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 chemical name of this product is (±)-9-fluoro-2,3-dihydro-trimethyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyridinium[1,2,3-de][1,4]benzoxazine-6-carboxylic acid, and its molecular weight is 361.37.

This product is a white 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, chronic bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis complicated with infection, pneumonia, pharyngitis, tonsillitis (peritonsillar abscess); urinary system infections: pyelonephritis, complicated urinary tract infection, etc.; reproductive system infections: prostatitis, 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: bacterial dysentery, infectious enteritis, salmonella enteritis, typhoid and paratyphoid, etc.; other infections: trauma, burns and postoperative wound infection, abdominal cavity

Oral administration: 200-600 mg per day, 1-3 times a day. Adjust the dose appropriately according to the symptoms.

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: 1. Epileptic seizures, mental abnormalities, irritability, confusion, hallucinations, tremors. 2. Manifestations of interstitial nephritis such as hematuria, fever, and rash. 3. Phlebitis. 4. Crystalluria, more common in high doses. 5. Joint pain. 5 A small number of patients may experience elevated serum aminotransferase, increased blood urea nitrogen, and decreased peripheral white blood cells, as well as irritation symptoms at the injection site, which are mostly mild and transient.

Patients who are allergic to this product and quinolones 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 (t1/2), 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 increase in the 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 (t1/2), and may cause central nervous system toxicity.

Keep sealed.

0.1g

Tentative two years

PKU HealthCare Corp., Ltd.

• Founded in:

  1993-05-18

• Address:

  No. 21, Fangzheng Avenue, Shuitu Town, Beibei District, Chongqing

• Tax NO.:

  91500000450533779H

• Registered Funds:

  595.987425 yuan

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