Levofloxacin Hydrochloride for Injection

Pharmacological action: This product is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase (bacterial topoisomerase II) and hinder the replication of bacterial DNA to achieve antibacterial effect. This product has the characteristics of broad antibacterial spectrum and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter, and Gram-negative bacteria such as Pseudomonas aeruginosa, Haemophilus influenzae, and Neisseria gonorrhoeae. It also has good antibacterial effect on some methicillin-sensitive Staphylococci, Streptococcus pneumoniae, Streptococcus pyogenes, hemolytic Streptococci, and Legionella, Mycoplasma, and Chlamydia, but has poor effect on anaerobic bacteria and enterococci. Toxicological effects Repeated dose toxicity: Rats were orally administered this product at doses of 50, 200, and 800 mg/kg for 4 consecutive weeks. Only the animals in the 800 mg/kg group showed a decrease in neutrophils and an increase in bone marrow M/E; pathological histology showed mild degenerative changes on the surface of the limb joints. Rhesus monkeys were orally administered for 4 weeks, and the animals in the 100 mg/kg group showed salivation, diarrhea, light weight, and decreased pH in urine. Rats were orally administered for 26 weeks, and animals in the 80 and 320 mg/kg dose groups showed salivation and high pH in urine. The feces of animals in the 320 mg/kg group increased, and goblet cells in the cecal mucosa were swollen. When the macaques were orally administered for 26 weeks, no obvious toxic reactions were observed at doses of 10, 25, and 62.5 mg/kg. Reproductive toxicity: When rats were orally administered at a dose of 360 mg/kg before pregnancy and in the early stages of pregnancy, no effect was observed on the reproductive capacity of female and male animals, nor on the fetus. When rats were given the drug during the organogenesis period, the dose reached 90 mg/kg, and no significant effects were observed on the fetus and newborn. When rabbits were given 50 mg/kg orally, no embryonic and fetal lethality, delayed fetal growth, or teratogenic effects were observed. When rats were given 360 mg/kg orally during the perinatal and lactation periods, no significant effects were observed on the animals' delivery, lactation, and newborns. Other studies: Effects on articular cartilage: When young and 3-4 week old rats and 4-month old beagle dogs were given the drug orally for 7 days, articular cartilage lesions occurred in rats at doses above 300 mg/kg and in beagle dogs at doses above 10 mg/kg, and joint toxicity was prone to occur in young and young beagle dogs. For 13-month-old dogs, extremely mild joint toxicity occurred at a dose of 40 mg/kg when the drug was administered orally for 7 days. However, no joint toxicity was observed at a dose of 30 mg/kg when 18-month-old adult dogs were intravenously injected for 14 days. Phototoxicity experiment: When irradiating with long-wavelength ultraviolet rays (320-400nm), the change in the thickness of the mouse ear was used as an indicator to study the phototoxicity. No significant changes were observed when the oral dose reached 200mg/kg.

The main ingredient is levofloxacin hydrochloride [chemical name] (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de][1,4]-benzoxazine-6-carboxylic acid hydrochloride monohydrate.

This product is off-white or light yellow freeze-dried powder; easily soluble in water.

This product is suitable for the following moderate and severe infections caused by sensitive bacteria: respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bacterial bronchitis, bronchiectasis and infection, pneumonia, tonsillitis (peritonsillar abscess); urinary system infections: pyelonephritis, complicated urinary tract infection; reproductive system infections: acute prostatitis, acute epididymitis, uterine cavity infection, uterine adnexitis, pelvic inflammatory disease (metronidazole can be used in combination when anaerobic infection is suspected); skin and soft tissue infections: infectious impetigo, cellulitis, lymphangiitis (adenitis), subcutaneous abscess, perianal abscess, etc.; intestinal infections: bacillary dysentery, infectious enteritis, salmonella enteritis, typhoid and paratyphoid; various infections in patients with sepsis, neutropenia and immunodeficiency; other infections: mastitis, trauma, burns and postoperative wound infection, abdominal infection (metronidazole can be used in combination when necessary), cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

Intravenous drip: 0.4g per day for adults, divided into 2 intravenous drips, 0.2g each time, first dissolve with 5-10ml 5% glucose injection or 5% glucose sodium chloride injection, then add to 100ml 5% glucose injection or 5% glucose sodium chloride injection. For patients with severe infection and those whose pathogens are less sensitive to this product (such as Pseudomonas aeruginosa), the maximum daily dose can be increased to 0.6g (according to the type and symptoms of infection, it can be increased or decreased appropriately), divided into 2 intravenous drips.

During the medication, symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, and bloating may occur; neurological symptoms such as insomnia, dizziness, and headache; rash, itching, erythema, and redness, itching, or phlebitis at the injection site may occur. Transient liver function abnormalities may also occur, such as increased blood transaminase and increased serum total bilirubin. The incidence of the above adverse reactions is between 0.1 and 0.5%. Occasionally, blood urea nitrogen rises, fatigue, fever, palpitations, abnormal taste, and vascular pain after injection are observed, which are generally tolerated and disappear quickly after the end of the course of treatment.

It is contraindicated for patients who are allergic to quinolones, pregnant or lactating women, and patients under 18 years of age.

1. This product cannot be used in the same infusion tube with polyvalent metal ion solutions such as magnesium and calcium, and should not be used simultaneously with theophylline. If simultaneous use is required, the blood concentration of theophylline should be monitored and the dosage adjusted accordingly. 2. When used simultaneously with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 3. When used simultaneously with non-steroidal anti-inflammatory drugs, convulsions may be induced. 4. When used simultaneously with oral hypoglycemic drugs, blood sugar disorders may be caused, including hyperglycemia and hypoglycemia. Therefore, blood sugar concentrations should be monitored during medication. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given.

Keep away from light, tightly closed, in a cool place.

0.2g

Shanxi Weiqidaguangming Pharmaceutical Co., Ltd.

• Founded in:

  2008-04-30

• Address:

  Datong Economic and Technological Development Zone First Pharmaceutical Park

• Tax NO.:

  91140200674471538G

• Registered Funds:

  50 million yuan

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