Ofloxacin Sodium Chloride Injection

[Pharmacology and Toxicology] 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 effect 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. [Pharmacokinetics] After administration, this product is widely distributed to various tissues and body fluids, and the concentration in the tissues often exceeds the blood concentration to reach an effective level. This product can also pass through the placental barrier. The protein binding rate is 20% to 25%. This product is mainly excreted from the kidneys in its original form, and a small amount (3%) is metabolized in the liver. There are very few metabolites in the urine. This product is excreted in small amounts in the feces in its original form, and the cumulative excretion within 24 hours and 48 hours after administration is 1.6% and 3.9% of the dose, respectively. This product can also be secreted through breast milk.

The main ingredient of this product is ofloxacin, and its chemical name is (±)-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.

This product is light yellow transparent liquid.

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 attacks of bronchial infections and lung infections 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.

Intravenous drip. Common dosage for adults: 1. Bronchial infection, lung infection: 0.3g once, twice a day, the course of treatment is 7 to 14 days. 2. Acute simple lower urinary tract infection: 0.2g once, twice a day, the course of treatment is 5 to 7 days; complicated urinary tract infection: 0.2g once, twice a day, the course of treatment is 10 to 14 days. 3. Prostatitis: 0.3g once, twice a day, the course of treatment is 6 weeks; chlamydial cervicitis or urethritis, 0.3g once, twice a day, the course of treatment is 7 to 14 days. 4. Simple gonorrhea: 0.4g once, single dose. 5. Typhoid fever: 0.3g once, twice a day, the course of treatment is 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, 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 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 is not suitable for 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 breastfeeding women need to suspend breastfeeding. 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 drug 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 drug 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 (t1/2β), and may cause central nervous system toxicity.

Protect from light, seal tightly, and store in a cool and dry place.

100ml: Ofloxacin 0.2g and sodium chloride 0.9g

24 months

Shijiazhuang No.4 Pharmaceutical Co., Ltd.

• Founded in:

  1994-06-28

• Address:

  No. 518, Huaian East Road, Shijiazhuang High-tech Industrial Development Zone

• Tax NO.:

  911301001044060055

• Registered Funds:

  950 million yuan

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