Cefprozil Granules

This product is a second-generation cephalosporin drug with a broad-spectrum antibacterial effect. The bactericidal mechanism of this drug is to synthesize with penicillin-binding proteins (PBPs) on the bacterial cell membrane, hinder the synthesis of bacterial cell walls, and thus cause the bacteria to dissolve and die. Long-term carcinogenicity studies have not yet been conducted. No mutagenic effects were found in the Ames test conducted in Salmonella or Escherichia coli and the chromosome aberration test conducted in Chinese hamster ovary cells. In the mouse bone marrow micronucleus test, no chromosome aberration was found when the oral dose was more than 30 times the highest human dose (calculated in mg/m2). No damage to reproductive capacity was found in male or female rats given cefprozil orally at a dose of 18.5 times the highest human dose (calculated in mg/m2).

Main ingredients: The main ingredient of this product is cefprozil, of which the Z isomer accounts for about 90%.

This product is white or off-white suspension granules; it tastes sweet.

For the following mild and moderate infections caused by sensitive bacteria. Upper respiratory tract infection Streptococcus pyogenes pharyngitis/tonsillitis. Note: Intramuscular penicillin should usually be selected for the treatment and prevention of streptococcal infections (including the prevention of rheumatic fever). Although cefprozil can generally effectively eliminate Streptococcus pyogenes in the nasopharynx, there is currently no reference data on the use of cefprozil in the prevention of secondary rheumatic fever. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). Acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). Lower respiratory tract infection Acute bronchitis secondary to bacterial infection and acute exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). Skin and skin tissue infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes are uncomplicated, but abscesses usually require surgical drainage. Bacterial culture and susceptibility testing should be performed to determine the susceptibility of the pathogen to cefprozil when appropriate.

Oral. Adult upper respiratory tract infection: 0.5g once, once a day; lower respiratory tract infection: 0.5g once, twice a day; skin or skin soft tissue infection: 0.5g a day, taken once or twice; severe cases: 0.5g (10ml) once, twice a day. The course of treatment is generally 7 to 14 days, but the course of treatment for acute tonsillitis and pharyngitis caused by beta-hemolytic streptococci is at least 10 days. Children (2 to 12 years old) Upper respiratory tract infection: 7.5mg/kg once, twice a day; skin or skin soft tissue infection: 20mg/kg once, once a day. Children (6 months to 12 years old) Otitis media: 15mg/kg once, twice a day; acute sinusitis: 7.5mg/kg once, twice a day, severe cases, 15mg/kg once, twice a day. The course of treatment is generally 7 to 14 days, but the course of treatment for acute tonsillitis and pharyngitis caused by beta-hemolytic streptococci is at least 10 days. Patients with renal insufficiency should adjust the dose of this product according to the following table: Creatinine clearance (m1/minute) Dose (mg) Medication interval, 30-120 Common dose Regular interval, 0-29*50% Common dose Regular interval, Hemodialysis can remove part of this product from the body, so it should be taken after hemodialysis is completed. Patients with impaired liver function do not need to adjust the dose. Preparation method: This product contains 125 mg of cefprozil per package. First shake the granules loose, add drinking water twice to prepare a 5 ml solution, that is, 125 mg/5 ml, shake well and take.

1. The adverse reactions of cefuroxime are similar to those of other oral cephalosporins, mainly gastrointestinal reactions, including diarrhea, nausea, vomiting and abdominal pain. Allergic reactions may also occur, most commonly rash and urticaria. Allergic reactions are more common in children than in adults, and often occur within a few days after the start of treatment and disappear within a few days after stopping the drug. Other adverse reactions are rare, including: Hepatobiliary system: AST (aspartate aminotransferase) and ALT (alanine aminotransferase). Occasionally, alkaline phosphatase and bilirubin are increased. Cholestatic jaundice is rare. Central nervous system: dizziness, hyperactivity, headache, mental tension, insomnia, and occasionally drowsiness. All these reactions are reversible. Blood system: leukopenia, eosinophilia. Kidney: increased serum urea nitrogen and increased serum creatinine. Others: diaper dermatitis-like rash and superinfection, genital itching and vaginitis. The following adverse events, regardless of whether their causal relationship with cefuroxime has been clearly established, are rare in post-marketing monitoring. Including allergies, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum sickness-like reactions, Stevens-Johnson syndrome and thrombocytopenia. 2. Adverse reactions of cephalosporins In addition to the adverse reactions listed above for the use of cefprozil, cephalosporins also have the following adverse reactions and cause laboratory abnormalities: aplastic anemia, hemolytic anemia, bleeding, renal insufficiency, toxic epidermal necrosis, toxic nephropathy, prolonged prothrombin time, positive Coombs test, increased LDH, pancytopenia, neutropenia, agranulocytosis. Several cephalosporin drugs are associated with epileptic seizures, especially when the dosage is not reduced in patients with renal impairment (see Dosage and Administration). If an epileptic seizure is related to drug treatment, the drug should be discontinued and anticonvulsant treatment should be given according to clinical manifestations.

Contraindicated in patients allergic to cephalosporins.

Precautions for children: There is no data on the safety and efficacy of cefprozil in children under 6 months of age. However, there have been reports of other cephalosporins accumulating in neonates (due to the extended half-life of the drug in this age group). Precautions for pregnancy and lactation: A lactating woman who takes 1 gram of cefprozil orally once can detect a small amount of the drug in breast milk (<0.3% of the dose taken). The average concentration over 24 hours is 0.25-3.3μg/ml. Since the effect of cefprozil on infants is not yet clear, lactating women should be cautious when taking this product. Precautions for the elderly: The average area under the blood concentration-time curve (AUC) of the elderly (≥65 years old) is about 35%-60% higher than that of young adults, and the area under the blood concentration-time curve (AUC) of women is 15%-20% higher than that of men. However, the pharmacokinetics of cefprozil do not differ between age and gender enough to justify the need for adjustment of measurements.

Nephrotoxicity has been reported with the combined use of aminoglycosides and cephalosporins. Coadministration with probenecid can double the AUC of cefprozil. Drug/Laboratory Test Interactions Cephalosporin antibiotics can cause false-positive reactions in urine glucose reduction tests [Benedict or Feling's reagents or copper sulfate tablets (Clinitest tablets)], but not in urine glucose enzymatic tests (such as Tes-Tape urine glucose test strips). This class of drugs can cause false-negative blood glucose ferrocyanide reactions. Cefprozil in the blood does not interfere with the determination of creatinine in the blood or urine by the alkaline picrate method.

Keep away from light, seal tightly, and store in a cool (not exceeding 20℃) and dry place.

0.125g (based on C18H19N3O5S)

24 months

Qilu Antibiotics Pharmaceutical Co., Ltd.

• Founded in:

  1995-05-29

• Address:

  No. 849, Dongjia Street, Licheng District, Jinan City, Shandong Province

• Tax NO.:

  91370100614074047M

• Registered Funds:

  $86 million

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