Gentamicina

Presentación

Solución 40 mg/mL (y 10 mg/mL pediátrica) — documentado: Fresenius Kabi (FDA)

¿Para qué sirve gentamicina? Indicaciones autorizadas

INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or…

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INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection, USP and other antibacterial drugs, Gentamicin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Gentamicin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. Gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the BOXED WARNINGS . If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group D streptococci. Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.

FDA (DailyMed) · Gentamicin · Indications and usage · texto original en inglés

Contraindicaciones de gentamicina

CONTRAINDICATIONS: Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

FDA (DailyMed) · Gentamicin · Contraindications · texto original en inglés

Ajuste en insuficiencia renal

Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Creatinina sérica · Diálisis / TRRC

PATIENTS WITH NORMAL RENAL FUNCTION Adults The recommended dosage of gentamicin injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours ( Table 3 ) .

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

TABLE 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION *The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. **for q6h schedules, dosage should be recalculated.

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

In such cases monitoring of renal, auditory and vestibular functions is recommended, since toxicity is more apt to occur with treatment extended for more than 10 days.

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

PATIENTS WITH IMPAIRED RENAL FUNCTION Dosage must be adjusted in patients with impaired renal function to assure therapeutically adequate, but not excessive blood levels.

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

Since the serum creatinine concentration has a high correlation with the serum half-life of gentamicin, this laboratory test may provide guidance for adjustment of the interval between doses. The interval between doses (in hours) may be approximated by multiplying the serum creatinine level (mg/100 mL) by 8. For example, a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 60 mg (1 mg/kg) every 16 hours (2 x 8). In patients with serious systemic infections and renal impairment, it may be desirable to administer the antibiotic more frequently but in reduced dosage.

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level ( Table 4 ) . For example, after an initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 30 mg every eight hours (60 ÷ 2). It should be noted that the status of renal function may be…

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After the usual initial dose, a rough guide for determining reduced dosage at eight-hour intervals is to divide the normally recommended dose by the serum creatinine level ( Table 4 ) . For example, after an initial dose of 60 mg (1 mg/kg), a patient weighing 60 kg with a serum creatinine level of 2 mg/100 mL could be given 30 mg every eight hours (60 ÷ 2). It should be noted that the status of renal function may be changing over the course of the infectious process. It is important to recognize that deteriorating renal function may require a greater reduction in dosage than that specified in the above guidelines for patients with stable renal impairment. TABLE 4 DOSAGE ADJUSTMENT GUIDE FOR PATIENTS WITH RENAL IMPAIRMENT (Dosage at Eight-Hour Intervals After the Usual Initial Dose) Serum Creatinine (mg %) Approximate Creatinine Clearance Rate (mL/min/1.73m 2 ) Percent of Usual Doses Shown Above ≤1 > 100 100 1.1 to 1.3 70 to 100 80 1.4 to 1.6 55 to 70 65 1.7 to 1.9 45 to 55 55 2 to 2.2 40 to 45 50 2.3 to 2.5 35 to 40 40 2.6 to 3 30 to 35 35 3.1 to 3.5 25 to 30 30 3.6 to 4 20 to 25 25 4.1 to 5.1 15 to 20 20 5.2 to 6.6 10 to 15 15 6.7 to 8 < 10 10 In adults with renal failure undergoing hemodialysis, the amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An eight-hour hemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of the infection.

FDA (DailyMed) · Gentamicin · Dosage and administration · texto original en inglés

TABLE 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION *The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. **for q6h schedules, dosage should be recalculated. (Dosage at Eight-Hour Intervals) 40 mg per mL Patient's Weight* | Usual Dose for Serious Infections 1 mg/kg q8h (3 mg/kg/day) | Dose for Life-Threatening Infections (Reduce As Soon As Clinically…

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TABLE 3 DOSAGE SCHEDULE GUIDE FOR ADULTS WITH NORMAL RENAL FUNCTION *The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass.

**for q6h schedules, dosage should be recalculated.

(Dosage at Eight-Hour Intervals) 40 mg per mL

Patient's Weight* | Usual Dose for Serious Infections 1 mg/kg q8h (3 mg/kg/day) | Dose for Life-Threatening Infections (Reduce As Soon As Clinically Indicated) 1.7 mg/kg q8h** (5 mg/kg/day)

kg | (lb)

mg/dose | mL/dose | mg/dose | mL/dose

q8h | q8h

40 | ( 88 ) | 40 | 1 | 66 | 1.6

45 | (99) | 45 | 1.1 | 75 | 1.9

50 | (110) | 50 | 1.25 | 83 | 2.1

55 | (121) | 55 | 1.4 | 91 | 2.25

60 | (132) | 60 | 1.5 | 100 | 2.5

65 | (143) | 65 | 1.6 | 108 | 2.7

70 | (154) | 70 | 1.75 | 116 | 2.9

75 | (165) | 75 | 1.9 | 125 | 3.1

80 | (176) | 80 | 2 | 133 | 3.3

85 | (187) | 85 | 2.1 | 141 | 3.5

90 | (198) | 90 | 2.25 | 150 | 3.75

95 | (209) | 95 | 2.4 | 158 | 4

100 | (220) | 100 | 2.5 | 166 | 4.2

TABLE 4 DOSAGE ADJUSTMENT GUIDE FOR PATIENTS WITH RENAL IMPAIRMENT (Dosage at Eight-Hour Intervals After the Usual Initial Dose)

Serum Creatinine (mg %) | Approximate Creatinine Clearance Rate (mL/min/1.73m 2 ) | Percent of Usual Doses Shown Above

≤1 | > 100 | 100

1.1 to 1.3 | 70 to 100 | 80

1.4 to 1.6 | 55 to 70 | 65

1.7 to 1.9 | 45 to 55 | 55

2 to 2.2 | 40 to 45 | 50

2.3 to 2.5 | 35 to 40 | 40

2.6 to 3 | 30 to 35 | 35

3.1 to 3.5 | 25 to 30 | 30

3.6 to 4 | 20 to 25 | 25

4.1 to 5.1 | 15 to 20 | 20

5.2 to 6.6 | 10 to 15 | 15

6.7 to 8 | < 10 | 10

FDA (DailyMed) · Gentamicin · Dosage and administration table · texto original en inglés

Reconstitución de gentamicina

No requiere (solución lista).

Dilución de gentamicina

Adultos: dosis en 50–200 mL de SF o glucosa 5%; menos volumen en niños.

Administración de gentamicina

Infusión IV, IV lenta o IM.

Compatibilidad de gentamicina

Compatible con

• SF 0.9%
• Glucosa 5%

Incompatible con

• Betalactámicos en la misma bolsa (según las fichas de piperacilina/tazobactam y ampicilina)

Conservación y protección de la luz

20–25 °C.

La fuente no indica protección de la luz.

Advertencias

• Riesgo de nefrotoxicidad y ototoxicidad: monitorizar niveles.

Fuentes

1. FDA (DailyMed) · GentamicinFresenius Kabi USA, LLC · Viales multidosis 40 mg/mL (2 y 20 mL); pediátrico 10 mg/mL · versión 2023-10-31

Interacciones de gentamicina

7 medicamentos del catálogo con una interacción documentada en sus fichas oficiales. Abre cada una para ver el efecto, la recomendación y su fuente.

• AmpicilinaMayor
• CeftriaxonaMayor
• FurosemidaMayor
• Piperacilina / tazobactamMayor
• TobramicinaMayor
• CitarabinaModerada
• DigoxinaModerada

Identificación

SNOMED CT (VTM)

57752001

RxNorm

1596450