Medication info

Megalevofloxacin 100 mg (Levofloxacin Hemihydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Levofloxacin Hydrate›100mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201908615 · Approved 2019.12.24 · Insurance code 661305490

This product's status changed to Approval withdrawn on 2024.05.31. 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, secondary infections in chronic respiratory diseases, etc.
Who takes it
Adults
Adult dose
The usual adult dosage of levofloxacin is 100 mg orally 2 to 3 times a day. For severe cases or insufficient response, 200 mg may be administered 3 times a day. Adjust according to age and symptoms.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment of 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 medication is an antibiotic that acts effectively against various types of bacterial infections. It is used to treat complicated skin and soft tissue infections, as well as respiratory-related infections such as chronic bronchitis, community-acquired pneumonia, and bronchiectasis. It is also effective against urinary tract infections such as pyelonephritis, cystitis, and prostatitis, as well as gonococcal urethritis and non-gonococcal urethritis. Gastrointestinal infections such as enteritis and bacterial dysentery, infections of the uterus and surrounding tissues, and eye-related inflammation and infections can also be treated. It is used for ENT (ear, nose, and throat) infections such as otitis media, sinusitis, and periodontal tissue infections, as well as biliary infections like cholecystitis and cholangitis. However, this drug, as a fluoroquinolone antibiotic, may cause serious adverse reactions, so it should only be used when there are no alternative treatments for acute bacterial sinusitis, acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease, uncomplicated urinary tract infections, acute otitis media, and complicated skin and soft tissue infections. It is safely and effectively used for the treatment of these various infections.

How to take

Adult dose

The usual adult dosage of levofloxacin is 100 mg orally 2 to 3 times a day. For severe cases or insufficient response, 200 mg may be administered 3 times a day. Adjust according to age and symptoms.

Precautions

This medication is a fluoroquinolone antibiotic used to treat certain bacterial infections. However, it can cause serious side effects such as tendonitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of severe myasthenia gravis, so caution is necessary. If these side effects occur, the medication should be discontinued immediately, and drugs from the same class should not be used again. This drug should not be administered to patients with a history of severe myasthenia gravis. Additionally, this drug is only to be used for certain infections such as acute bacterial sinusitis, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute otitis media when there are no other treatment options. Tendon pain or inflammation, or symptoms of tendon rupture may occur during the use of this drug, especially in elderly patients or those with impaired kidney function, or those taking corticosteroids, which increases the risk. If these symptoms arise, use should be stopped immediately, and rest and limitation of activities are necessary. Patients with severe myasthenia gravis should be cautious as muscle weakness symptoms may worsen with this medication. This drug should not be used by patients with an allergic reaction to it or a past history of tendonitis or tendon rupture from the same class of medication, children or adolescents under 18 years old, pregnant or breastfeeding women, or patients with epilepsy. It should be used cautiously in patients with severely reduced kidney function, patients with central nervous system diseases or a history of seizures, those taking certain anti-inflammatory drugs or theophylline, elderly patients, patients with diabetes, etc. This medication can cause various side effects such as severe allergic reactions, difficulty breathing, skin rash, mental disorders, heart rhythm abnormalities, liver and kidney dysfunction, blood abnormalities, gastrointestinal issues, muscle pain, tendonitis, and severe skin reactions, so if any unusual symptoms develop, medical attention should be sought immediately. Moreover, this drug can cause photosensitivity reactions, so exposure to strong sunlight or artificial UV light should be avoided, and caution is needed when driving or operating machinery due to symptoms like dizziness or drowsiness. Diabetic patients should frequently check their blood sugar levels as this medication may affect blood sugar control. This drug may interact with other medications, so caution is necessary when taken with antacids, iron supplements, calcium supplements, warfarin, theophylline, cyclosporine, etc. Pregnant or breastfeeding women should not use this medication, and it should not be administered to growing children or adolescents. Elderly patients may require dosage adjustments and monitoring due to potential increases in drug concentrations from renal function decline. Overdose can lead to central nervous system symptoms and cardiac rhythm abnormalities, requiring immediate treatment. It is crucial to strictly follow the physician's instructions while using this medication and consult promptly if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Tendonitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of severe myasthenia gravis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), shock, anaphylactic reactions, cardiovascular collapse, hypotensive shock, seizures, loss of consciousness, numbness, vascular edema, airway obstruction, difficulty breathing, severe cutaneous adverse reactions (severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes)

Mild side effects

Insomnia, dizziness, headaches, tremors, anxiety, depression, psychotic reactions (hallucinations, paranoia, nervousness, delirium, disorientation, attention deficits, nightmares, etc.), agitation, confusion, visual and auditory disturbances, taste and smell disturbances, auditory hallucinations, paresthesia, sensory loss, sensory disturbances, weakness, palpitations, QT interval prolongation, arrhythmia, increased BUN and serum creatinine, nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain,

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, preferably at a cool room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/bottle, 60 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.