Cefpodoxime Proxetil Tablets

Pharmacological action Cefpodoxime axetil is an oral broad-spectrum third-generation cephalosporin. After entering the body, it is hydrolyzed into cefpodoxime by nonspecific 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 beta-lactamase, so many beta-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 beta-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 beta-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 rettgeri, Haemophilus parainfluenzae. This product is inactive against most Pseudomonas and Enterobacter species. Anaerobic Gram-positive microorganisms: Peptostreptococcus spp. Toxicological studies: Genotoxicity: In vivo and in vitro studies (including Ames test, chromosome aberration test, unscheduled 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 axetil, whose chemical name is: (6R,7R)-7-[2-(2-aminothiazol-4-yl)-2-(Z)-(methoxyimino)-acetamido]-3-methoxymethyl-8-oxo-5-thio-1-azabicyclo-[4,2,0]oct-2-ene-2-carboxylic acid isopropyloxycarbonyloxyethyl ester.

This product is a film-coated tablet. After removing the coating, it appears white or slightly yellow.

Respiratory tract infection: including pharyngitis, pharyngeal abscess, tonsillitis, peritonsillitis, peritonsillar abscess, acute tracheobronchitis, acute exacerbation of chronic bronchitis, secondary infection of bronchiectasis, pneumonia. Urogenital system infection: including pyelonephritis, cystitis, Bartholinitis, Bartholin's abscess, gonococcal urethritis, etc. Skin and soft tissue infection: including folliculitis, furunculosis, furunculosis, carbuncle, erysipelas, cellulitis, lymphangiitis (nodal) whitlow, suppurative paronychia, subcutaneous abscess, hidradenitis, infectious atheroma, perianal abscess, etc. Otitis media, sinusitis. Mastitis.

Oral. Adults take 1~2 tablets (0.1~0.2g) each time, twice a day, depending on the disease and condition. Generally, for upper respiratory tract infection and simple urinary tract infection, take 1 tablet (0.1g) each time, twice a day; for severe cases, increase to 2 tablets (0.2g), twice a day, for a course of 5~7 days. For lower respiratory tract infection, complicated urinary tract infection, skin and soft tissue infection, ear, nose and throat infection, take 0.2g (2 tablets) each time, twice a day, for a course of 7~14 days. Take orally after meals or as directed by a doctor.

1. Serious adverse reaction: Shock: It may occasionally cause shock reaction, so you should pay attention to observation. If you experience discomfort, abnormal sensation in the mouth and tongue, wheezing, dizziness, urge to defecate, tinnitus, sweating, etc., you should stop the drug immediately and give further observation and necessary treatment. Skin mucosal eye syndrome (Stevens-Johnson) and toxic epidermal necrolysis (Lyell syndrome) may occasionally occur, so pay attention to observation. If the corresponding abnormalities occur, you should stop the drug and give appropriate treatment. Severe enteritis such as pseudomembranous colitis accompanied by bloody stools may occasionally occur. If you experience abdominal pain and frequent diarrhea, you should stop the drug immediately and give appropriate treatment. Like other cephalexin antibiotics, this product may occasionally cause whole blood.

Patients with a history of allergy to this product or cephalosporin antibiotics are contraindicated.

Precautions for children: The safety of pediatric use has not yet been established (little experience in use). Precautions for pregnancy and lactation: There is currently no sufficient and rigorous research data on pregnant women. Since animal experiments 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 found 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.

When used in combination with antacids (such as aluminum hydroxide) or H2 receptor antagonists (such as ranitidine), the plasma concentration and drug absorption of CPDX can be reduced after taking CPDX-PR because gastric acid is neutralized.

Sealed, store in a cool, dry place.

Calculated as C15H17N5O6S2 50mg

24 months

Hainan Sanye Pharmaceutical Factory Co., Ltd.

• Founded in:

  1989-01-19

• Address:

  No. 6, Sanye East Road, Longhua District, Haikou City, Hainan Province

• Tax NO.:

  914600002012496387

• Registered Funds:

  10 million yuan

• Email:

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