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 off-white tablets, odorless and bitter.

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 bacteria 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, etc.; other infections: trauma, burns and postoperative wound infection, abdominal infection (metronidazole can be used in combination when necessary), mastitis, cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

Oral administration: Adults: 0.2-0.3g at a time, twice a day or as directed by a doctor.

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, increased blood urea nitrogen, and decreased peripheral white blood cell counts, as well as injection site irritation symptoms, 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 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, it may cause toxicity due to the increased blood concentration of this product. 6. This product may interfere with the metabolism of caffeine, thereby reducing caffeine elimination, prolonging the blood elimination half-life (t1/2), and possibly causing central nervous system toxicity.

Keep in a light-proof and airtight container. Valid for 18 months.

0.1g

Tentative two years

Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

• Founded in:

  1995-08-08

• Address:

  No. 333, Jiangnan Road, Hengdian, Dongyang City, Zhejiang Province

• Tax NO.:

  913307831475538495

• Registered Funds:

  108.75 million yuan

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