Cefprozil Capsules

This product is a second-generation cephalosporin drug with a broad-spectrum antibacterial effect. The bactericidal mechanism of this 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 bacteria to dissolve and die. In vitro tests have shown that cefprozil has a significant effect on Gram-positive aerobic bacteria such as Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae, and Streptococcus pyogenes, 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 aureus 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), and 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, but 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, but has no antibacterial effect on most strains of Bacillus fragilis.

The main ingredient of this product is cefprozil (C18H19N3O5S).

The content of this product is off-white to light yellow powder.

For the following mild and moderate infections caused by sensitive bacteria. 1. Upper respiratory tract infections (1) Pharyngitis/tonsillitis caused by Streptococcus pyogenes. Note: Intramuscular penicillin should usually be used to treat and prevent streptococcal infections (including prevention of rheumatic fever). Although cefuroxime can generally effectively eliminate Streptococcus pyogenes in the nasopharynx, there is currently no data available for reference on the use of cefuroxime to prevent secondary rheumatic fever. (2) Otitis media and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). 2. Lower respiratory tract infections Secondary bacterial infections of acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains). 3. Uncomplicated skin and skin soft 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 cefprozil.

Oral. For upper respiratory tract infection in adults (13 years or older), 0.5g each time, once a day; for lower respiratory tract infection, 0.5g each time, twice a day; for skin or skin soft tissue infection, 0.5g per day, once or twice a day; for severe cases, 0.5g each time, twice a day. For upper respiratory tract infection in children aged 2 to 12 years, 7.5mg/kg body weight each time, twice a day; for skin or skin soft tissue infection, 20mg/kg body weight each time, once a day. For otitis media in infants from 6 months to 12 years old, 15mg/kg body weight each time, twice a day; for acute sinusitis, generally 7.5mg/kg body weight each time, twice a day; for severe cases, 15mg/kg body weight each time, twice a day. The course of treatment is generally 7-14 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 (m1/min) Dose (mg) Dosing interval 30-120 Common dose Regular time 0-29*50% Common 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. 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, 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 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 epileptic seizures related to drug treatment occur, 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 drugs in children of this age group). Precautions for pregnancy and lactation: Oral administration of 0.8, 8.5, and 18.5 times (calculated in mg/m2) of the maximum human dose (1000 mg) to rabbits, mice, and rats, respectively, did not find any effect on the fetus. 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), with an average concentration of 0.25-3.3 mg/l over 24 hours. 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.

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 elderly people receive the same dose as adults, the safety and efficacy are acceptable and comparable to those of non-elderly patients.

Keep in a dark place, sealed and stored in a cool (not exceeding 20℃) and dry place.

0.25g (based on C18H19N3O5 tablets)

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

• Website:

  Log in to view

• Email:

  Log in to view