Enoxacin 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. Enoxacin is a bactericide that acts on the A subunit of bacterial DNA helicase, inhibiting DNA synthesis and replication, leading to bacterial death. It is completely absorbed after oral administration, and the relative bioavailability is about 90%. The peak time (Tmax) of the blood drug after a single dose is about 1 to 3 hours. The blood elimination half-life (t1/2?) is about 3.3 to 5.8 hours, and the protein binding rate is 18% to 57%. After absorption, this product is widely distributed to various tissues and body fluids, and the concentration in the tissues often exceeds the blood drug concentration to reach an effective level. This product is mainly excreted from the kidneys. Within 48 hours, 52% to 60% of the dose is excreted in the urine in its original form, and a part (20%) is metabolized in the body. Bile excretion exceeds 18%.

Enoxacin

This product is off-white or slightly yellow tablets or film-coated tablets.

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: 0.3-0.4g once, twice a day, 7-14 days of treatment. 2. Acute simple lower urinary tract infection: 0.2g once, twice a day, 5-7 days of treatment; complicated urinary tract infection: 0.4g once, twice a day, 10-14 days of treatment. 3. Simple gonorrheal Neisseria urethritis: 0.4g once, single dose. 4. Intestinal infection: 0.2g once, twice a day, 5-7 days of treatment. 5. Typhoid fever: 0.4g once, twice a day, 10-14 days of treatment.

1. Gastrointestinal reactions are common and may manifest as 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. A small number of patients have photosensitivity reactions. 4. Occasionally, the following may occur: (1) epileptic seizures, mental abnormalities, irritability, confusion, hallucinations, and 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 cell counts, which are mostly mild and transient. [Contraindications] This product is contraindicated in patients who are allergic to this product and fluoroquinolones or who lack glucose-6-phosphate dehydrogenase.

Patients who are allergic to this product and fluoroquinolones or lack glucose-6-phosphate dehydrogenase are contraindicated to use this product.

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 this product is used in combination with theophylline, competitive inhibition of the cytochrome P450 binding site may lead to a significant reduction in the elimination of theophylline in the liver, a prolonged 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., so it should be avoided to use them together. If it cannot be avoided, the blood drug concentration of theophylline should be measured and the dose adjusted. 3. When cyclosporine is used in combination with this product, its blood drug concentration increases. The blood concentration of cyclosporine must be monitored and the dose adjusted. 4. When this product is used in combination with the anticoagulant warfarin, it can enhance the latter's anticoagulant effect, so the combination of the two should be avoided. If it cannot be avoided, the patient's prothrombin time should be closely monitored and the dose adjusted. 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 interferes with the metabolism of caffeine, resulting in reduced caffeine elimination, prolonged blood elimination half-life (t1/2β), and possible central nervous system toxicity, so the two should be avoided in combination. If it cannot be avoided, the patient's blood caffeine concentration should be closely monitored and the dose adjusted. 7. Antacids containing aluminum and magnesium can reduce the oral absorption of this product and should not be used in combination. 8. When this product is used in combination with the non-steroidal anti-inflammatory drug fenbufen, convulsions occasionally occur, so it should not be used in combination with fenbufen.

Keep away from light and store in sealed container.

0.1g

24 months

Suicheng Pharmaceutical Co., Ltd.

• Founded in:

  1997-10-17

• Address:

  No. 219, Qing'an Road, Xinzheng City

• Tax NO.:

  91410100712635557P

• Registered Funds:

  111.68 million yuan

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