Ofloxacin Tablets

This product has a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic Gram-negative bacilli. It has good antibacterial activity in vitro against the following bacteria: most bacteria of the Enterobacteriaceae family, including Citrobacter, Enterobacter cloacae, Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It often has antibacterial activity against multi-drug resistant bacteria. It has high antibacterial activity against penicillin-resistant Neisseria gonorrhoeae, enzyme-producing Haemophilus influenzae and Moraxella. It has antibacterial activity against most strains of Pseudomonas such as Pseudomonas aeruginosa. This product has antibacterial activity against methicillin-sensitive Staphylococcus aureus, and only moderate antibacterial activity against Streptococcus pneumoniae, hemolytic Streptococcus and Enterococcus faecalis. It has good antimicrobial activity against Chlamydia trachomatis, Mycoplasma, Legionella, and also has antibacterial activity against Mycobacterium tuberculosis and atypical mycobacteria. Poor antibacterial activity against anaerobic bacteria. Ofloxacin is a bactericide that acts on the A subunit of bacterial DNA helicase, inhibiting DNA synthesis and replication, leading to bacterial death.

The main ingredient of this product is: ofloxacin, whose chemical name is: (plusmn;)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-[1,4]benzo[omicron]oxazine-6-carboxylic acid.

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

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. Common dosage for adults: 1 Bronchial infection, lung infection: 0.3g once, twice a day, course of treatment 7 to 14 days. 2 Acute simple lower urinary tract infection: 0.2g once, twice a day, course of treatment 5 to 7 days; complicated urinary tract infection: 0.2g once, twice a day, course of treatment 10 to 14 days. 3 Prostatitis: 0.3g once, twice a day, course of treatment 6 weeks; Chlamydia cervicitis or urethritis, 0.3g once, twice a day, course of treatment 7 to 14 days. 4 Simple gonorrhea: 0.4g once, single dose. 5 Typhoid fever: 0.3g once, twice a day, course of treatment 10 to 14 days. For Pseudomonas aeruginosa infection or more severe infection, the dose can be increased to 0.4g once, twice 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, skin itching, occasionally exudative erythema multiforme and angioneurotic edema. Photosensitivity reactions are less common. 4 Occasionally, the following may occur: (1) epileptic seizures, mental abnormalities, irritability, confusion, hallucinations, tremors. (2) interstitial nephritis manifestations 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 aminotransferase, elevated blood urea nitrogen, and decreased peripheral white blood cells, which are mostly mild and transient.

Patients who are allergic to this product and fluoroquinolones are contraindicated.

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 (t1/2b), 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 a small 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 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 in combination, toxicity may occur due to the increased blood concentration of this product. 6. This product can interfere with the metabolism of caffeine, resulting in reduced caffeine elimination, prolonged blood elimination half-life (t1/2b), and possible central nervous system toxicity. 7. Antacids containing aluminum and magnesium can reduce the oral absorption of this product and should not be used together.

Keep away from light and store in sealed container.

0.1g

Tentative two years

Guangdong Xinfeng Pharmaceutical Co., Ltd.

• Founded in:

  1995-09-28

• Address:

  Hongbo Industrial Zone, Boluo County

• Tax NO.:

  914413001961374115

• Registered Funds:

  102 million yuan

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