Bonac

Bonac is indicated for the treatment / prophylaxis of infections caused by Bonac-sensitive organisms:-

- upper and lower respiratory tract infections

- Skin and soft tissue infections

- bone infections

- gastro -intestinal infections

- oral/dental infections

- eye infections

- sexually transmitted diseases

- prophylaxis of whooping cough and diphtheria

- as an alternative to penicillin for staphylococcal infections in sensitive patients

Consideration should be given to official guidance on the appropriate use of antimicrobial agents

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.

The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ery-Ped and other antibacterial drugs, Ery-Ped 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.

Ery-Ped is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae,or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)

Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumonia or Streptococcus pyogenes.

Listeriosis caused by Listeria monocytogenes.

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoebahistolytica (oral erythromycins only). Extra enteric amebiasis requires treatment with other agents. Acute Pelvic Inflammatory Disease Caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Syphilis Caused by Treponemapallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.

Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Urea plasma urealyticum.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever

Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.⁴ The therapeutic dose should be administered for 10 days.

Prevention of Recurrent Attacks of Rheumatic Fever

Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).⁴

For the prophylaxis and treatment of infections caused by erythromycin-sensitive organisms.

Erythromycin is highly effective in the treatment of a great variety of clinical infections such as:

1. Upper Respiratory Tract infections: tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in influenza and common colds

2. Lower Respiratory Tract infections: tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire's disease

3. Ear infection: otitis media and otitis externa, mastoiditis

4. Oral infections: gingivitis, Vincent's angina

5. Eye infections: blepharitis

6. Skin and soft tissue infections: boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas

7. Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis

8. Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever

9. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bonac tablets and other antibacterial drugs, Bonac tablets 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.

Bonac tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae.

Listeriosis caused by Listeria monocytogenes.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever

Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).⁴ Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever

Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).⁴

Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information).

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.

Listeriosis caused by Listeria monocytogenes.

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever: Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.³ The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever: Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).³

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bonac and other antibacterial drugs, Bonac 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.

Bonac® (erythromycin topical gel) Topical Gel is indicated for the topical treatment of acne vulgaris.

Método de administración

Solo para administración oral

Posología

Adultos, incluidos ancianos y niños mayores de 8 años :

250 - 500 mg cada seis horas, hasta 4 g diarios para infecciones más graves.

Para el acné vulgar, la dosis habitual es de 250 mg tres veces al día antes de las comidas durante una o cuatro semanas y luego se reduce a dos veces al día hasta que se produce una mejoría.

Niños de 2 a 8 años :

250 mg cada seis horas, duplicado para infecciones graves.

30 mg / kg / día en dosis divididas. Para infecciones graves de hasta 50 mg / kg / día en dosis divididas.

Niños hasta 2 años :

125 mg cada seis horas, duplicado para infecciones graves.

30 mg / kg / día en dosis divididas. Para infecciones graves de hasta 50 mg / kg / día en dosis divididas.

Deterioro renal

Si el deterioro es grave (TFG <10 ml / min), la dosis diaria no debe exceder 1,5 g debido al riesgo de ototoxicidad.

En el tratamiento de infecciones oculares superficiales, se debe aplicar una cinta de aproximadamente 1 cm de longitud de ungüento oftálmico Bonac ™ directamente a la estructura infectada hasta 6 veces al día, dependiendo de la gravedad de la infección.

Para la profilaxis de la conjuntivitis gonocococo o clamidial neonatal, se debe inculcar una cinta de ungüento de aproximadamente 1 cm de longitud en cada saco conjuntival inferior. La pomada no debe enjuagarse del ojo después de la instilación. Se debe usar un nuevo tubo para cada bebé.

Se pueden administrar suspensiones orales de ory-Ped (eritromicina etilsuccinato) sin tener en cuenta las comidas.

Niños

La edad, el peso y la gravedad de la infección son factores importantes para determinar la dosis adecuada. En infecciones leves a moderadas, la dosis habitual de eritromicina etilsuccinato para niños es de 30 a 50 mg / kg / día en dosis igualmente divididas cada 6 horas. Para infecciones más graves, esta dosis puede duplicarse. Si se desea una dosis de dos veces al día, se puede administrar la mitad de la dosis diaria total cada 12 horas. Las dosis también se pueden administrar tres veces al día administrando un tercio de la dosis diaria total cada 8 horas.

Se sugiere el siguiente programa de dosificación para infecciones leves a moderadas:

Adultos

400 mg de eritromicina etilsuccinato cada 6 horas es la dosis habitual. La dosis puede aumentarse hasta 4 g por día según la gravedad de la infección. Si se desea una dosis de dos veces al día, se puede administrar la mitad de la dosis diaria total cada 12 horas. Las dosis también se pueden administrar tres veces al día administrando un tercio de la dosis diaria total cada 8 horas.

Para el cálculo de la dosis en adultos, use una proporción de 400 mg de actividad eritromicina como etilsuccinato a 250 mg de actividad eritromicina como estearato, base o estolato.

En el tratamiento de infecciones estreptocócicas, se debe administrar una dosis terapéutica de eritromicina etilsuccinato durante al menos 10 días. En la profilaxis continua contra las recurrencias de infecciones estreptocócicas en personas con antecedentes de enfermedad cardíaca reumática, la dosis habitual es de 400 mg dos veces al día.

Para el tratamiento de la uretritis debido a C. trachomatisor U. urealyticum: 800 mg tres veces al día durante 7 días.

Para el tratamiento de la sífilis primaria: Adultos: 48 a 64 g administrados en dosis divididas durante un período de 10 a 15 días.

Para la amebiasis intestinal: Adultos: 400 mg cuatro veces al día durante 10 a 14 días. Niños: 30 a 50 mg / kg / día en dosis divididas durante 10 a 14 días.

Para uso en tos ferina: Aunque no se han establecido la dosis y la duración óptimas, las dosis de eritromicina utilizadas en estudios clínicos informados fueron de 40 a 50 mg / kg / día, administradas en dosis divididas durante 5 a 14 días.

Para el tratamiento de la enfermedad del legionario : Aunque no se han establecido dosis óptimas, las dosis utilizadas en los datos clínicos informados fueron de 1.6 a 4 g diarios en dosis divididas.

Para administración oral

Adultos y niños mayores de 8 años: para infecciones leves a moderadas 2 g al día en dosis divididas. Hasta 4 g diarios en infecciones graves.

Ancianos: No hay recomendaciones especiales de dosificación.

Nota: Para niños más pequeños, bebés y bebés, normalmente se recomiendan suspensiones de eritromicina etilsuccinato de eritromicina. La dosis recomendada para niños de 2 a 8 años, para infecciones leves a moderadas, es de 1 gramo diario en dosis divididas. La dosis recomendada para bebés y bebés, para infecciones leves a moderadas, es de 500 mg diarios en dosis divididas. Para infecciones graves, las dosis pueden duplicarse.

En la mayoría de los pacientes, las tabletas de Bonac se absorben bien y se pueden dosificar por vía oral sin tener en cuenta las comidas. Sin embargo, se obtienen niveles óptimos en sangre cuando se administran tabletas Bonac 333 mg o Bonac 500 mg en ayunas (al menos ½ hora y preferiblemente 2 horas antes de las comidas).

Adultos

La dosis habitual de tabletas Bonac es una tableta de 333 mg cada 8 horas o una tableta de 500 mg cada 12 horas. La dosis puede aumentarse hasta 4 g por día según la gravedad de la infección. Sin embargo, no se recomienda dosificar dos veces al día cuando se administran dosis superiores a 1 g al día.

Niños

La edad, el peso y la gravedad de la infección son factores importantes para determinar la dosis adecuada. La dosis habitual es de 30 a 50 mg / kg / día, en dosis igualmente divididas. Para infecciones más graves, esta dosis puede duplicarse pero no debe exceder los 4 g por día.

En el tratamiento de infecciones estreptocócicas del tracto respiratorio superior (p. Ej., amigdalitis o faringitis), la dosis terapéutica de eritromicina debe administrarse durante al menos diez días.

La American Heart Association sugiere una dosis de 250 mg de eritromicina por vía oral, dos veces al día en profilaxis a largo plazo de infecciones estreptocócicas del tracto respiratorio superior para la prevención de ataques recurrentes de fiebre reumática en pacientes alérgicos a la penicilina y las sulfonamidas.⁴

Conjuntivitis del recién nacido causada por Chlamydia trachomatis

Suspensión oral de eritromicina 50 mg / kg / día en 4 dosis divididas durante al menos 2 semanas.⁴

Neumonía de la infancia causada por Chlamydia trachomatis

Aunque no se ha establecido la duración óptima de la terapia, la terapia recomendada es la suspensión oral de eritromicina 50 mg / kg / día en 4 dosis divididas durante al menos 3 semanas.

Infecciones urogenitales durante el embarazo debido a clamidia trachomatis

Aunque no se ha establecido la dosis óptima y la duración de la terapia, el tratamiento sugerido es de 500 mg de eritromicina por vía oral cuatro veces al día o dos tabletas de eritromicina 333 mg por vía oral cada 8 horas con el estómago vacío durante al menos 7 días. Para las mujeres que no pueden tolerar este régimen, se debe usar una dosis disminuida de una tableta de eritromicina 500 mg por vía oral cada 12 horas, una tableta de 333 mg por vía oral cada 8 horas o 250 mg por vía oral cuatro veces al día durante al menos 14 días.⁶

Para adultos con infecciones uretrales, endocervicales o rectales no complicadas causadas por Chlamydia trachomatis, cuando la tetraciclina está contraindicada o no se tolera

500 mg de eritromicina por vía oral cuatro veces al día o dos tabletas de 333 mg por vía oral cada 8 horas durante al menos 7 días.⁶

Para pacientes con uretritis nongonococo causada por Ureaplasma urealyticum cuando la tetraciclina está contraindicada o no se tolera

500 mg de eritromicina por vía oral cuatro veces al día o dos tabletas de 333 mg por vía oral cada 8 horas durante al menos siete días.⁶

Sífilis primaria

30 a 40 g administrados en dosis divididas durante un período de 10 a 15 días.

Enfermedad inflamatoria pélvica aguda causada por N. gonorrhoeae

500 mg de lactobionato de eritrocina-I.V. (lactobionato de eritromicina inyectable, USP) cada 6 horas durante 3 días, seguido de 500 mg de base de eritromicina por vía oral cada 12 horas, o 333 mg de base de eritromicina por vía oral cada 8 horas durante 7 días.

Amebiasis intestinal

Adultos

500 mg cada 12 horas, 333 mg cada 8 horas o 250 mg cada 6 horas durante 10 a 14 días.

Niños

30 a 50 mg / kg / día en dosis divididas durante 10 a 14 días.

Tos ferina

Aunque no se han establecido la dosis y la duración óptimas, las dosis de eritromicina utilizadas en estudios clínicos informados fueron de 40 a 50 mg / kg / día, administradas en dosis divididas durante 5 a 14 días.

Enfermedad del legionario

Aunque no se ha establecido una dosis óptima, las dosis utilizadas en los datos clínicos informados fueron de 1 a 4 g diarios en dosis divididas.

La eritromicina se absorbe bien y se puede administrar sin tener en cuenta las comidas. Los niveles óptimos de sangre se obtienen en ayunas (administración al menos media hora y preferiblemente dos horas antes o después de una comida) sin embargo, Los niveles sanguíneos obtenidos al administrar productos eritromicina recubiertos de enteric en presencia de alimentos aún están por encima de las concentraciones inhibitorias mínimas (MICs) de la mayoría de los organismos para los que está indicada la eritromicina.

Adultos: La dosis habitual es de 250 mg cada 6 horas tomadas una hora antes de las comidas. Si se desea una dosis dos veces al día, la dosis recomendada es de 500 mg cada 12 horas. La dosis puede aumentarse hasta 4 gramos por día, según la gravedad de la infección. No se recomienda dosificar al día cuando se administran dosis superiores a 1 gramo al día.

Niños: La edad, el peso y la gravedad de la infección son factores importantes para determinar la dosis adecuada. La dosis habitual es de 30 a 50 mg / kg / día en dosis divididas. Para el tratamiento de infecciones más graves, esta dosis puede duplicarse.

Infecciones estreptocócicas

Se debe administrar una dosis terapéutica de eritromicina oral durante al menos 10 días. Para la profilaxis continua contra las recurrencias de infecciones estreptocócicas en personas con antecedentes de enfermedad cardíaca reumática, la dosis es de 250 mg dos veces al día.

Sífilis primaria

30 a 40 gramos administrados en dosis divididas durante un período de 10 a 15 días.

Amebiasis intestinal

250 mg cuatro veces al día durante 10 a 14 días para adultos; 30 a 50 mg / kg / día en dosis divididas durante 10 a 14 días para niños.

Enfermedad del legionario

Aunque no se han establecido dosis óptimas, las dosis utilizadas en los datos clínicos informados fueron las recomendadas anteriormente (1 a 4 gramos diarios en dosis divididas).

Infecciones urogenitales durante el embarazo debido a Chlamydia trachomatis

Aunque no se ha establecido la dosis óptima y la duración de la terapia, el tratamiento sugerido es eritromicina 500 mg, por vía oral, 4 veces al día con el estómago vacío durante al menos 7 días. Para las mujeres que no pueden tolerar este régimen, se debe usar una dosis disminuida de 250 mg por vía oral, 4 veces al día durante al menos 14 días.

Para adultos con infecciones uretrales, endocervicales o rectales sin complicaciones causadas por Chlamydia trachomatis en quienes las tetraciclinas están contraindicadas o no toleradas: 500 mg, por vía oral, 4 veces al día durante al menos 7 días.

Tos ferina

Aunque no se ha establecido una dosis óptima y la duración de la terapia, las dosis de eritromicina utilizadas en estudios clínicos informados fueron de 40 a 50 mg / kg / día, administradas en dosis divididas durante 5 a 14 días.

Uretritis nogonocócica debido a Ureaplasma urealyticum

Cuando la tetraciclina está contraindicada o no se tolera: 500 mg de eritromicina, por vía oral, cuatro veces al día durante al menos 7 días.

Enfermedad inflamatoria pélvica aguda debido a N gonorrhoeae

500 mg IV de lactobionato de eritromicina inyectable, USP cada 6 horas durante 3 días seguido de 250 mg de eritromicina, por vía oral cada seis horas durante 7 días.

Bonac® (gel tópico de eritromicina) El gel tópico debe aplicarse con moderación como una película delgada en el área o áreas afectadas una o dos veces al día después de que la piel se limpia completamente y se seca. Si no ha habido mejoría después de 6 a 8 semanas, o si la afección empeora, se debe suspender el tratamiento y volver a consultar al médico. Extienda el medicamento ligeramente en lugar de frotarlo. No hay datos que comparen directamente la seguridad y la eficacia de b.i.d. versus q.d. dosificación.

Bonac está contraindicado en pacientes que toman simvastatina, tolterodina, mizolastina, amisulprida, astemizol, terfenadina, domperidona, cisaprida o pimozida.

Bonac está contraindicado con ergotamina y dihidroergotamina.

Este medicamento está contraindicado en pacientes con antecedentes de hipersensibilidad a la eritromicina.

La eritromicina está contraindicada en pacientes con hipersensibilidad conocida a este antibiótico.

La eritromicina está contraindicada en pacientes que toman terfenadina, astemizol, pimozida o cisaprida. (Ver PRECAUCIONES - INTERACCIONES DE DROGAS.)

Hipersensibilidad conocida a la eritromicina.

La eritromicina está contraindicada en pacientes que toman simvastatina, tolterodina, mizolastina, amisulprida, astemizol, terfenadina, domperidona, cisaprida o pimozida.

La eritromicina está contraindicada con ergotamina y dihidroergotamina.

La eritromicina está contraindicada en pacientes con hipersensibilidad conocida a este antibiótico.

La eritromicina está contraindicada en pacientes que toman terfenadina, astemizol, cisaprida, pimozida, ergotamina o dihidroergotamina. (Ver PRECAUCIONES :INTERACCIONES DE DROGAS.)

La eritromicina está contraindicada en pacientes con hipersensibilidad conocida a este antibiótico.

La eritromicina está contraindicada en pacientes que toman terfenadina, astemizol, cisaprida, pimozida, ergotamina o dihidroergotamina (ver PRECAUCIONES : INTERACCIONES DE DROGAS).

Bonac® (gel tópico de eritromicina) Topical Gel está contraindicado en aquellas personas que han mostrado hipersensibilidad a cualquiera de sus 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.

Bonac 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 Bonac.

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

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

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

Bonac interferes with the fluorometric determination of urinary catecholamines.

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

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following Bonac therapy. In one cohort of 157 newborns who were given Bonac 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 Bonac 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 Bonac 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 Bonac 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 Bonac 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 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%) 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).

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

Bonac 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 Bonac 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 Bonac 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 Bonac 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.)

Bonac 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.

Ninguno conocido

Ninguno reportado

Trastornos de la sangre y del sistema linfático

Eosinofilia.

Trastornos del sistema inmunitario

Se han producido reacciones alérgicas que van desde urticaria y erupciones cutáneas leves hasta anafilaxia.

Trastornos psiquiátricos

Alucinaciones

Trastornos del sistema nervioso

Ha habido informes aislados de efectos secundarios transitorios del sistema nervioso central, incluyendo confusión, convulsiones y vértigo; sin embargo, no se ha establecido una relación de causa y efecto.

Trastornos oculares

Neuropatía óptica mitocondrial

Trastornos del oído y del laberinto

Sordera, tinnitus

Se han notificado informes aislados de pérdida auditiva reversible que ocurre principalmente en pacientes con insuficiencia renal o que toman dosis altas.

Trastornos cardíacos

Prolongación del intervalo QTc, torsades de pointes, palpitaciones y trastornos del ritmo cardíaco, incluidas las taquiarritmias ventriculares.

Trastornos vasculares

Hipotensión.

Trastornos gastrointestinales

Los efectos secundarios más frecuentes de las preparaciones orales de Bonac son gastrointestinales y están relacionados con la dosis. Se ha informado lo siguiente:

molestias abdominales superiores, náuseas, vómitos, diarrea, pancreatitis, anorexia, estenosis pilórica hipertrófica infantil.

La colitis pseudomembranosa rara vez se ha informado en asociación con la terapia con Bonac.

Trastornos hepatobiliares

Hepatitis colestática, ictericia, di hepáticaydisfunción, hepatomegalia, insuficiencia hepática, hepatitis hepatocelular.

Trastornos de la piel y del tejido subcutáneo

Erupciones cutáneas, prurito, urticaria, exantema, angioedema, síndrome de Stevens-Johnson, necrólisis epidérmica tóxica, eritema multiforme.

Frecuencia no conocida: pustulosis exantematosa generalizada aguda (AGEP).

Trastornos renales y urinarios

Nefritis intersticial

Trastornos generales y condiciones del sitio de administración

Dolor en el pecho, fiebre, malestar general.

Investigaciones

Aumento de los valores de la enzima hepática.

Informe de sospechas de reacciones adversas

Informar sospechas de reacciones adversas después de la autorización del medicamento es importante. Permite un monitoreo continuo del equilibrio beneficio / riesgo del medicamento. Se les pide a los profesionales de la salud que informen sobre cualquier sospecha de reacciones adversas a través del Esquema de la Tarjeta Amarilla en www.mhra.gov.uk/yellowcard o que busquen la Tarjeta Amarilla MHRA en Google Play o Apple App Store.

Las reacciones adversas notificadas con mayor frecuencia son irritaciones oculares leves, enrojecimiento y reacciones de hipersensibilidad.

Para informar REACCIONES ADVERSAS SUSPECTADAS, comuníquese con Fera Pharmaceuticals, LLC al (414) 434-6604 de lunes a viernes de 9 a.m. a 5 p.m. EST o FDA al 1-800-FDA-1088 o www.fda.gov/medwatch.

Los efectos secundarios más frecuentes de las preparaciones orales de eritromicina son gastrointestinales y están relacionados con la dosis. Incluyen náuseas, vómitos, dolor abdominal, diarrea y anorexia. Pueden producirse síntomas de hepatitis, disfunción hepática y / o resultados anormales de la prueba de función hepática. (Ver ADVERTENCIAS sección.)

El inicio de los síntomas de colitis pseudomembranosa puede ocurrir durante o después del tratamiento antibacteriano. (Ver ADVERTENCIAS.)

La eritromicina se ha asociado con la prolongación del intervalo QT y las arritmias ventriculares, incluida la taquicardia ventricular y los torsades de pointes. (Ver ADVERTENCIAS.)

Se han producido reacciones alérgicas que van desde urticaria hasta anafilaxia. Raramente se han notificado reacciones cutáneas que van desde erupciones leves hasta eritema multiforme, síndrome de Stevens-Johnson y necrólisis epidérmica tóxica.

Ha habido informes de nefritis intersticial coincidente con el uso de eritromicina.

Ha habido informes poco frecuentes de pancreatitis y convulsiones.

Se han notificado informes aislados de pérdida auditiva reversible que ocurre principalmente en pacientes con insuficiencia renal y en pacientes que reciben altas dosis de eritromicina.

Trastornos de la sangre y del sistema linfático:

Eosinofilia.

Trastornos cardíacos

Prolongación del intervalo QTc, torsades de pointes, palpitaciones y trastornos del ritmo cardíaco, incluidas las taquiarritmias ventriculares.

Trastornos del oído y del laberinto

Sordera, tinnitus

Se han notificado informes aislados de pérdida auditiva reversible que ocurre principalmente en pacientes con insuficiencia renal o dosis altas.

Trastornos gastrointestinales

Los efectos secundarios más frecuentes de las preparaciones orales de eritromicina son gastrointestinales y están relacionados con la dosis. Se ha informado lo siguiente:

molestias abdominales superiores, náuseas, vómitos, diarrea, pancreatitis, anorexia, estenosis pilórica hipertrófica infantil.

La colitis pseudomembranosa rara vez se ha informado en asociación con la terapia con eritromicina.

Trastornos generales y condiciones del sitio de administración

Dolor en el pecho, fiebre, malestar general.

Trastornos hepatobiliares

Hepatitis colestática, ictericia, disfunción hepática, hepatomegalia, insuficiencia hepática, hepatitis hepatocelular.

Trastornos del sistema inmunitario

Se han producido reacciones alérgicas que van desde urticaria y erupciones cutáneas leves hasta anafilaxia.

Investigaciones

Aumento de los valores de la enzima hepática.

Trastornos del sistema nervioso

Ha habido informes aislados de efectos secundarios transitorios del sistema nervioso central, incluyendo confusión, convulsiones y vértigo; sin embargo, no se ha establecido una relación de causa y efecto.

Trastornos psiquiátricos

Alucinaciones

Trastornos oculares

Neuropatía óptica mitocondrial

Trastornos renales y urinarios

Nefritis intersticial

Trastornos de la piel y del tejido subcutáneo

Erupciones cutáneas, prurito, urticaria, exantema, angioedema, síndrome de Stevens-Johnson, necrólisis epidérmica tóxica, eritema multiforme.

Frecuencia no conocida: pustulosis exantematosa generalizada aguda (AGEP).

Trastornos vasculares

Hipotensión.

Informe de sospechas de reacciones adversas

Informar sospechas de reacciones adversas después de la autorización del medicamento es importante. Permite un monitoreo continuo del equilibrio beneficio / riesgo del medicamento. Se solicita a los profesionales de la salud que informen sobre cualquier sospecha de reacciones adversas a través del Esquema de la Tarjeta Amarilla en: www.mhra.gov.uk/yellowcard

Los efectos secundarios más frecuentes de las preparaciones orales de eritromicina son gastrointestinales y están relacionados con la dosis. Incluyen náuseas, vómitos, dolor abdominal, diarrea y anorexia. Pueden producirse síntomas de hepatitis, disfunción hepática y / o resultados anormales de la prueba de función hepática. (Ver ADVERTENCIAS) El inicio de los síntomas de colitis pseudomembranosa puede ocurrir durante o después del tratamiento antibacteriano. (Ver. ADVERTENCIAS) La eritromicina se ha asociado con la prolongación del intervalo QT y las arritmias ventriculares, incluida la taquicardia ventricular y los torsades de pointes. (Ver. ADVERTENCIAS.)

Se han producido reacciones alérgicas que van desde urticaria hasta anafilaxia. Raramente se han notificado reacciones cutáneas que van desde erupciones leves hasta eritema multiforme, síndrome de Stevens-Johnson y necrólisis epidérmica tóxica.

Ha habido informes de nefritis intersticial coincidente con el uso de eritromicina.

Ha habido informes poco frecuentes de pancreatitis y convulsiones.

Se han notificado informes aislados de pérdida auditiva reversible que ocurre principalmente en pacientes con insuficiencia renal y en pacientes que reciben altas dosis de eritromicina.

Los efectos secundarios más frecuentes de las preparaciones orales de eritromicina son gastrointestinales y están relacionados con la dosis. Incluyen náuseas, vómitos, dolor abdominal, diarrea y anorexia. Pueden producirse síntomas de hepatitis, disfunción hepática y / o resultados anormales de la prueba de función hepática (ver ADVERTENCIAS).

El inicio de los síntomas de colitis pseudomembranosa puede ocurrir durante o después del tratamiento antibacteriano (ver ADVERTENCIAS).

La eritromicina se ha asociado con la prolongación del intervalo QT y las arritmias ventriculares, incluida la taquicardia ventricular y la torsade de pointes (ver ADVERTENCIAS).

Se han producido reacciones alérgicas que van desde urticaria hasta anafilaxia. Raramente se han notificado reacciones cutáneas que van desde erupciones leves hasta eritema multiforme, síndrome de Stevens-Johnson y necrólisis epidérmica tóxica.

Ha habido informes de nefritis intersticial coincidente con el uso de eritromicina.

Ha habido informes de pancreatitis y convulsiones.

Se han notificado informes aislados de pérdida auditiva reversible que ocurre principalmente en pacientes con insuficiencia renal y en pacientes que reciben altas dosis de eritromicina.

En ensayos clínicos controlados, la incidencia de ardor asociado con Bonac® (gel tópico de eritromicina) Topical Gel fue aproximadamente del 25%. Las siguientes reacciones adversas locales adicionales se han informado ocasionalmente: descamación, sequedad, picazón, eritema y grasa. La irritación de los ojos y la sensibilidad de la piel también se han informado con el uso tópico de eritromicina. Se ha informado una reacción urticarial generalizada, posiblemente relacionada con el uso de eritromicina, que requirió terapia esteroide sistémica.

Grupo farmacoterapéutico: Macrólidos, lincosamidas y estreptograminas, macrólidos, Código ATC: J01F A01

Mecanismo de acción

Bonac ejerce su acción antimicrobiana al unirse a la subunidad ribosómica 50S de microorganismos susceptibles y suprime la síntesis de proteínas. Bonac generalmente es activo contra la mayoría de las cepas de los siguientes organismos tanto in vitro como en infecciones clínicas.

Bacterias gram positivas: Listeria monocytogenes, Corynebacterium diphtheriae (como complemento de la antitoxina), Staphylococci spp, Streptococci spp (incluidos los enterococos).

Bacterias gramnegativas: Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.

Micoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.

Otros organismos: Treponema pallidum, Chlamydia spp, Clostridia spp, formas L, los agentes que causan tracoma y linfogranuloma venéreo.

Nota: La mayoría de las cepas de Haemophilus influenzae son susceptibles a las concentraciones alcanzadas después de las dosis ordinarias.

Código ATC: J01FA01

La eritromicina ejerce su acción antimicrobiana al unirse a la subunidad ribosómica 50S de microorganismos susceptibles y suprime la síntesis de proteínas. La eritromicina generalmente es activa contra la mayoría de las cepas de los siguientes organismos, tanto in vitro como en infecciones clínicas:

Bacterias gram positivas: Listeria monocytogenes, Corynebacterium diphtheriae (como complemento de la antitoxina), Staphylococci spp, Streptococci spp (incluidos los enterococos).

Bacterias gramnegativas: Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.

Micoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.

Otros organismos: Treponema pallidum, Chlamydia spp, Clostridia spp, formas L, los agentes que causan tracoma y linfogranuloma venéreo.

Nota: La mayoría de las cepas de Haemophilus influenzae son susceptibles a las concentraciones alcanzadas después de las dosis ordinarias.

La absorción se facilita si el estómago está vacío.

Los niveles sanguíneos máximos normalmente ocurren dentro de 1 hora de la dosificación de gránulos de etilsuccinato de Bonac. La vida media de eliminación es de aproximadamente 2 horas. Las dosis se pueden administrar 2, 3 o 4 veces al día.

El etilsuccinato de bonaco es menos susceptible que el bonac al efecto adverso del ácido gástrico. Se absorbe del intestino delgado. Está ampliamente distribuido en todos los tejidos del cuerpo. Se produce poco metabolismo y solo alrededor del 5% se excreta en la orina. Se excreta principalmente por el hígado.

El medicamento no se elimina ni por diálisis peritoneal ni por hemodiálisis. Se difunde fácilmente en fluidos intracelulares y se puede lograr actividad antibacteriana en esencialmente todos los sitios. Hay cierta retención en el hígado y el bazo. Solo se logran bajas concentraciones en el líquido cefalorraquídeo, a menos que las meninges estén inflamadas. La difusión en el humor acuoso, pero no el humor vítreo del ojo es bueno. Una proporción significativa se une a las proteínas séricas.

Los niveles sanguíneos máximos normalmente ocurren dentro de una hora de la dosificación de gránulos de etilsuccinato de eritromicina. La vida media de eliminación es de aproximadamente dos horas. Las dosis se pueden administrar dos, tres o cuatro veces al día.

El etilsuccinato de eritromicina es menos susceptible que la eritromicina al efecto adverso del ácido gástrico. Se absorbe del intestino delgado. Está ampliamente distribuido en todos los tejidos del cuerpo. Se produce poco metabolismo y solo alrededor del 5% se excreta en la orina. Se excreta principalmente por el hígado.

Ninguno sabe

Ninguno declarado.

60 ml de suspensión : para reconstituir agregue 48 ml de agua y agite la botella vigorosamente. La suspensión resultante es de color amarillo.

100 ml de suspensión : para reconstituir agregue 80 ml de agua y agite la botella vigorosamente. La suspensión resultante es de color amarillo

140 ml de suspensión : para reconstituir agregue 112 ml de agua y agite la botella vigorosamente. La suspensión resultante es de color amarillo

No aplica