Levofloxacin Hydrochloride Eye Drops

Pharmacological action 1. Levofloxacin is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial topoisomerase IV and DNA gyrase (both are type II topoisomerases) and hinder the replication of bacterial DNA to achieve antibacterial effect. 2. Levofloxacin has the characteristics of broad antibacterial spectrum and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter, and Gram-negative bacteria such as Pseudomonas aeruginosa, Haemophilus influenzae, and Neisseria gonorrhoeae. It also has good antibacterial effect on some methicillin-sensitive Staphylococci, Streptococcus pneumoniae, Streptococcus pyogenes, hemolytic Streptococci, and Legionella, Mycoplasma, and Chlamydia, but has poor effect on anaerobic bacteria and enterococci. Toxicological studies 3. Genetic toxicity: The results of the levofloxacin Ames test, CHO/HGPRT mutation test, mouse micronucleus test, rat unscheduled DNA synthesis test (UDS), and mouse sister chromosome exchange test were all negative. The results of the in vitro CHL cell line chromosome aberration test and the CHL/IU cell line sister chromosome exchange test were all positive. 4. Reproductive toxicity: When the oral dose of rats before pregnancy and early pregnancy reached 360 mg/kg (equivalent to 2900 times the maximum recommended dose in ophthalmology), there was no effect on the reproductive capacity and fetus of female and male animals. When rats were given the drug during the organogenesis period, the dose reached 90 mg/kg, and there was no significant effect on the fetus and newborn. When rabbits were given 50 mg/kg orally, there was no embryonic or fetal lethality, fetal growth retardation, or teratogenic effect. When rats were given the drug orally during the perinatal and lactation period, there was no significant effect on the delivery, lactation, and birth of the animals. 5. Carcinogenic effect: Rats were given levofloxacin up to 100 mg/kg/day by oral administration for 2 years without any carcinogenic effect.

Levofloxacin Hydrochloride

This product is a light yellow-green or slightly yellow clear liquid.

This product is suitable for the treatment of bacterial conjunctivitis and bacterial keratitis caused by sensitive bacteria.

Drop the product into the conjunctival sac of the affected eye. 3-5 times a day, 1-2 drops each time. Recommended course of treatment: 7 days for bacterial conjunctivitis, 10-14 days for bacterial keratitis. Or follow the doctor's advice.

The most commonly reported adverse reactions are temporary decreased vision, fever, transient eye burning, eye pain or discomfort, pharyngitis and photophobia, with an incidence of about 1% to 3%. Other adverse reactions with an incidence of less than 1% include: allergies, eyelid edema, dry eyes and itching.

Patients who are allergic to levofloxacin hydrochloride or other quinolones or any components of this product are contraindicated.

Precautions for children: The efficacy and safety of this product for infants under 1 year old have not been established. Oral administration of quinolones to immature animals can cause arthritis, but there is no evidence that levofloxacin eye drops have any effect on weight-bearing joints. Precautions for pregnancy and lactation: Since there is insufficient research and data on the use of this product in pregnant women, it is not recommended for pregnant women. Based on the data of ofloxacin, it is speculated that levofloxacin can be excreted through human milk, so it should be used with caution in lactating women. Precautions for the elderly: There is no overall difference in the efficacy and safety of this product for the elderly and other adult patients.

The drug interaction studies of this product are not sufficient. It has been shown that some quinolones can increase the blood concentration of theophylline when taken systemically, interfere with the metabolism of caffeine, increase the effect of the oral anticoagulant warfarin and its derivatives, and if taken with cyclosporine, the patient may have a transient increase in serum creatinine. It has been shown that some quinolones can increase the blood concentration of theophylline when taken systemically, interfere with the metabolism of caffeine, increase the effect of the oral anticoagulant warfarin and its derivatives, and if taken with cyclosporine, the patient may have a transient increase in serum creatinine.

Keep tightly closed in a cool place.

0.3% (0.8ml: 2.4mg) (calculated as levofloxacin)

24 months

Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd.

• Founded in:

  1992-03-31

• Address:

  No. 789, Xinluo Street, Jinan High-tech Development Zone

• Tax NO.:

  913701006140705563

• Registered Funds:

  90 million yuan

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