Medication info
Celltrion Ofloxacin Tablet 100 mg (Ofloxacin)

Celltrion Ofloxacin Tablet 100 mg (Ofloxacin)

Prescription medicationTabletOral
Ingredient · strength
Ofloxacin›100mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
White to off-white round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200500476 · Notified 2005.09.30 · Insurance code 693900900

Summary

Main use
Combination treatment of respiratory, ear, skin, soft tissue, and eye infections; genitourinary and intestinal infections; and leprosy
Who takes it
Adults
Adult dose
○ The usual adult dose is ofloxacin 300~600 mg daily in 2~3 divided doses. ○ For Hansen's disease, take 400~600 mg of this medicine daily in 2~3 divided doses. In principle, use in combination with other antileprosy drugs. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Combination treatment of respiratory, ear, skin, soft tissue, and eye infections; genitourinary and intestinal infections; and leprosy

  • Complex skin and 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
  • epididymitis
View approved original text

This medication is an antibiotic effective against various bacteria, demonstrating therapeutic effects against a range of pathogens including Staphylococcus, Streptococcus, and Pneumococcus. It is used to treat complex skin and soft tissue infections, acute and chronic otitis media, sinusitis, pneumonia, and acute exacerbation symptoms of chronic obstructive pulmonary disease. Additionally, it aids in the treatment of urinary tract infections such as pyelonephritis, cystitis, and prostatitis, as well as gonococcal and non-gonococcal urethritis. This drug is also used for bacterial infections in various parts of the body, including gastrointestinal infections, gynecological infections, and ocular infections, and is included in the combination therapy for Hansen's disease. However, it is recommended for use only when other treatment options are unavailable due to the potential for serious adverse reactions. Overall, this medication is effective for the treatment of various bacterial infections.

How to take

Adult dose

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

Precautions

This medication is a fluoroquinolone antibiotic and should be used with caution due to the potential for certain serious side effects. First, severe adverse reactions such as tendonitis or tendon rupture, peripheral neuropathy, central nervous system disorders, and exacerbation of myasthenia gravis may occur. If these symptoms appear, the medication should be discontinued immediately, and re-administration should be avoided. Particularly, patients with severe myasthenia gravis should refrain from taking this drug. Second, this medication is used restrictively for specific bacterial infections and should only be administered when no alternative treatment options are available. Third, in elderly patients, those with renal impairment, or when used concurrently with corticosteroids, there is an increased risk of tendon rupture, so such combinations should be avoided, and any pain or inflammatory symptoms should prompt immediate cessation and rest. Fourth, this medication has neuromuscular blocking effects and may exacerbate symptoms in patients with severe myasthenia gravis, hence should be used with caution. Fifth, patients with hypersensitivity to this drug, history of tendonitis or tendon rupture, those who are pregnant or children in growth phases, or those with specific allergic histories should not be administered this drug. Sixth, particular patient groups such as those with kidney disease, liver disease, mental disorders, and the elderly require more careful monitoring during the administration of this medication. Seventh, though rare, various side effects like anaphylactic shock, hepatitis, pseudomembranous colitis, severe skin reactions, central nervous system disorders, and musculoskeletal disorders may occur, necessitating immediate consultation with medical personnel upon symptom occurrence. Eighth, because it may cause photosensitivity reactions, exposure to sunlight or artificial UV light should be avoided, and those with central nervous system disorders should take special care due to increased seizure risk. Ninth, this medication may interact with other drugs; therefore, when taken with warfarin, hypoglycemic agents, antacids, etc., it’s necessary to inform healthcare providers and monitor closely. Lastly, pregnant or breastfeeding women should not take this medication, and breastfeeding should be discontinued if administration is necessary. It is crucial to adhere to proper dosage and administration as directed by a physician and consult an expert immediately if any severe adverse reactions are suspected.

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, blisters, erythema, photosensitivity reactions, hematuria, acute renal failure, kidney stones, interstitial nephritis, elevated BUN, elevated serum creatinine, jaundice, hepatic failure, elevated AST/ALT, elevated ALP, elevated γ-GTP, elevated total bilirubin, cholestatic jaundice, fulminant hepatitis, membranous colitis, abdominal pain, diarrhea, nausea, vomiting, gastrointestinal discomfort, cirrhosis, loss of appetite, stomach pain, dyspepsia, chest pain, thirst, taste disorder, stomatitis, glossitis, abdominal distension, constipation, dysphagia, gastrointestinal bleeding, oral mucosal pain, intestinal perforation, anemia, leukopenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, petechiae and purpura, prolonged prothrombin time, reversible bone marrow suppression, lymphopenia, neutropenia, increased ESR, insomnia, dizziness, headache, seizures, tremors, numbness, peripheral nerve disorders, visual disturbances, auditory disturbances, hallucinations, drowsiness, nervousness, sleep disorders, confusion, anxiety, depression, agitation, hypochondriasis, delirium, suicidal ideation, suicide, perceptual disturbances, olfactory and vestibular sensory disorders, ataxia, aphasia, heaviness of the head, Stevens-Johnson syndrome, toxic epidermal necrolysis, arthralgia, myalgia, muscle weakness, myositis, fatigue, elevated CPK, elevated myoglobin, rhabdomyolysis, pharyngitis, dyspnea, bronchospasm, allergic pneumonia, epistaxis, stridor, fever, cough, interstitial pneumonia, cerebral thrombosis, pulmonary edema, tachycardia, hypertension, hypotension, palpitations, vasodilation, circulatory collapse, QT prolongation, ventricular tachycardia, dysuria, polyuria, urinary retention, anuria, polyuria, pyuria, diabetes, proteinuria, alkaline urine, vaginitis, vaginal candidiasis, increased vaginal discharge, itching of the female external genitalia, menstrual irregularities, uterine cramps, genital rash, pain, irritation, burning sensation, hypoglycemic symptoms, limb pain, malaise, fever

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 exposure and kept at a temperature between 1 to 30 degrees Celsius. Proper storage maintains the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

White to off-white round film-coated tablet

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.