Medication info

Ofloxacine Tablet (Ofloxacin)

Prescription medicationTabletExpired
Ingredient · strength
Ofloxacin›100mg / 1 tablet
Manufacturer / importer
AhnGook New Farm Co., Ltd.
Appearance
White to off-white round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201906835 · Approved 2019.09.25

This product's status changed to Expired on 2024.09.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of various bacterial infections (urinary tract, respiratory tract, skin, etc.); combination treatment for leprosy
Who uses it
Adults
Adult dosage
○ The usual adult dose is 300~600 mg of ofloxacin daily, divided into 2~3 doses. ○ For Hansen's disease, the dose of this medicine is 400~600 mg daily, divided into 2~3 doses. In principle, it should be used in combination with other anti-Hansen's disease medicines. The dose may be adjusted as appropriate according to age and symptoms.

Ingredients

Manufacturer
AhnGook New Farm Co., Ltd.

Efficacy & effects

Treatment of various bacterial infections (urinary tract, respiratory tract, skin, etc.); combination treatment for leprosy

  • Complex skin infections
  • soft tissue infections
  • acute otitis media
  • chronic suppurative otitis media
  • acute bacterial sinusitis
  • chronic bacterial sinusitis
  • community-acquired pneumonia
  • acute exacerbation of chronic bronchitis
  • acute exacerbation of chronic obstructive pulmonary disease
  • acute pyelonephritis
  • simple acute cystitis
  • bacterial prostatitis
View approved original text

This medication is effective against a variety of bacterial infections and is used to treat complex skin and soft tissue infections, acute and chronic otitis media, bacterial sinusitis, community-acquired pneumonia, and acute exacerbations of chronic obstructive pulmonary disease. It is also effective for urogenital infections like urinary tract infections, prostatitis, and intrauterine infections, as well as gastrointestinal infections such as gastroenteritis and bacterial dysentery. Useful for eye-related infections like blepharitis, styes, and corneal ulcers, it can also be used in combination therapy for leprosy. However, due to the characteristics of fluoroquinolone drugs, serious adverse reactions may occur, so it should be used cautiously and only when other treatment options are unavailable. Overall, this drug is used for the treatment of a wide range of bacterial infections.

Dosage and Administration

Adult dosage

○ The usual adult dose is 300~600 mg of ofloxacin daily, divided into 2~3 doses. ○ For Hansen's disease, the dose of this medicine is 400~600 mg daily, divided into 2~3 doses. In principle, it should be used in combination with other anti-Hansen's disease medicines. The dose may be adjusted as appropriate according to age and symptoms.

Precautions

This drug may cause serious side effects, including tendonitis and tendon rupture, peripheral neuropathy, central nervous system abnormalities, and worsening of myasthenia gravis. If these symptoms occur, discontinue the use of this medication immediately, and fluoroquinolone drugs should not be administered to patients with myasthenia gravis. Additionally, this drug should be used cautiously in elderly patients, those with impaired kidney function, solid organ transplant recipients, and in combination with corticosteroids, as the risk of tendonitis and tendon rupture is increased. If symptoms of pain, inflammation, or tendon rupture occur, discontinue administration and refrain from physical activities until a clear diagnosis is established. This drug may increase the risk of seizures and exacerbate myasthenia gravis symptoms due to its neuromuscular blocking effects, hence caution is warranted for patients with epilepsy or central nervous system disorders. Patients who cannot be given this drug include those with hypersensitivity to this drug or similar medications, a history of tendonitis or tendon rupture, growing adolescents under 18 years, pregnant and breastfeeding women, G-6-PD deficiency patients, and those with a history of epilepsy. Caution is also necessary in patients with severely impaired renal function, the elderly, those with mental disorders, liver dysfunction, severe myasthenia gravis patients, and those with aortic aneurysms or heart valve abnormalities. This drug can trigger severe allergic reactions like anaphylaxis; if symptoms occur, discontinue immediately and seek appropriate treatment. Since it can affect the liver and kidneys, regular check-ups and monitoring are necessary. If severe diarrhea or abdominal pain appears as gastrointestinal side effects, discontinue immediately. Neurological side effects may include insomnia, dizziness, headaches, hallucinations, and confusion; treatment should be stopped if abnormal symptoms occur. Serious skin reactions may arise, so if rashes or blisters occur, discontinue immediately. Musculoskeletal side effects like myalgia, arthralgia, and, in severe cases, rhabdomyolysis may happen, so caution is warranted. There may also be abnormalities in the respiratory and circulatory systems; therefore, monitoring of symptoms is essential. This drug interacts with many other medications; particular caution should be exercised when combined with anticoagulants, antidiabetic agents, anti-inflammatory drugs, and antacids, and consultation with a physician is advised for combination therapy. This drug should not be administered to pregnant or potentially pregnant women, nor to nursing women; safety has not been established for children and adolescents. Older adults may have increased drug concentrations due to reduced kidney function, necessitating dosage adjustment and careful monitoring. During the course of treatment, avoid exposure to sunlight or artificial UV rays, maintain adequate hydration, and exercise caution when driving or operating hazardous machinery. In the event of overdose, contact a medical facility immediately for appropriate care, and when administering intravenously, it should be done slowly to reduce the risk of hypotension. Finally, this medication should be kept out of the reach of children and not transferred to other containers.

Side effects

Tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of myasthenia gravis, anaphylactic shock, anaphylactic reaction, rash, itching, erythema, edema, fever, warmth, blisters, erythema, photosensitivity reaction, hematuria, acute renal 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, membranous colitis, colitis with bloody stools, nausea, vomiting, abdominal discomfort, diarrhea, cirrhosis, anorexia, abdominal pain, dyspepsia, chest pain, thirst, taste disturbances, stomatitis, glossitis, abdominal distension, constipation, dysphagia, gastrointestinal bleeding, oral mucosal pain, intestinal perforation, anemia, leukopenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, petechial and purpuric bleeding, prolonged prothrombin time, reversible bone marrow suppression, lymphopenia, neutropenia, increased ESR, insomnia, dizziness, headache, seizures, tremors, paresthesia, peripheral neuropathy, visual disturbances, auditory disturbances, hallucinations, drowsiness, hyperexcitability, sleep disorders, confusion, anxiety, depression, restlessness, dysphoria, delirium, seizures, nightmares, paranoia, disorientation, attention deficit, memory impairment, delirium, suicidal thoughts, suicide, perceptual disturbances, reversible olfactory and vestibular sensory disturbances, ataxia, aphasia, heaviness of the head, skin mucosal syndrome, toxic epidermal necrolysis, arthralgia, myalgia, muscle weakness, myositis, malaise, elevated CPK, elevated serum myoglobin, elevated urinary myoglobin, pharyngitis, dyspnea, bronchospasm, allergic pneumonia, epistaxis, stridor, fever, cough, abnormal chest X-ray, eosinophilia, interstitial pneumonia, cerebral thrombosis, pulmonary edema, tachycardia, hypertension, hypotension, palpitations, vasodilation, circulatory collapse, QT prolongation, ventricular tachycardia, dysuria, frequent urination, urinary retention, anuria, polyuria, hematuria, urinary storage, pyuria, diabetes, proteinuria, alkaline urine, vaginitis, vaginal candidiasis, increased vaginal discharge, female genital itching, irregular menstruation, uterine cramping, female genital rash, pain, irritation, burning sensation, symptoms of hypoglycemia, limb pain, fatigue, fever, aortic aneurysm, aortic dissection, valvular regurgitation, valvular insufficiency, drowsiness, nausea, facial flushing, facial edema, paresthesia, inaccurate speech, loss of spatial orientation

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it should be kept at a safe temperature between 1 to 30 degrees Celsius. Proper storage will help maintain its efficacy for a longer period.

Appearance and packaging

Appearance

White to off-white round film-coated tablets

Package unit

30 tablets/bottle, 300 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.