

Para epididimo-orquite e doenças inflamatórias pélvicas, a ciprofloxacina empírica só deve ser considerada em combinação com outro agente antibacteriano apropriado (por exemplo, uma cefalosporina), a não ser que a Neisseria gonorrhoeae resistente à ciprofloxacina possa ser excluída com base em dados de prevalência locais. Se a melhora clínica não for alcançada após 3 dias de tratamento, a terapia deve ser reconsiderada.

Infecções do trato urinário.

Resistência a fluoroquinolonas de Escherichia coli & # 150; o patógeno mais comum envolvido em infecções do trato urinário e # 150; varia em toda a União Européia. Os prescritores são aconselhados a levar em consideração a prevalência local de resistência em Escherichia coli para fluoroquinolonas.

A dose única de ciprofloxacina que pode ser utilizada na cistite não complicada em mulheres pré-menopáusicas deverá ser associada com menor eficácia do que a duração do tratamento mais longo. Isto é ainda mais a ser levado em consideração no que diz respeito ao aumento do nível de resistência de Escherichia coli a quinolonas.

Existem dados limitados sobre a eficácia da ciprofloxacina no tratamento de infecções intra-abdominais pós-cirúrgicas.

A escolha da ciprofloxacina deve levar em consideração as informações sobre a resistência à ciprofloxacina em patógenos relevantes nos países visitados.

Infecções dos ossos e articulações.

A ciprofloxacina deve ser utilizada em combinação com outros agentes antimicrobianos, dependendo dos resultados da documentação microbiológica.

O uso em humanos é baseado em dados de susceptibilidade in vitro e em dados experimentais de animais, juntamente com dados humanos limitados. Os médicos que tratam devem consultar documentos de consenso nacionais e / ou internacionais sobre o tratamento do antraz.

O uso de ciprofloxacina em crianças e adolescentes deve seguir orientação oficial disponível. O tratamento com ciprofloxacina deve ser iniciado apenas por médicos experientes no tratamento de fibrose cística e / ou infecções graves em crianças e adolescentes. O tratamento deve ser iniciado somente após uma cuidadosa avaliação de benefício / risco, devido a possíveis eventos adversos relacionados às articulações e / ou ao tecido circundante (ver seção 4.8).

A ciprofloxacina mostrou causar artropatia nas articulações portadoras de peso de animais imaturos. Dados de segurança de um estudo randomizado duplo-cego sobre o uso de ciprofloxacina em crianças (ciprofloxacina: n = 335, idade média = 6,3 anos e # 894; comparadores: n = 349, idade média = 6,2 anos & # 894; faixa etária = 1 a 17 anos ) revelou uma incidência de artropatologia suspeita relacionada à droga (discernida a partir de sinais e sintomas clínicos relacionados à articulação) no dia +42 de 7,2% e 4,6%. Respectivamente, uma incidência de artropatia relacionada à droga em um período de seguimento de 1 ano foi de 9,0% e 5,7%. O aumento de suspeitas de casos de artropatia relacionada à droga ao longo do tempo não foi estatisticamente significante entre os grupos. O tratamento deve ser iniciado somente após uma avaliação cuidadosa de benefício / risco, devido a possíveis eventos adversos relacionados às articulações e / ou ao tecido circundante (ver seção 4.8).

Infecções bronco-pulmonares na fibrose cística.

Os ensaios clínicos incluíram crianças e adolescentes de 5 a 17 anos. Uma experiência mais limitada está disponível no tratamento de crianças entre 1 e 5 anos de idade.

Infecções do trato urinário complicadas e pielonefrite.

O tratamento com ciprofloxacina das infecções do trato urinário deve ser considerado quando outros tratamentos não podem ser utilizados e devem ser baseados nos resultados da documentação microbiológica.

Os ensaios clínicos incluíram crianças e adolescentes com idade entre 1-17 anos.

Outras infecções graves específicas.

Outras infecções graves de acordo com a orientação oficial, ou após uma avaliação cuidadosa dos benefícios-risco quando outros tratamentos não podem ser utilizados, ou após falha na terapia convencional e quando a documentação microbiológica pode justificar o uso de ciprofloxacina.

O uso de ciprofloxacina para infecções severas específicas além das mencionadas acima não foi avaliado em ensaios clínicos e a experiência clínica é limitada. Conseqüentemente, é aconselhável o cuidado ao tratar pacientes com essas infecções.

Hipersensibilidade e reações alérgicas, incluindo anafilaxia e reações anafilactóides, podem ocorrer após uma única dose (ver secção 4.8) e podem ser fatais. Se tal reação ocorrer, a ciprofloxacina deve ser descontinuada e é necessário um tratamento médico adequado.

A ciprofloxacina geralmente não deve ser utilizada em pacientes com história de tendão doença / desordem relacionada ao tratamento com quinolona. No entanto, em casos muito raros, após a documentação microbiológica do organismo causador e avaliação do equilíbrio risco / benefício, a ciprofloxacina pode ser prescrita para esses pacientes para o tratamento de certas infecções graves, particularmente em caso de falha na terapia padrão ou bacteriana resistência, onde os dados microbiológicos podem justificar o uso de ciprofloxacina.

A tendinite e a ruptura do tendão (especialmente o tendão de Aquiles), às vezes bilateral, podem ocorrer com ciprofloxacina, mesmo nas primeiras 48 horas de tratamento. Inflamação e rupturas do tendão podem ocorrer até vários meses após a interrupção da terapia com ciprofloxacina. O risco de tendinopatia pode ser aumentado em pacientes idosos ou em pacientes tratados concomitantemente com corticosteróides (ver seção 4.8). Em qualquer sinal de tendinite (por exemplo, inchaço doloroso, inflamação), o tratamento com ciprofloxacina deve ser descontinuado. Deve-se ter cuidado para manter o membro afetado em repouso.

A ciprofloxacina deve ser utilizada com precaução em pacientes com miastenia gravis (ver secção 4.8).

A ciprofloxacina demonstrou causar reacções de fotossensibilidade. Os doentes que tomam ciprofloxacina devem ser aconselhados a evitar a exposição directa à luz solar extensa ou à irradiação UV durante o tratamento (ver secção 4.8).

Sistema nervoso central.

A ciprofloxacina como outras quinolonas é conhecida por desencadear convulsões ou diminuir o limiar de convulsão. Foram relatados casos de status epilepticus. A ciprofloxacina deve ser usada com precaução em pacientes com distúrbios do SNC que podem estar predispostos à convulsão. Se ocorrerem convulsões, a ciprofloxacina deve ser descontinuada (ver secção 4.8). Reações psiquiátricas podem ocorrer mesmo após a primeira administração de ciprofloxacina. Em casos raros, depressão ou psicose podem progredir em ideias / pensamentos suicidas que culminem em tentativa de suicídio ou suicídio completo. Na ocorrência desses casos, a ciprofloxacina deve ser descontinuada.

Foram notificados casos de polineuropatia (com base em sintomas neurológicos como dor, queimação, distúrbios sensoriais ou fraqueza muscular, isolados ou em combinação) em pacientes que receberam ciprofloxacina. A ciprofloxacina deve ser interrompida em pacientes com sintomas de neuropatia, incluindo dor, queimação, formigamento, dormência e / ou fraqueza, a fim de evitar o desenvolvimento de uma condição irreversível (ver seção 4.8).

Deve ter cuidado ao usar fluoroquinolonas, incluindo ciprofloxacina, em pacientes com fatores de risco conhecidos para prolongamento do intervalo QT, como, por exemplo:

- síndrome congênita do QT longo.

- concomitant use of drugs that are known to prolong the QT interval (e. g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)

- uncorrected electrolyte imbalance (e. g. hypokalaemia, hypomagnesaemia)

- cardiac disease (e. g. heart failure, myocardial infarction, bradycardia)

Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.

(See section 4.2 Geriatric patients, section 4.5, section 4.8, section 4.9).

As with other quinolones, hypoglycemia has been reported most often in diabetic patients, predominantly in the elderly population. In all diabetic patients, careful monitoring of blood glucose is recommended (see section 4.8).

The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8). In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.

Renal and urinary system.

Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8). Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.

Impaired renal function.

Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.2 to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.

Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.

Glucose-6-phosphate dehydrogenase deficiency.

Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored.

During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for ciprofloxacin - resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.

Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Co-administration of ciprofloxacin and tizanidine is contra-indicated. Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e. g. of theophylline) may be necessary (see section 4.5).

The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).

Interaction with tests.

The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give falsenegative bacteriological test results in specimens from patients currently taking ciprofloxacin.

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

Effects of other products on ciprofloxacin:

Drugs known to prolong QT interval.

Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e. g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).

Chelation complex formation.

The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e. g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e. g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e. g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers.

Food and Dairy products:

Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e. g. milk, yoghurt, calcium fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.

Probenecid interferes with renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.

Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.

Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin.

Effects of ciprofloxacin on other medicinal products:

Tizanidine must not be administered together with ciprofloxacin (see section 4.3). In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with ciprofloxacin. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.

In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration ('Cytochrome P450' in section 'Special warnings and precautions for use).

Co-administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.

Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended (see section 4.4).

Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration. This can lead to theophylline induced side effects that may rarely be life threatening or fatal. During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).

Other xanthine derivatives.

On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.

Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.

A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.

Simultaneous administration of ciprofloxacin with a vitamin K antagonist may augment its anti-coagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalised ratio) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with a vitamin K antagonist (e. g., warfarin, acenocoumarol, phenprocoumon, or fluindione).

In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration (see section 4.4).

It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co - administration with ciprofloxacin (see section 4.4).

It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.

Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised (see section 4.4).

Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.

The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

Due to its neurological effects, ciprofloxacin may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea. ADRs derived from clinical studies and post-marketing surveillance with ciprofloxacin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.

System Organ Class.

Frequency not known.

(cannot be estimated from available data)

Infections and Infestations.

Blood and Lymphatic System Disorders.

Pancytopenia (life - threatening)

Bone marrow depression (life - threatening)

Immune System Disorders.

Allergic oedema / angiooedema.

Anaphylactic shock (life - threatening) (see section 4.4)

Serum sickness - like reaction.

Metabolism and Nutrition Disorders.

Hypoglycaemia (see section 4.4)

Psychomotor hyperactivity / agitation.

Confusion and disorientation.

(potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Psychotic reactions (potentially culminating in suicidal ideations/ thoughts or suicide attempts and completed suicide) (see section 4.4)

Nervous System Disorders.

Par - and Dysaesthesia.

Seizures (including status epilepticus see section 4.4)

Olfactory nerve disorders.

Peripheral neuropathy and polyneuropathy (see section 4.4)

Visual disturbances (e. g. diplopia)

Visual colour distortions.

Ear and Labyrinth Disorders.

Hearing loss / Hearing impaired.

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see section 4.4 and 4.9)

Respiratory, Thoracic and Mediastinal Disorders.

Dyspnoea (including asthmatic condition)

Gastro-intestinal and abdominal pains.

Increase in transaminases.

Liver necrosis (very rarely progressing to life - threatening hepatic failure) (see section 4.4)

Skin and Subcutaneous Tissue Disorders.

Photosensitivity reactions (see section 4.4)

Stevens-Johnson syndrome (potentially life - threatening)

Toxic epidermal necrolysis (potentially life - threatening)

Acute generalised exanthematous pustulosis (AGEP)

DRESS (Drug reaction with eosinophilia and systemic symptoms) syndrome.

Musculoskeletal, Connective Tissue and Bone Disorders.

Musculoskeletal pain (e. g. extremity pain, back pain, chest pain) Arthralgia.

Increased muscle tone and cramping.

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

Renal and Urinary Disorders.

Crystalluria (see section 4.4)

General Disorders and Administration Site Conditions.

Increase in blood alkaline phosphatase.

International normalised ratio increased (in patients treated with Vitamin K antagonists)

The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme,

An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.

Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.

Apart from routine emergency measures, e. g. ventricular emptying followed by medical carbon it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.

Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

Pharmacotherapeutic group: Quinolone Antibacterials, Fluoroquinolones, ATC code: J 01 MA 02.

As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.

Efficacy mainly depends on the relation between the maximum concentration in serum (C max ) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

Mechanism of resistance:

In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.

Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance. All in-vitro mechanisms of resistance are commonly observed in clinical isolates. Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.

Plasmid-mediated resistance encoded by qnr-genes has been reported.

Spectrum of antibacterial activity:

Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:

Staphylococcus spp. 1.

Haemophilus influenzae and Moraxella catarrhalis.

1 Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy.

* Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4)

COMMONLY SUSCEPTIBLE SPECIES.

Aerobic Gram-positive micro-organisms.

Bacillus anthracis (1)

Aerobic Gram-negative micro-organisms.

SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM.

Aerobic Gram-positive micro-organisms.

Staphylococcus spp. *(2)

Aerobic Gram-negative micro-organisms.

INHERENTLY RESISTANT ORGANISMS.

Aerobic Gram-positive micro-organisms.

Aerobic Gram-negative micro-organisms.

Excepted as listed above.

* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.

+ Resistance rate ≥50% in one or more EU countries.

($): Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

(1): Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose. The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data. Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans. The treating physician should refer to national and/or international consensus documents regarding treatment of anthrax.

(2): Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones. The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.

Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.

Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (C max ) between 0.56 and 3.7 mg/L. Serum concentrations increase proportionately with doses up to 1000 mg.

The absolute bioavailability is approximately 70-80%.

A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.

Protein binding of ciprofloxacin is low (20-30%). Ciprofloxacin is present in plasma largely in a non-ionised form and has a large steady state distribution volume of 2-3 L/kg body weight. Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.

Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.

Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally. The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.

Excretion of ciprofloxacin (% of dose)

Metabolites (M1- M4)

Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h. Ciprofloxacin undergoes both glomerular filtration and tubular secretion. Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.

Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism. 1% of the dose is excreted via the biliary route. Ciprofloxacin is present in the bile in high concentrations.

The pharmacokinetic data in paediatric patients are limited.

In a study in children C max and AUC were not age-dependent (above one year of age). No notable increase in C max and AUC upon multiple dosing (10 mg/kg three times daily) was observed.

In 10 children with severe sepsis C max was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age. The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.

These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.

Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.

Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels. Data on photomutagenicity/photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments. This effect was comparable to that of other gyrase inhibitors.

As reported for other gyrase inhibitors, ciprofloxacin causes damage to the large weight-bearing joints in immature animals. The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints. Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions. In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.

Each tablet contains:

The tablet film-coat consists of:

- titanium dioxide E171,

Do not store above 25 °C. Store in the original package.

PVC 250 μm//Al 20 μm blisters.

The Ciprofloxacin 500mg Tablets are available in pack sizes of 10, 12, 20 and 100 tablets.

Not all pack sizes may be marketed.

No special instructions for use/handling.

ACCORD HEALTHCARE LIMITED.

319 PINNER ROAD.

Report Side Effect Related Medicines Same active ingredients Same company Bookmark Email.

Company contact details.

Accord Healthcare Limited.

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK.

+44 (0)208 8631 427.

+44 (0)208 901 3370.

+44 (0)208 861 4867.

+44 (0)208 861 4867.

Este site usa cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continuar.

Ciprofloxacin 500mg Film-Coated Tablets.

Dr. Reddy's Laboratories (UK) Ltd contact details.

Active ingredient.

ciprofloxacin hydrochloride.

Legal Category.

POM: Prescription only medicine.

Report Side Effect Related Medicines Same active ingredients Same company Bookmark Email.

Last updated on eMC: 13 Apr 2018.

What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0174.

Ciprofloxacin 500mg Film-Coated Tablets.

Package leaflet: Information for the user.

Ciprofloxacin 500 mg Film-Coated Tablets.

Read all of this leaflet carefully before taking this medicine because it contains important information for you:

Keep this leaflet as you may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ciprofloxacin 500mg Tablets are and what they are used for.

2. What you need to know before you take Ciprofloxacin 500mg Tablets.

3. How to take Ciprofloxacin 500mg Tablets.

4. Possible side effects.

5. How to store your Ciprofloxacin 500mg Tablets.

6. Contents of the pack and other information.

1. What Ciprofloxacin 500mg Tablets are and what they are used for.

Ciprofloxacin 500mg Tablets are an antibiotic belonging to the fluoroquinolone family.

Ciprofloxacin Tablets are used for the treatment of severe bacterial infections. They only work with specific strains of bacteria.

respiratory tract, urinary tract, genital tract infections in men and women, stomach and intra-abdominal infections, skin and soft tissue, bone and joint infections. long lasting or recurring ear or sinus infections to prevent infections due to the bacterium Neisseria meningitidis anthrax inhalation exposure.

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Tablets.

Children and adolescents.

Ciprofloxacin Tablets are used in children and adolescents, under specialist medical supervision to treat the following bacterial infections:

lung and bronchial infections in children and adolescents suffering from cystic fibrosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure.

Ciprofloxacin Tablets may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you take Ciprofloxacin 500mg Tablets.

Do NOT take Ciprofloxacin 500mg Tablets if you or your child:

have a known allergic reaction to ciprofloxacin, to other quinolone drugs or to any of the other ingredients of this medicine listed in Section 6. are taking tizanidine (see section 2: Taking other medicines)

Warnings and precautions.

Talk to your doctor before taking Ciprofloxacin 500mg Tablets.

if you have ever had kidney problems because your treatment may need to be adjusted if you suffer from epilepsy or other neurological conditions if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Tablets if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin if you have myasthenia gravis (a type of muscle weakness) if you have heart problems : Caution should be taken when using this kind of medicine, if you were born with or have a family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Ciprofloxacin 500mg Tablets) if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD) (disease of the red blood cells based on a hereditary enzyme deficiency)because taking ciprofloxacin may lead to a destruction of red blood cells causing anaemia. Signs of anaemia are a feeling of weakness and in more severe cases, breathlessness and pale skin.

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While taking Ciprofloxacin 500mg Tablets.

Tell your doctor immediately if any of the following occurs while taking Ciprofloxacin 500mg Tablets . Your doctor will decide whether treatment with Ciprofloxacin 500mg Tablets needs to be stopped.

Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even after the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint or experiencing dizziness when standing up. If this happens stop taking Ciprofloxacin and contact your doctor immediately. If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately. Pain and swelling in the joints and tendinitis , in particular of the Achilles (heel) tendon. This medicine may cause these side effects, particularly if you are older or take medicine of the steroid group, such as hydrocortisone. . Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciprofloxacin therapy If you experience these symptoms rest the sore leg and consult your doctor immediately. Avoid any unnecessary exercise as this might increase the risk of tendon rupture. if you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin and contact your doctor immediately. You may experience psychiatric reactions the first time you take Ciprofloxacin. If you suffer from depression or psychosis , your symptoms may become worse under treatment with Ciprofloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciprofloxacin and contact your doctor immediately. You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens stop taking Ciprofloxacin and contact your doctor immediately. Hypoglycaemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately. Diarrhoea may develop while you are taking antibiotics including Ciprofloxacin, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements and contact your doctor. T ell the doctor or laboratory staff that you are taking Ciprofloxacin if you have to provide a blood or urine sample. If you suffer from kidney problems , tell the doctor because your dose may need to be adjusted. Ciprofloxacin may cause liver damage : If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or tenderness of the stomach, stop taking Ciprofloxacin and contact your doctor immediately. Ciprofloxacin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine. Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin. Avoid exposure to strong sunlight, sunlamps or other sources of UV radiation. If exposure to sunlight is inevitable you should use sun cream to protect yourself. If you experience a fever, rash, itching or small red spots on the skin, you should consult your doctor immediately since the treatment may be discontinued. Crystalluria , (presence of crystals in the urine with discomfort when passing urine) may occur. Consult your doctor as your urine needs to be tested. Furthermore, you should drink a sufficient amount of liquid (about 1.5-2 litres per day). Tuberculosis test ( Mycobacterium ). Ciprofloxacin may cause a false test result. If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

Other medicines and Ciprofloxacin 500mg Tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ciprofloxacin can increase the level of the following substances in the blood:

Do not take Ciprofloxacin together with tizanidine , because this may cause side effects such as low blood pressure and sleepiness (see section 2: "Do not take Ciprofloxacin").

If Ciprofloxacin 500mg Tablets and one of the following medicines are given at the same time, special care must be taken:

Tell your doctor if you are taking:

Vitamin K antagonists (e. g. warfarin) or other oral-anti-coagulants (to thin the blood) probenecid (for gout) methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) theophylline (for breathing problems) tizanidine (for muscle spasticity in multiple sclerosis) olanzapine and clozapine (antipsychotics) ropinirole (for Parkinson’s disease) phenytoin (for epilepsy) metoclopramide (for nausea and vomiting) cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation) anti-arrhythmics: medicines that can alter your heart rhythm (e. g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides ), some antipsychotics.

Ciprofloxacin may increase the levels of the following medicines in your blood:

pentoxifylline (for circulatory disorders) caffeine duloxetine (for depression, diabetic nerve damage or incontinence) lidocaine (for heart conditions or anaesthetic use) sildenafil (e. g. for erectile dysfunction).

Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you take or wish to take:.

antacids omeprazole mineral supplements sucralfate a polymeric phosphate binder (e. g. sevelamer or lanthanum carbonate) medicine or supplements containing calcium, magnesium, aluminium or iron .

If these preparations are essential, take Ciprofloxacin about two hours before or no sooner than four hours after taking them.

Ciprofloxacin 500mg Tablets with food and drink.

Large amounts of dairy products particularly milk or yoghurt may slow down ciprofloxacin uptake, therefore ciprofloxacin should be taken 1 to 2 hours before or at least 4 hours after these products.

Tell your doctor that you are taking ciprofloxacin because pain relief and sedative medicines administered prior to surgery can also be affected by ciprofloxacin.

If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe another medicine or to adjust the dose of Ciprofloxacin 500mg Tablets or the other medicine.

It is advisable never to use several medicines at the same time without consulting your doctor first.

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of Ciprofloxacin during pregnancy.

Ciprofloxacin is passed into human breast milk. You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.

Driving and using machines.

Ciprofloxacin can reduce your attention. If you suffer from dizziness, do not drive or operate machines, which require your full concentration.

3. How to take Ciprofloxacin 500mg Tablets.

You should follow your doctor's instructions and check the pharmacist's label for how many tablets to take, and when. The usual doses for different types of infections treated with Ciprofloxacin 500mg Tablets are given below as a guide:

Respiratory tract infections 1 tablet twice a day for 7 to 14 days.

Pyelonephritis 1 tablet twice a day for 7 to 14 days.

Prostatitis 1 tablet twice a day for up to 28 days.

Severe gastroenteritis 1 tablet twice a day for 3 to 7 days.

Skin and soft tissue infections 1 tablet twice a day for 5 to 10 days.

Bone and joint infections 1 tablet twice a day for 4 to 6 weeks or longer.

Severe systemic infections 1 tablet twice a day.

Acute, uncomplicated gonorrhea a single dose of 1 tablet.

The actual dose may be adjusted to take into account your age, severity of infection and how well your kidneys are working. If you have a severe infection and serious kidney problems your doctor may take regular blood samples to check your recovery and ensure you are receiving the correct dose. Ideally these tablets should be swallowed whole with a glass of water. These tablets can be taken at any time, with or without food. Taking the tablets on an empty stomach will speed up the uptake, whilst dairy products such as milk or yoghurt may slow down the uptake of ciprofloxacin in the stomach.

If you take more Ciprofloxacin 500mg Tablets than you should.

If you take more than you should, or in the event of an overdose, seek medical advice immediately and, if possible, take any remaining tablets or this leaflet with you to show the doctor.

If you forget to take Ciprofloxacin 500mg Tablets.

If you forget to take your medicine take the missed dose as soon as possible and then continue as normal. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for the forgotten one.

If you stop taking Ciprofloxacin 500mg Tablets.

You should continue to take these tablets for as long as directed by your doctor. It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects.

Like all medicines, this medicine can cause side-effects although not everybody gets them.

muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tone and cramping, inflammation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions) unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy) (see Section 2: Warnings and precautions) severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal – serum sickness) (see Section 2: Warnings and precautions) mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2 Warnings and precautions) depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide) flu-like symptoms, followed by a painful red or purplish rash that spreads, blisters on your skin, mouth, nose or genitals, or red, painful, watery eyes, signs of the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis yellow and/or itchy skin, a sign of jaundice (cholestatic icterus).

Common side effects (may affect up to 1 in 10 people):

Uncommon side effects (may affect up to 1 in 100 people):

fungal superinfections a high concentration of eosinophils, a type of white blood cell. loss of appetite (anorexia) hyperactivity or agitation headache, dizziness, sleeping problems or taste disorders vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind increased amount of certain substances in the blood (transaminase and/or bilirubin) rash, itching or hives joint pain in adults poor kidney function pains in your muscles and bones, feeling unwell (asthenia), or fever increase in blood alkaline phosphatase (a certain substance in the blood).

Rare side effects (may affect up to 1 in 1,000 people):

inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and precautions) changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes) allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) increased blood sugar levels (hyperglycaemia) decreased blood sugar levels (hypoglycaemia) (see Section 2: Warnings and precautions) confusion, disorientation, anxiety reactions, strange dreams, or hallucinations pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see Section 2: Warnings and precautions), or giddiness eyesight problems including double vision (diplopia) ringing in the ear (tinnitus), temporary hearing loss (particularly high frequencies), impaired hearing increased heart rate (tachycardia) widening of blood vessel (vasodilation), low blood pressure, or fainting shortness of breath (dyspnoea) including asthmatic symptoms, swelling of the voice box (larynx) with difficulties in breathing (larynx oedema) liver disorders, or hepatitis sensitivity to light (see Section 2: Warnings and precautions) sudden (acute) kidney failure, blood or crystals in the urine with discomfort when passing urine (crystalluria) (see Section 2: Warnings and precautions), urinary tract inflammation fluid retention or excessive sweating increased levels of the enzyme amylase.

Very rare side effects (may affect up to 1 in 10,000 people):

reduction in red blood cells due to extensive destruction of these cells (haemolytic anaemia), a dangerous drop in a type of white blood cells (agranulocytosis), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Warnings and precautions) migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and psuedotumor cerebri) visual colour distortions inflammation of the wall of the blood vessels (vasculitis) pancreatitis death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure small pin-point bleeding under the skin (petechiae); various skin eruptions or rashes worsening of the symptoms of myasthenia gravis (see Section2: Warnings and precautions).

Frequency not known (cannot be estimated from the available data)

trouble associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the extremities abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart) pustular rash influence on blood clotting (in patients treated with Vitamin K antagonists).

Reporting of side effects.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: mhra. gov. uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin 500mg Tablets.

Keep this medicine out of the sight and reach of children. Do not store above 25°C and keep in the original container. Do not use this medicine after the expiry date which is stated on the label after ‘Exp (MM/YY)’. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information.

What Ciprofloxacin 500mg Tablets contain:

Each tablet contains ciprofloxacin hydrochloride equivalent to 500mg ciprofloxacin. The other ingredients are maize starch, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 400 and titanium dioxide (E171).

What Ciprofloxacin 500mg Tablets looks like and contents of the pack:

Ciprofloxacin 500mg Tablets are white, oval shaped film-coated tablets debossed ‘C500’ on one side with a breakline on the other. They are packaged in blister packs of 10, 12, 20 or 100 tablets or also in high-density polyethylene containers of 50, 100 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

6 Riverview Road.

6 Riverview Road.

Ciprofloxacin 500mg Tablets PL08553/0174.

Date of preparation 11/2018.

Report Side Effect Related Medicines Same active ingredients Same company Bookmark Email.

Company contact details.

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, Hull, HU17 0LD.

+44 (0)1482 860228.

+44 (0)1748 828873.

+44 (0)1482 389858.

+44 (0)1482 860204.

+44 (0)1748 828801.

Este site usa cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continuar.

Fluxacord Uses.

1 day 2 days 3 days 5 days 1 week 2 weeks 1 month 3 month 3 month" id="key9"> > 3 month.

What is Fluxacord?

Fluxacord injection is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure.

Fluxacord belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Fluxacord indications.

Fluxacord Injection, USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see for specific recommendations.

Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia), Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible Enterococcus faecalis.

Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae*. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.

*Fluxacord is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Nosocomial Pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.

Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections (used in conjunction with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.

Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

Empirical Therapy for Febrile Neutropenic Patients in combination with piperacillin sodium.

Pediatric Patients (1 to 17 years of age)

Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.

NOTE: Although effective in clinical trials, Fluxacord is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Fluxacord, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Adult and Pediatric Patients.

Inhalational Anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Fluxacord serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.6 Supportive clinical information for Fluxacord for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Fluxacord. Therapy with Fluxacord Injection, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Fluxacord. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fluxacord Injection, USP and other antibacterial drugs, Fluxacord Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

How should I use Fluxacord?

Use Fluxacord as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Fluxacord comes with an extra patient information sheet called a Medication Guide. Leia atentamente. Read it again each time you get Fluxacord refilled. Take Fluxacord by mouth with the evening meal, unless directed otherwise by your doctor. Swallow Fluxacord whole with a full glass of water. Do not break, crush, or chew before swallowing. If you cannot swallow Fluxacord whole, tell your doctor. Drinking extra fluids while you are taking Fluxacord is recommended. Check with your doctor for instructions. If you also take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate, do not take them within 6 hours before or 2 hours after taking Fluxacord. Check with your doctor if you have questions. If you also take sevelamer, do not take it within 4 hours before or after taking Fluxacord. Check with your doctor if you have questions. To clear up your infection completely, take Fluxacord for the full course of treatment. Keep taking it even if you feel better in a few days. Avoid taking Fluxacord with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Fluxacord as part of a full meal that contains milk or milk products is permitted. If you miss a dose of Fluxacord, take it as soon as possible if you remember on the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.

Ask your health care provider any questions you may have about how to use Fluxacord.

Uses of Fluxacord in details.

Fluxacord is used to treat wide range of bacterial infections including lung or respiratory tract infections, eye infection, bladder and kidney infections, reproductive tract infections, skin and soft tissue infections and bone and joint infections.

Fluxacord description.

Fluxacord is a drug used to treat bacterial infections. It is a second generation fluoroquinolone antibacterial. It kills bacteria by interfering with the enzymes that cause DNA to rewind after being copied, which stops DNA and protein synthesis.

Fluxacord is marketed worldwide with over three hundred different brand names. In the United States, Canada and the UK, it is marketed as Ciloxan, Cipro, Cipro XR, Cipro XL Ciproxin and, most recently, Proquin. In Mexico it is available over the counter and marketed under the names Ciproflox or Ciprofloxacino. In Ecuador it is available and marketed under the name Cidrax. In Nigeria it is sold as Ciprotab while in Bangladesh it is marketed as Tablets and Microcapsules for Suspension by numerous companies, one of which is by Edruc Limited as Cipron. Additionally, Fluxacord is available as a generic drug under a variety of different brand names and is also available for limited use in veterinary medicine.

Fluxacord was first patented in 1983 by Bayer A. G. and subsequently approved by the United States Food and Drug Administration (FDA) in 1987.Fluxacord has 12 F. D.A.-approved human uses and other veterinary uses, but it is often used for non-approved uses (off-label).

Fluxacord interacts with other drugs, herbal and natural supplements, and thyroid medications.

Active ingredient matches for Fluxacord:

List of Fluxacord substitutes (brand and generic names)

View all 6837 substitutes for Fluxacord.

Referências.

DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed. nlm. nih. gov/dailymed/se. (accessed September 18, 2017). Wikipedia. "ciprofloxacin: Link to the compound information in Wikipedia.". https://en. wikipedia/wiki/Ciprofloxa. (accessed September 18, 2017). PubChem. "ciprofloxacin". https://pubchem. ncbi. nlm. nih. gov/compoun. (accessed September 18, 2017). FDA Orange Book. "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE: The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).". https://fda. gov/Drugs/InformationOnD. (accessed September 18, 2017).

User reports.

Consumer reported useful.

Consumer reported price estimates.

1 consumer reported time for results.

As part of the reports released by ndrugs website users, it takes 5 days and a few days before you notice an improvement in your health conditions.

Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Fluxacord. To get the time effectiveness of using Fluxacord drug by other patients, please click here.

5 consumers reported age.

Consumer reviews.

Não há comentários ainda. Be the first to write one!

Forexin Uses.

1 day 2 days 3 days 5 days 1 week 2 weeks 1 month 3 month 3 month" id="key9"> > 3 month.

What is Forexin?

Forexin is used to treat bacterial infections in many different parts of the body. Forexin oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Forexin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Forexin extended-release tablets are only used to treat urinary tract infections, including acute uncomplicated pyelonephritis.

Proquin® XR tablets are only used to treat uncomplicated or simple urinary tract infections (acute cystitis).

Forexin belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Forexin will not work for colds, flu, or other virus infections.

Forexin is available only with your doctor's prescription.

Forexin indications.

Forexin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration is needed.

Urinary Tract Infections.

Forexin is indicated in adult patients for treatment of urinary tract infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Lower Respiratory Tract Infections.

Forexin is indicated in adult patients for treatment of lower respiratory tract infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.* Also, Forexin is indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis.

Nosocomial Pneumonia.

Forexin is indicated in adult patients for treatment of nosocomial pneumoniacaused by caused by Haemophilus influenzae or Klebsiella pneumoniae.

Skin and Skin Structure Infections.

Forexin is indicated in adult patients for treatment of skin and skin structure infectionscaused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections.

Forexin is indicated in adult patients for treatment of bone and joint infectionscaused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections.

Forexin is indicated in adult patients for treatment of complicated intra-abdominal infections(used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Acute Sinusitis.

Forexin is indicated in adult patients for treatment of acute sinusitiscaused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Chronic Bacterial Prostatitis.

Forexin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Empirical Therapy for Febrile Neutropenic Patients.

Forexin is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium.

Complicated Urinary Tract Infections and Pyelonephritis.

Forexin is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli.

Inhalational Anthrax (post-exposure)

Forexin is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Forexin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for Forexin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

​1.12 Plague.

​Forexin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of Forexin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.​

Limitation of Use.

Use in Pediatric Patients.

Although effective in clinical trials, Forexin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Forexin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Lower Respiratory Tract Infections.

Forexin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Forexin and other antibacterial drugs, Forexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Forexin. Therapy with Forexin may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Forexin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

How should I use Forexin?

Use Forexin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Forexin comes with an extra patient information sheet called a Medication Guide. Leia atentamente. Read it again each time you get Forexin refilled. An extra patient leaflet may be available with Forexin. Talk to your pharmacist if you have questions about this information. Take Forexin by mouth with or without food. The preferred dosing time is 2 hours after a meal. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Take Forexin with a full glass of water (8 oz [240 mL]). Drinking extra fluids while you are taking Forexin is recommended. Check with your doctor for instructions. If you also take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate, do not take them within 6 hours before or 2 hours after taking Forexin. Check with your doctor if you have questions. If you also take sevelamer, do not take it within 4 hours before or after taking Forexin. Check with your doctor if you have questions. Forexin works best if it is taken at the same time each day. To clear up your infection completely, take Forexin for the full course of treatment. Keep taking it even if you feel better in a few days. Avoid taking Forexin with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Forexin as part of a full meal that contains milk or milk products is permitted. Do not miss any doses. If you miss a dose of Forexin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Forexin.

Uses of Forexin in details.

Forexin is used to treat wide range of bacterial infections including lung or respiratory tract infections, eye infection, bladder and kidney infections, reproductive tract infections, skin and soft tissue infections and bone and joint infections.

Forexin description.

Forexin is a drug used to treat bacterial infections. It is a second generation fluoroquinolone antibacterial. It kills bacteria by interfering with the enzymes that cause DNA to rewind after being copied, which stops DNA and protein synthesis.

Forexin is marketed worldwide with over three hundred different brand names. In the United States, Canada and the UK, it is marketed as Ciloxan, Cipro, Cipro XR, Cipro XL Ciproxin and, most recently, Proquin. In Mexico it is available over the counter and marketed under the names Ciproflox or Ciprofloxacino. In Ecuador it is available and marketed under the name Cidrax. In Nigeria it is sold as Ciprotab while in Bangladesh it is marketed as Tablets and Microcapsules for Suspension by numerous companies, one of which is by Edruc Limited as Cipron. Additionally, Forexin is available as a generic drug under a variety of different brand names and is also available for limited use in veterinary medicine.

Forexin was first patented in 1983 by Bayer A. G. and subsequently approved by the United States Food and Drug Administration (FDA) in 1987.Forexin has 12 F. D.A.-approved human uses and other veterinary uses, but it is often used for non-approved uses (off-label).

Forexin interacts with other drugs, herbal and natural supplements, and thyroid medications.

Active ingredient matches for Forexin:

List of Forexin substitutes (brand and generic names):

View all 6836 substitutes for Forexin.

Referências.

DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed. nlm. nih. gov/dailymed/se. (accessed September 18, 2017). Wikipedia. "ciprofloxacin: Link to the compound information in Wikipedia.". https://en. wikipedia/wiki/Ciprofloxa. (accessed September 18, 2017). PubChem. "ciprofloxacin". https://pubchem. ncbi. nlm. nih. gov/compoun. (accessed September 18, 2017). FDA Orange Book. "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE: The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).". https://fda. gov/Drugs/InformationOnD. (accessed September 18, 2017).

User reports.

Consumer reported useful.

Consumer reported price estimates.

Consumer reported time for results.

Consumer reported age.

Consumer reviews.

Não há comentários ainda. Be the first to write one!