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The main component of this product is gentamicin sulfate, which is a multi-component antibiotic containing C1, C1a, C2a, C2 and other components.
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This product is a colorless or almost colorless clear liquid.
Pharmacology and Toxicology
This product is an aminoglycoside antibiotic. It has a good antibacterial effect on various gram-negative bacteria and gram-positive bacteria. It has good antibacterial effects on various Enterobacteriaceae such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Enterobacter, Serratia and Pseudomonas aeruginosa have good antibacterial effects. Neisseria and Haemophilus influenzae are moderately sensitive to this product. It also has a certain effect on Brucella, Yersinia pestis, Acinetobacter and Campylobacter fetus. It has a good antibacterial effect on about 80% of methicillin-sensitive strains in Staphylococcus (including Staphylococcus aureus and coagulase-negative Staphylococcus), but most of the methicillin-resistant strains are resistant to this product. The effect on Streptococcus and Streptococcus pneumoniae is poor, and most of Enterococcus is resistant to this product. When this product is used in combination with β-lactams, most of them can obtain a synergistic antibacterial effect.
The mechanism of action of this product is to bind to the 30S subunit of the bacterial ribosome and inhibit the synthesis of bacterial protein. In recent years, gram-negative bacilli have significantly increased resistance to gentamicin.
Pharmacokinetics
This product is absorbed rapidly and completely after intramuscular injection, reaching the peak plasma concentration (Cmax) within 0.5 to 1 hour. The blood elimination half-life (t1/2b) is about 2 to 3 hours, and it can be significantly prolonged in patients with impaired renal function. The protein binding rate is low. It can be distributed in various tissues and body fluids in the body, accumulate in renal cortex cells, and can also enter the fetus through the placental barrier, and cannot easily enter the brain tissue and cerebrospinal fluid through the blood-cerebrospinal fluid barrier. It is not metabolized in the body, and is excreted in urine as a prototype through glomerular filtration, and excretes 50% to 93% of the dose within 24 hours after administration.
Hemodialysis and peritoneal dialysis can remove a considerable amount of medicine from the blood and significantly shorten the half-life.
Indications
1. Suitable for the treatment of sensitive gram-negative bacilli, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Serratia, Pseudomonas aeruginosa and Staphylococcus methicillin sensitive strains Serious infections, such as sepsis, lower respiratory tract infection, intestinal infection, pelvic infection, abdominal infection, skin and soft tissue infection, complicated urinary tract infection, etc. In the treatment of abdominal infection and pelvic infection, it should be combined with anti-anaerobic drugs. In clinical practice, gentamicin and other antibacterial drugs are used in combination. Combined with penicillin (or ampicillin) can treat Enterococcus infections.
2. When used for central nervous system infections caused by sensitive bacteria, such as meningitis and ventriculitis, intrathecal injection of this product can be used as an adjuvant treatment at the same time.
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1. Adult intramuscular injection or intravenous drip after dilution, 80mg (80,000 units) once, or 1~1.7mg/kg according to body weight once, once every 8 hours; or once 5mg/kg, once every 24 hours. The course of treatment is 7 to 14 days. During intravenous infusion, add a dose of 50~200ml of 0.9% sodium chloride injection or 5% glucose injection. The amount of liquid added during intravenous infusion once a day should not be less than 300ml, so that the concentration of the drug solution does not exceed 0.1 %, the solution should be instilled slowly within 30 to 60 minutes to avoid neuromuscular blockade.
2. Pediatric intramuscular injection or intravenous drip after dilution, 2.5 mg/kg once, once every 12 hours; or 1.7 mg/kg once, once every 8 hours. The course of treatment is 7 to 14 days, during which the blood drug concentration should be monitored as much as possible, especially for newborns or infants.
3. The dose for intrathecal and intraventricular administration is 4~8mg once for adults and children
(Above 3 months) 1~2mg once, once every 2~3 days. During injection, dilute the drug solution to a concentration of not more than 0.2%, and pump it into a 5ml or 10ml sterile syringe. After lumbar puncture, first make a considerable amount of cerebrospinal fluid flow into the syringe. Push while pumping to remove all the drug solution. Slowly inject within 3~5 minutes.
4. Dosage for patients with impaired renal function: once every 8 hours for patients with normal renal function, the normal dose for one time is 1~1.7mg/kg, and the creatinine clearance rate is 10~50ml/min, once every 12 hours, once It is 30~70% of the normal dose; when the creatinine clearance rate is less than 10ml/min, give 20~30% of the normal dose every 24 to 48 hours.
The creatinine clearance rate can be directly measured or calculated from the patient's blood creatinine value as follows:
(140-age)×standard weight (kg)
Adult male creatinine clearance rate=──────────────
72×Patient's serum creatinine concentration (mg/dl)
(140-age)×standard weight (kg)
Or =──────────────
50×Patient's serum creatinine concentration (umol/L)
(140-age)×standard weight (kg)
Adult female creatinine clearance rate=─────────────×0.85
72×Patient's serum creatinine concentration (mg/dl)
(140-age)×standard weight (kg)
Or=──────────────×0.85
50×Patient's serum creatinine concentration (umol/L)
5. After hemodialysis, according to the severity of infection, adults can be given a dose of 1~1.7mg/kg according to their body weight once, and children (over 3 months) can be given a dose of 2~2.5mg/kg once.
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