Levofloxacin Injection (Levofloxacin Hemihydrate)

Adult administration

1. Typically administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative organism, generally starting with intravenous administration for the first few days, after which it can be switched to oral administration based on the patient's condition. In this case, the dosage will be the same as the intravenous dosing. 2. This drug should only be administered by intravenous infusion and can be given once or twice a day for a maximum of 14 days. 3. Treatment duration varies depending on the disease progression; typically, administration (either as a solution or tablet) should continue for a minimum of 48 to 72 hours after the patient has become afebrile or has evidence of sterilization. 4. Recommended dosing: 1) Dosing in patients with normal kidney function (creatinine clearance > 50mL/min) Indication/ Daily dose prescription (according to patient condition) Community-acquired pneumonia: 1 to 2 times a day, 500mg per dose Complicated urinary tract infections, including acute pyelonephritis: Once daily, 250mg per dose Complicated skin and soft tissue infections: Twice daily, 500mg per dose Acute sinusitis: Once daily, 500mg per dose Acute bacterial exacerbation of chronic bronchitis: Once daily, 500mg per dose * In cases of severe infection, dose escalation may be considered. 2) Dosing in patients with impaired renal function (creatinine clearance ≤ 50mL/min) 250mg/24 hours 500mg/24 hours 500mg/12 hours Creatinine clearance Initial dose 250mg Initial dose 500mg Initial dose 500mg 50 to 20mL/min Then 125mg/24 hours Then 250mg/24 hours Then 250mg/12 hours 19 to 10mL/min Then 125mg/48 hours Then 125mg/24 hours Then 125mg/12 hours Less than 10mL/min (including hemodialysis and continuous ambulatory peritoneal dialysis) Then 125mg/48 hours Then 125mg/24 hours Then 125mg/24 hours * No additional dosing is necessary after hemodialysis or continuous ambulatory peritoneal dialysis. 3) Dosing in patients with liver dysfunction: Levofloxacin is minimally metabolized by the liver and primarily excreted by the kidneys, therefore no dose adjustment is needed. 4) Dosing in the elderly: Except for considerations of renal function, there is no need for dose adjustment in elderly patients.

This drug is a fluoroquinolone antibiotic used for the treatment of various bacterial infections. However, it can cause serious side effects such as tendinitis or tendon rupture, peripheral neuropathy, and central nervous system effects, necessitating caution. In particular, it should not be used in patients with myasthenia gravis as it can exacerbate symptoms. This drug is used only when alternative treatment is not available for specific infections such as acute bacterial non-sinusitis, acute bacterial exacerbation of chronic bronchitis or chronic obstructive pulmonary disease, simple urinary tract infections, and acute otitis media. When administered as an injection, 250mg should be injected slowly intravenously for at least 30 minutes and 500mg for at least 60 minutes, and if there is a rapid drop in blood pressure during infusion, administration should be stopped immediately. Co-administration with corticosteroids increases the risk of tendon rupture, hence it should be avoided, and if tendon pain or inflammation occurs, administration should be stopped immediately and rest should be taken. This drug may increase the risk of seizures, so it should be used carefully in patients with epilepsy or a history of seizures. Additionally, it should not be used in patients with hypersensitivity to this drug or a history of tendinitis or tendon rupture, children and adolescents in the growth period, or women who are pregnant or nursing. During treatment, allergy reactions such as rash, urticaria, and dyspnea may occur; if such symptoms arise, treatment should be stopped immediately and a doctor consulted. This drug may cause side effects such as nausea, diarrhea, headache, dizziness, insomnia, and in rare cases, serious skin reactions or blood disorders. Diabetic patients should frequently check their blood sugar levels as it may become unstable. Elderly patients or those with impaired renal function may require dose adjustment, and special caution is needed for those with a history of aneurysm or heart valve disease. In the case of overdose, central nervous system symptoms or cardiac abnormalities may occur, requiring immediate treatment. This drug may interact with certain medications, so it is essential to inform healthcare professionals if other drugs are being taken. During treatment, exposure to strong sunlight or artificial ultraviolet light should be avoided, and care should be taken when driving or operating machinery as dizziness or drowsiness may occur. This drug should be administered within 3 hours after preparation and must be mixed only with specific solutions.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of severe myasthenia gravis, severe allergic reactions (anaphylaxis, hypotensive shock, angioedema, airway obstruction, dyspnea), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), respiratory issues (bronchospasm, acute respiratory distress), liver abnormalities,

Mild side effects

• Itching
• rash
• nausea
• diarrhea
• loss of appetite
• vomiting
• abdominal pain
• dyspepsia
• bloating
• constipation

This drug is sensitive to light and should be stored in a tightly closed container that prevents light exposure. Furthermore, it is essential to maintain a storage temperature between 1°C and 30°C. This ensures the sustained effectiveness and safety of the drug.

Appearance

A colorless and transparent vial injection containing a clear liquid that is light yellow with a faint green tint.

Package unit

50mL, 100mL, 150mL x 10