Medication info

Roxabite Tablets (Levofloxacin Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Levofloxacin Hydrate›100mg / 1 tablet
Manufacturer / importer
(주)씨티씨바이오
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201405387 · Approved 2014.11.19

This product's status changed to Expired on 2024.11.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for complicated skin and soft tissue infections, secondary infections in chronic respiratory diseases, etc.
Who takes it
Adults
Adult dose
For adult patients, Levofloxacin is usually administered 100 mg orally 2 to 3 times daily. For severe cases or if the effects are insufficient, 200 mg should be given 3 times a day. Adjustments may be made according to age and symptoms.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Treatment for complicated skin and soft tissue infections, secondary infections in chronic respiratory diseases, etc.

  • Complicated skin infections
  • soft tissue infections
  • chronic bronchitis
  • diffuse panbronchiolitis
  • secondary infections of chronic respiratory diseases
  • community-acquired pneumonia
  • bronchiectasis infections
  • acute pyelonephritis
  • cystitis
  • prostatitis
  • gonococcal urethritis
  • non-gonococcal urethritis
View approved original text

This drug is an antibiotic effective against a variety of bacterial infections, treating harmful bacteria such as Staphylococcus, Streptococcus pneumoniae, and Escherichia coli. It is widely used for skin and soft tissue infections, respiratory infections such as chronic bronchitis or pneumonia, urinary infections such as acute pyelonephritis, as well as bacterial gastroenteritis and reproductive infections. It also helps in the treatment of infections around the eyes and ears, sinusitis, periodontitis, and cholecystitis. However, due to the risk of serious adverse reactions, it should be used cautiously for certain infections when other treatment options are not available. This drug effectively treats complicated bacterial infections, aiding in patient recovery.

How to take

Adult dose

For adult patients, Levofloxacin is usually administered 100 mg orally 2 to 3 times daily. For severe cases or if the effects are insufficient, 200 mg should be given 3 times a day. Adjustments may be made according to age and symptoms.

Precautions

This drug can cause tendon-related disorders such as tendonitis and tendon rupture, and if such symptoms appear, it should be discontinued immediately. Peripheral neuropathy or central nervous system abnormalities have also been reported, so if any neurological symptoms are felt, the drug should be stopped and a doctor consulted. It is safer not to use this drug in patients with myasthenia gravis, as it may worsen symptoms. This drug is only used for specific bacterial infections and is recommended to be administered only when no other treatment options are available. Elderly patients or those with impaired kidney function, as well as those taking corticosteroids together, should be cautious due to the increased risk of tendon rupture. Severe allergic shock may occur due to hypersensitivity reactions, so if symptoms such as difficulty breathing or hives appear, use should be discontinued immediately. Side effects related to the nervous system such as insomnia, dizziness, anxiety, and in severe cases hallucinations or seizures may occur, so patients should inform healthcare providers if these symptoms arise. Cardiac-related side effects such as arrhythmias or QT interval prolongation may also occur, requiring caution in patients with heart disease. As it may affect liver and kidney function, if symptoms of hepatitis or signs of impaired kidney function appear, discontinue and consult a doctor immediately. If gastrointestinal symptoms such as abdominal pain, diarrhea, or bloody stools occur, there may be a possibility of pseudomembranous colitis, and prompt medical evaluation is necessary. This drug may affect blood sugar control, so diabetic patients should check their blood sugar levels frequently and seek treatment if symptoms of hypoglycemia occur. It is safest for pregnant or breastfeeding women, as well as growing children or adolescents, not to take this drug. Dizziness or drowsiness may occur while driving or operating machinery, so caution is required. There may be possible interactions with other medications taken concurrently, so if other medications are being used, it is essential to inform healthcare providers. In case of overdose, symptoms related to the central nervous system and heart may appear, requiring immediate treatment and electrocardiogram monitoring in emergencies. Overall, this drug may cause serious side effects, so it should be taken cautiously under the supervision of a doctor, and any unusual symptoms should be immediately reported to healthcare providers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, allergic reactions, shock, anaphylactic reactions, hypotensive shock, seizures, loss of consciousness, numbness, vascular edema, airway obstruction, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS]), exacerbation of myasthenia gravis, tendonitis, tendon rupture, peripheral neuropathy, central nervous system effects.

Mild side effects

  • Nausea
  • diarrhea
  • vaginitis
  • insomnia
  • abdominal pain
  • bloating
  • itching
  • dizziness
  • rash
  • indigestion
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  • stomatitis
  • glossitis
  • dry mouth
  • constipation
  • vomiting
  • fungal infections
  • genital itching
  • headache
  • neurosis
  • erythematous rash
  • loss of appetite
  • drowsiness
  • agitation
  • thirst
  • tremors
  • allergic reactions
  • palpitations
  • elevated BUN
  • increased serum creatinine
  • leukopenia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • eosinophilia.

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

Storage

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is safe to store the drug at room temperature between 1°C and 30°C, avoiding extremely hot or cold conditions.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.