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, and its chemical name is (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-l-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 together when necessary), cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

Intravenous drip: 400 ml (0.4 g) per day for adults, divided into 2 intravenous drips. For patients with severe infections and pathogens with poor sensitivity to this product (such as Pseudomonas aeruginosa), the maximum daily dose can be increased to 600 ml (0.6 g) per day, divided into 2 intravenous drips.

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 patients who are allergic to quinolones.

Precautions for children: It is contraindicated for patients under 18 years old. Precautions for pregnancy and lactation: It is contraindicated for pregnant and lactating women. 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 are at 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. Cases 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 tendonitis or tendon rupture occur, it is recommended to stop levofloxacin treatment and contact a 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 aged 75 years or older. 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 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 prolong the QT interval (such as Class IA or Class III antiarrhythmic drugs) or have risk factors for torsades de pointes (such as known QT 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 the dose should be selected with caution and renal function should 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 simultaneously with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 3. When used simultaneously with non-steroidal anti-inflammatory drugs, it may cause convulsions. 4. When used simultaneously with oral hypoglycemic drugs, it may cause blood sugar disorders, including hyperglycemia and hypoglycemia. Therefore, blood sugar concentrations 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: 0.2g levofloxacin and 0.9g sodium chloride

Tentatively 24 months.

Suzhou Pharmaceutical Factory

• Founded in:

  2006-02-14

• Address:

  No. 2-1, Dongwu South Road, Wuzhong District, Suzhou City

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  91320506138170408U

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