Cefpirome Sulfate for Injection

This product is a cephalosporin bactericidal antibiotic that is stable to β-lactamase. It works by blocking the synthesis of bacterial cell wall polymers - peptidoglycan. Because it can quickly penetrate the bacterial cell wall and bind to the target enzyme (penicillin binding protein) with high affinity, it can kill a wide spectrum of Gram-negative and Gram-positive pathogens at low concentrations. This has been confirmed in many in vitro studies on hospital- and community-acquired pathogens worldwide. Recent studies have shown that its sensitivity has not changed. Many strains resistant to other injectable cephalosporins or aminoglycosides are still sensitive to this product. Antibacterial activity: The following pathogens are sensitive to cefpirome in vitro: Gram-positive bacteria: Staphylococcus aureus (including penicillin-resistant strains), coagulase-negative Staphylococci (including penicillin-resistant but not methicillin-resistant strains), Streptococcus A (Streptococcus pyogenes), Streptococcus B (Streptococcus agalactiae), C, F and G, Streptococcus mitis, Streptococcus sanguinis, Streptococcus viridans, Streptococcus pneumoniae, Propionibacterium acnes, anaerobic Streptococcus, Corynebacterium diphtheriae, Corynebacterium pyogenes. Gram-negative bacteria: Citrobacter, Escherichia coli, Salmonella, Shigella, Klebsiella (indole-positive and indole-negative), Enterobacter, Hafnia, Serratia, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia, Yersinia enterocolitica, Pasteurella multocida, Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Neisseria meningitidis, Neisseria gonorrhoeae, Aeromonas hydrophila. Most strains of the following species were shown to be susceptible to cefpirome in vitro: Gram-positive: Clostridium. Gram-negative: Pseudomonas aeruginosa, Pseudomonas (non-Pseudomonas aeruginosa), Bacteroides fragilis (non-β-lactamase-producing strains). Most strains of the following species were resistant to cefpirome in vitro: Gram-positive: Enterococcus faecalis, Listeria monocytogenes, Clostridium difficile. Gram-negative: Xanthomonas maltophilia, Fusobacterium variatum, Bacteroides fragilis (β-lactamase-producing strains). Cefpirome and aminoglycoside antibiotics have synergistic effects on a variety of bacteria. In clinical trials, infections caused by the following pathogens have been successfully cured: Gram-positive: Staphylococcus aureus and coagulase-negative Staphylococci (Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus hominis, Staphylococcus varroa), hemolytic and non-hemolytic streptococci, Streptococcus pyogenes (Group A), serogroups B and F streptococci, Streptococcus pneumoniae, Streptococcus agalactiae, Group A streptococci, Corynebacterium spp. Gram-negative: Escherichia coli, Enterobacter spp., indole-positive and indole-negative Klebsiella and Proteus spp., Morganella morganii, Providencia, Citrobacter spp., Salmonella spp., Hafnia spp., Serratia marcescens, Pasteurella multocida, Haemophilus influenzae and other Haemophilus spp., Moraxella catarrhalis, Neisseria spp., Alcaligenes spp., Pseudomonas aeruginosa and other Pseudomonas spp., Bacteroides spp.

Cefpirome Sulfate

This product is off-white or light yellow crystalline powder.

This product can be used to treat the following infections caused by unknown pathogens or known sensitive bacteria: lower respiratory tract infection, pyelonephritis, lower urinary tract infection, skin and soft tissue infection

This product is administered parenterally, and its dosage, administration method and course of treatment are determined by the severity of the infection, the sensitivity of the pathogen, the patient's condition and the renal function. The following dosage is recommended for patients with moderate to severe infections with normal renal function. For very serious cases of urinary tract, skin and soft tissue infections, the unit dose can be increased to 2.0 grams. Dosage for patients with impaired renal function: Cefpirome is mainly excreted through the kidneys, so the dose must be reduced in patients with impaired renal function to balance its slower excretion. Usage: Intravenous injection: Dissolve 1 vial of 1.0 or 2.0 grams of cefpirome powder in 10 ml or 20 ml of sterile water for injection, respectively, and then inject the liquid directly into the vein or the distal end of the clamped infusion line within 3 to 5 minutes.

1. Allergic reactions are mainly manifested by symptoms such as rash, urticaria, itching, and drug fever; severe acute allergic reaction symptoms such as angioedema and bronchospasm are occasionally seen; there are also individual reports of erythema multiforme and toxic epithelial necrolysis of Stevens-Johnson syndrome. 2. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur in the gastrointestinal tract; pseudomembranous colitis is rare. 3. Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, and bilirubin may increase in the liver, but rarely exceed twice the upper limit of the normal value. 4. Serum creatinine and blood urea nitrogen may increase slightly in the kidneys. 5. Thrombocytopenia and eosinophilia may occur in the blood system; granulocytopenia and hemolytic anemia are extremely rare. 6. Occasionally, headaches and convulsions have been reported in the nervous system; reversible encephalopathy has been reported in patients with renal insufficiency with large doses of the drug. 7. Local reactions: Intravenous administration may cause injection site pain and phlebitis. 8 Long-term use of the drug for dual infection may lead to overgrowth of non-sensitive pathogens (such as Candida albicans). 9 There have been reports of abnormal taste and/or smell after other injections.

Contraindicated in patients allergic to cephalosporins

Drug interactions: No drug interactions have been observed for cefpirome. Although there is no evidence that cefpirome affects renal function at normal therapeutic doses, cephalosporins may enhance their nephrotoxic effects if used in combination with certain drugs (such as aminoglycosides). Probenecid can affect the renal tubular transport of cefpirome, thereby delaying its excretion and increasing its plasma concentration. Other interactions: False-positive results may occur in the Coombs test in very few patients receiving cefpirome. False-positive results may occur when non-enzymatic methods are used to determine urine sugar during treatment, so enzymatic methods should be used to determine whether there is glycosuria. When creatinine is determined by the picrate method, this product can show a strong creatinine-like reaction. Therefore, it is recommended to use enzymatic methods to avoid false increases in creatinine levels. If there is no enzymatic method, a blood sample should be drawn immediately before the next dose of cefpirome, because if the recommended dose and dosing interval are used, the serum level of cefpirome at this time will be below its interference limit.

Keep in a dark, airtight container in a cool (not exceeding 20°C) and dry place.

1.0g (calculated as cefpirome)

24 months

Shanghai SPH New ASIA Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-11

• Address:

  No. 978 Chuansha Road, Pudong New Area, Shanghai

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  91310115133738906M

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