Medication info

Samsung Levofloxacin Tablet 100 mg (Levofloxacin Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Levofloxacin Hydrate›100mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Pale yellow round film-coated tablet
Packaging
Domestic use - 30 tablets/bottle, Domestic use - 500 tablets/bottle
Approval status
Expired

MFDS item code 201904258 · Approved 2019.06.19

This product's status changed to Expired on 2024.06.19. 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 for levofloxacin is 100 mg orally, 2 to 3 times a day. For patients with severe or insufficient response, 200 mg may be administered, 3 times a day. Adjustments may be made based on age and symptoms.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

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

This medication is effective against various bacteria including Staphylococcus, Streptococcus pneumoniae, and Escherichia coli, and is used to treat complicated skin and soft tissue infections, secondary infections in chronic bronchitis and chronic respiratory diseases, urinary tract infections such as acute pyelonephritis and cystitis, bacterial gastroenteritis, infections of the uterus and appendages, inflammatory conditions around the eyes and corneal ulcers, otitis media and sinusitis, and cholecystitis among other infectious diseases. In particular, as a fluoroquinolone-class medication, it carries a risk of serious adverse reactions and should only be used when there are no alternative treatment options in cases such as acute bacterial sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. This drug is effective in treating various bacterial infections and helps patients recover their health.

How to take

Adult dose

The usual adult dosage for levofloxacin is 100 mg orally, 2 to 3 times a day. For patients with severe or insufficient response, 200 mg may be administered, 3 times a day. Adjustments may be made based on age and symptoms.

Precautions

This medication is used as a fluoroquinolone antibiotic for the treatment of various bacterial infections. However, it requires caution as serious side effects such as tendonitis or tendon rupture, peripheral neuropathy, central nervous system adverse effects, and exacerbation of severe myasthenia gravis may occur. In particular, if such serious side effects appear, immediate discontinuation of this medication is necessary, and other drugs of the same class should not be used. It is unsafe to administer this medication to patients with a history of severe myasthenia gravis. This drug is recommended to be used in the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infections, acute otitis media, but only when there are no alternative treatment options available. For the elderly, patients with impaired renal function, organ transplant recipients, and those using corticosteroids, the risk of tendon rupture is increased, so co-administration should be avoided. Additionally, this drug may affect the central nervous system, so patients with seizure risk or history of convulsions should also be used cautiously. This medication should not be used by patients with a history of hypersensitivity to it or a history of tendonitis or tendon rupture, adolescents under 18 years of age, pregnant or nursing women, or patients with epilepsy. While taking this medication, various side effects such as nausea, diarrhea, headache, dizziness, rash, myalgia, tendinitis, tendon rupture, severe allergic reactions may occur, so if any abnormal symptoms appear, immediate consultation with medical personnel is necessary. In particular, if serious skin reactions or symptoms such as difficulty breathing or low blood pressure occur, immediate discontinuation of the medication is necessary and urgent treatment is required. This drug may interact with other medications; therefore, caution is required when used with non-steroidal anti-inflammatory drugs, hypoglycemic agents, anticoagulants, antacids, and it may be necessary to adjust dosing intervals or amounts. When taking this medication, avoid strong sunlight or exposure to artificial UV rays, and be cautious of accidents due to dizziness or drowsiness while driving or operating machinery. It is recommended that women who are pregnant or may become pregnant, and nursing women, not use this drug. It should not be administered to children and adolescents who are growing. In case of overdose, central nervous system symptoms and cardiac side effects may occur, so immediate medical treatment should be sought, and this drug is not removed by hemodialysis. It is important to take this medication for the minimum required duration to prevent the occurrence of bacterial resistance, and to take it exactly as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, acute renal failure, jaundice, acute liver necrosis, acute liver failure, severe hepatitis, liver dysfunction, confusion, lightning headache, seizures, visual disturbances, paralysis, severe edema, increased blood pressure, tendonitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of severe myasthenia gravis, severe allergic reactions, severe skin reactions (Stevens-Johnson syndrome,

Mild side effects

Insomnia, dizziness, headache, tremor, anxiety, depression, psychotic reactions (hallucinations, paranoia, hyperactivity, delirium, disorientation, attention deficits, nightmares, etc.), agitation, confusion, visual and auditory disturbances, taste and smell disorders, tinnitus, sensory abnormalities, sensory deficit, weakness, palpitations, leukopenia, anemia, decreased hemoglobin, decreased hematocrit, increased eosinophils, pancytopenia, hemolytic anemia.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius, to retain the drug's effectiveness and safety for as long as possible.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 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.