Cefuroxime Axetil Granules

This product is an oral broad-spectrum second-generation cephalosporin. Cefuroxime axetil is an esterified derivative of cefuroxime. After oral intestinal absorption, it is hydrolyzed and deesterified to form active cefuroxime and play an antibacterial role. Its antibacterial mechanism is to inhibit the synthesis of bacterial cell walls by binding to bacterial proteins. Cefuroxime has a wide range of antibacterial activity against pathogens and is stable to many β-lactamases, especially plasmid-mediated enzymes commonly found in Enterobacteriaceae.

Cefuroxime axetil.

This product is white or off-white granules.

This product is suitable for the following infections caused by sensitive bacteria: 1. Upper respiratory tract infection: including pharyngitis and tonsillitis caused by Streptococcus pyogenes; acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including strains producing β-lactamase), Moraxella catarrhalis (including strains producing β-lactamase) or Streptococcus pyogenes; acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (only strains not producing β-lactamase), etc. 2. Lower respiratory tract infection: including acute bacterial infection of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase negative strain) or Haemophilus influenzae (β-lactamase negative strain) and secondary bacterial infection of acute bronchitis, etc. 3. Urinary tract infection: including simple urinary tract infection caused by Escherichia coli or Klebsiella pneumoniae; simple gonorrhea (such as urethritis and cervicitis) caused by Neisseria gonorrhoeae strains that produce or do not produce penicillinase, and simple gonorrheal proctitis in women caused by Neisseria gonorrhoeae strains that do not produce penicillinase, etc. 4. Skin and soft tissue infection: including simple skin and soft tissue infection caused by Staphylococcus aureus (including strains that produce β-lactamase) or Streptococcus pyogenes, and impetigo caused by Staphylococcus aureus (including strains that produce β-lactamase) or Streptococcus pyogenes, etc. 5. Others: early Lyme disease (migratory erythema) caused by Borrelia burgdorferi, etc.

Oral administration, after meals. For adults, generally 0.25g each time, twice a day, and the general course of treatment is 5-10 days. For mild to moderate lower respiratory tract infections such as bronchitis, 0.25g each time, twice a day; for severe infections or suspected pneumonia, 0.5g each time, twice a day; for general urinary tract infections, 0.125g each time, twice a day, and the recommended dose for patients with uncomplicated gonorrhea is 1g, taken as a single dose. The general dosage for children is 0.125g each time, twice a day; for patients with otitis media under two years old, 0.125g each time, twice a day; for patients with otitis media over two years old, 0.25g each time, twice a day. For children over 12 years old, the dosage is the same as that for adults.

1. The main adverse reactions of this product include digestive system reactions (such as abdominal pain, diarrhea, nausea, vomiting, loss of appetite, oral ulcers, etc.), skin reactions (such as rash, erythema, itching) and headaches. 2. Like other cephalosporins, rare adverse reactions include: 1) Allergic reactions: including allergic reactions, angioedema, pruritus, rash, drug-induced fever, serum sickness-like reactions and urticaria. 2) Digestive tract reactions: pseudomembranous colitis and liver damage (including hepatitis, cholestasis and jaundice). 3) Hematological examination: hemolytic anemia, leukopenia, pancytopenia and thrombocytopenia. 4) Skin: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (eruptive epidermal necrolysis). 5) Urinary system: renal function damage, etc. 3. Others: In addition to the adverse reactions observed in patients treated with cefuroxime axetil listed above, the following adverse reactions and laboratory changes have been observed in patients treated with cephalosporins: reports of eosinophilia and transient elevations in ALT, AST, and LDH. As with other cephalosporins, reports of jaundice are rare. There have been reports of positive Coombs’ test reactions during cephalosporin treatment, which can interfere with blood cross-matching. 4. Renal insufficiency, toxic nephropathy, hepatobiliary stasis, aplastic anemia, hemolytic anemia, bleeding, prolonged clotting time, elevated BUN, elevated inosine, elevated alkaline phosphatase, neutropenia, thrombocytopenia, leukopenia, elevated bilirubin, pancytopenia, and agranulocytosis.

It is contraindicated in patients who are allergic to cephalosporin antibiotics.

Precautions for children: 1. There is still a lack of research data on the use of this drug in infants under three months old. 2. It is recommended that children choose cefuroxime axetil dry suspension. 3. This product can be used for patients with mild to moderate upper respiratory tract infections and impetigo caused by sensitive bacteria in children aged 3 months to 12 years old. Precautions for pregnancy and lactation: Use with caution in pregnant women. Since cefuroxime is excreted in human milk, it should be used with caution in lactating women. If it is necessary to use it, breastfeeding should be temporarily stopped. Precautions for the elderly: Elderly patients do not need to adjust the dose according to age factors.

1. It has been reported that the combined use of aminoglycoside antibiotics and cephalosporins can cause nephrotoxicity. 2. Patients who use cephalosporins clinically will have false positive reactions when checking urine sugar with Banerjee, Feeble or Clintesttabets test strips, but there will be no false positives when using enzyme methods. False negative results may occur when checking blood sugar if the ferricyanide method is used. Cefuroxime sodium will not interfere with the determination of urine and blood creatinine values using the alkaline picric acid method. 3. When probenecid is taken with cefuroxime axetil tablets, the area under the drug-time curve can increase by 50%. The peak blood concentration of 1.5g single dose of cefuroxime axetil and 1g probenecid taken at the same time (average 14.8micro;g/ml) is higher than the peak blood concentration of not taking probenecid (average 12.2micro;g/ml). 4. Drugs that reduce gastric acid can cause a decrease in the bioavailability of this product and affect the absorption effect after meals.

Protect from light, seal tightly and store in a cool place.

0.125g (calculated as cefuroxime)

24 months

Shijiazhuang No.4 Pharmaceutical Co., Ltd.

• Founded in:

  1994-06-28

• Address:

  No. 518, Huaian East Road, Shijiazhuang High-tech Industrial Development Zone

• Tax NO.:

  911301001044060055

• Registered Funds:

  950 million yuan

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