Medication info
Exen Tablet (Ofloxacin)

Exen Tablet (Ofloxacin)

Prescription medicationTablet
Ingredient · strength
Ofloxacin›100mg / 1 tablet
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
White round film-coated tablet (For export: white round film-coated tablet)
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199603322 · Notified 1996.04.06

Summary

Main use
Combination treatment of respiratory, ear, nose, and throat, and ocular infections; skin, intestinal, and genitourinary infections; and Hansen's disease
Who uses it
Adults
Adult dosage
○ Adults usually take 300~600 mg of ofloxacin in 2~3 divided doses daily. ○ For Hansen's disease, take 400~600 mg of this medicine in 2~3 divided doses daily. In principle, use in combination with other anti-Hansen's disease drugs. The dose may be adjusted appropriately according to age and symptoms.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

Combination treatment of respiratory, ear, nose, and throat, and ocular infections; skin, intestinal, and genitourinary infections; and Hansen's disease

  • Complex skin and soft tissue infections
  • acute otitis media
  • chronic suppurative otitis media
  • acute and chronic bacterial sinusitis
  • community-acquired pneumonia
  • acute exacerbation of chronic bronchitis in chronic obstructive pulmonary disease
  • acute pyelonephritis
  • uncomplicated acute cystitis
  • bacterial prostatitis
  • epididymitis
  • gonococcal urethritis
  • non-gonococcal urethritis
View approved original text

This medicine is an antibiotic effective against various bacteria, used to treat several infections, from complex skin and soft tissue infections to acute and chronic otitis media, bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis, urinary tract infections, genital infections, and enteritis. It is especially used selectively when there are no other treatment options available in cases such as acute bacterial sinusitis, acute exacerbation of chronic obstructive pulmonary disease, and uncomplicated urinary tract infections. Additionally, it is used for ophthalmic infections such as blepharitis and corneal ulcers, and in combination therapy for leprosy. To use safely, it is important to be fully aware of the risk of serious adverse reactions and take the medication according to a doctor's prescription when necessary. Overall, this drug is effective for the treatment of various bacterial infections and helps patients recover quickly.

Dosage and Administration

Adult dosage

○ Adults usually take 300~600 mg of ofloxacin in 2~3 divided doses daily. ○ For Hansen's disease, take 400~600 mg of this medicine in 2~3 divided doses daily. In principle, use in combination with other anti-Hansen's disease drugs. The dose may be adjusted appropriately according to age and symptoms.

Precautions

This drug is a fluoroquinolone antibiotic and may cause serious side effects such as tendinitis, tendon rupture, peripheral neuropathy, central nervous system disorders, and exacerbation of myasthenia gravis. If these symptoms occur, the medication should be stopped immediately and it should not be used in patients with myasthenia gravis. This drug is recommended for use only when there are no other treatment options available for acute bacterial sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. The risk of tendon rupture increases in the elderly or when used in combination with steroids, so treatment should be discontinued and rest taken if there are symptoms of pain or inflammation. Myasthenia gravis patients should be cautious as symptoms may worsen due to neuromuscular blocking effects. This drug may cause various side effects, including hypersensitivity reactions, renal and hepatic dysfunction, gastrointestinal issues, blood abnormalities, neurological disorders, skin diseases, musculoskeletal issues, respiratory and circulatory system problems. Particularly, serious cardiovascular abnormalities such as cardiac valve regurgitation or aneurysm may occur, so medical attention should be sought immediately if symptoms appear. While taking this drug, unnecessary sun exposure should be avoided, and if any phototoxicity symptoms occur, the medication should be discontinued. Moreover, patients at risk for neurological disorders should be cautious, as neurological symptoms may arise. Regular assessments of liver and kidney functions and blood tests are recommended during treatment, and adequate hydration should be maintained to reduce renal burden. Neurological abnormalities such as dizziness may occur, requiring caution when driving or operating machinery. This drug may interact with certain foods or other medications, so consultation with a doctor or pharmacist is necessary if any co-administered medications are present. It should not be used in pregnant or breastfeeding women, growing children and adolescents, or patients with specific genetic disorders, and dose adjustments are needed for the elderly due to decreased renal function. In case of overdose, immediate medical attention should be sought, and intravenous injections should be administered slowly to prevent side effects such as hypotension. This drug should be stored out of 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 reactions, rash, itching, erythema, edema, fever, warmth, vesicles, erythema, photosensitivity reactions, 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, pseudomembranous colitis, abdominal pain, frequent diarrhea, nausea, vomiting, stomach and abdominal discomfort, diarrhea, cirrhosis, loss of appetite, stomach pain, dyspepsia, chest pain, thirst, taste disturbance, 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 and ecchymosis, prolonged prothrombin time, reversible bone marrow suppression, lymphocytopenia, neutropenia, elevated ESR, insomnia, dizziness, headache, seizures, tremors, numbness, peripheral neuropathy, visual disturbances, auditory disturbances, hallucinations, drowsiness, neuroexcitability, sleep disorders, confusional state, anxiety, depression, restlessness, dysphoria, confusion, seizures, nightmares, delirium, perceptual disturbances, reversible olfactory and vestibular sensory disturbances, ataxia, aphasia, heaviness in the head, mucocutaneous syndrome, toxic epidermal necrolysis, arthralgia, myalgia, muscle weakness, myositis, rhabdomyolysis, pharyngitis, dyspnea, bronchospasm, allergic pneumonia, epistaxis, stridor, fever, cough, abnormal chest X-ray, eosinophilia, interstitial lung disease, cerebral thrombosis, pulmonary edema, tachycardia, hypertension, hypotension, palpitations, vasodilation, circulatory collapse, QT prolongation, ventricular tachycardia, dysuria, polyuria, urinary retention, anuria, polyuria, hematuria, storage urine, pyuria, diabetes, proteinuria, alkaluria, vaginitis, vaginal candidiasis, increased vaginal discharge, vulvar itching in women, irregular menstruation, uterine cramps, female genital rash, pain, irritation, burning sensation, symptoms of hypoglycemia, limb pain, malaise, fever, drowsiness, nausea, dizziness, facial flushing, facial edema, numbness, inaccurate speech, loss of directional sense

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

Storage

This drug should be stored in a tightly sealed container to prevent air from entering, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage conditions help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

White round film-coated tablet (For export: white round film-coated tablet)

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.