Medication info

Entifloxacin 250 mg (Levofloxacin Hemihydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Levofloxacin Hydrate›256.15mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pink elongated film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201907049 · Approved 2019.10.04

This product's status changed to Expired on 2024.10.04. 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
Who takes it
Adults
Adult dose
For adults, Levofloxacin is given orally once daily at a dosage of 250–750 mg. In patients with normal renal function, for complicated skin and soft tissue infections, a dose of 750 mg is given once every 24 hours for 10–14 days. For community-acquired pneumonia, 500 mg is given once every 24 hours for 7 days. Acute bacterial exacerbation of chronic bronchitis lasts for 7 days, acute sinusitis for 10–14 days, and chronic bacterial prostatitis for 28 days.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment of complicated skin and soft tissue infections, 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 medication is used to treat infections caused by various bacteria. Major indications include complicated skin and soft tissue infections, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute sinusitis, chronic bacterial prostatitis, complicated urinary tract infections, and uncomplicated urinary tract infections. As a fluoroquinolone antibiotic, it carries a risk of serious adverse reactions, thus it is used when other treatments are ineffective for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infection, and complicated skin and soft tissue infections. This medication is effective against various pathogens including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Pseudomonas aeruginosa, among others. Therefore, it should be used cautiously to improve the patient's condition.

How to take

Adult dose

For adults, Levofloxacin is given orally once daily at a dosage of 250–750 mg. In patients with normal renal function, for complicated skin and soft tissue infections, a dose of 750 mg is given once every 24 hours for 10–14 days. For community-acquired pneumonia, 500 mg is given once every 24 hours for 7 days. Acute bacterial exacerbation of chronic bronchitis lasts for 7 days, acute sinusitis for 10–14 days, and chronic bacterial prostatitis for 28 days.

Precautions

As a fluoroquinolone antibiotic, this medication may cause serious adverse effects including tendon disorders such as tendonitis or tendon rupture, peripheral neuropathy, central nervous system symptoms, and exacerbation of myasthenia gravis. If any of these severe symptoms occur, discontinue the use of this medication immediately and do not use any drugs from the same class again. Patients with myasthenia gravis should avoid this medication as it may worsen their symptoms. This medication is only to be used for specific infections if no alternative therapies are available, including acute bacterial rhinosinusitis, acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease, uncomplicated urinary tract infections, and acute otitis media. There is a risk of tendon rupture, particularly in the shoulder, hands, Achilles tendon, especially in elderly patients, those with renal dysfunction, organ transplant recipients, and those receiving corticosteroids. Co-administration with corticosteroids should be avoided, and if there are pain, inflammation, or rupture symptoms in the tendons, discontinue use and rest immediately. This medication has neuromuscular blocking effects and may worsen symptoms in patients with myasthenia gravis, hence caution is advised. This medication should not be used in patients with hypersensitivity to this medication or other drugs in the same class, history of tendon rupture, adolescents under the age of 18, pregnant or potentially pregnant women, nursing mothers, patients with epilepsy, and some genetically predisposed lactose intolerant patients. Patients with severe renal impairment, central nervous system disorders, history of seizures, those taking certain anti-inflammatory drugs or theophylline, the elderly, diabetic patients, those with specific enzyme deficiencies, patients with severe myasthenia gravis, those allergic to Yellow No. 5 dye, aortic aneurysm, or history of valvular heart disease should be administered this medication with caution. This medication may rarely cause various adverse effects including shock, severe allergic reactions, central nervous system disturbances, cardiac arrhythmias, renal and liver dysfunction, hematologic abnormalities, gastrointestinal disturbances, musculoskeletal abnormalities, severe skin reactions, pneumonia, glucose metabolism disturbances; if any abnormal symptoms occur, consult a physician immediately. This medication may increase the risk of seizures, especially in patients with epilepsy or central nervous system disorders, and exposure to strong sunlight or artificial ultraviolet light should be avoided. Dizziness, drowsiness, and visual disturbances may occur, so caution is needed when driving or operating machinery. This medication may interact with other drugs, hence it is important to consult a doctor or pharmacist when taking antacids, iron supplements, calcium supplements, certain anti-inflammatory drugs, theophylline, warfarin, cyclosporine, and antidiabetic medications. Pregnant or nursing women should not use this medication, and nursing should be discontinued. In pediatric and adolescent populations, it may affect bones and joints, therefore it should not be used. The elderly should be administered this medication cautiously, adjusting dosage and intervals due to prolonged presence in the body from reduced renal function, which increases the risk of side effects. In cases of overdose, central nervous system symptoms and cardiac abnormalities may occur, and immediate medical attention is required, as this medication is not removed by dialysis. When this medication is used, it is important to administer it for the minimum required duration to prevent bacterial resistance and to immediately notify healthcare professionals of any adverse symptoms.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headaches, lightning-like headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Dizziness
  • headache
  • insomnia
  • tremors
  • anxiety
  • depression
  • psychotic reactions
  • restlessness
  • confusion
  • visual and auditory disturbances
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  • taste and smell disturbances
  • hallucinations
  • paresthesia
  • sensory deficit
  • weakness
  • palpitations
  • QT interval prolongation
  • arrhythmia
  • elevated BUN
  • increased serum creatinine
  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • abdominal pain
  • bloating
  • dyspepsia
  • stomatitis
  • glossitis
  • dry mouth
  • constipation
  • myalgia
  • fatigue
  • CP

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It should be kept away from extremes of temperature and stored safely at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink elongated film-coated tablet

Package unit

30 tablets/bottle, 100 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.