Ilocin

Ilocin está indicado no tratamento / profilaxia de infecções causadas por organismos sensíveis à ilocin: -

- infecções do trato respiratório superior e inferior

- Infecções na pele e nos tecidos moles

- infecções ósseas

- infecções gastrointestinais

- infecções orais / dentárias

- infecções oculares

- doenças sexualmente transmissíveis

- profilaxia da tosse convulsa e da difteria

- como alternativa à penicilina para infecções estafilocócicas em pacientes sensíveis

Deve-se considerar as orientações oficiais sobre o uso apropriado de agentes antimicrobianos

Para o tratamento de infecções oculares superficiais envolvendo a conjuntiva e / ou córnea causadas por organismos suscetíveis à eritromicina.

Para profilaxia de oftalmia neonatorum devido a N. gonorrhoeae ou C. trachomatis.

A eficácia da eritromicina na prevenção da oftalmia causada pela produção de penicilinase N. gonorrhoeae não está estabelecido.

Para bebês nascidos de mães com gonorréia clinicamente aparente, devem ser administradas injeções intravenosas ou intramusculares de penicilina G cristalina aquosa; uma dose única de 50.000 unidades para bebês a termo ou 20.000 unidades para bebês com baixo peso ao nascer. A profilaxia tópica sozinha é inadequada para esses bebês.

Para reduzir o desenvolvimento de bactérias resistentes a medicamentos e manter a eficácia de Ery-Ped e outros medicamentos antibacterianos, o Ery-Ped deve ser usado apenas para tratar ou prevenir infecções comprovadas ou fortemente suspeitas de serem causadas por bactérias suscetíveis. Quando informações sobre cultura e suscetibilidade estão disponíveis, elas devem ser consideradas na seleção ou modificação da terapia antibacteriana. Na ausência de tais dados, epidemiologia local e padrões de suscetibilidade podem contribuir para a seleção empírica da terapia.

Ery-Ped é indicado no tratamento de infecções causadas por cepas suscetíveis dos organismos designados nas doenças listadas abaixo :

Infecções do trato respiratório superior de grau leve a moderado causadas por Streptococcus pyogenes, Streptococcus pneumoniaeou Haemophilus influenzae (quando usado concomitantemente com doses adequadas de sulfonamidas, já que muitas cepas de H. influenzae não são suscetíveis às concentrações de eritromicina normalmente alcançadas). (Vejo rotulagem apropriada de sulfonamida para prescrever informações.)

Infecções do trato respiratório inferior de gravidade leve a moderada causadas por Pneumonia por Streptococcus ou Streptococcus pyogenes.

Listeriose causada por Listeria monocytogenes.

Coqueluche (tosse convulsa) causada por Bordetella pertussis A eritromicina é eficaz na eliminação do organismo da nasofaringe de indivíduos infectados, tornando-os não infecciosos. Alguns estudos clínicos sugerem que a eritromicina pode ser útil na profilaxia da coqueluche em indivíduos suscetíveis expostos.

Infecções do trato respiratório devido a Mycoplasma pneumoniae.

Infecções na pele e na estrutura da pele de gravidade leve a moderada causadas por Streptococcus pyogenes ou Staphylococcus aureus (estafilococos resistentes podem surgir durante o tratamento).

Difteria: Infecções devido a Corynebacterium diftheriae, como complemento da antitoxina, para impedir o estabelecimento de portadores e erradicar o organismo nos portadores.

Eritrasma: No tratamento de infecções devido a Corynebacterium minutissimum Amebíase intestinal causada por. Entamoebahistolytica (somente eritromicina oral). A amebíase entérica extra requer tratamento com outros agentes. Doença inflamatória pélvica aguda causada por Neisseria gonorrhoeae: Como medicamento alternativo no tratamento de doença inflamatória pélvica aguda causada por N. gonorrhoeae em pacientes do sexo feminino com histórico de sensibilidade à penicilina. Os pacientes devem fazer um teste sorológico para sífilis antes de receber eritromicina como tratamento de gonorréia e um teste sorológico de acompanhamento para sífilis após 3 meses.

Sífilis Causada por Treponemapallidum : A eritromicina é uma escolha alternativa de tratamento para sífilis primária em pacientes alérgicos à penicilina. Na sífilis primária, os exames de líquido espinhal devem ser realizados antes do tratamento e como parte do acompanhamento após o tratamento.

As eritromicina são indicadas para o tratamento das seguintes infecções causadas por Chlamydia trachomatis: Conjuntivite do recém-nascido, pneumonia da infância e infecções urogenitais durante a gravidez. Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento de infecções uretrais, endocervicais ou retais não complicadas em adultos devido à clamídia tracomatis.

Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento da uretrite nongonocócica causada por Ureia urealítica plasmática.

Doença dos legionários causada por Legionella pneumophila Embora não tenham sido realizados estudos controlados de eficácia clínica. in vitro e dados clínicos preliminares limitados sugerem que a eritromicina pode ser eficaz no tratamento da doença dos legionários.

Profilaxia

Prevenção de ataques iniciais de febre reumática

A penicilina é considerada pela American Heart Association como a droga de escolha na prevenção de ataques iniciais de febre reumática (tratamento de Streptococcus pyogenes infecções do trato respiratório superior, p.amigdalite ou faringite). A eritromicina é indicada para o tratamento de pacientes alérgicos à penicilina.⁴ A dose terapêutica deve ser administrada por 10 dias.

Prevenção de ataques recorrentes de febre reumática

A penicilina ou sulfonamidas são consideradas pela American Heart Association como os medicamentos de escolha na prevenção de ataques recorrentes de febre reumática. Em pacientes alérgicos à penicilina e sulfonamidas, a eritromicina oral é recomendada pela American Heart Association na profilaxia a longo prazo da faringite estreptocócica (para prevenção de ataques recorrentes de febre reumática).⁴

Para a profilaxia e tratamento de infecções causadas por organismos sensíveis à eritromicina.

A eritromicina é altamente eficaz no tratamento de uma grande variedade de infecções clínicas, como:

1. Infecções do trato respiratório superior: amigdalite, abscesso peritonsilar, faringite, laringite, sinusite, infecções secundárias na gripe e resfriados comuns

2). Infecções do trato respiratório inferior: traqueite, bronquite aguda e crônica, pneumonia (pneumonia lóbrica, broncopneumonia, pneumonia atípica primária), bronquiectasia, doença do legionário

3). Infecção no ouvido: otite média e otite externa, mastoidite

4). Infecções orais: gengivite, angina de Vincent

5). Infecções oculares: blefarite

6. Infecções na pele e nos tecidos moles: furúnculos e carbúnculos, paroníquia, abscessos, acne pustular, impetigo, celulite, erisipela

7). Infecções gastrointestinais: colecistite, enterocolite estafilocócica

8). Profilaxia: trauma pré e pós-operatório, queimaduras, febre reumática

9. Outras infecções: osteomielite, uretrite, gonorréia, sífilis, linfogranuloma venéreo, difteria, prostatite, escarlatina

Para reduzir o desenvolvimento de bactérias resistentes a medicamentos e manter a eficácia dos comprimidos de Ilocin e outros medicamentos antibacterianos, os comprimidos de Ilocin devem ser usados apenas para tratar ou prevenir infecções comprovadas ou fortemente suspeitas de serem causadas por bactérias suscetíveis. Quando informações sobre cultura e suscetibilidade estão disponíveis, elas devem ser consideradas na seleção ou modificação da terapia antibacteriana. Na ausência de tais dados, epidemiologia local e padrões de suscetibilidade podem contribuir para a seleção empírica da terapia.

Os comprimidos de locina são indicados no tratamento de infecções causadas por cepas suscetíveis dos microrganismos designados nas doenças listadas abaixo :

Infecções do trato respiratório superior de grau leve a moderado causadas por Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (quando usado concomitantemente com doses adequadas de sulfonamidas, já que muitas cepas de H. influenzae não são suscetíveis às concentrações de eritromicina normalmente alcançadas). (Vejo rotulagem apropriada de sulfonamida para prescrever informações.)

Infecções do trato respiratório inferior de gravidade leve a moderada causadas por Streptococcus pyogenes ou Streptococcus pneumoniae.

Listeriose causada por Listeria monocytogenes.

Infecções do trato respiratório devido a Mycoplasma pneumoniae.

Infecções na pele e na estrutura da pele de gravidade leve a moderada causadas por Streptococcus pyogenes ou Staphylococcus aureus (estafilococos resistentes podem surgir durante o tratamento).

Coqueluche (tosse convulsa) causada por Bordetella pertussis A eritromicina é eficaz na eliminação do organismo da nasofaringe de indivíduos infectados, tornando-os não infecciosos. Alguns estudos clínicos sugerem que a eritromicina pode ser útil na profilaxia da coqueluche em indivíduos suscetíveis expostos.

Difteria: Infecções devido a Corynebacterium diftheriae, como complemento da antitoxina, para impedir o estabelecimento de portadores e erradicar o organismo nos portadores.

Eritrasma: No tratamento de infecções devido a Corynebacterium minutissimum.

Amebíase intestinal causada por Entamoeba histolytica (somente eritromicina oral). A amebíase extraentérica requer tratamento com outros agentes.

Doença inflamatória pélvica aguda causada por Neisseria gonorrhoeae: Lactobionato de eritrocin®-I.V. (ladobionato de eritromicina para injeção, USP) seguido por base de eritromicina por via oral, como medicamento alternativo no tratamento de doença inflamatória pélvica aguda causada por N. gonorrhoeae em pacientes do sexo feminino com histórico de sensibilidade à penicilina. Os pacientes devem fazer um teste sorológico para sífilis antes de receber eritromicina como tratamento de gonorréia e um teste sorológico de acompanhamento para sífilis após 3 meses.

As eritromicina são indicadas para o tratamento das seguintes infecções causadas por Chlamydia trachomatis: conjuntivite do recém-nascido, pneumonia da infância e infecções urogenitais durante a gravidez. Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento de infecções uretrais, endocervicais ou retais não complicadas em adultos devido a Chlamydia trachomatis.

Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento da uretrite nongonocócica causada por Ureaplasma urealyticum.

Sífilis primária causada por Treponema pallidum A eritromicina (somente formas orais) é uma escolha alternativa de tratamento para a sífilis primária em pacientes alérgicos às penicilinas. No tratamento da sífilis primária, o líquido espinhal deve ser examinado antes do tratamento e como parte do acompanhamento após o tratamento.

Doença dos legionários causada por Legionella pneumophila Embora não tenham sido realizados estudos controlados de eficácia clínica. in vitro e dados clínicos preliminares limitados sugerem que a eritromicina pode ser eficaz no tratamento da doença dos legionários.

Profilaxia

Prevenção de ataques iniciais de febre reumática

A penicilina é considerada pela American Heart Association como a droga de escolha na prevenção de ataques iniciais de febre reumática (tratamento de infecções por Streptococcus pyogenes do trato respiratório superior, p.amigdalite ou faringite).⁴ A eritromicina é indicada para o tratamento de pacientes alérgicos à penicilina. A dose terapêutica deve ser administrada por dez dias.

Prevenção de ataques recorrentes de febre reumática

A penicilina ou sulfonamidas são consideradas pela American Heart Association como os medicamentos de escolha na prevenção de ataques recorrentes de febre reumática. Em pacientes alérgicos à penicilina e sulfonamidas, a eritromicina oral é recomendada pela American Heart Association na profilaxia a longo prazo da faringite estreptocócica (para a prevenção de ataques recorrentes de febre reumática).⁴

A eritromicina é indicada no tratamento de infecções causadas por cepas suscetíveis dos organismos designados nas doenças listadas abaixo :

Infecções do trato respiratório superior de grau leve a moderado causadas por Streptococcus pyogenes, Streptococcus pneumoniae, ou Haemophilus influenzae (quando usado concomitantemente com doses adequadas de sulfonamidas, já que muitas cepas de H. influenzae não são suscetíveis às concentrações de eritromicina normalmente alcançadas) (ver rotulagem apropriada de sulfonamida para prescrever informações).

Infecções do trato respiratório inferior de gravidade leve a moderada causadas por Streptococcus pneumoniae ou Streptococcus pyogenes.

Listeriose causada por Listeria monocytogenes.

Coqueluche (tosse convulsa) causada por Bordetella pertussis A eritromicina é eficaz na eliminação do organismo da nasofaringe de indivíduos infectados, tornando-os não infecciosos. Alguns estudos clínicos sugerem que a eritromicina pode ser útil na profilaxia da coqueluche em indivíduos suscetíveis expostos.

Infecções do trato respiratório devido a Mycoplasma pneumoniae.

Infecções na pele e na estrutura da pele de gravidade leve a moderada causadas por Streptococcus pyogenes ou Staphylococcus aureus (estafilococos resistentes podem surgir durante o tratamento).

Difteria: Infecções devido a Corynebacterium diftheriae, como complemento da antitoxina, para impedir o estabelecimento de portadores e erradicar o organismo nos portadores.

Eritrasma: No tratamento de infecções devido a Corynebacterium minutissimum.

Sífilis causada por Treponema pallidum: A eritromicina é uma escolha alternativa de tratamento para sífilis primária em pacientes alérgicos à penicilina. Na sífilis primária, os exames de líquido espinhal devem ser realizados antes do tratamento e como parte do acompanhamento após o tratamento.

Amebíase intestinal causada por Entamoeba histolytica (somente eritromicina oral). A amebíase extraentérica requer tratamento com outros agentes.

Doença inflamatória pélvica aguda causada por Neisseria gonorréiae: Lactobionato de eritromicina para injeção, USP seguido por base de eritromicina por via oral, como medicamento alternativo no tratamento de doença inflamatória pélvica aguda causada por N. gonorrhoeae em pacientes do sexo feminino com histórico de sensibilidade à penicilina. Os pacientes devem fazer um teste sorológico para sífilis antes de receber eritromicina como tratamento de gonorréia e um teste sorológico de acompanhamento para sífilis após 3 meses.

As eritromicina são indicadas para o tratamento das seguintes infecções causadas por Chlamydia trachomatis: conjuntivite do recém-nascido, pneumonia da infância e infecções urogenitais durante a gravidez. Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento de infecções uretrais, endocervicais ou retais não complicadas em adultos devido a Chlamydia trachomatis.

Quando as tetraciclinas são contra-indicadas ou não são toleradas, a eritromicina é indicada para o tratamento da uretrite nongonocócica causada por Ureaplasma urealyticum.

Doença dos legionários causada por Legionella pneumophila Embora não tenham sido realizados estudos controlados de eficácia clínica. in vitro e dados clínicos preliminares limitados sugerem que a eritromicina pode ser eficaz no tratamento da doença dos legionários.

Profilaxia

Prevenção de ataques iniciais de febre reumática: A penicilina é considerada pela American Heart Association como a droga de escolha na prevenção de ataques iniciais de febre reumática (tratamento de infecções por Streptococcus pyogenes do trato respiratório superior, p.amigdalite ou faringite). A eritromicina é indicada para o tratamento de pacientes alérgicos à penicilina.³ A dose terapêutica deve ser administrada por dez dias.

Prevenção de ataques recorrentes de febre reumática: A penicilina ou as sulfonamidas são consideradas pela American Heart Association como os medicamentos de escolha na prevenção de ataques recorrentes de febre reumática. Em pacientes alérgicos à penicilina e sulfonamidas, a eritromicina oral é recomendada pela American Heart Association na profilaxia a longo prazo da faringite estreptocócica (para a prevenção de ataques recorrentes de febre reumática).³

Para reduzir o desenvolvimento de bactérias resistentes a medicamentos e manter a eficácia de Ilocin e outros medicamentos antibacterianos, Ilocin deve ser usado apenas para tratar ou prevenir infecções comprovadas ou fortemente suspeitas de serem causadas por bactérias suscetíveis. Quando informações sobre cultura e suscetibilidade estão disponíveis, elas devem ser consideradas na seleção ou modificação da terapia antibacteriana. Na ausência de tais dados, epidemiologia local e padrões de suscetibilidade podem contribuir para a seleção empírica da terapia.

Ilocin® (gel tópico de eritromicina) O gel tópico é indicado para o tratamento tópico da acne vulgar.

Method of Administration

For oral administration only

Posology

Adults, including elderly, and children over 8 years:

250 - 500 mg every six hours, up to 4 g daily for more severe infections.

For acne vulgaris the usual dose is 250 mg three times daily before meals for one to four weeks and then reduced to twice daily until improvement occurs.

Children 2 to 8 years:

250 mg every six hours, doubled for severe infections.

30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Children up to 2 years:

125 mg every six hours, doubled for severe infections.

30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Renal Impairment

If impairment is severe (GFR< 10 ml/min), the daily dose should not exceed 1.5 g due to risk of ototoxicity.

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Ilocin™ Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

Ery-Ped (erythromycin ethylsuccinate) oral suspensions may be administered without regard to meals.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections, the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours. For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

The following dosage schedule is suggested for mild to moderate infections:

Adults

400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate.

In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.

For treatment of urethritis due to C. trachomatisor U. urealyticum: 800 mg three times a day for 7 days.

For treatment of primary syphilis: Adults: 48 to 64 g given in divided doses over a period of 10 to 15 days.

For intestinal amebiasis: Adults: 400 mg four times daily for 10 to 14 days.Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days.

For use in pertussis: Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

For treatment of Legionnaires' Disease: Although optimal doses have not been established, doses utilized in reported clinical data were 1.6 to 4 g daily in divided doses.

For oral administration

Adults and children over 8 years: For mild to moderate infections 2g daily in divided doses. Up to 4g daily in severe infections.

Elderly: No special dosage recommendations.

Note: For younger children, infants and babies, Erythroped, erythromycin ethylsuccinate suspensions, are normally recommended. The recommended dose for children age 2-8 years, for mild to moderate infections, is 1 gram daily in divided doses. The recommended dose for infants and babies, for mild to moderate infections, is 500 mg daily in divided doses. For severe infections doses may be doubled.

In most patients, Ilocin tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when either Ilocin 333 mg or Ilocin 500 mg tablets are given in the fasting state (at least ½ hour and preferably 2 hours before meals).

Adults

The usual dosage of Ilocin tablets are one 333 mg tablet every 8 hours or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.⁴

Conjunctivitis of the Newborn Caused by Chlamydia trachomatis

Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.⁴

Pneumonia of Infancy Caused by Chlamydia trachomatis

Although the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital Infections During Pregnancy Due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day or two erythromycin 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days.⁶

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days.⁶

For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.⁶

Primary Syphilis

30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae

500 mg Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours, or 333 mg of erythromycin base orally every 8 hours for 7 days.

Intestinal Amebiasis

Adults

500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertussis

Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Legionnaires' Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

Erythromycin is well absorbed and may be given without regard to meals. Optimum blood levels are obtained in a fasting state (administration at least one half hour and preferably two hours before or after a meal); however, blood levels obtained upon administration of enteric-coated erythromycin products in the presence of food are still above minimal inhibitory concentrations (MICs) of most organisms for which erythromycin is indicated.

Adults: The usual dose is 250 mg every 6 hours taken one hour before meals. If twice-a-day dosage is desired, the recommended dose is 500 mg every 12 hours. Dosage may be increased up to 4 grams per day, according to the severity of the infection. Twice-a-day dosing is not recommended when doses larger than 1 gram daily are administered.

Children: Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day in divided doses. For the treatment of more severe infections, this dose may be doubled.

Streptococcal infections

A therapeutic dosage of oral erythromycin should be administered for at least 10 days. For continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the dose is 250 mg twice a day.

Primary syphilis

30 to 40 grams given in divided doses over a period of 10 to 15 days.

Intestinal amebiasis

250 mg four times daily for 10 to 14 days for adults; 30 to 50 mg/kg/day in divided doses for 10 to 14 days for children.

Legionnaires' disease

Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1 to 4 grams daily in divided doses).

Urogenital infections during pregnancy due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is erythromycin 500 mg, by mouth, 4 times a day on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of 250 mg, by mouth, 4 times a day should be used for at least 14 days.

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis in whom tetracyclines are contraindicated or not tolerated: 500 mg, by mouth, 4 times a day for at least 7 days.

Pertussis

Although optimum dosage and duration of therapy have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Nongonococcal urethritis due to Ureaplasma urealyticum

When tetracycline is contraindicated or not tolerated: 500 mg of erythromycin, orally, four times daily for at least 7 days.

Acute pelvic inflammatory disease due to N gonorrhoeae

500 mg IV of erythromycin lactobionate for injection, USP every 6 hours for 3 days followed by 250 mg of erythromycin, orally every six hours for 7 days.

Ilocin® (erythromycin topical gel) Topical Gel should be applied sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.

Ilocin está contra-indicado em doentes a tomar sinvastatina, tolterodina, mizolastina, amisulprida, astemizol, terfenadina, domperidona, cisaprida ou pimozida.

A ilocina é contra-indicada com ergotamina e di-hidroergotamina.

Este medicamento está contra-indicado em pacientes com histórico de hipersensibilidade à eritromicina.

A eritromicina é contra-indicada em pacientes com hipersensibilidade conhecida a este antibiótico.

A eritromicina é contra-indicada em pacientes em uso de terfenadina, astemizol, pimozida ou cisaprida. (Vejo PRECAUÇÕES - INTERAÇÕES DE DROGAS.)

Hipersensibilidade conhecida à eritromicina.

A eritromicina está contra-indicada em pacientes em uso de sinvastatina, tolterodina, mizolastina, amisulprida, astemizol, terfenadina, domperidona, cisaprida ou pimozida.

A eritromicina é contra-indicada com ergotamina e di-hidroergotamina.

A eritromicina é contra-indicada em pacientes com hipersensibilidade conhecida a este antibiótico.

A eritromicina é contra-indicada em pacientes em uso de terfenadina, astemizol, cisaprida, pimozida, ergotamina ou di-hidroergotamina. (Vejo PRECAUÇÕES:INTERAÇÕES DE DROGAS.)

A eritromicina é contra-indicada em pacientes com hipersensibilidade conhecida a este antibiótico.

A eritromicina é contra-indicada em pacientes em uso de terfenadina, astemizol, cisaprida, pimozida, ergotamina ou di-hidroergotamina (ver PRECAUÇÕES: INTERAÇÕES DE DROGAS).

Ilocin® (gel tópico de eritromicina) O gel tópico é contra-indicado naqueles indivíduos que demonstraram hipersensibilidade a qualquer um de seus componentes.

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Ilocin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with Ilocin.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including Ilocin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

Patients receiving Ilocin concurrently with drugs which can cause prolongation of the QT interval should be carefully monitored. The concomitant use of Ilocin with some of these drugs is contraindicated.

There have been reports suggesting Ilocin does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral Ilocin for early syphilis should be treated with an appropriate penicillin regimen.

There have been reports that Ilocin may aggravate the weakness of patients with myasthenia gravis.

Ilocin interferes with the fluorometric determination of urinary catecholamines.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving Ilocin concomitantly with statins.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following Ilocin therapy. In one cohort of 157 newborns who were given Ilocin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since Ilocin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of Ilocin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

This medicine contains 1193 mg sorbitol in each 5 ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium free'.

WARNINGS

No information provided.

PRECAUTIONS

General

The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies.

Pregnancy

Teratogenic effects -Pregnancy category B

Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Nursing Mothers

Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS and DOSAGE AND ADMINISTRATION.

WARNINGS

Hepatotoxicity

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.

QT Prolongation

Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Syphilis in Pregnancy

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ery-Ped, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (e.g. verapamil, amlodipine, diltiazem) (see PRECAUTIONS – DRUG INTERACTIONS).

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at their recommended doses (see PRECAUTIONS – DRUG INTERACTIONS).

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin)

PRECAUTIONS

General

Prescribing Ery-Ped in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS sections.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.⁵ Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs. Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy. Observational studies in humans have reported cardiovascular malformations after exposure to drug products containing erythromycin during early pregnancy.

REFERENCES

5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999;354 (9196): 2101-5

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with erythromycin stearate in rats up to 400 mg/kg/day and in mice up to 500 mg/kg/day (approximately 1-2 fold of the maximum human dose on a body surface area basis) did not provide evidence of tumorigenicity. Erythromycin stearate did not show genotoxic potential in the Ames, and mouse lymphoma assays or induce chromosomal aberrations in CHO cells. There was no apparent effect on male or female fertility in rats treated with erythromycin base by oral gavage at 700 mg/kg/day (approximately 3 times the maximum human dose on a body surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy Category B: There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended human dose on a body surface area) prior to and during mating, during gestation, and through weaning. No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day (approximately 1-3 times the maximum recommended human dose).

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. (See WARNINGS).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See PRECAUTIONS - DRUG INTERACTIONS).

Ery-Ped 200 contains 117.5 mg (5.1 mEq) of sodium per individual dose.

Ery-Ped 400 contains 117.5 mg (5.1 mEq) of sodium per individual dose.

Based on the 200 mg/5 mL strength, at the usual recommended doses, adult patients would receive a total of 940 mg/day (40.8 mEq) of sodium. Based on the 400 mg/5 mL strength, at the usual recommended doses, adult patients would receive a total of 470 mg/day (20.4 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.

Erythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including erythromycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Patients receiving erythromycin concurrently with drugs which can cause prolongation of the QT interval should be carefully monitored. The concomitant use of erythromycin with some of these drugs is contraindicated.

There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with statins.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

WARNINGS

Hepatotoxicity

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.

QT Prolongation

Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Syphilis in Pregnancy

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ilocin tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) (see PRECAUTIONS: DRUG INTERACTIONS).

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at their recommended doses (see PRECAUTIONS: DRUG INTERACTIONS).

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

PRECAUTIONS

General

Prescribing Ilocin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See and WARNINGS.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10% for infants who took erythromycin for 15-21 days.⁵ Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Observational studies in humans have reported cardiovascular malformations after exposure to drug products containing erythromycin during early pregnancy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with erythromycin stearate in rats up to 400 mg/kg/day and in mice up to about 500 mg/kg/day (approximately 1-2 fold of the maximum human dose on a body surface area basis) did not provide evidence of tumorigenicity. Erythromycin stearate did not show genotoxic potential in the Ames, and mouse lymphoma assays or induce chromosomal aberrations in CHO cells. There was no apparent effect on male or female fertility in rats treated with erythromycin base by oral gavage at 700 mg/kg/day (approximately 3 times the maximum human dose on a body surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy Category B: There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended human dose on a body surface area) prior to and during mating, during gestation, and through weaning. No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day (approximately 1-3 times the maximum recommended human dose).

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. (See WARNINGS).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See PRECAUTIONS: DRUG INTERACTIONS).

Ilocin 333 MG Tablets contain 0.5 mg (0.02 mEq) of sodium per individual dose.

Ilocin 500 MG Tablets do not contain sodium.

REFERENCES

5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999; 354 (9196):2101-5.

WARNINGS

Hepatotoxicity

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products.

QT Prolongation

Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Syphilis in pregnancy

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile-associated diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ilocin Capsules, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (for example, verapamil, amlodipine, diltiazem) (see PRECAUTIONS: DRUG INTERACTIONS).

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine. This interaction is potentially life-threatening, and may occure while using both drugs at their recommended doses (see PRECAUTIONS: DRUG INTERACTIONS).

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

PRECAUTIONS

General

Prescribing Ilocin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function (see CLINICAL PHARMACOLOGY and WARNINGS.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5 percent) developed symptoms of non bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1 percent for infants who took erythromycin for 8 to 14 days and 10 percent for infants who took erythromycin for 15 to 21 days.⁴ Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

REFERENCES

4. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study. The Lancet 1999;354 (9196): 2101-5.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term (2-year) oral studies conducted in rats with erythromycin base did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25 percent of diet.

Pregnancy

Teratogenic Effects

Pregnancy Category B: There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25 percent of diet) prior to and during mating, during gestation, and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Geriatric Use

Clinical studies with Ilocin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients (see WARNINGS).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin (see PRECAUTIONS: DRUG INTERACTIONS.)

Ilocin 250 mg capsules do not contain sodium.

WARNINGS

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

PRECAUTIONS

General: For topical use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. The use of antibiotic agents may be associated with the overgrowth of antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures.

Avoid contact with eyes and all mucous membranes.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No animal studies have been performed to evaluate carcinogenic and mutagenic potential or effects on fertility of topical erythromycin. However, long-term (2-year) oral studies in rats with erythromycin ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.

Pregnancy: Teratogenic effects: Pregnancy Category B: There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation and through weaning of two successive litters. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.

Nursing Women: It is not known whether erythromycin is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Nenhum conhecido

Nenhum relatado

Doenças do sangue e do sistema linfático

Eosinofilia.

Distúrbios do sistema imunológico

Ocorreram reações alérgicas que variam de urticária e erupções cutâneas leves a anafilaxia.

Distúrbios psiquiátricos

Alucinações

Distúrbios do sistema nervoso

Houve relatos isolados de efeitos colaterais transitórios do sistema nervoso central, incluindo confusão, convulsões e vertigem; no entanto, uma relação de causa e efeito não foi estabelecida.

Distúrbios oculares

Neuropatia óptica mitocondrial

Distúrbios do ouvido e do labirinto

Surdez, zumbido

Houve relatos isolados de perda auditiva reversível ocorrendo principalmente em pacientes com insuficiência renal ou em altas doses.

Cardiopatias

Prolongamento do intervalo QTc, torsades de pointes, palpitações e distúrbios do ritmo cardíaco, incluindo taquiarritmias ventriculares.

Distúrbios vasculares

Hipotensão.

Distúrbios gastrointestinais

Os efeitos colaterais mais frequentes das preparações orais de Ilocin são gastrointestinais e estão relacionados à dose. Os seguintes foram relatados:

desconforto abdominal superior, náusea, vômito, diarréia, pancreatite, anorexia, estenose pilórica hipertrófica infantil.

A colite pseudomembranosa foi raramente relatada em associação com a terapia com Ilocin.

Distúrbios hepatobiliares

Hepatite colestática, icterícia, di hepáticoydisfunção, hepatomegalia, insuficiência hepática, hepatite hepatocelular.

Afecções dos tecidos cutâneos e subcutâneos

Erupções cutâneas, prurido, urticária, exantema, angioedema, síndrome de Stevens-Johnson, necrólise epidérmica tóxica, eritema multiforme.

Desconhecido: pustulose exantema aguda generalizada (AGEP).

Distúrbios renais e urinários

Nefrite intersticial

Perturbações gerais e alterações no local de administração

Dor no peito, febre, mal-estar.

Investigações

Aumento dos valores das enzimas hepáticas.

Relato de suspeitas de reações adversas

A notificação de suspeitas de reações adversas após a autorização do medicamento é importante. Permite a monitorização contínua da relação benefício / risco do medicamento. Solicita-se aos profissionais de saúde que relatem qualquer suspeita de reação adversa por meio do Esquema do Cartão Amarelo em www.mhra.gov.uk/yellowcard ou pesquisem o Cartão Amarelo MHRA no Google Play ou na Apple App Store.

As reações adversas mais frequentemente relatadas são pequenas irritações oculares, vermelhidão e reações de hipersensibilidade.

Para relatar REAÇÕES ADVERSAS SUSPEITAS, entre em contato com a Fera Pharmaceuticals, LLC pelo telefone (414) 434-6604 de segunda a sexta-feira, das 9h às 17h EST ou FDA pelo telefone 1-800-FDA-1088 ou www.fda.gov/medwatch.

Os efeitos colaterais mais frequentes das preparações orais de eritromicina são gastrointestinais e estão relacionados à dose. Eles incluem náusea, vômito, dor abdominal, diarréia e anorexia. Podem ocorrer sintomas de hepatite, disfunção hepática e / ou resultados anormais dos testes de função hepática. (Vejo AVISO seção.)

O aparecimento de sintomas de colite pseudomembranosa pode ocorrer durante ou após o tratamento antibacteriano. (Vejo AVISO.)

A eritromicina tem sido associada ao prolongamento do intervalo QT e arritmias ventriculares, incluindo taquicardia ventricular e torsades de pointes. (Vejo AVISO.)

Ocorreram reações alérgicas que variam de urticária a anafilaxia. Reações cutâneas que variam de erupções leves a eritema multiforme, síndrome de Stevens-Johnson e necrólise epidérmica tóxica foram relatadas raramente.

Houve relatos de nefrite intersticial coincidentes com o uso de eritromicina.

Houve raros relatos de pancreatite e convulsões.

Houve relatos isolados de perda auditiva reversível ocorrendo principalmente em pacientes com insuficiência renal e em pacientes recebendo altas doses de eritromicina.

Doenças do sangue e do sistema linfático :

Eosinofilia.

Cardiopatias

Prolongamento do intervalo QTc, torsades de pointes, palpitações e distúrbios do ritmo cardíaco, incluindo taquiarritmias ventriculares.

Distúrbios do ouvido e do labirinto

Surdez, zumbido

Houve relatos isolados de perda auditiva reversível ocorrendo principalmente em pacientes com insuficiência renal ou altas doses.

Distúrbios gastrointestinais

Os efeitos colaterais mais frequentes das preparações orais de eritromicina são gastrointestinais e estão relacionados à dose. Os seguintes foram relatados:

desconforto abdominal superior, náusea, vômito, diarréia, pancreatite, anorexia, estenose pilórica hipertrófica infantil.

A colite pseudomembranosa foi raramente relatada em associação com a terapia com eritromicina.

Perturbações gerais e alterações no local de administração

Dor no peito, febre, mal-estar.

Distúrbios hepatobiliares

Hepatite colestática, icterícia, disfunção hepática, hepatomegalia, insuficiência hepática, hepatite hepatocelular.

Distúrbios do sistema imunológico

Ocorreram reações alérgicas que variam de urticária e erupções cutâneas leves a anafilaxia.

Investigações

Aumento dos valores das enzimas hepáticas.

Distúrbios do sistema nervoso

Houve relatos isolados de efeitos colaterais transitórios do sistema nervoso central, incluindo confusão, convulsões e vertigem; no entanto, uma relação de causa e efeito não foi estabelecida.

Distúrbios psiquiátricos

Alucinações

Distúrbios oculares

Neuropatia óptica mitocondrial

Distúrbios renais e urinários

Nefrite intersticial

Afecções dos tecidos cutâneos e subcutâneos

Erupções cutâneas, prurido, urticária, exantema, angioedema, síndrome de Stevens-Johnson, necrólise epidérmica tóxica, eritema multiforme.

Desconhecido: pustulose exantema aguda generalizada (AGEP).

Distúrbios vasculares

Hipotensão.

Relato de suspeitas de reações adversas

A notificação de suspeitas de reações adversas após a autorização do medicamento é importante. Permite a monitorização contínua da relação benefício / risco do medicamento. Solicita-se aos profissionais de saúde que relatem qualquer suspeita de reação adversa por meio do Esquema do Cartão Amarelo em: www.mhra.gov.uk/yellowcard

Os efeitos colaterais mais frequentes das preparações orais de eritromicina são gastrointestinais e estão relacionados à dose. Eles incluem náusea, vômito, dor abdominal, diarréia e anorexia. Podem ocorrer sintomas de hepatite, disfunção hepática e / ou resultados anormais dos testes de função hepática. (Vejo AVISO) O aparecimento de sintomas de colite pseudomembranosa pode ocorrer durante ou após o tratamento antibacteriano. (Vejo. AVISO) A eritromicina tem sido associada ao prolongamento do intervalo QT e arritmias ventriculares, incluindo taquicardia ventricular e torsades de pointes. (Vejo. AVISO.)

Ocorreram reações alérgicas que variam de urticária a anafilaxia. Reações cutâneas que variam de erupções leves a eritema multiforme, síndrome de Stevens-Johnson e necrólise epidérmica tóxica foram relatadas raramente.

Houve relatos de nefrite intersticial coincidentes com o uso de eritromicina.

Houve raros relatos de pancreatite e convulsões.

Houve relatos isolados de perda auditiva reversível ocorrendo principalmente em pacientes com insuficiência renal e em pacientes recebendo altas doses de eritromicina.

Os efeitos colaterais mais frequentes das preparações orais de eritromicina são gastrointestinais e estão relacionados à dose. Eles incluem náusea, vômito, dor abdominal, diarréia e anorexia. Podem ocorrer sintomas de hepatite, disfunção hepática e / ou resultados anormais dos testes de função hepática (ver AVISO).

O aparecimento de sintomas de colite pseudomembranosa pode ocorrer durante ou após o tratamento antibacteriano (ver AVISO).

A eritromicina tem sido associada ao prolongamento do intervalo QT e arritmias ventriculares, incluindo taquicardia ventricular e torsade de pointes (ver AVISO).

Ocorreram reações alérgicas que variam de urticária a anafilaxia. Reações cutâneas que variam de erupções leves a eritema multiforme, síndrome de Stevens-Johnson e necrólise epidérmica tóxica foram relatadas raramente.

Houve relatos de nefrite intersticial coincidentes com o uso de eritromicina.

Houve relatos de pancreatite e convulsões.

Houve relatos isolados de perda auditiva reversível ocorrendo principalmente em pacientes com insuficiência renal e em pacientes recebendo altas doses de eritromicina.

Em ensaios clínicos controlados, a incidência de queimação associada ao gel tópico Ilocin® (gel tópico de eritromicina) foi de aproximadamente 25%. As seguintes reações adversas locais adicionais foram relatadas ocasionalmente: descamação, secura, coceira, eritema e oleosidade. Irritação dos olhos e sensibilidade da pele também foram relatadas com o uso tópico de eritromicina. Foi relatada reação urticária generalizada, possivelmente relacionada ao uso de eritromicina, que exigiu terapia sistêmica com esteróides.

Grupo farmacoterapêutico : Macrolídeos, Lincosamidas e Estreptograminas, Macrolídeos, Código ATC : J01F A01

Mecanismo de ação

A ilocina exerce sua ação antimicrobiana ligando-se à subunidade ribossômica 50S de microrganismos suscetíveis e suprime a síntese de proteínas. A ilocina é geralmente ativa contra a maioria das cepas dos seguintes organismos, tanto in vitro quanto em infecções clínicas.

Bactérias Gram-positivas - Listeria monocytogenes, Corynebacterium diftheriae (como um complemento à antitoxina), Staphylococci spp, Streptococci spp (incluindo Enterococci).

Bactérias Gram-negativas - Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.

Mycoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.

Outros organismos - Treponema pallidum, Chlamydia spp, Clostridia spp, formas L, agentes que causam tracoma e linfogranuloma venéreo.

Nota: A maioria das cepas de Haemophilus influenzae é suscetível às concentrações atingidas após doses comuns.

Código ATC: J01FA01

A eritromicina exerce sua ação antimicrobiana ligando-se à subunidade ribossômica 50S de microrganismos suscetíveis e suprime a síntese de proteínas. A eritromicina é geralmente ativa contra a maioria das cepas dos seguintes organismos, tanto in vitro quanto em infecções clínicas :

Bactérias Gram-positivas - Listeria monocytogenes, Corynebacterium diftheriae (como um complemento à antitoxina), Staphylococci spp, Streptococci spp (incluindo Enterococci).

Bactérias Gram-negativas - Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.

Mycoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.

Outros organismos - Treponema pallidum, Chlamydia spp, Clostridia spp, formas L, agentes que causam tracoma e linfogranuloma venéreo.

Nota: A maioria das cepas de Haemophilus influenzae é suscetível às concentrações atingidas após doses comuns.

A absorção é facilitada se o estômago estiver vazio.

Os níveis sanguíneos máximos ocorrem normalmente dentro de 1 hora após a administração dos grânulos de etilsuccinato de Ilocin. A meia-vida de eliminação é de aproximadamente 2 horas. As doses podem ser administradas 2, 3 ou 4 vezes ao dia.

O etilsuccinato de ilocin é menos suscetível que o Ilocin ao efeito adverso do ácido gástrico. É absorvido pelo intestino delgado. É amplamente distribuído pelos tecidos do corpo. Pouco metabolismo ocorre e apenas cerca de 5% é excretado na urina. É excretado principalmente pelo fígado.

O medicamento não é removido por diálise peritoneal ou hemodiálise. Difunde-se rapidamente em fluidos intracelulares e a atividade antibacteriana pode ser alcançada em essencialmente todos os locais. Há alguma retenção no fígado e no baço. Somente baixas concentrações são alcançadas no líquido cefalorraquidiano, a menos que as meninges estejam inflamadas. Difusão no humor aquoso, mas não o humor vítreo do olho é bom. Uma proporção significativa está ligada às proteínas séricas.

Os níveis sanguíneos máximos ocorrem normalmente dentro de uma hora após a administração dos grânulos de etilsuccinato de eritromicina. A meia-vida de eliminação é de aproximadamente duas horas. As doses podem ser administradas duas, três ou quatro vezes ao dia.

O etilsuccinato de eritromicina é menos suscetível que a eritromicina ao efeito adverso do ácido gástrico. É absorvido pelo intestino delgado. É amplamente distribuído pelos tecidos do corpo. Pouco metabolismo ocorre e apenas cerca de 5% é excretado na urina. É excretado principalmente pelo fígado.

Ninguém sabe

Nenhum afirmou.

60 ml de suspensão : para reconstituir, adicione 48 ml de água e agite vigorosamente o frasco. A suspensão resultante é de cor amarela.

100 ml de suspensão : para reconstituir, adicione 80 ml de água e agite vigorosamente o frasco. A suspensão resultante é de cor amarela

140 ml de suspensão : para reconstituir, adicione 112 ml de água e agite vigorosamente o frasco. A suspensão resultante é de cor amarela

Não aplicável