ANTIBIÓTICO · PENICILINA + INHIBIDOR DE BETALACTAMASA
Ampicilina / sulbactam
Ficha de consulta para farmacia hospitalaria: indicaciones, preparación, dilución, estabilidad y compatibilidad de ampicilina / sulbactam, con la fuente oficial de cada dato.
También conocido como: ampicilina + sulbactam, ampicillin / sulbactam, Unasyn
Presentación
Polvo 1.5 g y 3 g — documentado: Meitheal (FDA)
| Producto de referencia | Titular | Vía | Fuente |
|---|---|---|---|
| Ampicillin and Sulbactam | Meitheal Pharmaceuticals Inc. | Intravenous | FDA (DailyMed) |
¿Para qué sirve ampicilina / sulbactam? Indicaciones autorizadas
INDICATIONS AND USAGE Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli * , Klebsiella spp. * (including K. pneumoniae * ), Proteus mirabilis * , Bacteroides fragilis * ,…
FDA (DailyMed) · Ampicillin and Sulbactam · Indications and usage · texto original en inglésLeer la sección completa
INDICATIONS AND USAGE Ampicillin and Sulbactam for Injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli * , Klebsiella spp. * (including K. pneumoniae * ), Proteus mirabilis * , Bacteroides fragilis * , Enterobacter spp. * , and Acinetobacter calcoaceticus * . NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli , Klebsiella spp. (including K. pneumoniae *), Bacteroides spp. (including B. fragilis ), and Enterobacter spp. * Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli *, and Bacteroides spp.* (including B. fragilis *). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. While Ampicillin and Sulbactam for Injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat 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.
Dosis máximas y límites de ampicilina / sulbactam
Límites que la fuente establece para un contexto concreto. Una dosis recomendada no equivale a una dosis máxima; la posología completa por indicación, edad y peso está en la app.
| Contexto | Límite | Condiciones y cita |
|---|---|---|
| Etiqueta FDA citada · límite del componente sulbactam | 4 g de sulbactam al día | El límite corresponde a sulbactam, no a la masa total de la combinación. Ajustar intervalo en insuficiencia renal y consultar dosis según población.«The total dose of sulbactam should not exceed 4 g per day.» · FDA (DailyMed), Dosage and administration |
Contraindicaciones de ampicilina / sulbactam
CONTRAINDICATIONS The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.
FDA (DailyMed) · Ampicillin and Sulbactam · Contraindications · texto original en inglés
Ajuste en insuficiencia renal
Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Creatinina sérica
Impaired Renal Function In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function.
FDA (DailyMed) · Ampicillin and Sulbactam · Dosage and administration · texto original en inglés
Ampicillin And Sulbactam For Injection Dosage Guide for Patients with Renal Impairment Creatinine Clearance (mL/min/1.73m 2 ) Ampicillin and Sulbactam Half-Life (Hours) Recommended Ampicillin And Sulbactam For Injection Dosage ≥30 1 1.5 g to 3 g every 6 to 8 hours 15 to 29 5 1.5 g to 3 g every 12 hours 5 to 14 9 1.5 g to 3 g every 24 hours When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function. Males Weight (kg) x (140 - age) 72 x serum creatinine Females 0.85 x above value
FDA (DailyMed) · Ampicillin and Sulbactam · Dosage and administration · texto original en inglés
TABLE 3: Ampicillin And Sulbactam For Injection Dosage Guide for Patients with Renal Impairment
Creatinine Clearance (mL/min/1.73m 2 ) | Ampicillin and Sulbactam Half-Life (Hours) | Recommended Ampicillin And Sulbactam For Injection Dosage
≥30 | 1 | 1.5 g to 3 g every 6 to 8 hours
15 to 29 | 5 | 1.5 g to 3 g every 12 hours
5 to 14 | 9 | 1.5 g to 3 g every 24 hours
FDA (DailyMed) · Ampicillin and Sulbactam · Dosage and administration table · texto original en inglés
Reconstitución de ampicilina / sulbactam
Con agua inyectable o un diluyente compatible según la tabla del fabricante.
Dilución de ampicilina / sulbactam
SF 0.9% (preferido; menos estable en glucosa).
Administración de ampicilina / sulbactam
IV lenta (≥10–15 min), infusión en 15–30 min o IM.
Estabilidad y periodo de validez
| Condición | Tiempo | Nota |
|---|---|---|
| Diluida en agua o SF hasta 45 mg/mL, 25 °C | 8 h | Hasta 45 mg/mL a 5 °C: 48 h; hasta 30 mg/mL a 5 °C: 72 h. |
| Diluida en glucosa 5% hasta 30 mg/mL, 25 °C | 2 h | A 5 °C: 4 h. |
| Diluida en Ringer lactato hasta 45 mg/mL, 25 °C | 8 h | A 5 °C: 24 h. |
| Envase de farmacia reconstituido, temperatura ambiente | 2 h | Refrigerado: 4 h. |
Compatibilidad de ampicilina / sulbactam
Compatible con
- SF 0.9%
Incompatible con
- Aminoglucósidos en la misma bolsa o jeringa
Conservación y protección de la luz
Polvo a 20–25 °C antes de reconstituir.
La fuente no indica protección de la luz.
Advertencias
- La estabilidad depende del diluyente, la concentración y la temperatura: consultar la tabla de la IPP y capturar el dato al validar.
- Desechar las soluciones al terminar los tiempos indicados.
Fuentes
- FDA (DailyMed) · Ampicillin and SulbactamMeitheal Pharmaceuticals Inc. · Viales 1.5 g y 3 g y envase de farmacia 15 g · versión 2026-07-23
Diagnósticos relacionados
Diagnósticos que la ficha técnica de ampicilina / sulbactam menciona en sus indicaciones. Cada uno abre su definición y los demás medicamentos indicados.
Identificación
- SNOMED CT (VTM)
- 398786001
- RxNorm
- 1009148
Información de consulta profesional extraída de las fichas técnicas y etiquetas oficiales citadas. Las condiciones de preparación, estabilidad y administración dependen del producto concreto: verifica el documento del producto que utilizas. No sustituye el criterio clínico ni la valoración del paciente.