Cefuroxime Axetil Capsules

Pharmacological action: This product is an oral broad-spectrum second-generation cephalosporin. Cefuroxime axetil is an esterified derivative of cefuroxime. After oral administration, it is hydrolyzed and deesterified after intestinal absorption to form active cefuroxime and exert antibacterial effects. Its mechanism of action 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 against many β-lactamases, especially against plasmid-mediated enzymes commonly found in Enterobacteriaceae. Animal in vitro tests and clinical infection treatment have confirmed that cefuroxime has antibacterial activity against most of the following bacteria. Aerobic Gram-positive bacteria: Staphylococcus aureus (including β-lactamase-producing bacteria), Streptococcus pneumoniae, and Streptococcus pyogenes. Aerobic Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including β-lactamase-producing bacteria), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including β-lactamase-producing bacteria), and Neisseria gonorrhoeae (including β-lactamase-producing bacteria). In vitro tests have shown that most strains of Enterococcus faecalis, methicillin-resistant Staphylococcus aureus, Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime. Toxicological studies: Genetic toxicity tests have shown that although lifelong studies on animals have not been conducted to evaluate the carcinogenic potential of this product, no mutagenic effects of cefuroxime axetil were found in micronucleus tests and bacterial mutation tests. Reproductive toxicity tests have shown that when rats were given this product at a dose of 1000 mg/kg/day, there was no significant effect on animal fertility; when mice and rats were given this product at a dose of 32000 mg/kg/day, no damage to fetal development was observed. However, there is no clinical research to support the correlation between animals and humans.

Cefuroxime Axetil

This product is a hard capsule, and the content is off-white powder.

This product is suitable for acute pharyngitis or tonsillitis in adults, acute otitis media, maxillary sinusitis, acute exacerbation of chronic bronchitis, acute bronchitis, simple urinary tract infection, skin and soft tissue infection, and uncomplicated gonorrhea Neisseria urethritis and cervicitis caused by sensitive strains of Enterobacteriaceae such as hemolytic streptococci, Staphylococcus aureus (except methicillin-resistant strains), Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. It is also suitable for pharyngitis or tonsillitis, acute otitis media, and impetigo in children.

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; for patients with uncomplicated gonorrhea, the recommended dose 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. For patients who have achieved a certain effect of injection of cefuroxime sodium and still need to continue treatment, oral treatment of this product can be switched.

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 anaphylactic shock, angioneurotic edema, 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 necrosis (eruptive epidermal necrosis), etc. 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 seen 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 Coombs' test-positive reactions during cephalosporin treatment, which can interfere with blood cross-matching; renal insufficiency, toxic nephropathy, hepatobiliary stasis, aplastic anemia, hemolytic anemia, bleeding, prolonged clotting time, increased BUN, increased inosine, increased alkaline phosphatase, neutropenia, thrombocytopenia, leukopenia, increased bilirubin, pancytopenia, and agranulocytosis.

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

Precautions for children: It is forbidden for children under 5 years old. Precautions for pregnancy and lactation: Use with caution for lactating women and pregnant women. Precautions for the elderly: Elderly patients do not need to adjust the dosage based on age factors.

1. There are reports that the combined use of aminoglycoside antibiotics and cephalosporins can cause nephrotoxicity. 2. Patients who use cephalosporins clinically will have false positive reactions when using Banerjee, Feeble or Clintesttabets test strips to check urine sugar, but there will be no false positives when using enzyme methods. When checking blood sugar, false negative results may occur if the ferricyanide method is used. Cefuroxime sodium will not interfere with the determination of urine and blood inosine 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 together (average 14.8μg/ml) is higher than the peak blood concentration of not taking probenecid (average 12.2μg/ml). 4. Drugs that reduce gastric acid can cause a decrease in the bioavailability of this product and affect the absorption effect after meals.

Keep in a dark, sealed container and stored in a cool place. Validity period: two years

0.125g (calculated based on C16H16N4O8 tablets)

24 months

ShenZhen Lijian Pharmaceutical Co., Ltd.

• Founded in:

  2001-04-28

• Address:

  1st Floor, Building B2, No. 1 Yuanfu Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen

• Tax NO.:

  91440300728555703C

• Registered Funds:

  40 million yuan

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