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Levofloxacin hydrochloride sodium chloride injection

Product description
Date of approval: November 14, 2006 Registered trademark
Date of revision: December 31, 2012
          June 22, 2016
          July 05, 2017
 
Levofloxacin hydrochloride sodium chloride injection instructions
Please read the instructions carefully and use them under the guidance of a physician.
For food and feed processing
 
caveat:
In all age groups, fluoroquinolones, including levofloxacin hydrochloride, can increase the risk of tendonitis and tendon rupture. This risk is further increased in elderly patients over the age of 60, patients receiving glucocorticoid therapy, and patients receiving kidney transplantation, heart transplantation, or lung transplantation.
Serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects, and increased myasthenia gravis.
• The use of fluoroquinolone drugs (including levofloxacin hydrochloride sodium chloride injection) has been reported to have both severe and potentially irreversible serious adverse effects (see [Precautions]), including:
o Tendinitis and tendon rupture (see [Precautions])
o Peripheral neuropathy (see [Precautions])
o The effects of the central nervous system (see [Notes])
When these serious adverse reactions occur (see [Precautions]), levofloxacin hydrochloride sodium chloride injection should be stopped immediately and fluoroquinolone drugs should be avoided.
• Fluoroquinolone drugs may aggravate myasthenia gravis in patients with myasthenia gravis. Patients with a history of myasthenia gravis should be advised to avoid levofloxacin hydrochloride sodium chloride injection (see [Precautions]).
• Serious adverse reactions have been reported due to the use of fluoroquinolone drugs (including levofloxacin hydrochloride sodium chloride injection) (see [Precautions]). For patients with the following indications, they should be used without other medications. Levofloxacin Hydrochloride Sodium Chloride Injection:
o Acute bacterial sinusitis (see [Indications] and [Usage and Dosage])
o Acute bacterial attack of chronic bronchitis (see [Indications] and [Usage and Dosage])
o Non-complex urinary tract infections (see [Indications] and [Usage and Dosage])
 
【Drug Name】
Common name: levofloxacin hydrochloride sodium chloride injection
English name: Levofloxacin Hydrochloride and Sodium Chloride Injection
Chinese Pinyin: Yansuan Zuoyangfushaxing Lühuana Zhusheye
[ingredients]
The main component of this product is: levofloxacin hydrochloride. Its chemical name is: (-)-(S)-3-methyl-9-fluoro-2,3-dihydro-10-(4-methyl-1-piperazinyl)-7-oxo-7H Pyrido[1,2,3-de]-[1,4]benzoxazine-6-carboxylic acid hydrochloride-hydrate.
Chemical Structure:
 
Molecular formula: C18H20FN3O4·HCl·H2O
Molecular weight: 415.85
Excipients are: sodium chloride, sodium hydroxide, sodium edetate.
【Properties】 This product is a light yellow-green or yellow-green clear liquid.
[indications]
In order to reduce the production of drug-resistant bacteria and ensure the effectiveness of levofloxacin hydrochloride and other antibiotics, levofloxacin is only used to treat or prevent infections that have been proven or highly suspected to be caused by sensitive bacteria. The results of bacterial culture and susceptibility testing should be considered when selecting or modifying an antimicrobial treatment regimen. If there is no data for these trials, empirical treatment should be based on local epidemiology and pathogen sensitivity.
Bacterial culture and susceptibility testing should be performed prior to treatment to isolate and identify infectious pathogens and determine their sensitivity to levofloxacin hydrochloride. Levofloxacin can be used for treatment before the above test results are obtained, and the appropriate treatment is selected after the test results are obtained.
As with other drugs in this class, certain strains of P. aeruginosa can quickly develop resistance when treated with levofloxacin hydrochloride. Bacterial culture and drug susceptibility testing should be carried out regularly during treatment to see if the pathogen is continuously sensitive to antimicrobial agents and can be detected in time after bacterial resistance develops.
Oral formulations and injections of levofloxacin hydrochloride can be used to treat the following mild, moderate, and severe infections caused by sensitive strains of the following bacteria in adults (≥ 18 years old). If intravenous drip is more beneficial to the patient (eg, the patient cannot tolerate oral administration, etc.) levofloxacin hydrochloride injection can be used.
Hospital acquired pneumonia
Treatment of hospital acquired by methicillin-sensitive Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae or Streptococcus pneumoniae pneumonia. At the same time, other ancillary treatments should be taken according to clinical needs. If Pseudomonas aeruginosa infection has been proven or suspected, it is recommended to use anti-Pseudomonas β-lactam drugs for treatment.
2. Community acquired pneumonia
7 to 14 days of treatment: treatment of methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae [including multi-drug resistant strains (MDRSP*)], Haemophilus influenzae, Haemophilus parainfluenzae, pneumonia Community-acquired pneumonia caused by Bacillus, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumoniae or Mycoplasma pneumoniae.
Note: MDRSP (multi-drug resistant pneumococci) refers to strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 μg/mL), second-generation cephalosporins (such as cefuroxime), large Cyclolactones, tetracycline and trimethoprim/sulfamethoxazole.
5-day treatment regimen: treatment of community-acquired pneumonia caused by S. pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae.
3. Acute bacterial sinusitis
5-day treatment regimen: treatment of acute bacterial sinusitis caused by S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
10 to 14 days of treatment: treatment of acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
Serious adverse reactions have been reported due to the use of fluoroquinolones (including levofloxacin hydrochloride sodium chloride injection), and for some patients, acute bacterial sinusitis is self-limiting, and should be used without other medications. Levofloxacin sodium chloride injection.
4. Acute bacterial attack of chronic bronchitis
Treatment of acute bacterial outbreaks of chronic bronchitis caused by methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae or Moraxella catarrhalis.
Serious adverse reactions have been reported due to the use of fluoroquinolones (including levofloxacin hydrochloride sodium chloride injection), and for some patients, the acute bacterial attack of chronic bronchitis is self-limiting and should be treated without other medications. Levofloxacin hydrochloride sodium chloride injection can be used.
5. Complex skin and skin soft tissue infections
Treatment of complex skin and skin and soft tissue infections caused by methicillin-sensitive Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes or Proteus mirabilis.
6. Non-complex skin and skin soft tissue infections
Treatment of non-complex skin and soft tissue infections caused by methicillin-sensitive Staphylococcus aureus or Streptococcus pyogenes (mild to moderate), including abscesses, cellulitis, warts, impetigo, pyoderma ,Wound infection.
7. Chronic bacterial prostatitis
Treatment of chronic bacterial prostatitis caused by Escherichia coli, Enterococcus faecalis or methicillin-sensitive Staphylococcus epidermidis.
8. Complex urinary tract infections
5-day treatment regimen: treatment of complex urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis.
10-day treatment regimen: treatment of complex urinary tract infections (mild to moderate) caused by Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Pseudomonas aeruginosa.
9. Acute pyelonephritis
5-day treatment regimen: treatment of acute pyelonephritis caused by Escherichia coli, including the name of the bacteremia.
10-day treatment regimen: treatment of acute pyelonephritis caused by Escherichia coli, including the name of the bacteremia.
10. Uncomplicated urinary tract infections:
Treatment of uncomplicated urinary tract infections (mild to moderate) caused by Escherichia coli, Klebsiella pneumoniae or Staphylococcus aureus.
Serious adverse reactions have been reported due to the use of fluoroquinolones (including levofloxacin hydrochloride sodium chloride injection), and for some patients, non-complex urinary tract infections are self-limiting and should be used without other medications. Levofloxacin hydrochloride sodium chloride injection.
11. Inhalation anthrax (after exposure)
Suitable for inhalation anthrax (post-exposure) treatment, reducing the incidence of disease or slowing the progression of the disease after exposure to B. anthracis spray. The effectiveness of levofloxacin is based on the surrogate endpoint of human plasma concentrations to predict clinical outcomes.
The preventive effect of levofloxacin on inhalation exposure to anthrax has not been tested in humans. The safety of levofloxacin in more than 28 days of treatment in adults has not been studied. Long-term treatment with levofloxacin can only be used if the benefits outweigh the risks.
[Specifications] (1) 100ml: levofloxacin 0.1g and sodium chloride 0.9g; (2) 100ml: levofloxacin 0.2g and sodium chloride 0.9g;
        (3) 100ml: levofloxacin 0.3g and sodium chloride 0.9g
【Dosage】
Oral formulations and injections of levofloxacin hydrochloride are used for the treatment of the above-mentioned infectious diseases (see Indications). The general usage and dosage are as follows, but must be determined by the clinician in combination with the severity of the disease.
1. Dosage and administration method
(1) Dose in patients with normal renal function
The usual dose of levofloxacin hydrochloride oral formulation is 250 mg or 500 mg or 750 mg, orally once every 24 hours. According to the infection, take it as shown in the table below (Table 1).
The usual dose of levofloxacin hydrochloride injection is 250 mg or 500 mg, slow infusion, infusion time of not less than 60 minutes, intravenous infusion every 24 hours; or 750 mg, slow infusion, time not less than 90 minutes, every 24 Intensively once every hour. According to the infection, it is used as shown in Table 1.
There is no need to adjust the amount of creatinine clearance ≥ 50 mL / min. When the creatinine clearance rate is <50 mL/min, the dosage should be adjusted.
Table 1: Dose in patients with normal renal function (creatinine clearance ≥ 50 mL/min)
Infection type 1 every 24 hours dose course (days) 2
Hospital pneumonia 750 mg 7~14
Community acquired pneumonia 3 500 mg 7-14
Community acquired pneumonia 4 750 mg 5
Acute bacterial sinusitis 750 mg 5
500 mg 10~14
Acute bacterial exacerbation of chronic bronchitis 500 mg 7
Complex skin and skin soft tissue infections (cSSSI) 750 mg 7 to 14
Non-complex skin and skin soft tissue infections (uSSSI) 500 mg 7-10
Chronic bacterial prostatitis 500 mg 28
Complex urinary tract infection (cUTI) or acute pyelonephritis (AP) 5 750 mg 5
Complex urinary tract infection (cUTI) or acute pyelonephritis (AP) 6 250 mg 10
Uncomplicated urinary tract infection 250 mg 3
Inhalation anthrax (after exposure), adult and pediatric patients >50 kg and ≥6 months 7,8
Pediatric patients <50 kg and ≥6 months 7,8 500 mg
See the table below (Table 2) 608
608
Note: 1 caused by specific pathogens (see indications).
2 physicians can use continuous treatment (intravenous or oral) at their own discretion.
3 by methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae [including multi-drug resistant strains (MDRSP)], Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae (see indications).
4 caused by Streptococcus pneumoniae [including multi-drug resistant strains (MDRSP)], Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae (see indications).
5 This protocol is applicable to cUTI caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and acute pancreatitis caused by Escherichia coli, including the name of simultaneous bacteremia.
6 This protocol is applicable to cUTI caused by Enterococcus faecalis, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and acute pancreatitis caused by Escherichia coli.
7 should be administered as soon as possible after suspected or clear exposure to Bacillus anthracis spray. This indication is based on the surrogate endpoint. The plasma concentration of levofloxacin achieved in humans may predict clinical efficacy.
The safety of 8 levofloxacin hydrochloride in more than 28 days in adults and more than 14 days in pediatric patients has not been studied. An increased incidence of musculoskeletal adverse reactions was observed in pediatric patients compared to controls (see Warnings and Precautions for details). Long-term treatment with levofloxacin hydrochloride can only be used when the benefit exceeds the risk.
(2) Dose in pediatric patients (<18 years old)
The doses for pediatric patients (≥6 months) are described in the table below (Table 2).
Table 2: Dose of pediatric patients (≥6 months)
Infection type 1 dose per administration frequency course 2
Inhalation anthrax (after exposure) 3, 4
Pediatric patients >50 kg and ≥6 months 500 mg 24 hours 60 days 4
Pediatric patients <50 kg and ≥6 months 8 mg/kg (no more than 250 mg per dose) 12 hours 60 days 4
 
Note: 1 caused by Bacillus anthracis (see indications).
2 physicians can use continuous treatment (intravenous or oral) at their own discretion.
3 should be administered as soon as possible after suspected or clear exposure to B. anthracis spray. This indication is based on the surrogate endpoint. The plasma concentration of levofloxacin hydrochloride achieved in humans may predict clinical efficacy.
The safety of 4 levofloxacin hydrochloride in pediatric patients for more than 14 days has not been studied. An increased incidence of musculoskeletal adverse reactions was observed in pediatric patients compared to controls (see Warnings and Precautions). Long-term levofloxacin treatment can only be used when the benefit exceeds the risk.
(3) Dose adjustment in patients with renal insufficiency
If there is renal insufficiency, levofloxacin hydrochloride should be used with caution. Since the clearance of levofloxacin hydrochloride may be reduced, careful clinical observation and appropriate laboratory studies should be performed before and during the start of treatment.
There is no need for dose adjustment for patients with creatinine clearance ≥50 mL/min.
In patients with renal insufficiency (creatinine clearance <50 mL/min), due to decreased creatinine clearance, doses need to be adjusted to avoid accumulation of levofloxacin hydrochloride (see use in special populations).
The following table (Table 3) shows how to
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