Cefixime Tablets

1 Pharmacological action: This product is a broad-spectrum antibiotic, which has antibacterial activity against some Gram-positive and Gram-negative bacteria, especially against Streptococcus (except Enterococcus) and Pneumococcus among Gram-positive bacteria, and gonococci, Branhamella, Escherichia coli, Klebsiella, Serratia, Proteus, and influenza bacilli among Gram-negative bacteria. Its mechanism of action is bactericidal. This product has extremely strong stability against β-lactamase produced by various bacteria, and shows excellent antibacterial activity against bacteria producing β-lactamase. The mechanism of action of this product is to prevent the synthesis of bacterial cell walls. Its action point varies according to the strain, and it has a high affinity with 1 (la, lb, 1c) and 3 in penicillin binding protein (PBP). 2 Toxicological studies (1) Acute toxicity (LD50mg/kg) (2) Subacute and chronic toxicity Adult SD rats were orally administered with 100, 320 and 1,000 mg/kg for 13 weeks, and adult dogs were orally administered with 100, 200 and 400 mg/kg for 5 weeks. No abnormalities were found in all experiments. For immature SD rats (aged 4 days) who were orally administered with 10,000 mg/kg or more for 22 days, spermatocyte reduction was found in the group with a dose of 10,000 mg/kg or more, and weight gain inhibition accompanied by a decrease in testicular weight was found in the group with a dose of 3,200 mg/kg. However, the above situation was not found in the experiment in which immature rats of 21 days of development were orally administered with 3,200 mg/kg for 5 weeks and immature dogs were orally administered with 100, 200, 400 mg/kg for 5 weeks. In an experiment in which adult SD rats were orally administered 100, 320 and 1,000 mg/kg for 53 weeks, the dosage was changed and it was found that the weight gain of female rats was inhibited when they were administered 1,000 mg/kg, and the amount of urine protein in male rats increased. Kidney weight increase and chronic kidney disease were enhanced. (3) Effects on the reproductive system SD rats were orally administered 100-1,000 mg/kg before pregnancy and early pregnancy, and 320-3,200 mg/kg during the organ formation period, perinatal period and lactation period to observe its effects on the reproductive system. The results showed that it did not affect the reproductive capacity of rats and had teratogenic effects, and no abnormalities were found in the growth, development and reproductive capacity of newborn rats. 3 Effects on the kidneys Rabbits were orally administered 1,000 mg/kg at a time to observe its effects on the kidneys, and no abnormalities were found. SD rats were orally administered 560 mg/kg and used together with diuretics for 2 consecutive weeks. No abnormal conditions occurred after medication, nor did the renal function deteriorate due to diuretics. 4 Antigenicity The antigenicity of this drug to various animals is the same as or slightly weaker than that of cephalexin. This drug does not induce antigenicity, nor is it cross-immune with cephalexin, cefaclor and cefotaxime.

The main ingredient of this product is cefixime.

This product is off-white to light yellow tablets.

This product is effective for the following infections caused by streptococci (except enterococci) that are sensitive to cefixime, pneumococci, gonococci, catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus, influenza bacilli, etc. Acute exacerbation of chronic bronchitis, acute bronchitis with bacterial infection, bronchial tube dilatation with infection, pneumonia, pyelonephritis, cystitis, gonococcal urethritis, acute bacterial infection of the biliary system (cholecystitis, cholangitis), scarlet fever; otitis media, sinusitis.

Oral administration: 50-100 mg twice a day for adults and children weighing more than 30 kg. In severe cases, the dose can be increased to 0.2 g twice a day.

Most of the adverse reactions of cefixime are short-lived and mild. The most common are gastrointestinal reactions, including diarrhea (16%), increased bowel movement (6%), abdominal pain (3%), nausea (7%), indigestion (3%), and abdominal distension (4%); adverse reactions with an incidence rate of less than 2% include rash, urticaria, drug fever, itching, headache, and dizziness. Laboratory abnormalities include transient increases in ALT, AST, ALP, LDH, bilirubin, BUN, and Cr, transient decreases in platelet and white blood cell counts and eosinophilia, and positive direct Coombs test.

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

Precautions for children: Use with caution in newborns. Precautions for pregnancy and lactation: Use with caution in pregnant women. Precautions for the elderly: Use with caution in the elderly.

1. This product is incompatible with the following drugs: amikacin sulfate, gentamicin, kanamycin, tobramycin. Neomycin, chlortetracycline hydrochloride, tetracycline hydrochloride, oxytetracycline hydrochloride, colistin sodium methanesulfonate, polymyxin B sulfate, erythromycin gluconate, erythromycin lactobionate, lincomycin, sulfisoxazole, aminophylline, soluble barbiturates, calcium chloride, calcium gluconate, other antihistamines of diphenhydramine hydrochloride, lidocaine, norepinephrine, metahydroxylamine, methylphenidate, succinylcholine, etc. Occasionally, it may also be incompatible with the following drugs: penicillin, methicillin, hydrocortisone succinate, phenytoin sodium. Prochlorperazine, vitamin B group and vitamin C, hydrolyzed protein. 2. The combined use of strong diuretics such as furosemide, ethacrynic acid, bumetanide, anti-tumor drugs such as carmustine, streptozocin, and aminoglycoside antibiotics with this product may increase nephrotoxicity. (4) Clavulanic acid can increase the antibacterial activity of this product against certain Gram-negative bacteria that are resistant to it due to the production of B-lactamase.

Keep away from light, seal tightly and store in a cool dark place.

50mg (calculated as C16H15N5O7S2)

24 months

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

• Founded in:

  2001-11-30

• Address:

  Luoqi Road, Linyi High-tech Industrial Development Zone, Shandong Province

• Tax NO.:

  913700002658705037

• Registered Funds:

  60.96 million yuan

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