Levofloxacin Lactate Tablets

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 bacterial DNA replication. This product has the characteristics of a 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 effects on some methicillin-sensitive Staphylococci, Streptococcus pneumoniae, Streptococcus pyogenes, hemolytic Streptococci, and Legionella, Mycoplasma, Chlamydia, etc. However, it has poor effects on anaerobic bacteria and enterococci.

The main ingredient of this product is levofloxacin lactate. Its chemical name is: 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 lactate hemihydrate.

This product is a film-coated tablet, which appears off-white or slightly yellow after removing the film coating.

This product is suitable for the following mild and moderate infections caused by sensitive bacteria: respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis and infection, pneumonia, tonsillitis (peritonsillar abscess); urinary system infections: pyelonephritis, complicated urinary tract infection, etc.; 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 (nodal inflammation), 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.

Oral administration: 0.1-0.2g per time for adults, twice a day. For patients with severe conditions, it can be increased to three times a day.

During medication, symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, abdominal distension, insomnia, dizziness, headache and other neurological symptoms, as well as rash and itching 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 5%. Occasionally, blood urea nitrogen rises, fatigue, fever, palpitations, abnormal taste, etc. are observed, which are generally tolerated and disappear quickly after the end of the treatment.

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

Precautions for children: The safety of this product in infants and adolescents under 18 years of age has not been determined. However, this product can cause joint lesions when used in several young animals. Therefore, it should not be used in children and adolescents under 18 years of age. Precautions for pregnancy and lactation: Animal experiments have not confirmed that quinolones are teratogenic, but studies on the use of drugs in pregnant women have not yet reached a clear conclusion. Since this drug can cause joint lesions in underage animals, it is contraindicated for pregnant women, and lactating women should suspend breastfeeding when using this product. Precautions for the elderly: Elderly patients often have impaired renal function, and since this product is partially excreted through the kidneys, it needs to be used in reduced doses.

1. Urine alkalinizing agents can reduce the solubility of this product in urine, leading to crystalluria and nephrotoxicity. 2. When quinolone antibiotics are used in combination with theophylline, competitive inhibition of the cytochrome P450 binding site may lead to a significant reduction in the liver elimination of theophylline, a prolonged blood elimination half-life (t1/2β), an increase in blood drug concentration, and the appearance of symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, excitement, convulsions, palpitations, etc. This product has little effect on the metabolism of theophylline, but the blood concentration of theophylline should still be measured and the dosage adjusted when used in combination. 3. When this product is used in combination with cyclosporine, the blood concentration of cyclosporine can be increased. The blood concentration of cyclosporine must be monitored and the dosage adjusted. 4. When this product is used in combination with the anticoagulant warfarin, although the anticoagulant effect of the latter is slightly enhanced, the patient's prothrombin time should also be closely monitored when used in combination. 5. Probenecid can reduce the secretion of this product from the renal tubules by about 50%. When used together, it may cause toxicity due to the increased blood concentration of this product. 6. This product can interfere with the metabolism of caffeine, thereby reducing the elimination of caffeine, prolonging the blood elimination half-life (t1/2β), and may cause central nervous system toxicity. 7. Antacids and iron preparations containing aluminum and magnesium can reduce the oral absorption of this product and should not be used together. 8. When this product is used in combination with the non-steroidal anti-inflammatory drug fenbufen, convulsions occasionally occur, so it is not suitable for use with fenbufen. 9. This product may cause blood sugar disorders when used in combination with oral hypoglycemic drugs. 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 and store in a sealed container.

0.1g (calculated as levofloxacin)

24 months.