Medication info

Levoks Injection (Levofloxacin Hemihydrate)

Prescription medicationInjections정맥
Ingredient · strength
Levofloxacin Hydrate›5.1246mg / 1mL
Manufacturer / importer
(주)오스코리아제약
Appearance
A clear yellow solution with a light greenish hue contained in a colorless transparent vial injection.
Packaging
10 vials/box [(50 mL/vial) × 10], 10 vials/box [(100 mL/vial) × 10], 10 vials/box [(150 mL/vial) × 10]
Approval status
Active

MFDS item code 200401767 · Notified 2004.12.20 · Insurance code 629700101,629700111,629700761

Summary

Main use
Treatment of bacterial infections such as community-acquired pneumonia and complicated urinary tract infections.
Who receives it
Adults
Adult administration
Administered as a drip intravenous injection 1 to 2 times a day. Dosage should be determined by infection type and severity, as well as the sensitivity of the causative bacteria. It may be possible to switch to oral administration after a few days of intravenous administration, depending on the patient's condition, with the oral dosage being the same as the intravenous dosage. The method of administration is through intravenous drip, once or twice a day, for a maximum of 14 days, with a minimum infusion time of 60 minutes. Patients with normal renal function (creatinine clearance > 50 mL/min).

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Treatment of bacterial infections such as community-acquired pneumonia and complicated urinary tract infections.

  • Community-acquired pneumonia
  • acute pyelonephritis
  • complicated urinary tract infections
  • complicated skin infections
  • soft tissue infections
  • acute sinusitis
  • acute bacterial exacerbations of chronic bronchitis.
View approved original text

This drug acts effectively against various bacteria. For example, it is effective against Enterococcus, Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, and Pseudomonas aeruginosa. It is primarily used for the treatment of community-acquired pneumonia, acute pyelonephritis and other urinary infections, complicated skin and soft tissue infections, acute sinusitis, and acute bacterial exacerbations of chronic bronchitis. However, community-acquired acute sinusitis, acute exacerbation of chronic bronchitis, and complicated skin infections should only be used when other treatment options are not available. This drug has the potential for serious adverse reactions, hence caution is needed. It should be used appropriately according to the patient's condition to treat infections.

How it is given

Adult administration

Administered as a drip intravenous injection 1 to 2 times a day. Dosage should be determined by infection type and severity, as well as the sensitivity of the causative bacteria. It may be possible to switch to oral administration after a few days of intravenous administration, depending on the patient's condition, with the oral dosage being the same as the intravenous dosage. The method of administration is through intravenous drip, once or twice a day, for a maximum of 14 days, with a minimum infusion time of 60 minutes. Patients with normal renal function (creatinine clearance > 50 mL/min).

Precautions

This drug is a fluoroquinolone antibiotic and may cause several significant adverse reactions, so caution is necessary. Firstly, tendinitis or tendon rupture, peripheral neuropathy, and central nervous system side effects affecting the brain and nervous system may occur. If these symptoms occur, discontinue the medication immediately, and do not use other drugs from the same class. Also, patients with myasthenia gravis should not take this drug as it may worsen their symptoms. Secondly, this drug should only be used cautiously when there are no other treatment options for specific bacterial infections. Thirdly, the infusion rate must be maintained during intravenous administration, and if heart rate increases or blood pressure drops sharply during infusion, the infusion must be stopped immediately. Fourthly, elderly patients, those with impaired renal function, and organ transplant recipients are at higher risk of tendon rupture and should not take this medication alongside corticosteroids. If there is pain or inflammation in the tendon, treatment should be discontinued immediately, and rest should be taken. Fifthly, this drug may provoke seizures, so patients with epilepsy or central nervous system disorders should use it cautiously. If seizures occur, discontinue the medication immediately and consult a healthcare professional. Sixthly, patients with hypersensitivity to this drug or a history of tendinitis or tendon rupture with this drug or those in the same class, children under 18, pregnant women, or nursing mothers should not use this medication. Seventhly, this drug can cause various side effects, including abnormal heart rhythms, blood sugar changes, liver or kidney dysfunction, and severe skin reactions; therefore, any unusual symptoms should be reported to a healthcare provider immediately. Eighthly, there may be drug interactions, so if you are taking other medications, you must inform your healthcare provider, especially when combined with blood sugar-lowering agents, anticoagulants, or certain anti-inflammatory drugs. Ninthly, this drug may cause skin hypersensitivity if exposed to strong sunlight or artificial ultraviolet light, so it should be avoided. If skin rash occurs, discontinue use immediately. Finally, dizziness, drowsiness, or other symptoms may occur while driving or operating machinery; hence caution is advised. In case of overdose, central nervous system symptoms and heart problems may appear, so it is essential to adhere to prescribed doses.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest discomfort, difficulty breathing, cold sweat, paleness, severe allergic reactions and anaphylactic reactions, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), central nervous system effects (seizures, confusion, convulsions), worsening of myasthenia gravis, severe hypotension, significant edema, liver abnormalities (including jaundice), acute renal failure, rhabdomyolysis, bone marrow failure, agranulocytosis.

Mild side effects

  • Itching
  • rash
  • nausea
  • diarrhea
  • loss of appetite
  • vomiting
  • abdominal pain
  • dyspepsia
  • abdominal bloating
  • constipation
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  • headache
  • dizziness
  • drowsiness
  • insomnia
  • neurosis
  • sensory disturbances
  • tremors
  • anxiety
  • agitation
  • confusion
  • visual and auditory disturbances
  • taste and smell disorders
  • hallucinations
  • mania
  • tachycardia
  • hypotension
  • joint pain
  • muscle pain
  • elevated liver enzymes (AST/ALT)
  • increased bilirubin
  • increased serum creatinine
  • increased eosinophil count
  • decreased white blood cell count
  • neutrophils.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug is sensitive to light and should be stored in a container that prevents light exposure. It should be stored at room temperature between 1 degree and 30 degrees Celsius. This way, the drug's efficacy and safety can be well maintained.

Appearance and packaging

Appearance

A clear yellow solution with a light greenish hue contained in a colorless transparent vial injection.

Package unit

10 vials/box [(50 mL/vial) × 10], 10 vials/box [(100 mL/vial) × 10], 10 vials/box [(150 mL/vial) × 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.