Properties: This product is a colorless to yellowish or yellowish green clear liquid.
1. Applicable to 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 cavity infection, skin and soft tissue infection, complicated urinary tract infection, etc. The treatment of abdominal infection and pelvic infection should be combined with anti-anaerobic drugs, and gentamicin and other antibacterial drugs are often used in clinical practice. Combined with penicillin (or ampicillin) can treat Enterococcus infections.
2. 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.
[Specifications] 2m1: 80mg (80,000 units)
1. Adults: Intramuscular injection or intravenous drip after dilution, 80 mg (80,000 units) once, or 1 to 1.7 mg/kg according to body weight, once every 8 hours; or 5 mg/kg once, 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. In children, 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 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 1-2mg once for children (over 3 months), once every 2 to 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 and push while pumping to remove all the drug. Slowly inject within 3 to 5 minutes. 4. The dosage for patients with impaired renal function is once every 8 hours for those 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. 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:
Adult male creatinine clearance rate=
Adult female creatinine clearance rate=
5. After hemodialysis, according to the severity of infection, adults can be given a dose of 1 to 1.7 mg/kg according to their body weight, and children (over 3 months) can be given a dose of 2 to 2.5 mg/kg.
[Adverse reactions] 1. Ototoxic reactions such as hearing loss, tinnitus, or fullness of the ears may be caused during the medication. Unsteady walking and dizziness may occur when the vestibular function is affected. Nephrotoxic reactions such as hematuria, significant reduction in the frequency of urination, decreased urine output, loss of appetite, and extreme thirst may also occur. Those with a lower incidence have dyspnea, lethargy, weakness, etc. due to neuromuscular blockade or nephrotoxicity. Occasionally, skin rash, nausea, vomiting, decreased liver function, leukopenia, neutropenia, anemia, hypotension, etc. 2. A small number of patients may experience ototoxic symptoms such as hearing loss, tinnitus or fullness of the ears after stopping the drug, which should be paid attention to. 3. Systemic administration combined with intrathecal injection may cause leg twitching, skin rash, fever and body spasm.
[Contraindications] People who are allergic to this product or other aminoglycosides are prohibited.
[Precautions] 1. This product should be used with caution in the following situations: patients with dehydration, 8th brain nerve damage, myasthenia gravis or Parkinson’s disease and renal impairment. 2. Cross allergy. Patients who are allergic to an aminoglycoside antibiotic such as streptomycin and amikacin may be allergic to this product. 3. Routine urine and renal function tests should be performed regularly before and during medication to prevent severe nephrotoxic reactions. If necessary, do audiometry or audiogram, especially high-frequency audiometry and temperature stimulation test, to detect vestibular toxicity. 4. When possible, the blood drug concentration should be monitored during the course of treatment, and the dose should be adjusted accordingly, especially for newborns, elderly and patients with impaired renal function. The effective blood concentration of the drug should be kept at 4～10μg/ml to avoid the peak concentration if the drug is administered once every 8 hours
If the concentration exceeds 12μg/ml, the trough concentration should be maintained at 1~2μg/ml; the peak plasma concentration of the drug should be maintained at 16~24μg/ml, and the trough concentration should be <1μg/ml once every 24 hours. Those receiving intrathecal injection should also monitor the drug concentration in the cerebrospinal fluid. 5. When the blood concentration cannot be determined, the dosage should be adjusted according to the measured creatinine clearance rate. 6. After the first saturated dose (1～2mg/kg) is given, the maintenance dose for patients with renal insufficiency, vestibular function or hearing loss should be reduced accordingly. 7. Patients should be given enough water to reduce the damage to the renal tubules. 8. Long-term application may lead to overgrowth of resistant bacteria. 9. Not suitable for subcutaneous injection. 10. This product can inhibit respiration, so intravenous injection is not allowed. 11. Interference with diagnosis: This product can increase the measured values of alanine aminotransferase (ALT), aspartate aminotransferase (GOT), serum bilirubin concentration and lactate dehydrogenase concentration; blood calcium The measured values of, magnesium, potassium, and sodium concentrations may decrease.
[Medicine for pregnant and lactating women]
This product can pass through the placental barrier and enter the fetal tissue, which may cause fetal hearing damage. Pregnant women should fully weigh the pros and cons before using this product. The secretion of this product in milk is very small, but usually breastfeeding women should stop breastfeeding during the medication period.
Gentamicin is an aminoglycoside and should be used with caution in pediatrics, especially in premature infants and newborns. Because the kidney tissue is not fully developed, the half-life of this type of drug is prolonged, and it is easy to accumulate in the body and cause toxic reactions.
The renal function of elderly patients has a certain degree of physiological decline. Even if the measured value of renal function is within the normal range, a smaller amount of treatment should be used. Elderly patients are more likely to have various toxic reactions after applying this product, and blood concentration should be monitored during the course of treatment as much as possible.
1. Combined use with other aminoglycosides or successive local or systemic applications may increase the possibility of its ototoxicity, nephrotoxicity and neuromuscular blockade. 2. Combined use with neuromuscular blockers can aggravate the neuromuscular blockade, resulting in muscle weakness, respiratory depression and other symptoms. 3. Combined use with capreomycin, cisplatin, etanic acid, furosemide or vancomycin (or norvancomycin), or successive local or systemic applications, may increase ototoxicity and nephrotoxicity. 4. Local or systemic combination with cefalotin and cefazolin may increase nephrotoxicity. 5. Combined use with polymyxin injections or successive local or systemic applications can increase nephrotoxicity and neuromuscular blockade. 6. Other nephrotoxic and ototoxic drugs should not be combined with this product or applied successively, so as not to aggravate nephrotoxicity or ototoxicity. 7. Aminoglycosides and β-lactams (cephalosporins and penicillins) can cause mutual inactivation when mixed. This product must be instilled in separate bottles when combined with the above antibiotics. This product should not be instilled in the same bottle with other drugs.
This product has no specific antagonist. When it is overdose or causes toxic reactions, it is mainly used for symptomatic therapy and supportive therapy, while supplementing a lot of water. Hemodialysis or peritoneal dialysis helps to remove gentamicin from the blood.
【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 methicillin resistant strains are resistant to this product. It has a poor effect on Streptococcus and Streptococcus pneumoniae, while Enterococcus is mostly resistant to this product. When this product is used in combination with β-lactams, most synergistic antibacterial effects can be obtained. The mechanism of action of this product is to bind to the 30S subunit of bacterial ribosomes and inhibit bacterial protein synthesis. In recent years, the number of gram-negative bacilli resistant to gentamicin has increased significantly.
This product is absorbed rapidly and completely after intramuscular injection, reaching peak plasma concentration (Cmax) within 0.5 to 1 hour. The elimination half-life of blood medicine (t1/2β) is about 2 to 3 hours, and it can be significantly prolonged in patients with impaired renal function. Its 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 with urine in its original form 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.
【Storage】Sealed and kept in a cool and dark place.
【Packing】Ampoule packaging, l0pcs/box
【Validity Period】24 months
[Executive standard] "Chinese Pharmacopoeia" 2015 edition two
[Approval Number] National Medicine Standard H52020737
【Manufacturer】Company name: Guizhou Tiandi Pharmaceutical Co., Ltd.