Medication info
Withers Levofloxacin Tablet 100 mg (Levofloxacin Hemihydrate)

Withers Levofloxacin Tablet 100 mg (Levofloxacin Hemihydrate)

Prescription medicationTablet경구
Ingredient · strength
Levofloxacin Hydrate›102.49mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
White to off-white round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200301937 · Notified 2003.05.13 · Insurance code 660701110

Summary

Main use
Effective in the treatment of complicated skin and soft tissue infections, respiratory, and urogenital infections
Who takes it
Adults
Adult dose
Typically for adults, Levofloxacin is administered orally at a dose of 100 mg, 2-3 times daily. In cases of severe or insufficient effect, it is administered at a dose of 200 mg, 3 times daily. Adjustments are made according to age and symptoms.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Effective in the treatment of complicated skin and soft tissue infections, respiratory, and urogenital infections

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

This drug is effective against various bacteria and is used for complicated skin and soft tissue infections, secondary infections in chronic respiratory disease, community-acquired pneumonia, and so forth. It is also effective for urinary infections such as acute pyelonephritis, cystitis, and prostatitis, as well as bacterial enteritis, and infections of the uterus and its appendages. Additionally, it is used for various inflammatory diseases of the eyes and ears, sinusitis, periodontal infections, and cholecystitis and cholangitis. However, due to the characteristics of fluoroquinolone drugs, there is a risk of serious side effects, so it should only be used when there are no alternative treatments available for certain infections. Overall, this drug plays an important role in the treatment of various bacterial infections.

How to take

Adult dose

Typically for adults, Levofloxacin is administered orally at a dose of 100 mg, 2-3 times daily. In cases of severe or insufficient effect, it is administered at a dose of 200 mg, 3 times daily. Adjustments are made according to age and symptoms.

Precautions

This drug is a fluoroquinolone antibiotic used for the treatment of various bacterial infections. However, it can cause serious side effects such as tendinitis or tendon rupture, peripheral neuropathy, central nervous system disturbances, and exacerbation of myasthenia gravis. If these side effects occur, use should be discontinued immediately and it should not be administered to patients with myasthenia gravis. This drug is limited to the use of acute bacterial non-sinusitis, acute bacterial exacerbation of chronic bronchitis and chronic obstructive pulmonary disease, uncomplicated urinary infections, acute otitis media, and it should only be administered when no other treatment options are available. Especially in elderly patients, patients with decreased kidney function, solid organ transplant recipients, and those using corticosteroids in combination, there is an increased risk of tendon rupture, so co-administration should be avoided; if symptoms of pain, inflammation, or tendon rupture appear, treatment should be stopped and rest should be taken. This drug may exacerbate symptoms in patients with myasthenia gravis and can carry a risk of seizures, thus it should be administered with caution in patients with epilepsy or central nervous system disorders. Moreover, it should not be administered to patients with a history of hypersensitivity to this drug or similar drugs, patients under 18 years of age who are still growing, pregnant or breastfeeding women, patients with epilepsy, and patients with certain genetic lactose intolerance. During administration, careful monitoring of blood, liver, kidney function abnormalities, cardiac rhythm abnormalities, severe skin reactions, gastrointestinal disturbances, and neurological symptoms should be conducted, and if any abnormal symptoms appear, administration should be discontinued immediately. This drug may interact with other medications, particularly when co-administered with non-steroidal anti-inflammatory drugs, warfarin, theophylline, antacids, and iron preparations, so caution is needed. It should not be used during pregnancy or while breastfeeding, nor should it be administered to children and adolescents in growth stages. In elderly patients, renal function decline can increase drug concentration, so dosing and administration intervals should be adjusted and used with caution. In case of overdose, central nervous system symptoms and cardiovascular effects may appear, so immediate medical attention should be sought; this drug is not eliminated by dialysis. While taking this drug, caution should be taken to avoid excessive exposure to sunlight or artificial ultraviolet light, and care should be taken while driving or operating machinery as dizziness or drowsiness may occur.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
  • Severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain → severe skin abnormal reaction
  • Shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities with cough+fever → respiratory issues
  • Skin or eyes turning yellow (jaundice), extreme lethargy → liver issues (jaundice)

Mild side effects

  • Nausea
  • diarrhea
  • vulvovaginitis
  • insomnia
  • abdominal pain
  • bloating
  • itching
  • dizziness
  • rash
  • dyspepsia
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  • stomatitis
  • glossitis
  • thirst
  • constipation
  • genital itching
  • headache
  • neuroticism
  • erythematous rash
  • decreased appetite
  • drowsiness
  • agitation
  • dry mouth
  • tremors
  • allergic reactions
  • taste disorders
  • vomiting
  • fungal infections
  • genital candidiasis
  • urticaria
  • chest tightness (mild possibility)
  • palpitations

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

Storage

This drug can be sensitive to air and moisture, so it should be kept in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a longer duration.

Appearance and packaging

Appearance

White to off-white round film-coated tablet

Package unit

30 tablets/bottle, 500 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.