Medication info

Ofloksasin Tablets

Prescription medicationExpired
Ingredient · strength
Ofloxacin›Strength being verified
Manufacturer / importer
Austin Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 200102057 · Notified 2001.04.06

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of bacterial infections (e.g., respiratory and genitourinary infections); adjunctive treatment of Hansen's disease
Who uses it
Adults
Adult dosage
○ The usual adult dose is 300~600 mg of ofloxacin per day, divided into 2~3 doses. ○ For Hansen's disease, the dose of this medicine is 400~600 mg per day, divided into 2~3 doses. In principle, use in combination with other anti-leprosy drugs. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Austin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of bacterial infections (e.g., respiratory and genitourinary infections); adjunctive treatment of Hansen's disease

  • Infections of complex skin and soft tissues
  • acute otitis media
  • chronic suppurative otitis media
  • chronic cholesteatomatous otitis
  • chronic otitis media with bone metastasis
  • acute bacterial sinusitis
  • chronic bacterial sinusitis
  • pneumonia from community-acquired infections
  • chronic bronchitis
  • acute exacerbation of chronic obstructive pulmonary disease
  • acute pyelonephritis
  • uncomplicated acute cystitis
View approved original text

This medication is used to treat a variety of infections caused by different bacteria. It is primarily effective for complex skin and soft tissue infections, acute and chronic otitis media, bacterial sinusitis, pneumonia occurring in the community, and acute exacerbation of chronic obstructive pulmonary disease. It is also used for urogenital infections such as acute pyelonephritis, uncomplicated acute cystitis, bacterial prostatitis, and urethritis. This medication also helps in treating gastrointestinal related infections like bacterial dysentery and enteritis, infections of the uterus and surrounding tissues in women, as well as eye-related infections. As a fluoroquinolone-class medication, it may pose significant adverse reaction risks, so it should be used cautiously when no other treatment options are available. Overall, this medication is very effective in treating a variety of infections.

Dosage and Administration

Adult dosage

○ The usual adult dose is 300~600 mg of ofloxacin per day, divided into 2~3 doses. ○ For Hansen's disease, the dose of this medicine is 400~600 mg per day, divided into 2~3 doses. In principle, use in combination with other anti-leprosy drugs. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication can cause serious tendon problems such as tendonitis and tendon rupture; if these symptoms occur, use should be discontinued immediately. It may affect peripheral neuropathy or the central nervous system, so caution is necessary if sensory abnormalities or neurological symptoms occur. It should not be used in patients with myasthenia gravis due to the risk of worsening symptoms, and if a patient with myasthenia gravis is taking it, watch out for symptom exacerbation. Elderly patients, those with renal disorders, and patients taking steroids are at an increased risk of tendon rupture, so combining it with steroids should be avoided. This medication can cause seizures or convulsions, so patients with epilepsy or central nervous system disorders should be especially cautious. Pregnant women, breastfeeding mothers, and children and adolescents in growth should not use this medication. Serious hypersensitivity reactions, such as allergic reactions or anaphylaxis, may rarely occur; if symptoms such as rash or difficulty breathing occur, immediate treatment is necessary. It can affect liver and kidney functions, so routine blood tests and function tests are needed during prolonged use. Avoid exposure to sunlight or UV radiation while taking this medication, and discontinue use if photosensitivity reactions occur. Diabetic patients who need blood sugar control should carefully monitor for symptoms of hypoglycemia or hyperglycemia, and should be cautious if used in combination with antihypertensives or anticoagulants according to a physician's instructions. Be cautious of neurological adverse reactions such as dizziness or drowsiness while driving or operating machinery or during activities that require attention. This medication may have reduced absorption when taken with certain antacids or drugs containing iron or calcium, so the timing of doses should be adjusted. Store in a tightly sealed container away from children and do not transfer to another container for safety.

Side effects

Tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of myasthenia gravis, anaphylactic shock, anaphylactic reaction, rash, itching, redness, swelling, fever, warmth, vesicles, erythema, photosensitivity reaction, hematuria, acute kidney failure, kidney stones, interstitial nephritis, elevated BUN, elevated serum creatinine, jaundice, liver failure, elevated AST/ALT, elevated ALP, elevated γ-GTP, elevated total bilirubin, cholestatic jaundice, fulminant hepatitis, pseudomembranous colitis, abdominal pain, frequent diarrhea, nausea, vomiting, gastrointestinal discomfort, diarrhea, cirrhosis, loss of appetite, abdominal pain, dyspepsia, chest pain, thirst, taste alteration, stomatitis, glossitis, abdominal bloating, constipation, dysphagia, gastrointestinal bleeding, oral mucosal pain, intestinal perforation, anemia, leukopenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, eosinophilia, agranulocytosis, thrombotic thrombocytopenic purpura, petechiae, prolonged prothrombin time, reversible bone marrow suppression, lymphopenia, neutropenia, increased ESR, insomnia, dizziness, headache, convulsions, tremors, numbness, peripheral nerve disorders, visual disturbances, auditory disturbances, hallucinations, drowsiness, neurogenic irritability, sleep disorders, confusion, anxiety, depression, restlessness, psychosis, seizures, nightmares, paranoia, disorientation, attention deficit, memory impairment, delirium, suicidal ideation, suicide, perceptual disturbances, reversible olfactory and equilibrium disorders, ataxia, aphasia, heaviness in the head, skin-mucous membrane syndrome, toxic epidermal necrolysis, arthralgia, myalgia, muscle weakness, myositis, malaise, elevated CPK, increased myoglobin in blood and urine, rhabdomyolysis, pharyngitis, dyspnea, bronchospasm, allergic pneumonia, nosebleeds, stridor, fever, cough, abnormal chest X-ray, eosinophilia, interstitial pneumonia, cerebral thrombosis, pulmonary edema, tachycardia, hypertension, hypotension, palpitations, vasodilation, circulatory collapse, prolonged QT interval, ventricular tachycardia, dysuria, frequent urination, urinary retention, anuria, polyuria, hematuria, storage urine, pyuria, diabetes, proteinuria, alkaline urine, vaginitis, vaginal candidiasis, increased vaginal discharge, itching of the female external genitalia, menstrual irregularities, uterine cramps, female genital rash, pain, irritation, burning sensation, hypoglycemic symptoms, limb pain, fatigue, fever, drowsiness, nausea, facial flushing, facial swelling, numbness, speech inaccuracies, loss of directional sense

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

Storage

This medication should be stored in a tightly sealed container that allows for good air circulation, at room temperature, between 1 degree and 30 degrees Celsius. This helps to maintain the drug's effectiveness and prevent its degradation.

Appearance and packaging

Appearance

White round film-coated tablets

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.

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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.