Product name: Gentamycin Sulfate Injection Molecular formula: C11H12N4O3S Molecular weight: 280.31 Character: This product is a colorless or almost colorless clear liquid. Indications: 1. Applicable to the treatment of sensitive gram-negative bacilli, such as Escherichia coli, Klebsiella spp, Enterobacter spp, Proteus spp, Serratia spp, Pseudomonas aeruginosa and serious infections caused by staphylococcal methicillin-sensitive strains, such as sepsis, lower respiratory tract infections, intestinal infections, pelvic infections, abdominal infections, skin soft tissue infections, complicated urinary tract infections, etc. The treatment of abdominal infection and pelvic infection should be combined with anti-anaerobic drugs, and gentamicin is mostly used clinically in combination with other antibacterial drugs. Combined with penicillin (or ampicillin) can treat enterococcal infections. 2. For central nervous system infections caused by sensitive bacteria, such as meningitis and ventriculitis, this product can be used simultaneously for intrathecal injection as adjuvant therapy. Usage and Dosage: 1. Adults: Intramuscular injection or intravenous drip after dilution, 80mg (80,000 units) once, or 1~1.7mg/kg once every 8 hours according to body weight; or 5mg/kg once every 24 hours. The course of treatment is 7 to 14 days. Add one dose to 50-200ml of 0.9% sodium chloride injection or 5% glucose injection, and the amount of liquid added to the drip once a day should not be less than 300ml, so that the concentration of the drug does not exceed 0.1%, and the solution should be dripped slowly within 30-60 minutes to avoid neuromuscular blocking effect. 2. Children: Intramuscular injection or diluted intravenous drip, 2.5mg/kg once, once every 12 hours; or 1.7mg/kg once, once every 8 hours. The duration of treatment is 7 to 14 days, during which the blood concentration should be monitored as much as possible, especially in newborns or infants. 3. Intrathecal and intracerebroventricular administration: The dose is 4-8mg once for adults and 1-2mg once for children (over 3 months old), once every 2-3 days. When injecting, dilute the drug to a concentration of no more than 0.2%, pump it into a sterile 5ml or 10ml syringe, make a considerable amount of cerebrospinal fluid flow into the syringe after lumbar puncture, push while pumping, and inject the entire drug slowly within 3-5 minutes. 4. The dosage for patients with reduced renal function: the normal dose is 1~1.7mg/kg once every 8 hours for those with normal renal function, and 30~70% of the normal dose once every 12 hours for those with creatinine clearance of 10~50ml/min; 20~30% of the normal dose is given once every 24~48 hours for those with creatinine clearance 5. After hemodialysis, according to the severity of infection, adults can be given a single supplemental dose of 1~1.7mg/kg according to body weight, and children (over 3 months old) can be given a single supplemental dose of 2~2.5mg/kg. Adverse reactions: 1. The drug may cause ototoxic reactions such as hearing loss, tinnitus or a feeling of fullness in the ear, and unsteady gait and vertigo when vestibular function is affected. Nephrotoxic reactions such as hematuria, significant reduction in urination or urine output, loss of appetite, and extreme thirst may also occur. Less frequent are dyspnea, drowsiness, and weakness due to neuromuscular blockade or nephrotoxicity. Occasionally, rash, nausea, vomiting, hepatic decompensation, leukopenia, granulocytopenia, anemia, hypotension, etc. may occur. 2. A few patients may experience ototoxic symptoms such as hearing loss, tinnitus or fullness in the ear after discontinuation of the drug, which should be noted. 3. Systemic administration combined with intrathecal injection may cause leg convulsions, skin rash, fever and generalized cramps. Taboo: Contraindicated in persons with hypersensitivity to this product or other aminoglycosides. Matters needing attention: 1. This product should be used with caution in the following cases: patients with water loss, 8th pair of 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 or amikacin may be allergic to this product. 3.Urinary routine and renal function measurement should be performed regularly before and during the drug administration to prevent serious nephrotoxic reactions. Hearing examination or audiogram, especially high frequency audiometry and temperature stimulation test should be performed to detect vestibular toxicity when necessary. 4. Blood concentration should be monitored during the course of treatment and the dose should be adjusted accordingly, especially in neonates, elderly and patients with reduced renal function. The effective blood concentration should be maintained at 4-10g/ml for every 8-hour dose, avoiding peak concentration exceeding 12g/ml and trough concentration at 1-2g/ml; peak concentration should be maintained at 16-24g/ml and trough concentration should be 5. If the blood concentration cannot be measured, the dose should be adjusted according to the measured creatinine clearance. 6. After the first saturation dose (1-2mg/kg) is given, the maintenance dose should be reduced in patients with renal insufficiency, vestibular function or hearing loss. 7. Patients should be given sufficient water to reduce renal tubular damage. 8. Long-term application may lead to excessive growth of drug-resistant bacteria. 9. It should not be used for subcutaneous injection. 10. This product has the effect of inhibiting respiration and should not be injected intravenously. 11. Interference with diagnosis: This product may increase the measured values of alanine aminotransferase (ALT), menthyltransferase (GOT), serum bilirubin concentration and lactate dehydrogenase concentration; the measured values of blood calcium, magnesium, potassium and sodium concentration may decrease. Pharmacology and toxicology: Pharmacology: Broad-spectrum antiviral agent. It inhibits the growth of respiratory syncytial virus, influenza virus, hepatitis A virus, adenovirus and other viruses in vitro by a mechanism that is not fully understood. It does not alter viral adsorption, invasion and decapitation, nor does it induce the production of interferon. The drug is rapidly phosphorylated upon entry into virus-infected cells, and its products act as competitive inhibitors of viral synthase, inhibiting inosine monophosphate dehydrogenase, influenza virus RNA polymutase and mRNA guanosyltransferase, thereby causing a decrease in intracellular guanosine triphosphate, impairing viral RNA and protein synthesis, and inhibiting virus replication and propagation. It may also have immune effect and neutralizing antibody effect on respiratory syncytial virus. Toxicology: Animal studies have found that this product can induce benign tumors in the breast, pancreas, pituitary and adrenal glands, but its carcinogenicity in humans is not confirmed. The drug can cause malformations of the head, palate, eyes, jaws, bones and gastrointestinal tract and reduced offspring viability in hamsters and other animals, but experiments in primates did not reveal the effect of the drug on fetuses. Cardiac damage occurred in mice, rats and monkeys given oral ribavirin at doses of 30, 36 and 120 mg/kg or for more than 4 weeks (human equivalent: 4.8, 12.3 and 111.4 mg/kg for children weighing 5 kg or 2.5, 5.1 and 40 mg/kg for adults weighing 60 kg). Pharmacokinetics: It is rapidly and completely absorbed after intramuscular injection, reaching peak blood concentration (Cmax) in 0.5 to 1 hour. The blood elimination half-life (t1/2) is about 2-3 hours, which may be significantly prolonged in patients with reduced renal function. Low protein binding rate. It can be distributed in various tissues and body fluids in the body, accumulate in renal cortical cells, and also enter the fetus through the placental barrier, but does not easily cross the blood-cerebrospinal fluid barrier into brain tissue and cerebrospinal fluid. It is not metabolized in the body and is excreted in the urine by glomerular filtration as a prototype. 50%-93% of the administered amount is excreted within 24 hours after administration. Hemodialysis and peritoneal dialysis can remove an equivalent amount of the drug from the blood, resulting in a significantly shorter half-life. Drug Interaction: 1. Combination with other aminoglycosides or sequential topical or systemic application may increase the possibility of ototoxicity, nephrotoxicity and neuromuscular blocking effects. 2. Combination with neuromuscular blocking agents may aggravate the neuromuscular blocking effect and lead to muscle weakness, respiratory depression and other symptoms. 3. Combination with capreomycin, cisplatin, etanercept, furosemide or vancomycin (or desmethylvancomycin), or successive topical or systemic application may increase ototoxicity and nephrotoxicity. 4. Combined with cefothiophene and cefazolin topically or systemically may increase nephrotoxicity. 5. Combination with polymyxin injection or successive topical or systemic application may increase nephrotoxicity and neuromuscular blocking effect. 6. Other nephrotoxic and ototoxic drugs should not be combined with this product or applied successively to avoid aggravating nephrotoxicity or ototoxicity. 7. Aminoglycosides and β-lactams (cephalosporins and penicillins) may cause mutual inactivation when mixed. When combined with the above antibiotics, the product must be injected in separate bottles. This product should not be injected with other drugs in the same bottle. Overdose: It is not a specific antagonist, and in case of overdose or toxic reactions, symptomatic and supportive therapy with plenty of hydration is the mainstay. Hemodialysis or peritoneal dialysis helps to remove gentamicin from the blood. Medication: Pregnant women and nursing mothers: This product can cross the placental barrier into the fetal tissue and may cause fetal hearing damage. The secretion of this product in breast milk is very small, but usually breastfeeding women should still suspend breastfeeding during the period of drug use. Use in children: Gentamicin is an aminoglycoside and should be used with caution in pediatrics, especially in premature infants and neonates, because their renal tissues are not fully developed, which prolongs the half-life of this drug and makes it easy to accumulate in the body and produce toxic reactions. Use in elderly patients: The renal function of elderly patients has a certain degree of physiological decompensation, even if the renal function is measured within the normal range, a smaller therapeutic amount should be used. Elderly patients are more likely to have various toxic reactions after the application of this product, and blood concentration should be monitored during the course of treatment as far as possible. Storage: Keep airtight, in a cool, dark place.
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