Cefprozil Tablets

1. This product is a second-generation cephalosporin drug with a broad-spectrum antibacterial effect. 2. The bactericidal mechanism of this drug is to hinder the synthesis of bacterial cell walls. 3. In vitro tests have shown that cefprozil has a significant effect on Gram-positive aerobic bacteria such as Staphylococcus aureus (including beta-lactamase-producing strains), Streptococcus pneumoniae, and Streptococcus pyogenes, and has an inhibitory effect on Enterococcus tenacious, Listeria monocytogenes, Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus Wamei, Streptococcus agalactiae, Streptococcus C, D, F, G groups and Streptococcus viridans. It is ineffective against methicillin-resistant Staphylococcus aureus and enterococci, and is highly sensitive to gram-negative aerobic bacteria such as Haemophilus influenzae (including beta-lactamase-producing strains) and Moraxella catarrhalis (including beta-lactamase-producing strains); it can inhibit the growth of Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae (including beta-lactamase-producing strains), Proteus mirabilis, Salmonella, Shigella and Vibrio, and has no antibacterial effect on most strains of Acinetobacter, Encephalobacter, Morganella morganii, Proteus vulgaris, Providencia and Pseudomonas. Cefprozil has a certain inhibitory effect on melanin Bacillus, Clostridium difficile, Clostridium perfringens, Fusobacterium, Streptococcus and Propionibacterium acnes among anaerobic bacteria, and has no antibacterial effect on most strains of Bacillus fragilis.

The main ingredient of this product is cefprozil.

This product is a film-coated tablet, which appears off-white or light yellow after removing the coating.

1. For the following mild and moderate infections caused by sensitive bacteria: upper respiratory tract infection, purulent streptococcal pharyngitis/tonsillitis; 2. Intramuscular penicillin should be selected for the usual treatment and prevention of streptococcal infections (including the prevention of rheumatic fever); although cefoperazone can generally effectively eliminate purulent streptococci in the nasopharynx, there is currently no reference data on the use of cefoperazone to prevent secondary rheumatic fever; otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including (-lactamase-producing strains) and Moraxella catarrhalis (including (-lactamase-producing strains); acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including (-lactamase-producing strains) and Moraxella catarrhalis (including (-lactamase-producing strains); lower respiratory tract infections caused by Streptococcus pneumoniae

Oral 1. For upper respiratory tract infection in adults (13 years or older), 0.5g once a day; for lower respiratory tract infection, 0.5g once a day, twice a day; for skin or skin soft tissue infection, 0.5g a day, taken once or twice a day, for severe cases, 0.5g once a day, twice a day. 2. For upper respiratory tract infection in children aged 2 to 12 years: 7.5mg/kg once a day, twice a day; for skin or skin soft tissue infection: 20mg/kg once a day, once a day. 3. For otitis media in infants from 6 months to 12 years old: 15mg/kg once a day, twice a day; for acute sinusitis: generally 7.5mg/kg once a day, twice a day; for severe cases, 15mg/kg once a day, twice a day. 4. The course of treatment is generally 7-14 days, but the course of treatment for acute tonsillitis and pharyngitis caused by βhemolytic streptococci is at least 10 days. Renal insufficiency 1. Patients with renal insufficiency should adjust the dose of cefprozil as follows: 30≤creatinine clearance≤120ml/min: common dose, regular interval; 0≤creatinine clearance≤29ml/min: 50% common dose, regular interval. 2. Hemodialysis can remove some cefprozil from the body, so it should be taken after hemodialysis is completed. Liver damage Patients with impaired liver function do not need to adjust the dose.

The adverse reactions of ceftriaxone 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: 1. Hepatobiliary system: AST (aspartate aminotransferase) and ALT (alanine aminotransferase). Occasionally, alkaline phosphatase and bilirubin are increased. Cholestatic jaundice is rare. 2. Central nervous system: dizziness, hyperactivity, headache, mental tension, insomnia. Occasionally, drowsiness. All these reactions are reversible. 3. Blood system: leukopenia, eosinophilia. 4. Kidneys: increased serum urea nitrogen and serum creatinine. 5. Others: diaper dermatitis-like rash and superinfection, genital itching and vaginitis. The following adverse events, whether or not they have a clear causal relationship with cefprozil, are rare in post-marketing surveillance. They include allergies, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum sickness-like reactions, Stevens-Johnson syndrome, and thrombocytopenia. 6. Adverse reactions of cephalosporins In addition to the adverse reactions listed above with 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 Coomb test, increased LDH, pancytopenia, neutropenia, and agranulocytosis. Several cephalosporins have been 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 associated with drug-induced seizures, 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 cefoperazone in children under 6 months of age. 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: A lactating woman who takes 1 gram of cefoperazone 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 0.25-3.3 mg/L. Since the effect of cefoperazone on infants is not yet clear, lactating women should be cautious when taking this product. Precautions for the elderly: The average AUC of the elderly (ge; 65 years old) is about 35%-60% higher than that of young adults, and the AUC of women is 15%-20% higher than that of men. However, the differences in the pharmacokinetics of cefoperazone between age and gender are not sufficient to indicate the need for dose adjustment.

1. There have been reports of nephrotoxicity caused by the combined use of aminoglycoside antibiotics and cephalosporins. The combined use with probenecid can double the AUC of cefprozil. 2. Drug and 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 urine glucose enzymatic tests (such as Tes-Tape urine glucose test strips) do not produce false positives. This type of drug can cause false negative blood glucose ferrocyanide reactions. Cefprozil in the blood does not interfere with the determination of creatinine in blood or urine using the alkaline picrate method.

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

0.25g

24 months.

Hunan Fangsheng Pharmaceutical Co., Ltd.

• Founded in:

  1997-10-13

• Address:

  No. 789, Lusong Road, Changsha High-tech Zone

• Tax NO.:

  91430000183855019M

• Registered Funds:

  440.45112 million yuan

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