Cefpirome Sulfate for Injection

This product is a beta-lactamase-stable cephalosporin bactericidal antibiotic. As a beta-lactam antibiotic, it works by blocking the synthesis of the main cell wall polymer, 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 numerous in vitro studies on hospital-acquired and community-acquired pathogens worldwide, and 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.

The main ingredient of this product is cefpirome sulfate. Its chemical name is: (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetylamino]-3-(6,7-dihydro-5H-cyclopenta[b]pyridin-1-ylmethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxy monosulfate.

This product can be used to treat the following infections caused by unknown pathogens or known sensitive bacteria: lower respiratory tract infections (bronchopneumonia and lobar pneumonia); combined upper (pyelonephritis) and lower urinary tract infections; skin and soft tissue infections (cellulitis, skin abscesses and wound infections); infections in neutropenic patients; bacteremia/sepsis. Serious infections listed above.

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.

The following adverse reactions may be observed during cephalosporin therapy: Hypersensitivity reactions: allergic skin reactions; rash, urticaria, pruritus, drug fever; severe acute allergic reactions may occur; angioedema, bronchospasm, requiring emergency treatment. As with other cephalosporins, individual cases of macroscopic reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epithelial necrolysis have also been reported. Effects on the gastrointestinal tract: nausea, vomiting, diarrhea; in rare cases, pseudomembranous colitis may occur (see Special Warnings and Precautions for Use). Effects on liver function: serum liver enzymes (such as aspartate aminotransferase [GOT], alanine aminotransferase [GPT], alkaline phosphatase), gamma-GT, lactate dehydrogenase (LDH) and/or bilirubin increase. These laboratory test abnormalities (which can also be caused by infection) rarely exceed twice the upper limit of normal and cause symptoms of liver damage, usually cholestasis and often asymptomatic. Effects on Renal Function: Mild increases in serum creatinine and urea nitrogen may occur, but in most cases do not require discontinuation of treatment. Individual cases of interstitial nephritis and, rarely, acute renal failure have been observed during treatment with other cephalosporins. Changes in Blood Composition: Thrombocytopenia; Eosinophilia; Rarely, Hemolytic Anemia. As with other beta-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may occur during treatment with cefpirome, especially with prolonged treatment. Patients should monitor blood counts for treatment courses longer than 10 days (see Special Precautions and Warnings). Local Reactions: Inflammatory irritation of the vein wall and pain at the injection site. Neurological Effects: Rare cases of convulsions have been reported. As with other cephalosporins, reversible encephalopathy may occur with high-dose therapy, especially in patients with renal impairment. Superinfection: As with other cephalosporins, cefpirome, especially with prolonged use, may result in overgrowth of nonsusceptible pathogens, including Candida monoliasis. Repeated assessment of the patient's condition is critical. If secondary infection occurs, appropriate measures must be taken. Others: abnormal taste and/or smell after injection, headache, fever.

This product is contraindicated for patients who are allergic to cephalosporins and should be used with caution by patients who are allergic to penicillin antibiotics.

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 a very small number of patients receiving cefpirome. Non-enzymatic determination of urine sugar during treatment may result in false-positive results, so enzymatic determination is required to confirm the presence of glycosuria. This product can show a strong creatinine-like reaction when creatinine is determined by the picrate method. Therefore, it is recommended to use an enzymatic determination to avoid false increases in creatinine levels. If an enzymatic determination is not available, a blood sample should be drawn immediately before the next dose of cefpirome, because the serum level of cefpirome at this time should be below its interference limit if the recommended dose and dosing interval are used.

Keep away from light and in a cool place. Validity period: two years

2.0g (calculated as cefpirome)

24 months

Zhejiang Yongning Pharmaceutical Co., Ltd.

• Founded in:

  1990-01-01

• Address:

  No. 4 Meihuajing Road, Huangyan, Taizhou City, Zhejiang Province

• Tax NO.:

  913310001481462415

• Registered Funds:

  153.125 million yuan

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