Cefpodoxime Proxetil Dry Suspension

Pharmacological action 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. Both in vitro and clinical studies have confirmed that this product is active against most of the following microorganisms: 1. Aerobic Gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing strains, but ineffective against methicillin-resistant Staphylococci), saprophytic Staphylococci, Streptococcus pneumoniae (except penicillin-resistant strains), Streptococcus pyogenes. 2. 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 still unclear: 1. Aerobic Gram-positive microorganisms - Streptococcus agalactiae, Streptococcus (c, F, G groups). However, this product is ineffective against enterococci. 2. Aerobic Gram-negative microorganisms - Citrobacter heteromorphis, Klebsiella oxytoca, Proteus vulgaris, Providencia rettgeri, Haemophilus parainfluenzae. However, this product is inactive against most Pseudomonas and Enterobacter species. 3. Anaerobic Gram-positive microorganisms - Peptostreptococcus spp. Toxicological studies: Genetic toxicity: In vitro and in vivo 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 genetic toxicity. Reproductive toxicity: When rats were given this product orally at a dose of about 100 mg/kg/day (2 times the human dose based on body surface area), no effect on animal fertility and reproductive function was observed. When the rabbit dose reached 30 mg/kg/day (1-2 times the human dose based on body surface area), no teratogenicity or embryotoxicity was observed. There is currently no sufficient and rigorous research data on pregnant women. Since animal tests cannot fully predict the situation in humans, pregnant women can only use it when it is really necessary. There is no experience of using this product in delivery, so it can only be used when it is determined to be necessary. Cefpodoxime proxetil can be secreted in human breast milk. Since this product has potential serious reactions to breastfeeding infants, the pros and cons of the mother and the baby should be weighed before deciding whether to interrupt breastfeeding or discontinue the drug. Carcinogenicity: There is no long-term carcinogenicity study data on this product in animals.

The main ingredient of this product is cefpodoxime axetil. Chemical name: (6R,7R)-7-[2-(2-amino-4-thiazolyl)-(Z)-2-(methoxyimino)-acetylamino]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylic acid isopropyloxycarbonyloxyethyl ester

This product is in the form of fine granules and powder with flavoring agents; it has a fragrant aroma and sweet taste.

Mainly used to treat infections caused by sensitive bacteria: 1. Respiratory system infections: such as pneumonia, acute bronchitis, chronic bronchitis, pharyngitis (throat abscess), tonsillitis (peritonsillitis, peritonsillar abscess), bronchiectasis (infection), secondary infections of chronic respiratory diseases, etc. 2. Urogenital system infections: such as pyelonephritis, cystitis, gonorrhea, sexual urethritis, vestibular gland inflammation, vestibular gland abscess, etc. 3. Skin and soft tissue infections: such as folliculitis (including pustular acne), furunculosis, furunculosis, carbuncle, erysipelas, cellulitis, lymphangitis (adenitis), whitlow, suppurative onychomycosis (peri-onychomycosis), subcutaneous abscess, sweat gland inflammation, clustered acne, infection, atheroma, perianal abscess, etc. 4. Otolaryngology infections: such as otitis media, sinusitis, etc. 5. Others: such as mastitis, etc.

Oral administration after meals has better effects. Dry suspension: The usual dosage for adults is 2 packets each time, twice a day. During use, the dosage can be increased or decreased according to age and symptoms. For patients with severe symptoms or poor effects, the dosage can be increased to 4 packets each time, twice a day.

The incidence and severity of adverse reactions are comparable to those of other commonly used broad-spectrum cephalosporins, with an incidence of 2.5-5%. The main symptoms include digestive system symptoms (diarrhea and loose stools: 0.40%, stomach discomfort: 0.10%, nausea and vomiting: 0.09%), etc.

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

Precautions for children: Safety and efficacy data for infants under 5 months old have not been established. Precautions for pregnancy and lactation: 1. Pregnant women or women who may become pregnant should only be given the drug when the therapeutic benefits outweigh the risks [the safety of drug use during pregnancy has not been established]. 2. During medication, instructions should be given not to breastfeed (transfer into breast milk). Precautions for the elderly: The pharmacokinetic parameters of cefpodoxime proxetil are not affected by age, but the distribution of patients with renal insufficiency is changed, the elimination half-life is extended by 1.5 to 2 hours, and the plasma clearance rate and renal clearance rate are reduced. Therefore, patients with moderate to severe renal insufficiency (creatinine clearance [50ml/min]) can reduce the dose by 50% or take the drug once a day.

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 (no more than 20℃) dry place. Validity period: 24 months

36.0g:1.2g (100mg/5ml, calculated as cefpodoxime C15H17N5O6S2)

24 months

Guangzhou Nucien Pharmaceutical Co., Ltd.

• Founded in:

  1993-09-17

• Address:

  Building 1-2, No. 196, Kaiyuan Avenue, Luogang District, Guangzhou

• Tax NO.:

  91440101618440809W

• Registered Funds:

  65.25 million yuan

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