Kralebo Injection (Levofloxacin Hemihydrate)

Adult administration

Administered via slow intravenous drip infusion once or twice daily. The dosage is determined by the type of infection, severity of infection, and sensitivity of the causative bacteria, and generally can be transitioned to oral administration based on the patient's condition after a few days of intravenous infusion. The dosing for oral administration is the same as the intravenous dose. The method of administration is via slow intravenous infusion, given once or twice daily for a maximum of 14 days, with an infusion duration of at least 60 minutes.

This drug is a fluoroquinolone antibiotic that can cause serious side effects such as tendonitis, tendon rupture, peripheral neuropathy, central nervous system disturbances, and exacerbation of myasthenia gravis. If these adverse reactions occur, the use of this medication should be discontinued immediately, and it should not be administered to patients with myasthenia gravis. This drug should only be used for specific infections such as acute bacterial sinusitis, acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease, simple urinary tract infections, and acute otitis media when no other treatment is available. When administered as an injection, it should be infused slowly over a certain period, and the infusion should be stopped immediately if there is a sudden drop in blood pressure. Coadministration with corticosteroids increases the risk of tendon rupture, so it should be avoided, and administration should be stopped immediately if tendon pain or inflammation occurs. Caution is needed as patients with myasthenia gravis may experience worsening symptoms due to this medication. It should not be administered to individuals allergic to this drug or other antibiotics of the same class, patients with epilepsy, children in the growth stage, pregnant women, or nursing mothers. Patients with a history of seizure disorders, central nervous system disorders, severe kidney impairment, and diabetes should be used with care, monitoring for blood glucose fluctuations. This medication may cause various side effects such as hypersensitivity reactions, skin rashes, gastrointestinal symptoms, neurological symptoms, cardiovascular and musculoskeletal abnormalities, so any abnormal symptoms should be reported to a doctor immediately. Additionally, this drug may react sensitively to sunlight, so unnecessary exposure to ultraviolet light should be avoided, and caution should be taken to avoid dizziness or drowsiness when driving or operating machinery. It may affect blood coagulation, so bleeding risks should be monitored if taken with anticoagulants, and interactions with certain medications must be communicated. Pregnant women and nursing mothers should not use this drug, nor should it be administered to growing children. Elderly patients may experience increased drug concentration due to decreased kidney function, necessitating dose adjustments and monitoring for side effects. In case of overdose, central nervous system symptoms and cardiac disturbances may occur; immediate medical attention is required, and this medication cannot be removed by hemodialysis. This drug should not be mixed with specific solutions and should be used promptly after opening.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, cardiovascular collapse, hypotensive shock, seizures, loss of consciousness, paresthesia, angioedema (swelling of the tongue, larynx, throat, or face), airway obstruction (bronchospasm, acute respiratory distress), respiratory arrest, Stevens-Johnson syndrome (skin-mucosal syndrome), toxic epidermal necrolysis (Lyell syndrome), eosinophilia, and systemic symptoms.

Mild side effects

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

This medication is sensitive to light, so it should be stored in an airtight container shielded from light. It is recommended to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer time.

Appearance

A colorless transparent vial containing a clear yellow solution with a pale green tint.

Package unit

50mL, 100mL, 150mL/vial x 10