Lomefloxacin Hydrochloride Granules

1. Pharmacology This product is a quinolone antibacterial drug. It has high antibacterial activity against Enterobacteriaceae such as Escherichia coli, Shigella, Klebsiella, Proteus, Enterobacter, etc.; Haemophilus influenzae and Neisseria gonorrhoeae are also highly sensitive to this product; it also has certain antibacterial effects on Pseudomonas such as Acinetobacter and Pseudomonas aeruginosa, Staphylococcus, Pneumococcus, and hemolytic Streptococcus. This product acts on the A subunit of DNA helicase in bacterial cells, inhibiting DNA synthesis and replication to kill bacteria. 2. Toxicology: This product has a weak positive reaction only at a concentration of ge;226mu;g/ml in the in vitro mutagenicity test conducted by the CHO/HGPRT method. When mice were orally administered with 34 times the recommended human dose of this product, their fertility was not affected.

The main ingredient is lomefloxacin hydrochloride.

This product is light yellow granules with a sweet and slightly bitter taste.

This product is suitable for the following infections caused by sensitive bacteria: 1. Respiratory tract infections: acute exacerbation of chronic bronchitis, bronchiectasis with infection, acute bronchitis and pneumonia, etc. 2. Urogenital system infections: acute cystitis, acute pyelonephritis, complicated urinary tract infection, acute exacerbation of chronic urinary tract infection, acute and chronic prostatitis, and urethritis or cervicitis caused by Neisseria gonorrhoeae (including those caused by enzyme-producing strains), etc. 3. Gastrointestinal bacterial infections: caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Infections of the abdominal cavity, bile duct, typhoid, etc. 5. Bone and joint infections. 6. Skin and soft tissue infections. 7. Systemic infections such as sepsis. 8. Other infections, such as sinusitis, otitis media, blepharitis, etc.

1. Bacterial bronchial infection: Oral administration of 0.4g once a day, or 0.3g once a day, twice a day, for a course of 7 to 14 days. 2. Acute simple urinary tract infection: Oral administration of 0.4g once a day, for a course of 7 to 10 days; complicated urinary tract infection: Oral administration of 0.4g once a day, for a course of 14 days. 3. Simple gonorrhea: Oral administration of 0.3g once a day, twice a day. 4. Prevention of surgical infection: Oral administration of 0.4g once a day, 2 to 6 hours before surgery.

1. Gastrointestinal reactions are relatively common and may manifest as abdominal discomfort or pain, diarrhea, nausea or vomiting. 2. Central nervous system reactions: dizziness, headache, drowsiness or insomnia may occur. 3. Allergic reactions: rash, skin itching, and occasionally exudative erythema multiforme and angioneurotic edema. Photosensitivity reactions are more common than other commonly used quinolones. 4. A small number of patients may experience increased serum aminotransferase and BUN values and decreased peripheral blood white blood cells, which are mostly mild and transient. 5. 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) Crystalluria, which is more common when used in high doses. (4) Joint pain.

1. It is contraindicated for those who are allergic to this product or other quinolone drugs. 2. It is contraindicated for pregnant women, infants and patients under 18 years old.

Precautions for children: This product can cause permanent damage to the cartilage of the weight-bearing joints of dogs, resulting in lameness. It can also cause arthritis in several other underage animals, so it is contraindicated for infants and children under 18 years old. Precautions for pregnancy and lactation: This product can pass through the blood-placental barrier and is contraindicated for pregnant women. This product can also be secreted into breast milk, and its concentration is close to the blood drug concentration. Lactating women should stop breastfeeding when using this product. Precautions for the elderly: Elderly patients have decreased renal function, and the dosage should be reduced as appropriate.

1. This product has little effect on the liver metabolism and body clearance of theophylline drugs and caffeine. 2. Sucralfate and antacids can slow down the absorption rate of this product by 25%, and reduce the area under the curve (AUC) by about 30%. If sucralfate and antacids are taken 4 hours before or 6 hours after taking this product, the effect will be minimal. 3. Combination with fenbufen can cause central excitation and epileptic seizures. 4. Probenecid can delay the excretion of this product, increase the average area under the curve (AUC) by 63%, extend the average peak time (tmax) by 50%, and increase the average peak concentration (Cmax) by 4%; therefore, when used together, toxicity may occur due to the increased blood concentration of this product. 5. It can enhance the effects of oral anticoagulants such as warfarin, and the prothrombin time and other items should be monitored. 6. Urine alkalinizers can reduce the solubility of this product in urine, leading to crystalluria and nephrotoxicity. 7. Didanosine (DDI) preparations contain aluminum and magnesium that can chelate with quinolones and should not be used together. 8. When used together with cyclosporine, the blood concentration of cyclosporine may increase. The blood concentration of cyclosporine must be monitored and the dosage adjusted. 9. Nutritional supplements and vitamins containing metal ions should not be taken within 2 hours before or after taking this product.

Keep away from light and store in a sealed container.

5g: 0.1g (calculated as C17H19F2N3O3)

24 months.

Hainan Pharmaceutical Factory Co., Ltd. Pharmaceutical Plant 2

• Founded in:

  2008-11-20

• Address:

  Linzhou Shijiahe Industrial Park

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  91410581683161363N

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