Cefpodoxime Proxetil Granules

1. Pharmacological studies: Cefpodoxime axetil is an oral broad-spectrum third-generation cephalosporin. After entering the body, it is hydrolyzed into cefpodoxime by non-specific esterase to exert antibacterial effects. It is effective against both Gram-positive and Gram-negative bacteria. The mechanism of action of this product is to achieve bactericidal effects by inhibiting the biosynthesis of microbial cell walls. This product is stable to β-lactamase, so many β-lactamase-producing microorganisms that are resistant to penicillin and cephalosporins are still sensitive to this product. This product is ineffective against some ultra-extended-spectrum β-lactamases. In vitro and clinical infection studies have confirmed that this product is active against most of the following microorganisms: aerobic Gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing strains, but ineffective against methicillin-resistant Staphylococci), saprophytic Staphylococci, Streptococcus pneumoniae (except penicillin-resistant strains), and Streptococcus pyogenes. Aerobic Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis, Neisseria gonorrhoeae (including penicillinase-producing strains). This product is active against most of the following microorganisms in vitro, but its clinical significance is unclear: Aerobic Gram-positive microorganisms: Streptococcus agalactiae, Streptococcus (Groups C, F, and G). This product is ineffective against enterococci. Aerobic Gram-negative microorganisms: Citrobacter heteromorphus, Klebsiella oxytoca, Proteus vulgaris, Providencia rettgere, Haemophilus parainfluenzae. This product is inactive against most Pseudomonas and Enterobacter species. Anaerobic Gram-positive microorganisms: Peptostreptococcus spp. 2. Toxicological studies: Genotoxicity: In vivo and in vitro studies (including Ames test, chromosome aberration test, non-scheduled DNA synthesis test, mitotic recombination, gene recovery, forward gene mutation test and in vivo micronucleus test) did not find that this product has genotoxicity. Reproductive toxicity: When rats were given this product orally at a dose of about 100 mg/kg/day (based on body surface area, twice the human dose), no effect on animal fertility and reproductive function was observed. No teratogenicity or embryotoxicity was observed. When the dose of rabbits reached 30 mg/kg/day (based on body surface area, 1 to 2 times the human dose), no teratogenicity or embryotoxicity was observed.

The main ingredient of this product is cefpodoxime, and its chemical name is: (6R, 7R)-7-[2-(2-aminothiazol-4-yl)-(Z)-2-(methoxyimino)acetylamino]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid-1-(isopropoxycarbonyloxy)ethyl ester.

This product is light yellow granules, sweet taste

This product is suitable for the following infections caused by sensitive bacteria: 1. Upper respiratory tract infections: for example: ear, nose and throat infections, including acute otitis media, sinusitis, tonsillitis and pharyngitis; 2. Lower respiratory tract infections: for example: community-acquired pneumonia, acute exacerbation of chronic bronchitis; 3. Simple urinary tract infections: for example: cystitis; 4. Simple skin and skin soft tissue infections: folliculitis (including pustular acne), furuncle, carbuncle, erysipelas, cellulitis, lymphangitis (adenitis), suppurative paronychia, subcutaneous abscess, hidradenitis, clustered acne, and combined infection of sebaceous cysts; 5. Acute simple gonococcal urethritis and cervicitis, and perianal inflammation caused by Neisseria gonorrhoeae.

For children: 10 mg/kg/day, orally in 2 divided doses.

Literature reports that the following adverse reactions may occur when using this product for treatment: 1. Gastrointestinal reactions: nausea, vomiting, diarrhea, soft stools, stomach pain, abdominal pain, loss of appetite or stomach discomfort, and occasionally constipation, etc. may occur. 2. Allergies: If rash, urticaria, erythema, itching, fever, swollen lymph nodes or joint pain occur, the drug should be discontinued and treated appropriately. 3. Blood: eosinophilia, thrombocytopenia, and occasionally granulocytopenia may occur. 4. Liver: AST, ALT, ALF, LDH, etc. may increase. 5. Kidneys: BUN and Cr may increase. 6. Alternatosis: stomatitis and candidiasis may occur occasionally. 7. Vitamin deficiency: symptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B deficiency may occur occasionally.

1. Patients allergic to penicillin or β-lactam antibiotics are contraindicated. 2. Patients allergic to cefpodoxime are contraindicated.

Precautions for children: Safety for low birth weight infants, newborns, infants, toddlers or children has not been established (little experience in use). Precautions for pregnancy and lactation: There is currently no adequate and rigorous research data for pregnant women. Since animal tests cannot fully predict human conditions, pregnant women should only use this product when it is really necessary. There is no experience of using this product during delivery, so it should only be used when it is really necessary. This product can be secreted in human milk. Since this product has potential serious reactions to breastfeeding infants, the pros and cons to the mother should be weighed before deciding whether to interrupt breastfeeding or stop taking the drug. Precautions for the elderly: No difference in adverse reactions was observed between elderly patients and other adults, but elderly patients usually have reduced physiological functions, are prone to adverse reactions and bleeding tendencies caused by vitamin K deficiency, and should be used with caution.

Antacids or H2 receptor antagonists can reduce its absorption and lower its peak plasma concentration; probenecid can increase its plasma concentration level.

Seal and store in a cool place. Validity period: 24 months

40mg (calculated as C15H17N5O6S2)

24 months

Tianjin Pharmaceutical HOLDINGS Gencom Pharmacy Co., Ltd.

• Founded in:

  2003-07-02

• Address:

  No. 236, Jinyuan Road, Dagang Petrochemical Industrial Park, Binhai New Area, Tianjin

• Tax NO.:

  9112011675220273XC

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  189.5 million yuan

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