Medication info

Megarevofloxacin Tablet 250 mg (Levofloxacin Hemihydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Levofloxacin Hydrate›256.15mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Light pink, oblong film-coated tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201907810 · Approved 2019.11.07

This product's status changed to Approval withdrawn on 2024.04.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of complicated skin and soft tissue infections, community-acquired pneumonia, and other bacterial infections
Who takes it
Adults
Adult dose
Normally, in adults, levofloxacin is administered orally once daily at 250-750 mg. For patients with normal kidney function (creatinine clearance greater than 80 mL/min): - Complicated skin and soft tissue infections: 750 mg every 24 hours for 10-14 days. - Community-acquired pneumonia: 500 mg every 24 hours for 7 days. - Acute bacterial exacerbation of chronic bronchitis: 7-day course. - Acute sinusitis: 10-14 days

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment of complicated skin and soft tissue infections, community-acquired pneumonia, and other bacterial infections

  • Complicated skin infections
  • soft tissue infections
  • community-acquired pneumonia
  • acute bacterial exacerbation of chronic bronchitis
  • acute sinusitis
  • chronic bacterial prostatitis
  • acute pyelonephritis
  • complicated urinary infection
  • uncomplicated urinary infection
View approved original text

This drug is effective against a variety of bacteria, including Staphylococcus aureus, Streptococcus pyogenes, and Streptococcus pneumoniae, and is used for the treatment of complicated skin and soft tissue infections, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute sinusitis, chronic bacterial prostatitis, and urinary tract infections. However, as a fluoroquinolone class drug, there is a risk of serious adverse reactions, and it should be prescribed only when other treatment options are not available for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary infections, and complicated skin and soft tissue infections. Therefore, it should be used cautiously in necessary patients considering safety.

How to take

Adult dose

Normally, in adults, levofloxacin is administered orally once daily at 250-750 mg. For patients with normal kidney function (creatinine clearance greater than 80 mL/min): - Complicated skin and soft tissue infections: 750 mg every 24 hours for 10-14 days. - Community-acquired pneumonia: 500 mg every 24 hours for 7 days. - Acute bacterial exacerbation of chronic bronchitis: 7-day course. - Acute sinusitis: 10-14 days

Precautions

This drug, as a fluoroquinolone antibiotic, can cause serious side effects such as tendinitis or tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of severe myasthenia gravis. If these symptoms appear, the medication should be discontinued immediately, and patients with a history of severe myasthenia gravis should not use this drug. Additionally, it should only be used when alternative treatments are unavailable for specific infections such as acute bacterial sinusitis, acute exacerbation of chronic bronchitis, uncomplicated urinary infections, and acute otitis media. Caution is required for elderly patients, patients with kidney disorders, organ transplant recipients, and those taking corticosteroids due to an increased risk of tendon rupture; it should not be used in conjunction with corticosteroids. In patients with severe myasthenia gravis, muscle weakness may be exacerbated, so it should be used cautiously. This drug has been reported to cause various side effects, including allergic reactions, severe skin reactions, liver dysfunction, kidney dysfunction, blood disorders, gastrointestinal disturbances, and neurological symptoms; thus, any abnormal symptoms should prompt immediate consultation with a healthcare provider. Particularly, there is a risk of seizures, so patients with a history of epilepsy or central nervous system disorders should exercise caution and avoid strong sunlight or artificial UV exposure to prevent photosensitivity reactions. Symptoms such as dizziness or drowsiness may occur when driving or operating machinery, so caution is advised. This drug can have decreased absorption when taken with certain antacids, iron, calcium, etc., so it should be taken at different times; when used with anticoagulants such as warfarin, there may be an increased risk of bleeding, so blood tests are necessary. It should not be administered to pregnant or nursing women, growing children, and adolescents, and dosage adjustment and monitoring for side effects are crucial in elderly patients due to declines in kidney function. In cases of overdose, central nervous system symptoms and cardiac side effects may occur, necessitating immediate emergency treatment, and this drug is not removed by dialysis.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in the oral/ocular mucosa, difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Nausea
  • diarrhea
  • vaginitis
  • insomnia
  • abdominal pain
  • bloating
  • itching
  • dizziness
  • rash
  • dyspepsia
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  • stomatitis
  • glossitis
  • dry mouth
  • constipation
  • taste distortion
  • vomiting
  • fungal infection
  • genital itching
  • headache
  • neurosis
  • erythematous rash
  • urticaria
  • decreased appetite
  • drowsiness
  • agitation
  • thirst
  • tremors
  • allergic reactions
  • palpitations
  • elevated BUN
  • elevated serum creatinine
  • elevated liver enzymes (AST/ALT)
  • ALP
  • γ-GTP

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is safest when stored at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light pink, oblong film-coated tablet

Package unit

30 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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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.