Levofloxacin Hydrochloride and Sodium Chloride Injection

This product belongs to the quinolone antibacterial drug. It 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 DNA gyrase and the replication of bacterial DNA. This product has the characteristics of a broad antibacterial spectrum and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Klebsiella pneumoniae, Proteus, Salmonella typhi, Shigella, and some Escherichia coli. It also has good antibacterial effects on some Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Chlamydia, etc.

The main ingredient of this product is levofloxacin hydrochloride. Its chemical name is (S)-(—)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyridinyl[1,2,3,-de]-[1,4]benzoxazine-6-carboxylic acid hydrochloride-crystalline hydrate.

This product is a light yellow-green clear liquid.

This product is suitable for the following moderate and severe infections caused by sensitive bacteria: 1. Respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchitis, bronchiectasis with infection, pneumonia, tonsillitis (peritonsillar abscess). 2. Urinary system infections: pyelonephritis, complicated urinary tract infection, etc. 3. Reproductive system infections: acute prostatitis, acute epididymitis, uterine cavity infection, uterine adnexitis, pelvic inflammatory disease (metronidazole can be used in combination when anaerobic bacteria infection is suspected). 4. Skin and soft tissue infections: infectious impetigo, cellulitis, lymphangiitis (adenitis), subcutaneous abscess, anal abscess, etc. 5. Intestinal infections: bacillary dysentery, infectious enteritis, salmonella enteritis, typhoid and paratyphoid. 6. Various infections in patients with sepsis, neutropenia and immunodeficiency. 7. Other infections: mastitis, trauma, burns and postoperative wound infection, abdominal infection (use metronidazole when necessary), cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

[Overdose] Levofloxacin cannot be effectively eliminated through hemodialysis or peritoneal dialysis.

During medication, gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, lack of appetite, abdominal pain, abdominal distension, neurological symptoms such as insomnia, dizziness, headache, as well as rash and itching may occur. Transient liver function abnormalities may also occur, such as increased serum aminotransferase and increased serum total bilirubin. The incidence of the above adverse reactions is between 0.1% and 5%. Occasionally, increased blood urea nitrogen, fatigue, fever, palpitations, abnormal taste, etc. are seen. Generally, they are well tolerated and disappear quickly after the end of the course of treatment.

It is contraindicated for those who are allergic to quinolones. [Use in pregnant and lactating women] It is contraindicated for pregnant and lactating women. [Use in children] It is not suitable for patients under 18 years old. [Overdose] Levofloxacin cannot be effectively eliminated by hemodialysis or peritoneal dialysis.

Precautions for children: This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant information about levofloxacin reported in the literature is as follows: Quinolone antibiotics including levofloxacin can cause joint lesions and bone/cartilage lesions in young animals of certain species. The safety for children has not been established, so it is contraindicated for patients under 18 years old, except for protection against anthrax inhalation (after exposure). Inhalation anthrax (after exposure) levofloxacin is suitable for pediatric patients with inhalation anthrax (after exposure). The risk-benefit assessment suggests that it is appropriate to give levofloxacin to pediatric patients. The safety of levofloxacin treatment for more than 14 days has not been studied in pediatric patients. The pharmacokinetics of a single intravenous injection of levofloxacin have been studied in pediatric patients aged 6 months to 16 years. In pediatric patients, the clearance rate of levofloxacin is faster than that of adult patients, so at a specific mg/kg dose, the resulting plasma exposure level is lower than that of adults. Adverse Reactions In clinical trials, 1534 children (ages 6 months to 16 years) were treated with oral and intravenous levofloxacin. Children aged 6 months to 5 years received levofloxacin 10 mg/kg twice daily, and children aged 5 years and older received levofloxacin 10 mg/kg once daily (maximum dose 500 mg daily) for a total of 10 days. A subgroup of children in clinical trials (1340 treated with levofloxacin and 893 treated with non-fluoroquinolones) participated in a prospective long-term monitoring study to evaluate the incidence of protocol-defined musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) 60 days and 1 year after the first dose of study drug. The incidence of musculoskeletal disorders was significantly higher in children treated with levofloxacin than in children treated with non-fluoroquinolones, as shown in the following table (Table 8). Table 8: Incidence of musculoskeletal disorders in pediatric clinical trials Note: Non-fluoroquinolones: ceftriaxone, amoxicillin/clavulanic acid, clarithromycin. Bilateral Fishers exactness test. A 1-year evaluation visit was performed for 1199 levofloxacin-treated children and 804 non-fluoroquinolone-treated children. However, the incidence of musculoskeletal disorders was calculated using all reported events in all children participating in the trial during the specified period, regardless of whether they completed the 1-year evaluation visit. In both treatment groups, joint pain was the most common musculoskeletal disorder. In both groups, the majority of musculoskeletal disorders involved multiple weight-bearing joints. Disorders were moderate in 8/46 (17%) levofloxacin-treated children and mild in 35/46 (76%) levofloxacin-treated children, and the majority received analgesics. The median time of remission in the levofloxacin treatment group was 7 days, and in the non-fluoroquinolone treatment group it was 9 days (in both groups, approximately 80% of patients were relieved within 2 months). No children experienced severe or major illnesses, and all musculoskeletal diseases resolved without residual sequelae. Vomiting and diarrhea were the most commonly reported adverse events, with similar incidences in the levofloxacin treatment group and the non-fluoroquinolone treatment group. In addition to events reported in clinical trials of pediatric patients, events reported in clinical trials or post-marketing monitoring in adult patients may also occur in pediatric patients. Precautions for pregnancy and lactation: This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant information about levofloxacin reported in the literature is as follows: Pregnancy and pregnancy medication classification C. Levofloxacin has no teratogenic effect when the oral dose of rats is up to 810 mg/kg/day, which is equivalent to 9.4 times the maximum recommended human dose for the same relative body surface area. Levofloxacin has no teratogenic effect when the intravenous infusion dose is 160mg/kg/day, which is equivalent to 1.9 times the maximum recommended dose for humans when the relative body surface area is the same. When the oral dose of rats is 810mg/kg/day, the fetal weight can be reduced and the mortality rate can be increased. When the oral dose of rabbits reaches 50mg/kg/day, no teratogenic effect of levofloxacin is observed, which is equivalent to 1.1 times the maximum recommended dose for humans when the relative body surface area is the same. When the intravenous infusion dose is 25mg/kg/day, levofloxacin has no teratogenic effect, which is equivalent to 0.5 times the maximum recommended dose for humans when the relative body surface area is the same. However, there have not been enough well-controlled trials on pregnant women to ensure the safety of the drug for pregnant women, so pregnant women or women who may become pregnant are prohibited from using it. Levofloxacin can only be used in pregnant women when the potential benefits to the fetus outweigh the potential risks. Based on the limited data on other fluoroquinolones and levofloxacin for lactating women, it is speculated that levofloxacin should be secreted into human breast milk. Levofloxacin is contraindicated in breastfeeding women because it may cause serious adverse reactions in breast-feeding infants. Levofloxacin can only be used in breastfeeding women when the potential benefits outweigh the potential risks, but breastfeeding should be suspended. Precautions for the elderly: This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant information about levofloxacin reported in the literature is as follows: Elderly patients have an increased risk of serious adverse reactions (including tendon rupture) during treatment with fluoroquinolones, such as levofloxacin. This risk is further increased in patients receiving combined treatment with glucocorticoids. Tendonitis or tendon rupture can affect the heels, hands, shoulders, or other tendon sites, and can occur during or after treatment. Diseases have been reported to occur several months after the end of fluoroquinolone treatment. Levofloxacin must be used with caution in elderly patients, especially those receiving glucocorticoid treatment. Patients must be informed of these potential side effects, and if any symptoms of tendinitis or tendon rupture occur, it is recommended to stop levofloxacin treatment and contact their healthcare provider. In Phase III clinical trials, 1,945 patients (26%) treated with levofloxacin were aged ≥ 65 years, 1,081 (14%) were aged between 65 and 74 years, and 864 (12%) were equal to or older than 75 years. There was no significant difference in the safety and efficacy of the drug between these patients and younger patients, but it cannot be ruled out that some elderly patients may be more sensitive. In marketing reports, serious and even fatal hepatotoxicity associated with levofloxacin has been reported. The main fatal hepatotoxicity reports occurred in patients aged 65 years or older, and most of them did not have allergic reactions. If the patient has symptoms or indications of hepatitis, levofloxacin should be discontinued immediately. Elderly patients may be more sensitive to drug-related effects on the QT interval. Therefore, patients who use levofloxacin and certain drugs that can cause QT interval prolongation (such as Class IA or Class III antiarrhythmic drugs) or have risk factors for torsades de pointes (such as known QT interval prolongation, refractory hypokalemia) should be cautious when using levofloxacin. If the difference in creatinine clearance is taken into account, there is no significant difference in the pharmacokinetic characteristics of levofloxacin between young and elderly subjects. However, since most of levofloxacin is excreted from the kidneys, patients with renal impairment are at higher risk of drug toxicity. Elderly patients are more likely to have impaired renal function, so special caution should be exercised when selecting the dose, and renal function needs to be monitored at the same time.

1. Avoid using it with theophylline. If it is necessary to use it at the same time, the blood concentration of theophylline should be monitored to adjust the dosage. 2. When used with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 3. When used with non-steroidal anti-inflammatory drugs, it may cause convulsions. 4. When used with oral hypoglycemic drugs, it may cause blood sugar disorders, including hyperglycemia and hypoglycemia. Therefore, blood sugar concentration should be monitored during medication. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given.

Keep in dark, airtight and cool place.

100ml: 0.1g levofloxacin hydrochloride (calculated as levofloxacin) and 0.86g sodium chloride

Tentatively 24 months.

Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd.

• Founded in:

  1988-04-05

• Address:

  No. 505, Jinren Road, Jinshan District, Shanghai

• Tax NO.:

  91310116134213626T

• Registered Funds:

  75 million yuan

• Email:

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