Imipenem and Cilastatin Sodium for Injection

This product is a broad-spectrum β-lactam antibiotic. It is supplied in the form of an intravenous drip. This product contains two ingredients: (1) imipenem, which is a new type of β-lactam antibiotic - imipenem; (2) cilastatin sodium, which is a specific enzyme inhibitor that can block the metabolism of imipenem in the kidneys, thereby increasing the concentration of imipenem parent drug in the urinary tract. In this product, the weight ratio of imipenem to cilastatin sodium is 1:1. Imipenem belongs to the imipenem class of antibiotics, and its notable feature is that its bactericidal spectrum is broader than any other antibiotic that has been studied. Microbiology The broad-spectrum bactericidal effect of this product is due to its powerful ability to inhibit bacterial cell wall synthesis. It can kill most Gram-positive and Gram-positive bacteria.

This product is a compound preparation. Its components are 500 mg of imipenem and 500 mg of cilastatin sodium (calculated as C16H25N2O5S). The auxiliary material is sodium bicarbonate.

This product is white to off-white powder

1. Treatment This product (imipenem-cilastatin sodium for injection) is a very broad-spectrum antibiotic, especially suitable for mixed infections caused by multiple pathogens and aerobic/anaerobic bacteria, as well as early treatment before the pathogen is identified. This product is suitable for the following infections caused by sensitive bacteria: (1) Intra-abdominal infection (2) Lower respiratory tract infection (3) Gynecological infection (4) Sepsis (5) Urogenital tract infection (6) Bone and joint infection (7) Skin and soft tissue infection (8) Endocarditis This product is suitable for the treatment of mixed infections caused by sensitive aerobic/anaerobic strains. These mixed infections are mainly related to bacterial contamination of feces, vagina, skin and oral cavity. Bacteroides fragilis is the most common anaerobic bacteria in these mixed infections. They are usually resistant to chloroglycosides, cephalosporins and penicillins, but sensitive to this product. It has been proven that this product still has strong antibacterial activity against many cephalosporin-resistant bacteria, including infections caused by aerobic and anaerobic Gram-positive and Gram-negative bacteria; these bacteria are resistant to cephalosporin antibiotics including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, hydroxycarboxyoxylamide bacteriocins, cefamandole, ceftazidime and ceftriaxone. Similarly, many infections caused by bacteria resistant to aminoglycoside antibiotics (such as gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin, ticarcillin, piperacillin, azlocillin, mezlocillin) are still effective with this product. This product is not suitable for the treatment of meningitis. 2. Prevention of postoperative infection in patients who have undergone contaminated or potentially contaminated surgical operations or operations where postoperative infection will be particularly serious once it occurs. This product is suitable for preventing such postoperative infection.

This product is supplied in the form of intravenous drip. The recommended dose of this product is expressed as the amount of imipenem used, which also represents the equivalent dose of cilastatin. The total daily dose of this product depends on the type and severity of the infection; and according to the sensitivity of the pathogen, the patient's renal function and weight, consider giving the total daily dose to the patient in equal doses. Treatment: The dosage schedule for adult patients with normal renal function is based on the patient's normal renal function (creatinine clearance>70ml/min(min)/1.73m2) and body weight ≥70 kg. The dose must be reduced for patients with creatinine clearance ≤70ml/min(min)/1.73m2 (see Table (II)) and/or body weight <70 kg. For patients with very low body weight and/or moderate to severe renal function

In general, this product is well tolerated. Clinical controlled studies have shown that this product is as well tolerated as cefazolin, cephalothin and cefotaxime. Most side effects are mild and transient, rarely requiring discontinuation of the drug, and very few serious side effects occur. The most common adverse reactions are some local reactions. Local reactions erythema, local pain and nodules, thrombophlebitis. Allergic reactions/skin rash, itching, urticaria, erythema multiforme, Johnson syndrome, angioedema, toxic epidermal necrolysis (rare), exfoliative dermatitis (rare), candidiasis, including drug fever and allergic reactions. Gastrointestinal reactions nausea, vomiting, diarrhea, tooth and/or tongue stains. All other widely used drugs have been reported.

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

There have been reports of epileptic seizures in patients using ganciclovir and this product intravenously. In this case, it should not be used together unless the benefits outweigh the risks. Also refer to "Stability of this product infusion" under Dosage and Administration.

Sealed, stored below 25°C. Validity period: 24 months

0.5g (C12H17N3O4S 0.25g and C16H26N2O5S 0.25g)

Shenzhen Haibin Pharmaceutical Co., Ltd.

• Founded in:

  1989-08-22

• Address:

  No. 2003, Shenyan Road, Shatoujiao, Yantian District, Shenzhen

• Tax NO.:

  91440300618855174Y

• Registered Funds:

  700 million yuan

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