Levofloxacin Hydrochloride Capsules

This product has a broad-spectrum antibacterial effect and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, and Gram-negative bacteria such as Haemophilus influenzae, Legionella pneumophila, and Neisseria gonorrhoeae. It also has antibacterial effects on Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Mycoplasma pneumoniae and Chlamydia pneumoniae, but has poor effects on anaerobic bacteria and enterococci. This product is the levorotatory form of ofloxacin, and its in vitro antibacterial activity is about twice that of ofloxacin. Its mechanism of action is to inhibit the activity of bacterial DNA gyrase, prevent the synthesis and replication of bacterial DNA, and cause bacterial death.

The main ingredient of this product is levofloxacin hydrochloride. Its chemical name is (S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-[1,4]benzo[1,4]oxazine-6-carboxylic acid hydrochloride hydrate. [Molecular formula] C18H20FN3O4·HCl·H2O [Molecular weight] 415.85

This product is in the form of capsules.

Applicable to infections caused by sensitive bacteria: 1. Urinary and reproductive system infections, including simple and complicated urinary tract infections, bacterial prostatitis, urethritis or cervicitis caused by Neisseria gonorrhoeae (including those caused by enzyme-producing strains). 2. Respiratory tract infections, including acute onset of bronchial infection and lung infection caused by sensitive Gram-negative bacilli. 3. Gastrointestinal infections caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Typhoid fever. 5. Bone and joint infections. 6. Skin and soft tissue infections. 7. Systemic infections such as sepsis.

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.

1. Gastrointestinal reactions: abdominal discomfort or pain, diarrhea, nausea or vomiting. 2. Central nervous system reactions may include dizziness, headache, drowsiness or insomnia. 3. Allergic reactions: rash, itchy skin, occasionally exudative erythema multiforme and angioneurotic edema. Photosensitivity reactions are less common. 4. Occasionally, (1) epileptic seizures, mental abnormalities, irritability, confusion, hallucinations, and tremors may occur. (2) interstitial nephritis symptoms such as hematuria, fever, and rash. (3) phlebitis. (4) crystalluria, which is more common when high doses are used. (5) joint pain. 5. A small number of patients may experience elevated serum aminotransferases, elevated blood urea nitrogen, and decreased peripheral white blood cell counts, which are usually mild and transient.

Patients who are allergic to this product and fluoroquinolones are contraindicated. [Use in pregnant and lactating women] 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. [Use in children] The safety of this product in infants and adolescents under 18 years old has not yet been determined. However, this product can cause joint lesions when used in several young animals. Therefore, it is not suitable for children and adolescents under 18 years old. [Use in the elderly] Elderly patients often have impaired renal function. Because this product is partially excreted through the kidneys, it needs to be used in a reduced dose.

Precautions for children: Patients under 18 years of age are prohibited. Precautions for pregnancy and lactation: 1. Women who are pregnant or may become pregnant are prohibited; 2. Women who are lactating are prohibited. Precautions for the elderly: This product is mainly excreted in the kidney fluid in its original form. Elderly patients often have impaired renal function and should be used in reduced doses as appropriate. The recommended dose for elderly patients is one tablet at a time, once every 12 hours.

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 (t1/2b), an increase in blood drug concentration, and the appearance of symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, excitement, convulsions, palpitations, etc. Although this product has little effect on the metabolism of theophylline, theophylline blood drug concentration should still be measured and the dose adjusted when used in combination. 3. When this product is used in combination with cyclosporine, the blood drug concentration of cyclosporine can be increased. The blood concentration of cyclosporine must be monitored and the dose 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 (t1/2b), 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 may occasionally occur, so it is not suitable for use with fenbufen.

Keep away from light and store in sealed container.

0.1g (calculated as C18H20FN3O4)

24 months

Hainan Hailing Chemipharma Corporation Ltd.

• Founded in:

  2004-04-01

• Address:

  No. 281 Nanhai Avenue, Haikou City

• Tax NO.:

  91460000760353116G

• Registered Funds:

  116.669422 million yuan

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