Levofloxacin Hydrochloride and Sodium Chloride Injection

This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant information about levofloxacin reported in the literature is as follows: Pharmacological action Mechanism of action: Levofloxacin is the levorotatory form of ofloxacin (racemate) and is a quinolone antibacterial drug. The antibacterial effect of ofloxacin is mainly produced by the levorotatory form. The mechanism of action of levofloxacin and other fluoroquinolone antibacterial drugs is to inhibit topoisomerase IV and DNA gyrase (topoisomerase II) required for bacterial DNA replication, transcription, repair and recombination. Drug resistance: Fluoroquinolone resistance is caused by mutations in specific regions of DNA gyrase or topoisomerase IV, also known as quinolone resistance determining regions (ORDRs), or changes in the drug efflux system. Fluoroquinolone antibiotics, including levofloxacin, have different chemical structures and modes of action from aminoglycosides, macrolides, and beta-lactam antibacterial drugs (including penicillin). Therefore, fluoroquinolones may still be effective against bacteria resistant to the above antimicrobial drugs. In vitro resistance to levofloxacin due to spontaneous mutation is rare (range: 10-9 to 10-10). Although cross-resistance between levofloxacin and some other fluoroquinolones has been observed, bacteria resistant to other fluoroquinolones may still be sensitive to levofloxacin. In vitro and in vivo antibacterial activity: Levofloxacin has antibacterial effects on a variety of Gram-negative and Gram-positive bacteria in vitro, and has bactericidal activity when the concentration is equal to or slightly higher than the inhibitory concentration. In vitro studies and clinical infections have shown that levofloxacin has antibacterial effects on the following microorganisms: Gram-positive aerobic bacteria: Enterococcus faecalis (many strains are only moderately sensitive), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus saprophyticus, Streptococcus pneumoniae [including multidrug-resistant strains (MDRSP)*], Streptococcus pyogenes. Note: MDRSP (Multidrug-resistant Streptococcus pneumoniae) refers to strains that are resistant to two or more of the following antimicrobial agents: penicillin (MICge; 2mu; g/mL), second-generation cephalosporins (such as cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Gram-negative aerobic bacteria: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumococcus, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa*, Serratia marcescens. Note: *As with other drugs in this class, some strains of Pseudomonas aeruginosa can quickly develop resistance when treated with levofloxacin. Other microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae. Levofloxacin has been shown to have an antibacterial effect against Bacillus anthracis in the macaque anthrax (post-exposure) model and in vitro conditions using plasma concentrations as a surrogate marker. The following data are in vitro test results, but their clinical significance is unknown: Under in vitro conditions, the minimum inhibitory concentration (MIC value) of levofloxacin against most strains (ge; 90%) of the following microorganisms is 2mu; g/mL or lower; however, the safety and efficacy of levofloxacin in the treatment of clinical infections caused by these microorganisms have not been adequately and well-controlled experimentally studied. Gram-positive aerobic bacteria: hemolytic Staphylococcus, beta;-hemolytic Streptococcus (C/F group), beta;-hemolytic Streptococcus (G group), Streptococcus agalactiae, Streptococcus milleri, Streptococcus viridans. Gram-negative aerobic bacteria: Acinetobacter baumannii, Acinetobacter lwoffii, Bordetella pertussis, Citrobacter cohnii (differential Citrobacter), Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella, Enterobacter agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens. Gram-positive anaerobic bacteria: Clostridium perfringens.

The main ingredient of this product is levofloxacin hydrochloride.

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.

Levofloxacin hydrochloride oral preparations and injections are used to treat the above infectious diseases (see Indications for details). The general usage and dosage are as follows, but must be determined by the clinician in combination with the severity of the disease. Dosage and administration 1. Dosage in patients with normal renal function The usual dose of levofloxacin hydrochloride oral preparations is 250 mg, 500 mg or 750 mg, taken orally once every 24 hours. Take according to the infection situation as shown in the following table (Table 1). The usual dose of levofloxacin hydrochloride injection is 250 mg or 500 mg, slowly dripped, the drip time is not less than 60 minutes, once every 24 hours; or 750 mg, slowly dripped, the time is not less than 90 minutes, once every 24 hours. Use according to the infection situation as shown in Table 1. No dosage adjustment is required when the creatinine clearance rate is ≥50 mL/min. The dosage needs to be adjusted when the creatinine clearance rate is <50 mL/min. Note: 1. Caused by specific pathogens (see Indications). 2. The physician may use continuous therapy (intravenous or oral) at his or her discretion. 3. Caused by methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae [including multidrug-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 multidrug-resistant strains (MDRSP)], Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae (see Indications). 5. This regimen is applicable to cUTI caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pancreatitis caused by Escherichia coli, including those with concurrent bacteremia. 6. This regimen is applicable to cUTI caused by Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and acute pancreatitis caused by Escherichia coli. 7. The drug should be administered as soon as possible after suspected or confirmed anthrax aerosol exposure. This indication is based on a surrogate endpoint. The plasma concentration of levofloxacin achieved in humans may predict clinical efficacy. 8. The safety of levofloxacin hydrochloride treatment for 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 with controls (see Warnings and Precautions for details). Long-term treatment with levofloxacin hydrochloride can only be used if the benefits outweigh the risks. 2. Dosage in pediatric patients (<18 years old) The dosage for pediatric patients (≥6 months) is described in the table below (Table 2). Note: 1. Caused by Bacillus anthracis (see Indications). 2. Physicians can use continuous treatment (intravenous or oral) at their discretion. 3. The drug should be administered as soon as possible after suspected or confirmed anthrax aerosol exposure. This indication is based on a surrogate endpoint. The plasma concentration of levofloxacin hydrochloride achieved in humans may predict clinical efficacy. 4. The safety of levofloxacin hydrochloride treatment for more than 14 days in pediatric patients has not been studied. An increased incidence of musculoskeletal adverse reactions was observed in pediatric patients compared with controls (see Warnings and Precautions). Long-term levofloxacin treatment can only be used if the benefits outweigh the risks. 3. Dose adjustment in patients with renal insufficiency Levofloxacin hydrochloride should be used with caution if renal insufficiency exists. Because the clearance of levofloxacin hydrochloride may decrease, careful clinical observation and appropriate laboratory studies should be performed before starting treatment and during treatment. No dose adjustment is necessary for patients with creatinine clearance > 50mL/min. In patients with renal insufficiency (creatinine clearance < 50mL/min), the dosage needs to be adjusted due to decreased creatinine clearance to avoid accumulation of levofloxacin hydrochloride (see Use in Special Populations). The following table (Table 3) shows how to adjust the dose based on creatinine clearance. Table 3: Dosage adjustment in patients with renal insufficiency (creatinine clearance < 50 mL/min) 4. Administration instructions This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant situations of levofloxacin reported in the literature are as follows: Drug interactions with chelating agents: antacids, sucralfate, metal cations, multivitamins Levofloxacin oral preparations should be taken at least 2 hours before or after the use of the following drugs: magnesium-containing antacids, aluminum, sucralfate, metal cations such as iron ions, zinc-containing multivitamin preparations, didanosine chewable/dispersible tablets or pediatric granules. Levofloxacin injection cannot be administered simultaneously with any solution containing polyvalent cations (such as magnesium ions) through the same intravenous route. Food and levofloxacin oral preparations Levofloxacin oral preparations can be taken without considering the effect of food. It is recommended to take levofloxacin hydrochloride oral preparations at least 1 hour before or 2 hours after eating. Levofloxacin Injection Caution: Rapid intravenous administration or bolus of levofloxacin injection may cause hypotension and should be avoided. Levofloxacin injection should be administered slowly by intravenous infusion over a period of not less than 60 or 90 minutes, depending on the dose. Levofloxacin injection should only be administered by intravenous infusion and should not be used for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. Water intake for patients receiving oral or intravenous levofloxacin formulations and injections Patients receiving oral or intravenous oral formulations and injections should be adequately hydrated to prevent excessive drug concentrations in the urine. There have been reports of quinolones causing casts in the urine. Preparation of intravenous medications For non-oral drug preparations, visual inspection for particulate matter and discoloration should be performed prior to administration whenever the solution and container permit. Because only limited data are available on the compatibility of levofloxacin hydrochloride injection with other intravenous drugs, additives or other drugs should not be added to premixed levofloxacin hydrochloride injection in disposable flexible containers or levofloxacin hydrochloride injection in disposable vials, or infused with them from the same intravenous route. If the same intravenous route is used for continuous infusion of several different drugs, flushing with an injection solution that is compatible with levofloxacin hydrochloride injection and other drugs infused through the same route should be used before and after the infusion of levofloxacin hydrochloride injection. Levofloxacin hydrochloride sodium chloride injection (large infusion) can be administered directly by intravenous drip. The infusion time is at least 60 minutes or more than 90 minutes depending on the dose, and the infusion concentration should be 5 mg/mL. Levofloxacin hydrochloride injection (small needle) must be further diluted with an appropriate solution before intravenous drip. The compatible intravenous solutions are shown in Table 4. The final dilution concentration of the solution before use should be 5 mg/mL. Levofloxacin hydrochloride for injection must first be dissolved in water for injection before intravenous infusion, and then further diluted with an appropriate solution. The compatible intravenous solutions are shown in the table below (Table 4). The final dilution concentration of the solution before use should be 5 mg/mL. Compatible intravenous infusion solutions: Any of the following intravenous injection solutions can be used to prepare a 5 mg/mL levofloxacin hydrochloride solution of appropriate pH value. Table 4: Compatible intravenous infusion solutions Since the drug does not contain preservatives or antibacterial agents, aseptic techniques should be used when preparing intravenous infusion solutions. The solution should be carefully observed for particulate impurities before use. Drugs containing visible particles should be discarded. Stability of levofloxacin hydrochloride injection after dilution: Levofloxacin hydrochloride injection diluted with a compatible intravenous injection solution to a concentration of 5 mg/mL can be stored for 72 hours at 25°C (77°F) or below 25°C, and can be stored for 14 days in a plastic container for intravenous infusion in a refrigerator at 5°C (41°F). The solution diluted with a compatible IV solution, frozen in a glass bottle or plastic container for IV infusion, and stored at -20°C (-4°F) is stable for 6 months. Thaw the frozen solution at room temperature (25°C (77°F) or in a refrigerator at 8°C (46°F). Do not use a microwave or water bath to accelerate its dissolution. Do not freeze and thaw repeatedly after thawing once. Instructions for use of injection: Check the container for minor leaks before use. If there is a leak or the seal is not intact, the solution should be discarded because the solution may no longer be sterile. If the solution is cloudy or precipitates, it should not be used. Use sterile equipment. Warning: Do not chain containers in series. This may cause air embolism due to aspiration of residual air in the primary container before the liquid in the secondary container is infused.

This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant conditions of levofloxacin reported in the literature are as follows: Serious and other important adverse reactions The following serious and other important adverse reactions have been described in detail in [Precautions]: tendinitis and tendon rupture, worsening of myasthenia gravis, hypersensitivity reactions, other serious and sometimes fatal reactions, hepatotoxicity, central nervous system effects, Clostridium difficile-associated diarrhea, peripheral neuropathy, QT interval prolongation, musculoskeletal diseases in pediatric patients, blood sugar disorders, photosensitivity/phototoxicity and drug-resistant bacteria. Rapid intravenous infusion or push injection of levofloxacin may cause hypotension. Depending on the dose, intravenous infusion should be given for no less than 60 to 90 minutes. It has been reported that the use of quinolones (including levofloxacin) may cause crystalluria and tubular urine. Therefore, for patients receiving levofloxacin treatment, proper hydration should be maintained to prevent the formation of highly concentrated urine. Clinical Trial Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to adverse reaction rates of other drugs in clinical trials and may not reflect adverse reaction rates in actual use. The data described below reflect the combined exposure of 7537 patients to levofloxacin in 29 Phase III clinical trials. The mean age of the study population was 50 years (approximately 74% of the population was 65 years old), 50% were male, 71% were white, and 17% were black. Patients were treated with levofloxacin for a wide range of infectious diseases (see INDICATIONS). Patients received levofloxacin at a dose of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily, usually for 3 to 14 days, with an average course of 10 days. The overall incidence, type, and distribution of adverse reactions were similar in patients using levofloxacin 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. A total of 4.3% of patients discontinued levofloxacin due to adverse drug reactions, including 3.8% of patients receiving the 250 mg and 500 mg daily doses and 5.4% of patients receiving the 750 mg daily dose. The most common adverse drug reactions leading to discontinuation in patients receiving the 250 mg and 500 mg daily doses were gastrointestinal reactions (1.4%), primarily nausea (0.6%), vomiting (0.4%), dizziness (0.3%), and headache (0.2%). The most common adverse drug reactions leading to discontinuation in patients receiving the 750 mg daily dose were gastrointestinal reactions (1.2%), primarily nausea (0.6%), vomiting (0.5%), dizziness (0.3%), and headache (0.3%). The following tables (Tables 5 and 6) list adverse reactions occurring in ge to 1% of patients treated with levofloxacin and those occurring in 0.1 to 1% of patients treated with levofloxacin, respectively. The most common adverse reactions (ge; 3%) were nausea, headache, diarrhoea, insomnia, constipation and dizziness. Table 5: Common (ge; 1%) adverse reactions reported in clinical trials of levofloxacin Table 6: Less common (0.1 to 1%) adverse reactions reported in clinical trials of levofloxacin (N=7537) In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate patches of the lens, were noted in patients treated with quinolone antibiotics, including levofloxacin. No relationship between the drug and these events has been established. Postmarketing Surveillance The following table (Table 7) lists adverse reactions identified during post-approval use of levofloxacin. Because these reactions are reported spontaneously from a population of varying sizes, it is not always possible to reliably assess the incidence of these events or to establish a causal relationship between drug exposure and these events. Table 7: Postmarketing Adverse Drug Reaction Reporting

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

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.

This product is levofloxacin hydrochloride, and its active ingredient is levofloxacin. The relevant information about levofloxacin reported in the literature is as follows: Chelating agents: antacids, sucralfate, metal cations, multivitamin preparations Levofloxacin oral preparations Although the chelation effect of levofloxacin with divalent cations is weaker than that of other fluoroquinolone antibiotics, the simultaneous use of levofloxacin oral preparations and antacids such as magnesium or aluminum, as well as sucralfate, metal cations such as iron and zinc-containing multivitamin preparations can still affect the gastrointestinal absorption of levofloxacin, resulting in systemic drug concentrations significantly lower than expected. Drugs containing antacids such as magnesium or aluminum, as well as sucralfate, metal cations such as iron and zinc-containing multivitamin preparations, or didanosine can significantly affect the gastrointestinal absorption of levofloxacin, resulting in systemic drug concentrations significantly lower than expected. These drugs should be taken at least two hours before or two hours after taking levofloxacin. Levofloxacin injection: There is no data on the interaction between intravenous quinolone antibiotics and oral antacids, sucralfate, multivitamin preparations, didanosine or metal cations. However, quinolone antibiotics should not be infused through the same intravenous infusion channel with any solution containing polyvalent cations such as magnesium. Warfarin: A clinical trial conducted in healthy volunteers showed that levofloxacin had no significant effect on the peak plasma concentration, AUC and other metabolic parameters of R- and S-warfarin. Similarly, no significant effect of warfarin on the absorption and metabolism of levofloxacin was observed. Post-marketing monitoring reports have indicated that levofloxacin can enhance the efficacy of warfarin. The simultaneous use of warfarin and levofloxacin can prolong the prothrombin time, thereby prolonging the bleeding time. When levofloxacin and warfarin are used simultaneously, the prothrombin time, international normalized ratio (INR) or other anticoagulation tests should be closely monitored, and attention should be paid to whether the patient has bleeding symptoms. Patients who use quinolone antibiotics and antidiabetic drugs together may experience blood sugar disorders such as hyperglycemia and hypoglycemia. Therefore, blood sugar levels should be closely monitored when these drugs are used simultaneously. Nonsteroidal anti-inflammatory drugs The simultaneous use of nonsteroidal anti-inflammatory drugs and quinolone antibiotics, including levofloxacin, can increase the risk of CNS irritation and seizures. Theophylline In a clinical trial involving 14 healthy volunteers, no significant effect of levofloxacin on the plasma concentration, AUC, and other metabolic parameters of theophylline was found. Similarly, no significant effect of theophylline on the absorption and metabolism of levofloxacin was observed. However, the simultaneous use of other quinolone antibiotics and theophylline can lead to a prolonged elimination half-life of theophylline in patients and an increase in blood drug concentrations, thereby increasing the incidence of theophylline-related adverse reactions. Therefore, when used simultaneously with levofloxacin, theophylline levels should be closely monitored and the drug dosage should be appropriately adjusted. Adverse reactions such as epilepsy may occur regardless of whether the blood concentration of theophylline is increased. Cyclosporine A clinical trial conducted in healthy volunteers showed that levofloxacin had no significant effect on the peak plasma concentration, AUC and other metabolic parameters of cyclosporine. However, it has been reported that when used simultaneously with certain other quinolone antibiotics, the patient's cyclosporine blood level increased. Compared with other trials without concomitant medication, the simultaneous use of cyclosporine can slightly reduce the Cmax and ke of levofloxacin, while Tmax and t1/2 are slightly prolonged, but this difference is not clinically significant. Therefore, there is no need to adjust the dose of levofloxacin and cyclosporine when used simultaneously. Digoxin A clinical trial conducted in healthy volunteers showed that levofloxacin had no significant effect on the peak plasma concentration, AUC and other metabolic parameters of digoxin. Digoxin also had no significant effect on the absorption and metabolic kinetics of levofloxacin. Therefore, there is no need to adjust the dose of levofloxacin and digoxin when used simultaneously. Probenecid and cimetidine A clinical trial conducted in healthy volunteers showed that probenecid or cimetidine had no significant effect on the absorption rate and extent of levofloxacin. Compared with levofloxacin alone, when co-administered with probenecid or cimetidine, the AUC and t1/2 of levofloxacin increased by 27% to 38% and 30%, respectively, and the CL/F and CLR decreased by 21% to 35%. Although this difference was statistically significant, no dose adjustment of levofloxacin was required when co-administered with probenecid or cimetidine. Interactions with laboratory or diagnostic tests include fluoroquinolones in levofloxacin, and urine screening for opioids using commercially available kits may produce false positive results, and more specific methods are necessary to determine opioid-positive results.

Keep away from light, tightly closed, in a cool place.

100ml: 0.2g levofloxacin hydrochloride (calculated as levofloxacin) and 0.9g sodium chloride

Tentatively 24 months.