Medication info
Withus Levofloxacin Tablet 500 mg (Levofloxacin Hemihydrate)

Withus Levofloxacin Tablet 500 mg (Levofloxacin Hemihydrate)

Prescription medicationTablet경구
Ingredient · strength
Levofloxacin Hydrate›512.3mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Pink oblong film-coated tablets
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP x 3)], For export - 50 tablets/box [(10 tablets/PTP x 5)]
Approval status
Active

MFDS item code 201105697 · Approved 2011.08.26 · Insurance code 660702470

Summary

Main use
Treatment of complicated skin infections and community-acquired pneumonia
Who takes it
Adults
Adult dose
Typically, levofloxacin for adults is administered orally once daily at 250 to 750 mg. 1. For patients with normal renal function (creatinine clearance > 80 mL/min): - Complicated skin and soft tissue infections: 750 mg every 24 hours for 10 to 14 days - Community-acquired pneumonia: 500 mg every 24 hours for 7 days - Acute bacterial exacerbation of chronic bronchitis: 7 days - Acute sinusitis: 10 to 14 days - Chronic bacterial prostatitis: 28 days

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment of complicated skin infections and community-acquired pneumonia

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

This medicine is effective against various types of bacteria and is used to treat complicated skin and soft tissue infections, community-acquired pneumonia, acute exacerbations of chronic bronchitis, acute sinusitis, chronic bacterial prostatitis, and various types of urinary tract infections. As a fluoroquinolone class drug, it has potential for serious side effects and should only be prescribed to patients with no alternative treatment options for acute sinusitis, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and complicated skin and soft tissue infections. This drug effectively treats various bacterial infections and improves symptoms.

How to take

Adult dose

Typically, levofloxacin for adults is administered orally once daily at 250 to 750 mg. 1. For patients with normal renal function (creatinine clearance > 80 mL/min): - Complicated skin and soft tissue infections: 750 mg every 24 hours for 10 to 14 days - Community-acquired pneumonia: 500 mg every 24 hours for 7 days - Acute bacterial exacerbation of chronic bronchitis: 7 days - Acute sinusitis: 10 to 14 days - Chronic bacterial prostatitis: 28 days

Precautions

This drug may cause serious side effects related to tendons, such as tendonitis or tendon rupture; if such symptoms appear, use should be discontinued immediately. It can affect peripheral neuropathy and the central nervous system, requiring prompt treatment if sensory abnormalities or neurological symptoms occur. This drug should not be used in patients with myasthenia gravis as it may worsen their symptoms. It is recommended that this drug be used only when no alternative treatment options are available for certain infections, as there is a risk of side effects. In elderly patients or those with impaired renal function, and when used in conjunction with corticosteroids, there is an increased risk of tendon rupture, so concurrent use should be avoided. Due to the risk of seizures, this drug is not recommended for patients with epilepsy or a history of seizures. It should not be administered to pregnant or nursing women, or to children and adolescents who are still growing, and should be avoided in patients with lactose intolerance. This drug can cause serious allergic or skin reactions; if symptoms such as rash or difficulty breathing occur, it should be discontinued immediately and medical advice sought. It may affect blood glucose control, so diabetic patients should monitor their blood sugar closely. In cases of overdose, central nervous system symptoms and cardiac rhythm disturbances may occur, requiring prompt treatment and observation. While taking this medication, care should be taken to avoid strong sunlight or artificial UV exposure and to be cautious of dizziness or drowsiness when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, lightning-like headache, seizures, confusion of consciousness, vision abnormalities, paralysis, changes in urination amount

Mild side effects

  • Nausea
  • diarrhea
  • vulvovaginitis
  • insomnia
  • abdominal pain
  • bloating
  • itching
  • dizziness
  • rash
  • dyspepsia
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  • stomatitis
  • glossitis
  • dry mouth
  • constipation
  • vomiting
  • fungal infections
  • genital itching
  • headache
  • neuropathy
  • erythematous rash
  • decreased appetite
  • drowsiness
  • agitation
  • thirst
  • tremors
  • allergic reactions
  • palpitations
  • elevated BUN and serum creatinine
  • increased liver enzyme levels
  • leukopenia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit

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

Storage

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius room temperature to preserve the drug's efficacy and safety for a prolonged period.

Appearance and packaging

Appearance

Pink oblong film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/box [(10 tablets/PTP x 3)], For export - 50 tablets/box [(10 tablets/PTP x 5)]

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.