ANTIBIÓTICO HOSPITALARIO
Imipenem / cilastatina / relebactam
Ficha de consulta para farmacia hospitalaria: indicaciones, preparación, dilución, estabilidad y compatibilidad de imipenem / cilastatina / relebactam, con la fuente oficial de cada dato.
También conocido como: imipenem + cilastatina + relebactam, cilastatin / imipenem / relebactam, Recarbrio
Presentación
Recarbrio: 500 mg / 500 mg / 250 mg, polvo, vial unidosis — Merck Sharp & Dohme LLC
| Producto de referencia | Titular | Vía | Fuente |
|---|---|---|---|
| RECARBRIO | Merck Sharp & Dohme LLC | Intravenous | FDA (DailyMed) |
¿Para qué sirve imipenem / cilastatina / relebactam? Indicaciones autorizadas
1 INDICATIONS AND USAGE RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial…
FDA (DailyMed) · RECARBRIO · Indications and usage · texto original en inglésLeer la sección completa
1 INDICATIONS AND USAGE RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. ( 1.2 ) Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. ( 1.3 ) Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data for RECARBRIO. ( 1.2 , 1.3 , 14 ) Limitations of Use RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age). ( 1.4 , 2.2 ). RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment. ( 1.4 , 2.3 ). Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) RECARBRIO ® is indicated in adult and pediatric patients weighing at least 2 kg for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae , Escherichia coli , Haemophilus influenzae , Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. 1.2 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis RECARBRIO is indicated in adult and pediatric patients weighing at least 2 kg who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae , Escherichia coli , Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa . Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [see Clinical Studies (14.2) ] . 1.3 Complicated Intra-abdominal Infections (cIAI) RECARBRIO is indicated in adult and pediatric patients weighing at least 2 kg who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae , Bacteroides fragilis , Bacteroides ovatus , Bacteroides stercoris , Bacteroides thetaiotaomicron , Bacteroides uniformis , Bacteroides vulgatus , Citrobacter freundii , Enterobacter cloacae , Escherichia coli , Fusobacterium nucleatum , Klebsiella aerogenes, Klebsiella oxytoca , Klebsiella pneumoniae , Parabacteroides distasonis , and Pseudomonas aeruginosa . Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [see Clinical Studies (14.2) ] . 1.4 Limitations of Use RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age) [see Dosage and Administration (2.2) and Use in Specific Populations (8.4) ] . RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment [see Dosage and Administration (2.4) , Use in Specific Populations (8.4 , 8.6) and Clinical Pharmacology (12.3) ]. 1.5 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO 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.
Contraindicaciones de imipenem / cilastatina / relebactam
4 CONTRAINDICATIONS RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. ( 4 )
FDA (DailyMed) · RECARBRIO · Contraindications · texto original en inglés
Ajuste en insuficiencia renal
Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Diálisis / TRRC · TFGe (filtrado glomerular estimado)
The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours to adult patients with creatinine clearance (CLcr) 90 mL/min or greater.
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range Body Weight Dose Dosing Frequency Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months 2 kg or greater RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg Every 8 hours 60 minutes 3 months to less…
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglésLeer la sección completa
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range Body Weight Dose Dosing Frequency Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months 2 kg or greater RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg Every 8 hours 60 minutes 3 months to less than 18 years less than 30 kg RECARBRIO 37.5 mg/kg Every 6 hours 60 minutes 3 months to less than 18 years 30 kg or greater RECARBRIO 1.25 Provides 500 mg imipenem, 500 mg cilastatin, and 250 mg, relebactam grams Every 6 hours 30 minutes Dose reduction is required in adult and pediatric (weighing at least 30 kg) patients with renal impairment. ( 2.3 , 2.4 ) Do not administer RECARBRIO to adults with CLcr less than 15 mL/min unless hemodialysis is instituted within 48 hours after dose administration. ( 2.3 ) Do not administer RECARBRIO to pediatric patients weighing at least 30 kg with an eGFR less than 15 mL/min/1.73m 2 unless hemodialysis is instituted within 48 hours after dose administration.
( 2.7 , 2.8 ) 2.1 Recommended Dosage in Adult Patients The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours in adult patients with creatinine clearance (CLcr) of 90 mL/min or greater).
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
RECARBRIO is not recommended for pediatric patients weighing less than 30 kg with renal impairment [see Dosage and administration (2.4) and Use in Specific Populations (8.4) ] .
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range Body Weight Dose Dosing Frequency Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months 2 kg or greater RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg Every 8 hours 60 minutes 3 months to less…
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglésLeer la sección completa
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range Body Weight Dose Dosing Frequency Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months 2 kg or greater RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg Every 8 hours 60 minutes 3 months to less than 18 years less than 30 kg RECARBRIO 37.5 mg/kg Every 6 hours 60 minutes 3 months to less than 18 years 30 kg or greater RECARBRIO 1.25 Provides 500 mg imipenem, 500 mg cilastatin, and 250 mg, relebactam grams Every 6 hours 30 minutes 2.3 Recommended Dosage in Adult Patients with Renal Impairment Adult patients who have a CLcr less than 90 mL/min require dosage reduction of RECARBRIO. The recommended dosage of RECARBRIO in adult patients with renal impairment is shown in Table 2 .
Recommended Dosage of RECARBRIO in Adult Patients with Renal Impairment Creatinine Clearance (CLcr) ([mL/min)] CLcr calculated using the Cockcroft-Gault formula for adult patients.
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Dosing Frequency Infusion Duration 60 to 89 RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam Every 6 hours 30 minutes 30 to 59 RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam Every 6 hours 30 minutes 15 to 29 not receiving hemodialysis RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam Every 6 hours 30…
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglésLeer la sección completa
Dosing Frequency Infusion Duration 60 to 89 RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam Every 6 hours 30 minutes 30 to 59 RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam Every 6 hours 30 minutes 15 to 29 not receiving hemodialysis RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam Every 6 hours 30 minutes Receiving hemodialysis Administration should be timed to follow hemodialysis and at intervals timed from the end of that hemodialysis session. RECARBRIO 0.5 grams Every 6 hours 30 minutes Less than 15 not receiving hemodialysis Not recommended Do not administer RECARBRIO to adult patients with CLcr less than 15 mL/min unless hemodialysis is instituted within 48 hours after dose administration. Imipenem, cilastatin, and relebactam are cleared from the circulation during hemodialysis. For adult patients maintained on hemodialysis, administer the recommended dose of RECARBRIO after hemodialysis and at intervals timed from the end of that hemodialysis session. There is inadequate information to recommend dosage of RECARBRIO for adults undergoing peritoneal dialysis. 2.4 Recommended Dosage in Pediatric Patients Weighing at Least 30 kg with Renal Impairment Pediatric patients weighing at least 30 kg who have an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73m 2 require dosage reduction of RECARBRIO. The recommended dosage of RECARBRIO in pediatric patients weighing at least 30 kg with renal impairment is shown in Table 3 . There is insufficient information to recommend a dosage of RECARBRIO for pediatric patients weighing less than 30 kg with any degree of renal impairment.
Recommended Dosage of RECARBRIO in Pediatric Patients Weighing at Least 30 kg with Renal Impairment eGFR (mL/min/1.73 m 2 ) Calculated using a GFR estimating equation validated in pediatric patients weighing at least 30 kg.
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Dosing Frequency Infusion Duration 60 to 89 RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam Every 6 hours 30 minutes 30 to 59 RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam Every 6 hours 30 minutes 15 to 29 not receiving hemodialysis RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam Every 6 hours 30…
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglésLeer la sección completa
Dosing Frequency Infusion Duration 60 to 89 RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam Every 6 hours 30 minutes 30 to 59 RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam Every 6 hours 30 minutes 15 to 29 not receiving hemodialysis RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam Every 6 hours 30 minutes Receiving hemodialysis Administration should be timed to follow hemodialysis and at intervals timed from the end of that hemodialysis session. RECARBRIO 0.5 grams Every 6 hours 30 minutes Less than 15 not receiving hemodialysis Not recommended Do not administer RECARBRIO to pediatric patients weighing at least 30 kg with an eGFR less than 15 mL/min/1.73m 2 unless hemodialysis is instituted within 48 hours after dose administration. Imipenem, cilastatin, and relebactam are cleared from the circulation during hemodialysis. For pediatric patients weighing at least 30 kg maintained on hemodialysis, administer the recommended dose of RECARBRIO after hemodialysis and at intervals timed from the end of that hemodialysis session. There is inadequate information to recommend a dosage of RECARBRIO for pediatric patients undergoing peritoneal dialysis. 2.5 Preparation of RECARBRIO Solution for Intravenous Administration RECARBRIO is supplied as a dry powder in a single-dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion.
The above instructions for preparation of RECARBRIO solution for intravenous administration must be followed for all patients, irrespective of the intended patient’s renal function, age or weight. The volume of this prepared RECARBRIO solution to be administered in adult and pediatric (weighing at least 30 kg) patients is determined based on estimated renal function [see Dosage and Administration (2.6) ] . The volume of the prepared RECARBRIO solution to be administered to pediatric patients weighing 2 kg to less than 30 kg with normal renal function is calculated based on patient weight using the formula below [see Dosage and Administration (2.2) ]:
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Figure 2.6 Preparation of RECARBRIO Solution for Intravenous Administration in Adult and Pediatric Patients Weighing at Least 30 kg with Renal Impairment Prepare a reduced dose of RECARBRIO (1 gram, 0.75 grams, or 0.5 grams) [see Dosage and Administration (2.3 , 2.4) ] by preparing a 100 mL solution containing 1.25 grams as described above [see Dosage and Administration (2.5) ] then withdrawing and discarding the excess according to Table 4 .
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglés
Preparation of Reduced RECARBRIO Doses for Intravenous Administration in Adult and Pediatric Patients Weighing at Least 30 kg with Renal Impairment Estimated Renal Function Creatinine Clearance (mL/min) Calculated using the Cockcroft-Gault formula for adult patients Or Estimated Glomerular Filtration Rate eGFR (mL/min/1.73 m 2 ) Calculated using a GFR estimating equation validated in pediatric patients weighing at…
FDA (DailyMed) · RECARBRIO · Dosage and administration · texto original en inglésLeer la sección completa
Preparation of Reduced RECARBRIO Doses for Intravenous Administration in Adult and Pediatric Patients Weighing at Least 30 kg with Renal Impairment Estimated Renal Function Creatinine Clearance (mL/min) Calculated using the Cockcroft-Gault formula for adult patients Or Estimated Glomerular Filtration Rate eGFR (mL/min/1.73 m 2 ) Calculated using a GFR estimating equation validated in pediatric patients weighing at least 30 kg Dose After preparation as instructed above, remove from the 100 mL prepared bag the volume indicated below and discard Resulting volume that provides the indicated reduced dose 60 to 89 RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam 20 mL 80 mL 30 to 59 RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam 40 mL 60 mL 15 to 29 not receiving hemodialysis RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam 60 mL 40 mL Receiving hemodialysis RECARBRIO 0.5 grams 60 mL 40 mL 2.7 Storage of Constituted Solution RECARBRIO, as supplied in single-dose glass vials upon constitution with the appropriate diluent and following further dilution in the infusion bag, maintains satisfactory potency for at least 2 hours at room temperature (up to 30°C) or for at least 24 hours under refrigeration at 2°C to 8°C (36°F to 46°F).
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range | Body Weight | Dose | Dosing Frequency | Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months | 2 kg or greater | RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg | Every 8 hours | 60 minutes 3…
FDA (DailyMed) · RECARBRIO · Dosage and administration table · texto original en inglésLeer la sección completa
Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg
Age Range | Body Weight | Dose | Dosing Frequency | Infusion Duration
Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months | 2 kg or greater | RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg | Every 8 hours | 60 minutes
3 months to less than 18 years | less than 30 kg | RECARBRIO 37.5 mg/kg | Every 6 hours | 60 minutes
3 months to less than 18 years | 30 kg or greater | RECARBRIO 1.25 Provides 500 mg imipenem, 500 mg cilastatin, and 250 mg, relebactam grams | Every 6 hours | 30 minutes
Table 1: Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range | Body Weight | Dose | Dosing Frequency | Infusion Duration
Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months | 2 kg or greater | RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg | Every 8 hours | 60 minutes
3 months to less than 18 years | less than 30 kg | RECARBRIO 37.5 mg/kg | Every 6 hours | 60 minutes
3 months to less than 18 years | 30 kg or greater | RECARBRIO 1.25 Provides 500 mg imipenem, 500 mg cilastatin, and 250 mg, relebactam grams | Every 6 hours | 30 minutes
Table 2: Recommended Dosage of RECARBRIO in Adult Patients with Renal Impairment Creatinine Clearance (CLcr) ([mL/min)] CLcr calculated using the Cockcroft-Gault formula for adult patients. | Dose RECARBRIO is provided as a single vial in a fixed-dose combination; the dose for each component will be adjusted equally during preparation [see • Dosage and Administration (2.5) ] . | Dosing Frequency | Infusion Duration
60 to 89 | RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam | Every 6 hours | 30 minutes
30 to 59 | RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam | Every 6 hours | 30 minutes
15 to 29 not receiving hemodialysis | RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam | Every 6 hours | 30 minutes
Receiving hemodialysis Administration should be timed to follow hemodialysis and at intervals timed from the end of that hemodialysis session. | RECARBRIO 0.5 grams | Every 6 hours | 30 minutes
Less than 15 not receiving hemodialysis | Not recommended
Table 3. Recommended Dosage of RECARBRIO in Pediatric Patients Weighing at Least 30 kg with Renal Impairment eGFR (mL/min/1.73 m 2 ) Calculated using a GFR estimating equation validated in pediatric patients weighing at least 30 kg. | Recommended Dose RECARBRIO is provided as a single vial in a fixed-dose combination; the dose for each component will be adjusted equally during preparation [see • Dosage and Administration (2.5) ] . | Dosing Frequency | Infusion Duration
60 to 89 | RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam | Every 6 hours | 30 minutes
30 to 59 | RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam | Every 6 hours | 30 minutes
15 to 29 not receiving hemodialysis | RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam | Every 6 hours | 30 minutes
Receiving hemodialysis Administration should be timed to follow hemodialysis and at intervals timed from the end of that hemodialysis session. | RECARBRIO 0.5 grams | Every 6 hours | 30 minutes
Less than 15 not receiving hemodialysis | Not recommended
Table 4: Preparation of Reduced RECARBRIO Doses for Intravenous Administration in Adult and Pediatric Patients Weighing at Least 30 kg with Renal Impairment Estimated Renal Function Creatinine Clearance (mL/min) Calculated using the Cockcroft-Gault formula for adult patients Or Estimated Glomerular Filtration Rate eGFR (mL/min/1.73 m 2 ) Calculated using a GFR estimating equation validated in pediatric patients weighing at least 30 kg | Dose | After preparation as instructed above, remove from the 100 mL prepared bag the volume indicated below and discard | Resulting volume that provides the indicated reduced dose
60 to 89 | RECARBRIO 1 gram Provides 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam | 20 mL | 80 mL
30 to 59 | RECARBRIO 0.75 grams Provides 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam | 40 mL | 60 mL
15 to 29 not receiving hemodialysis | RECARBRIO 0.5 grams Provides 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam | 60 mL | 40 mL
Receiving hemodialysis | RECARBRIO 0.5 grams | 60 mL | 40 mL
RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age) or weighing less than 30 kg with renal impairment.
FDA (DailyMed) · RECARBRIO · Use in specific populations · texto original en inglés
RECARBRIO is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
FDA (DailyMed) · RECARBRIO · Use in specific populations · texto original en inglés
Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ]. 8.6 Renal Impairment Reduce RECARBRIO dosage in adult patients with a CLcr less than 90 mL/min and in pediatric patients weighing at least 30 kg with an eGFR less than 90 mL/min/1.73 m 2 [see Dosage and Administration (2.3 , 2.4) and Clinical Pharmacology (12.3) ] . RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment.
FDA (DailyMed) · RECARBRIO · Use in specific populations · texto original en inglés
Reconstitución de imipenem / cilastatina / relebactam
Reconstituir y diluir con técnica aséptica según sección 2.5; no administrar la suspensión sin diluir.
Dilución de imipenem / cilastatina / relebactam
Preparación final de 100 mL según sección 2.5.
Administración de imipenem / cilastatina / relebactam
Perfusión IV; duración según edad y peso en la etiqueta.
Estabilidad y periodo de validez
| Condición | Tiempo | Nota |
|---|---|---|
| Preparación reconstituida y diluida hasta 30 °C | 2 h | Límite de la etiqueta del producto; no sustituye el límite microbiológico del protocolo local. No sumar plazos de conservación. |
| Preparación reconstituida y diluida a 2–8 °C | 24 h | Límite de la etiqueta del producto; no sustituye el límite microbiológico del protocolo local. No sumar plazos de conservación. |
Compatibilidad de imipenem / cilastatina / relebactam
Compatible con
- NaCl 0.9% y glucosa 5% como diluyentes; no implica compatibilidad entre medicamentos.
Conservación y protección de la luz
20–25 °C; conservar en la caja.
La sección de almacenamiento indica conservar en la caja; no se afirma fotosensibilidad durante infusión.
¿Se puede triturar?
No aplica: inyectable.
Advertencias
- Verificar ajuste renal en la etiqueta y protocolo institucional.
- No congelar la solución diluida.
Fuentes
- FDA (DailyMed) · RECARBRIOMerck Sharp & Dohme LLC · 500 mg / 500 mg / 250 mg, polvo, vial unidosis · versión 2025-12-09
Interacciones de imipenem / cilastatina / relebactam
1 medicamento del catálogo con una interacción documentada en sus fichas oficiales. Abre cada una para ver el efecto, la recomendación y su fuente.
- GanciclovirMayor
Identificación
- SNOMED CT (VTM)
- 789073003
- RxNorm
- 2184141
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.