Ceftiofiorin Hydrochloride for Injection

1. Antibacterial effect: (1) It has a wide range of antibacterial effects on both Gram-negative and Gram-positive bacteria. In particular, it shows stronger antibacterial activity against Escherichia coli, Klebsiella, Proteus mirabilis, and Haemophilus influenzae. It also shows good antibacterial activity against enterobacteria, Citrobacter, indole-positive Proteus vulgaris, Proteus Rettgeri, and Proteus Morganii. (2) The antibacterial effect of this product is bactericidal. 2. Mechanism of action: The antibacterial mechanism of this product is to inhibit the synthesis of bacterial cell walls. This product has strong antibacterial activity against Gram-negative bacteria because it has good permeability to the bacterial cell outer membrane, is relatively stable to β-lactamase, and has a high affinity for penicillin-binding proteins 1B and 3, thereby enhancing the inhibitory effect on the cross-linking of cell wall mucopeptides. 3. Toxicological studies: In subacute and chronic toxicity experiments, the product was given to rats by intramuscular injection at 0.1, 0.3, 1, 3g/Kg/day for 1 month and by intramuscular injection at 0.03, 0.1, 0.3, 1g/Kg/day for 6 months; dogs were given intravenous and intramuscular injection at 0.1, 0.3, 1g/Kg/day for 1 month and by intramuscular injection at 0.03, 0.1, 0.3g/Kg/day for 6 months; monkeys were given intravenous or intramuscular injection at 0.1, 0.3, 1g/Kg/day for 1 month. The main findings caused by this product are as follows: (1) Effects on kidneys: In the 1g/Kg group of monkeys, no other abnormalities were observed except for proximal tubular epithelial necrosis and increased cellularity or glassy cylinders in the tubular lumen; in the experiments of intramuscular injection of 1g/Kg/day for 1 month in rats and 1g/Kg/day for monkeys, a comparative study was conducted with the 1g/Kg/day group of cephalosporin I, and the results showed that the effects of this product on kidneys were roughly the same as those of cephalosporin I. (2) Effects on liver: Except for hepatocyte fatification and increased GOT and GPT in the 1g/Kg group of monkeys and 3g/Kg group of rats, no other abnormal changes were observed. (3) Others: Local irritation and accompanying local vasoconstriction occurred at the injection site in the large-dose intramuscular injection groups of various animals, and no other abnormalities were observed in dogs except for specific skin flushing and swelling. In the reproductive experiment, rats and rabbits were given intramuscular injections of 0.03, 0.1, 0.3g/kg/day and 0.01, 0.03, 0.09g/kg/day of thiamethoxazole cephalosporin during the organogenesis period, except for the weight suppression and death of the female animals in the 0.09g/kg/day administration group of rabbits, no teratogenic effects and effects on the fetus were observed. No abnormal changes were observed in the administration experiments before and during pregnancy, and during the perinatal and lactation periods of rats.

The main ingredient of this product is ceftriaxone hydrochloride, and its chemical name is (6R-trans)-7-[[(2-amino-4-thiazolyl)acetyl]amino]-3-[[[1-[(2-(dimethylamino)ethyl]-1H-tetrazol-5-yl]thiomethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid dihydrochloride.

This product is white or slightly yellow powder.

Used to treat infections caused by sensitive bacteria, such as pneumonia, bronchitis, bile tract infection, peritonitis, urinary tract infection, as well as infections and sepsis caused by surgery and trauma.

Usually, adults take 0.5-2g (1/4-1 vial) a day, divided into 2-4 times; children take 40-80 mg/kg a day, divided into 3-4 times, intravenous injection. This product can be appropriately increased or decreased according to age and symptoms. For adults with sepsis, the daily dose can be increased to 4g (2 vials), and for children with severe and refractory infections such as sepsis and meningitis, the daily dose can be increased to 160 mg/kg. For intravenous injection, it can be dissolved in normal saline or glucose injection solution before use. In addition, a single dose of 0.25-2g of this product can be added to sugar solution, electrolyte solution or amino acid infusion and intravenously dripped within 30 minutes to 2 hours. For children, refer to the dosage described above, add it to the rehydration and drip it intravenously within 30 minutes to 1 hour. Preparation method of injection of this product: This product contains anhydrous sodium carbonate as a buffer. Since CO2 is generated when it is dissolved, it can be decompressed as appropriate. When 1g is dissolved, about 5 ml of dissolving solution can be injected into the bottle to dissolve it. (If 1g of this injection is used for intravenous drip, 100 ml of dissolving solution can be added to dissolve it.) For intravenous injection, 1g is generally diluted to 20 ml before injection. For intravenous drip, it cannot be diluted with injection water because it cannot form an isotonic solution. Please read this instruction manual carefully when dissolving this product. Contact measles may occur when preparing this injection. If swelling, itching, redness, systemic rash, itching, abdominal pain, nausea, and vomiting occur on the hands during preparation, you should avoid contact with this product in the future.

Allergic reactions, gastrointestinal reactions, changes in blood counts, and transient elevations in serum aminotransferases may occur occasionally. Changes in intestinal flora may result in vitamin B and K deficiencies. Secondary infections may occur occasionally. Large amounts of intravenous injection may cause vascular pain and thrombophlebitis.

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

Precautions for children: The safety of this drug for premature infants and newborns has not yet been determined. Precautions for pregnancy and lactation: The safety of this drug for pregnant women has not yet been determined. Therefore, it can only be given to pregnant women or women who may be pregnant when the benefits are considered to outweigh the risks. Precautions for the elderly: The dosage of elderly patients should be reduced as appropriate according to their renal function impairment. The dosage and dosing interval should be adjusted for elderly patients to prevent the occurrence of adverse reactions.

1. When used in combination with aminoglycoside antibiotics, it is generally believed to have a synergistic effect, but it may aggravate renal damage. Administering them in the same container may affect the potency of the drug. 2. When used in combination with strong diuretics such as furosemide, it may cause renal damage.

Seal tightly and store in a cool, dark (avoid light and not exceeding 20°C) dry place.

Calculated as C18H23N9O4S3 1.0g

18 months

Harbin Pharmaceutical Group Co., Ltd. GENERAL Pharm. FACTORY

• Founded in:

  1994-05-19

• Address:

  No. 388, Hahei Highway, Hulan District (production base No. 109, Xuefu Road, Nangang District, No. 1, Junmin Street, Xiangfang District)

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  912301008280277137

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