Medication info

YouYoung Levofloxacin Injection (Levofloxacin Hemihydrate)

Prescription medicationInjections정맥
Ingredient · strength
Levofloxacin Hydrate›5.1246mg / 1mL
Manufacturer / importer
(주)유영제약
Appearance
A colorless and transparent vial injectable solution containing a clear yellow liquid with a light green tint.
Packaging
For domestic use: 50mL, 100mL/vial x 10
Approval status
Active

MFDS item code 201700257 · Notified 2017.01.12 · Insurance code 648204001,648204002

Summary

Main use
Treatment of community-acquired pneumonia and complicated urinary tract infections
Who receives it
Adults
Adult administration
Administer by IV infusion 1-2 times daily. The dosing regimen is determined based on the type and severity of the infection and susceptibility. After the initial few days of IV infusion, it may be switched to oral administration based on the patient's condition; the dosage remains the same. Administration should be done only via IV infusion, once or twice daily, for a maximum of 14 days. The infusion time is at least 60 minutes. Dosage for patients with normal renal function (creatinine clearance > 50ml/min): -

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Treatment of community-acquired pneumonia and complicated urinary tract infections

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

This drug is effective against various bacteria such as enterococci, Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli. It is mainly used to treat community-acquired pneumonia, complicated urinary tract infections including acute pyelonephritis, complicated skin and soft tissue infections, acute sinusitis, and acute bacterial exacerbations of chronic bronchitis. However, as a fluoroquinolone, it carries a potential for serious adverse reactions, so it should only be used when there are no alternative treatment options available for acute sinusitis, exacerbations of chronic bronchitis, or complicated skin infections. This drug is effective for treating major bacterial infections, and caution is needed for safe use.

How it is given

Adult administration

Administer by IV infusion 1-2 times daily. The dosing regimen is determined based on the type and severity of the infection and susceptibility. After the initial few days of IV infusion, it may be switched to oral administration based on the patient's condition; the dosage remains the same. Administration should be done only via IV infusion, once or twice daily, for a maximum of 14 days. The infusion time is at least 60 minutes. Dosage for patients with normal renal function (creatinine clearance > 50ml/min): -

Precautions

This drug may cause tendon-related side effects such as tendonitis and tendon rupture; therefore, if there is pain or inflammation in the tendons, use should be discontinued immediately. Additionally, there is a risk of exacerbation of symptoms in cases of peripheral neuropathy, central nervous system abnormalities, and in patients with myasthenia gravis, so caution is required. This drug should only be used when treatment for specific infections is necessary and should be administered restrictively to patients with no alternative treatment options. Administering must adhere to the injection speed; if blood pressure drops significantly or severe side effects occur, administration should be stopped immediately. The risk of tendon damage is increased in elderly patients, renal impairment patients, and when used concomitantly with corticosteroids, so combination should be avoided. Hypersensitivity or severe allergic reactions may occur; if symptoms such as skin rash or difficulty breathing appear, the drug should be stopped immediately, and medical consultation is advised. Gastrointestinal symptoms may include nausea, diarrhea, loss of appetite, vomiting, abdominal pain, indigestion, abdominal bloating, constipation, headache, dizziness, drowsiness, insomnia, neurosis, sensory disturbances, tremors, anxiety, agitation, confusion, tachycardia, hypotension, joint pain, muscle pain, redness and pain at the injection site, injection site infections, phlebitis, weakness, fungal overgrowth, vaginitis, candidiasis, fungal infections, ascites, skin hyperpigmentation, hypoglycemia, elevated serum creatinine. Serious side effects include hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, airway obstruction (bronchospasm), shortness of breath, difficulty breathing or respiratory distress, asthma attack, cough accompanied by fever or respiratory abnormalities, jaundice (skin or eyes turning yellow), severe malaise, hepatic abnormalities (jaundice).

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions. Severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions. Airway obstruction (bronchospasm), shortness of breath, difficulty breathing or respiratory distress, asthma attack, cough accompanied by fever or respiratory abnormalities. Jaundice (skin or eyes turning yellow), severe malaise, hepatic abnormalities (jaundice).

Mild side effects

  • Itching
  • rash
  • nausea
  • diarrhea
  • loss of appetite
  • vomiting
  • abdominal pain
  • indigestion
  • abdominal bloating
  • constipation
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  • headache
  • dizziness
  • drowsiness
  • insomnia
  • neurosis
  • sensory disturbances
  • tremors
  • anxiety
  • agitation
  • confusion
  • tachycardia
  • hypotension
  • joint pain
  • muscle pain
  • redness and pain at the injection site
  • injection site infections
  • phlebitis
  • weakness
  • fungal overgrowth
  • vaginitis
  • candidiasis
  • fungal infections
  • ascites
  • skin hyperpigmentation
  • hypoglycemia
  • elevated serum creatinine.

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

Storage

This drug should be stored in a sealed container that blocks light and at a temperature between 1°C and 30°C. Proper storage will maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A colorless and transparent vial injectable solution containing a clear yellow liquid with a light green tint.

Package unit

For domestic use: 50mL, 100mL/vial x 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.

Questions about this medicine

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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.