Medication info

Proshin Injection (Levofloxacin Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Levofloxacin Hydrate›5.1246mg / 1mL
Manufacturer / importer
한국유니온제약(주)
Appearance
1. A colorless, transparent vial injection containing a clear yellowish liquid with a light green tint. 2. A transparent yellow solution with a light green tint filled in a colorless, transparent plastic container for infusion.
Packaging
Domestic use - 10 vials/box [50 milliliters/vial], Domestic use - 10 vials/box [100 milliliters/vial], Domestic use - 10 vials/box [150 milliliters/vial], Domestic use - 150 milliliters/bag, Domestic use - 100 milliliters/bag, Export use - 10 vials/box [50 milliliters/vial], Export use - 10 vials/box [100 milliliters/vial], Export use - 10 vials/box [150 milliliters/vial]
Approval status
Active

MFDS item code 200501434 · Notified 2005.01.18 · Insurance code 665504891,665504901,665504903,665506751,

Summary

Main use
Treatment of community-acquired pneumonia, complex urinary tract infections, etc.
Who receives it
Adults
Adult administration
Usually administered via slow intravenous infusion 1 to 2 times daily. The dosage depends on the type and severity of the infection and the susceptibility of the suspected causative organism. After a few initial days of intravenous infusion based on the patient's condition, it may be switched to oral administration, in which case the dosage should be the same as the intravenous dose. The duration of treatment may vary depending on the progression of the disease; however, it should continue for at least 48 to 72 hours after achieving a defervescence or evidence of sterilization.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of community-acquired pneumonia, complex urinary tract infections, etc.

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

This drug is effective against various bacteria, including Enterococcus, Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli. It is primarily used for treating community-acquired pneumonia, acute pyelonephritis including complex urinary tract infections, complicated skin and soft tissue infections, acute sinusitis, and acute bacterial exacerbations of chronic bronchitis. However, fluoroquinolone antibiotics, including this drug, carry a risk of serious adverse reactions and should only be used when other treatments have failed for acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, and complicated skin and soft tissue infections. Please refer to these considerations to aid in appropriate treatment.

How it is given

Adult administration

Usually administered via slow intravenous infusion 1 to 2 times daily. The dosage depends on the type and severity of the infection and the susceptibility of the suspected causative organism. After a few initial days of intravenous infusion based on the patient's condition, it may be switched to oral administration, in which case the dosage should be the same as the intravenous dose. The duration of treatment may vary depending on the progression of the disease; however, it should continue for at least 48 to 72 hours after achieving a defervescence or evidence of sterilization.

Precautions

This drug is used as a fluoroquinolone antibiotic for the treatment of certain bacterial infections. Serious side effects such as tendonitis or tendon rupture, peripheral neuropathy, central nervous system abnormalities, and exacerbation of myasthenia gravis may occur, requiring caution. If these symptoms occur, administration should be stopped immediately, and patients with a history of myasthenia gravis should not use this drug. When administered intravenously, it must be infused slowly over at least 30 to 60 minutes depending on the dose, and if blood pressure drops sharply during administration, it should be stopped immediately. Combining this drug with corticosteroids increases the risk of tendon rupture, so it should be avoided, and if tendon pain or inflammation occurs, administration should be stopped, and rest should be taken. Additionally, caution is needed for patients with seizure disorders or central nervous system conditions, kidney disorders, and diabetes, with close monitoring of blood glucose or neurological symptoms. This drug may cause various side effects, including allergic reactions, skin rashes, gastrointestinal disturbances, neurological disorders, and blood abnormalities, so if any unusual symptoms occur, medical personnel should be informed immediately. Particularly, it should not be used in pregnant women, nursing mothers, and growing children or adolescents, and dosage adjustments may be necessary for the elderly due to decreased kidney function. This drug may interact with other medications, so if any other medications are being taken, medical personnel must be informed, especially with anticoagulants, diabetes medications, and anti-inflammatory drugs. To prevent phototoxic reactions, exposure to strong sunlight or artificial UV light should be avoided, and caution should be taken when driving or operating machinery as dizziness or drowsiness may occur. In cases of overdose, central nervous system symptoms and cardiac abnormalities may arise, requiring immediate appropriate treatment at a medical institution. This drug should be stored in a container that can block light and kept in a closed state, ideally at room temperature between 1 to 30 degrees Celsius. The drug in the vial should be stored in a sealed container to prevent light exposure, and similarly, the drug in the bag should also be placed in a sealed container and stored at room temperature shielded from light. Proper storage can maintain the drug's effectiveness and prevent deterioration.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightening in the chest, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash, blisters, skin sloughing, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning.

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 abnormalities
  • tremors
  • anxiety
  • agitation
  • confusion
  • perceptual alterations
  • visual and auditory impairment
  • taste and smell disorders
  • hallucinations
  • mania
  • tachycardia
  • hypotension
  • arthralgia
  • myalgia
  • elevated liver enzyme levels (AST/ALT)
  • elevated bilirubin
  • elevated serum creatinine
  • increased eosinophils
  • leukocytes.

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

Storage

This drug should be stored in a sealed container that can block light, ideally at room temperature between 1 and 30 degrees Celsius. The drug in the vial should be stored in a sealed container to prevent light exposure, and the drug in the bag should also be placed in a sealed container and stored in a way that blocks light at room temperature. Proper storage can help maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

1. A colorless, transparent vial injection containing a clear yellowish liquid with a light green tint. 2. A transparent yellow solution with a light green tint filled in a colorless, transparent plastic container for infusion.

Package unit

Domestic use - 10 vials/box [50 milliliters/vial], Domestic use - 10 vials/box [100 milliliters/vial], Domestic use - 10 vials/box [150 milliliters/vial], Domestic use - 150 milliliters/bag, Domestic use - 100 milliliters/bag, Export use - 10 vials/box [50 milliliters/vial], Export use - 10 vials/box [100 milliliters/vial], Export use - 10 vials/box [150 milliliters/vial]

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.