Amikacin Sulfate for Injection

Amikacin sulfate is an aminoglycoside antibiotic. This product has a good effect on most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Shigella, Salmonella, Citrobacter, Serratia, etc. It also has a good effect on Pseudomonas aeruginosa and other Pseudomonas, Acinetobacter, Alcaligenes, etc. It also has a good antibacterial effect on Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Yersinia, Campylobacter fetus, Mycobacterium tuberculosis and some non-tuberculous mycobacteria. Its antibacterial activity is slightly lower than that of gentamicin. The most prominent advantage of this product is that it is stable against aminoglycoside inactivating enzymes produced by many intestinal Gram-negative bacilli and will not be inactivated by such enzymes and lose its antibacterial activity. Among the 12 inactivating enzymes isolated so far, this product can only be inactivated by AAC (6). In addition, AAD (4) and APH (3)-III can occasionally cause bacteria to be moderately resistant to this product. About 60% to 70% of clinically isolated Enterobacteriaceae that are resistant to aminoglycosides such as gentamicin, tobramycin and netilmicin are still sensitive to this product. In recent years, the number of strains resistant to amikacin in Gram-negative bacteria has also increased. Among Gram-positive cocci, this product has a good antibacterial effect on methicillin-sensitive strains of Staphylococcus, while Streptococcus pneumoniae, various groups of Streptococci and Enterococcus are mostly resistant to it. This product is ineffective against anaerobic bacteria. The mechanism of action of this product is to act on the 30S subunit of the bacterial ribosome and inhibit bacterial protein synthesis. Amikacin can often achieve a synergistic antibacterial effect when used in combination with semi-synthetic penicillins or cephalosporins.

Amikacin sulfate

This product is white or off-white crystalline powder or loose lumps

This product is suitable for serious infections caused by sensitive Gram-negative bacilli such as Pseudomonas aeruginosa and other Pseudomonas, Escherichia coli, Proteus, Klebsiella, Enterobacter, Serratia, Acinetobacter, and Staphylococcus (methicillin-sensitive strains), such as bacteremia or sepsis, bacterial endocarditis, lower respiratory tract infection, bone and joint infection, biliary tract infection, abdominal infection, complicated urinary tract infection, skin and soft tissue infection, etc. Since this product is stable to most aminoglycoside inactivating enzymes, it is particularly suitable for the treatment of serious infections caused by Gram-negative bacilli resistant to kanamycin, gentamicin or tobramycin.

1. Adults, intramuscular injection or intravenous drip. For simple urinary tract infection resistant to commonly used antibiotics, 0.2g every 12 hours; for other systemic infections, 7.5mg/kg every 12 hours, or 15mg/kg every 24 hours. Adults should not exceed 1.5g per day, and the course of treatment should not exceed 10 days. 2. Children, intramuscular injection or intravenous drip, the first dose is 10mg/kg according to body weight, followed by 7.5mg/kg every 12 hours, or 15mg/kg every 24 hours. 3. Patients with impaired renal function: For patients with creatinine clearance of 50-90ml/min, 60%-90% of the normal dose (7.5mg/kg) is given every 12 hours; for patients with creatinine clearance of 10-50ml/min, 20%-30% of 7.5mg/kg is used every 24-48 hours.

1. Patients may experience hearing loss, tinnitus or fullness in the ears; a few patients may also experience dizziness, unsteady gait and other symptoms. Hearing loss generally stops after discontinuation of the drug, but some may continue to develop into deafness after discontinuation of the drug. 2. This product has a certain degree of nephrotoxicity, and patients may experience hematuria, decreased urination frequency or urine volume, increased blood urea nitrogen and blood creatinine values. Most of them are reversible and will be alleviated after discontinuation of the drug, but there are also reports of individual cases of renal failure. 3. Neuromuscular blocking effects such as weakness, drowsiness, and dyspnea are rare. 4. Other adverse reactions include headache, numbness, needle infection, tremor, convulsion, joint pain, drug fever, eosinophilia, abnormal liver function, blurred vision, etc.

It is contraindicated in patients who are allergic to amikacin or other aminoglycosides.

1. This product combined with other aminoglycosides or applied topically or systemically successively may increase ototoxicity, nephrotoxicity and neuromuscular blocking effects. 2. This product combined with neuromuscular blocking drugs may aggravate neuromuscular blocking effects, leading to symptoms such as muscle weakness and respiratory depression. This product combined with capreomycin, cisplatin, ethacrynic acid, furosemide or vancomycin (or norvancomycin), etc., or applied topically or systemically successively may increase ototoxicity and nephrotoxicity. 3. This product combined with cephalothin or cefazolin topically or systemically may increase nephrotoxicity. This product should not be used in combination with injections such as amphotericin B, cephalothin, sulfadiazine and tetracycline, as incompatibility may occur. 4. This product combined with polymyxin injections or applied topically or systemically successively may increase nephrotoxicity and neuromuscular blocking effects. 5. Other nephrotoxic and ototoxic drugs should not be used together or applied sequentially with this product to avoid aggravating nephrotoxicity or ototoxicity.

Sealed and stored in a dry place

Calculated as C22H43N5O13 0.2g (200,000 units)