Levofloxacin Hydrochloride and Sodium Chloride Injection

This product is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit bacterial DNA gyrase activity and inhibit bacterial DNA replication. 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, some Escherichia coli, influenza bacillus, Pseudomonas aeruginosa, gonococci, etc. It also has good antibacterial effects on some Staphylococci, Streptococcus pneumoniae, Chlamydia, etc.

The main ingredient of this product is levofloxacin hydrochloride

This product is a light yellow-green clear liquid.

This product is suitable for the following moderate and severe infections caused by sensitive bacteria: respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis and infection, pneumonia, tonsillitis (peritonsillar abscess); urinary system infections: pyelonephritis, complicated urinary tract infection, etc.; reproductive system infections: acute prostatitis, acute epididymitis, intrauterine infection, adnexitis, pelvic inflammatory disease (metronidazole can be used in combination when anaerobic infection is suspected); skin and soft tissue infections: infectious impetigo, cellulitis, lymphangiitis (adenitis), subcutaneous abscess, perianal abscess, etc.; intestinal infections: bacillary dysentery, infectious enteritis, salmonella enteritis, typhoid and paratyphoid; sepsis, neutropenia and various infections in immunocompromised patients; other infections: mastitis, trauma, burns and postoperative wound infection, abdominal infection (metronidazole can be used in combination when necessary), cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

Intravenous drip: 0.4g per day for adults, divided into 2 intravenous drips. For patients with severe infection and those whose pathogens are less sensitive to this product (such as Pseudomonas aeruginosa), the maximum daily dose can be increased to 0.6g, divided into 2 intravenous drips.

During medication, symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, abdominal distension, insomnia, dizziness, and headache may occur; rash, itching, erythema, and redness, itching, or phlebitis at the injection site may occur. Transient liver function abnormalities may also occur, such as increased serum transaminase 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, which are generally tolerated and disappear after the end of the course of treatment.

It is contraindicated for patients who are allergic to quinolones, pregnant or lactating women, and patients under 18 years of age.

Precautions for children: Precautions for children during pregnancy and lactation: Precautions for pregnant and lactating women and 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.

Not yet clear

Keep away from light and store tightly closed in a cool place.

100ml: 0.2g levofloxacin and 0.9g sodium chloride

Tentatively 24 months.

Chongqing Lummy Pharmaceutical Co., Ltd.

• Founded in:

  1999-09-06

• Address:

  No. 99, Yuma Road, Nan'an District, Chongqing

• Tax NO.:

  915000006219193432

• Registered Funds:

  1,055,911,205 yuan

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