Imipenem and Cilastatin Sodium for Injection

Imipenem has antibacterial effects on Gram-positive and Gram-negative aerobic and anaerobic bacteria. This product is very sensitive to Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus (including enzyme-producing strains), Escherichia coli, Klebsiella, some strains of Acinetobacter, Bacteroides fragilis and other Bacteroides, Peptococcus and some strains of Peptostreptococcus. This product is also quite sensitive to Streptococcus faecalis, Streptococcus epidermidis, Haemophilus influenzae, Proteus mirabilis, Serratia marcescens, Enterobacter aerogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Clostridium difficile, Clostridium difficile, etc. This product has good enzyme resistance and rarely has cross-resistance with other beta-lactam drugs.

Imipenem and cilastatin sodium.

This product is white or off-white powder.

It is suitable for the treatment of serious infections caused by sensitive Gram-positive bacteria and Gram-negative bacteria, such as sepsis, infective endocarditis, lower respiratory tract infection, abdominal infection, pelvic infection, skin and soft tissue infection, bone and joint infection, urinary tract infection and mixed infection caused by multiple bacteria.

Intravenous drip or intramuscular injection. 1 The dosage is based on imipenem, and according to the condition, 0.25-1g at a time, 2-4 times a day. For moderate infection, it can generally be given at 1g once, twice a day. Isotonic sodium chloride injection and 5%-10% glucose solution can be used as solvents for intravenous drip. Use 100ml of solvent for every 0.5g of drug to make a 5mg/ml liquid, and drip it slowly. Use 1% lidocaine injection as a solvent for intramuscular injection to relieve pain. 2 For patients with renal insufficiency, the dose should be adjusted according to creatinine clearance: for patients with creatinine clearance of 31-70ml/min, use 0.5g every 6-8 hours, with a maximum daily dose of 1.5-2g; for patients with creatinine clearance of 21-30ml/min, use 0.5g every 8-12 hours, with a maximum daily dose of 1.5-2g.

1. This product can cause thrombophlebitis if it is used intravenously at too fast a speed. It can cause local pain, erythema, nodules, etc. when injected intramuscularly. It is advisable to change the injection site. 2. Liver: There may be an increase in aminotransferase, blood bilirubin or alkaline phosphatase. 3. Kidney: There may be an increase in blood creatinine and blood urea nitrogen. However, children often have red urine when using this drug. This is due to the discoloration caused by the drug, not hematuria. 4. There may be symptoms of the nervous system, such as muscle spasms, mental disorders, etc. 5. This product can cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, and occasionally pseudomembranous colitis. 6. There may be an increase in eosinophils, a decrease in leukocytes, a decrease in neutrophils, a decrease or increase in thrombocytopenia, a decrease in hemoglobin, etc., and it may cause a positive anti-human globulin (Coombs) test. 7. This product can also cause allergic reactions, such as skin itching, rash, urticaria, drug fever, etc.

This product is contraindicated for patients who are allergic to any of its ingredients

Precautions for children: There is currently insufficient clinical data to recommend this product for infants under 3 months of age or pediatric patients with renal impairment (serum creatinine> 2mg/dl) (please refer to the "Pediatric Dosage Schedule" in Dosage and Administration). Precautions for pregnancy and lactation: There is no sufficient and well-controlled research data on the use of this product in pregnant women. It can only be administered during pregnancy if the benefits to the fetus outweigh the potential risks. Lactating women: Imipenem can be detected in human milk. If it is determined that it is necessary to use this product in a lactating woman, the patient must stop breastfeeding. Precautions for the elderly: It is not yet clear.

1 The combined use of probenecid and imipenem/cilastatin sodium can prolong the plasma half-life of imipenem and increase its area under the plasma concentration-time curve (AUC) accordingly. Studies have shown that when the two are used together, the half-life of imipenem can be extended by about 6%, the AUC can be increased by about 13%, and the plasma clearance rate can be decreased by about 13%. 2 When imipenem/cilastatin sodium is used in combination with aminoglycoside antibiotics, it has a synergistic antibacterial effect on certain isolated Pseudomonas. 3 The combined use of imipenem/cilastatin sodium and cyclosporine can increase neurotoxic effects. 4 The combined use of imipenem/cilastatin sodium and theophylline can cause theophylline poisoning (nausea, vomiting, palpitations, epileptic seizures, etc.), and the possible mechanism is that the combined use may increase the central nervous system toxicity. 5 It has been reported that the combined use of imipenem and ganciclovir can cause epileptic seizures. 6 Imipenem/cilastatin sodium can weaken the immune response to live typhoid vaccine. The possible mechanism is that this product has antibacterial activity against Salmonella typhi.

Keep in airtight container and away from light.

0.5 g (calculated as 0.25 g of C12H17N304S and 0.25 g of C16H25N205S)

24 months

Han Hui Pharmaceuticals Company Limited

• Founded in:

  2012-09-06

• Address:

  No. 2 Haizheng Road, Xukou Town, Fuyang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100053653670B

• Registered Funds:

  1852.03035908 yuan

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