Cefprozil Granules

The product is a second-generation cephalosporin drug with a broad-spectrum antibacterial effect. The bactericidal mechanism of the drug is to bind to penicillin-binding proteins (PBPs) on the bacterial cell membrane, hinder the synthesis of bacterial cell walls, and thus cause the dissolution and death of bacteria. In vitro tests have shown that cefprozil has a significant effect on Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae, and Streptococcus pyogenes among Gram-positive aerobic bacteria, and has an inhibitory effect on Enterococcus tenacious, Listeria monocytogenes, Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus Warnei, Streptococcus agalactiae, Streptococcus C, D, F, G groups and Streptococcus viridans. It is ineffective against methicillin-resistant Staphylococcus and Enterococcus faecalis. It is highly sensitive to the gram-negative aerobic bacteria Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). It can inhibit the growth and reproduction of Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae (including β-lactamase-producing strains), Proteus mirabilis, Salmonella, Shigella and Vibrio. It has no antibacterial effect on most strains of Acinetobacter, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia and Pseudomonas. It has a certain inhibitory effect on melanin-producing Bacillus, Clostridium difficile, Clostridium perfringens, Fusobacterium, Streptococcus and Propionibacterium acnes among anaerobic bacteria, and has no antibacterial effect on most strains of Bacillus fragilis. Toxicological studies: Long-term carcinogenicity studies have not 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 chromosomal aberrations were found in oral administration of doses up to 30 times the highest human dose (calculated as mg/m2). No damage to reproductive capacity was found in male or female rats given cefprozil orally at doses up to 18.5 times the high human dose (calculated as mg/m2).

The main ingredient of this product is cefprozil

This product is in the form of granules or powder with a fragrant smell.

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

Oral administration, add appropriate amount of warm water, stir well and take. 　　Adults (13 years old or above) upper respiratory tract infection, 0.5g (4 bags) each time, once a day; lower respiratory tract infection, 0.5g (4 bags) each time, twice a day: skin or skin soft tissue infection, 0.5g (4 bags) per day, once or twice, severe cases, 0.5g (4 bags) each time, twice a day. 　　Children aged 2 to 12 years old upper respiratory tract infection, 7.5mg/kg body weight each time, twice a day: skin or skin soft tissue infection, 20mg/kg body weight each time, once a day 　　6 months old to 12 years old children otitis media, 15mg/kg body weight each time, twice a day; acute sinusitis, generally 7.5mg/kg body weight each time, twice a day: severe cases, 15mg/kg body weight each time, 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 β-hemolytic streptococci is at least 10 days. Renal insufficiency Patients with renal insufficiency should adjust the dose of cefprozil according to the following table: Creatinine clearance (ml/min) Dose (mg) Dosing interval 30-120 Usual dose Regular time 0-29*50% Usual dose Regular time *Hemodialysis can remove part of cefprozil from the body, so it should be taken after hemodialysis is completed. Hepatic insufficiency Patients with impaired liver function do not need to adjust the dose.

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 blood urea nitrogen and increased blood 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, angioneurotic edema, 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 laboratory abnormalities: aplastic anemia, hemolytic anemia, bleeding, renal insufficiency, toxic epidermal necrosis, toxic nephrogenicity, prolonged prothrombin time, positive Coomb 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 old. However, there have been reports of other cephalosporins accumulating in newborns (due to the extended half-life of drugs in children of this age group). Precautions for pregnancy and lactation: Domestic rabbits, mice and rats were given 0.8, 8.5 and 18.5 times (calculated as mg/m2) of the maximum human dose (100 mg) orally, and no effects on the fetus were found. However, adequate and well-controlled studies have not been conducted in pregnant women. Because animal reproductive toxicity studies cannot fully predict human responses, it should only be used in pregnant women when necessary. A single oral dose of 1g of cefprozil can be found in breast milk of lactating women (less than 0.3% of the dose), and the average level after 24 hours is in the range of 0.25-3.3μg/ml. Because the effect of cefprozil on lactating infants is still unclear, lactating women should use it with caution. Elderly precautions: When healthy elderly volunteers (over 65 years old) were given 1g of cefprozil, the AUC increased by 35%-60% and the renal clearance decreased by 40% compared with adults aged 20-40 years. Clinical studies have shown that when the elderly receive the same dose as adults, the safety and efficacy are acceptable and comparable to those of non-elderly patients.

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 Cephalosporins 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). These 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, tightly sealed, and stored in a cool and dry place.

0.125g per bag

24 months

Harbin Brightway Pharm. Co., Ltd.

• Founded in:

  1998-09-09

• Address:

  Beijing Road, Limin Development Zone, Hulan District, Harbin City, Heilongjiang Province

• Tax NO.:

  91230111702846756T

• Registered Funds:

  84.87 million yuan

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