Medication info

Opic Tablet (Ofloxacin)

Prescription medicationTabletExpired
Ingredient · strength
Ofloxacin›100mg / 1 tablet
Manufacturer / importer
Ahn-Guk Pharmaceutical Co., Ltd.
Appearance
White to slightly yellowish round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201906834 · 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 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
Ahn-Guk Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Complex skin and soft tissue infections
  • acute otitis media
  • chronic suppurative otitis media
  • acute bacterial sinusitis
  • chronic bacterial sinusitis
  • community-acquired pneumonia
  • acute exacerbations of chronic bronchitis
  • acute pyelonephritis
  • simple acute cystitis
  • bacterial prostatitis
  • epididymitis
  • gonococcal urethritis
View approved original text

This drug is an antibiotic effective against various bacterial infections, used for complex skin and soft tissue infections, as well as acute and chronic otitis media, bacterial sinusitis, community-acquired pneumonia, and acute exacerbation of chronic obstructive pulmonary disease. It is also effective for urinary tract infections such as acute pyelonephritis, urethritis, and bacterial prostatitis, and gastrointestinal infections like bacterial dysentery and enteritis. It may be applied to infections of the uterus and adnexa in women, various ocular infection symptoms, and as part of a combination therapy for leprosy. However, as a fluoroquinolone antibiotic, it carries a risk of severe adverse reactions and should only be used when other treatment options are unavailable. Use cautiously for the safe treatment of infections when necessary.

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 medication can cause serious side effects such as tendonitis, tendon rupture, peripheral neuropathy, central nervous system complications, and exacerbation of symptoms in myasthenia gravis. If these symptoms occur, discontinue this medication immediately, and it is not to be used in patients with a history of myasthenia gravis. Elderly patients, those with kidney impairment, and those using corticosteroids should be careful due to an increased risk of tendonitis or tendon rupture; particularly, rupture of the Achilles tendon can occur bilaterally and may appear within 48 hours of taking the medication or even months later. This drug can increase the risk of seizures; therefore, it should be used cautiously in patients with a history of epilepsy or central nervous system disorders. Various side effects such as hypersensitivity reactions, liver and kidney function abnormalities, gastrointestinal disturbances, blood abnormalities, neurological and psychiatric symptoms, skin rash have been reported, so patients should consult medical personnel immediately if unusual symptoms appear. This drug is not to be used in pregnant or lactating women, nor in growing children or adolescents. The elderly may require dose adjustments and careful monitoring due to the potential for increased drug concentration from reduced kidney function. This medication can interact with other drugs, so inform your healthcare provider if you are taking any other medications. Adequate hydration is necessary during treatment, and patients should be cautious of symptoms like dizziness while driving or operating machinery. Additionally, avoid excessive exposure to sunlight or artificial ultraviolet light, and if symptoms of photosensitivity arise, discontinue the medication. This drug should be administered slowly when given by intravenous injection and stored out of reach of children.

Side effects

tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of myasthenia gravis, anaphylactic shock, anaphylactic reactions, rash, itching, erythema, edema, fever, heat sensation, vesicles, erythema, phototoxic reactions, hematuria, acute renal failure, nephrolithiasis, interstitial nephritis, elevated BUN, elevated serum creatinine, jaundice, liver failure, elevated AST, elevated ALT, elevated ALP, elevated γ-GTP, elevated total bilirubin, cholestatic jaundice, fulminant hepatitis, pseudomembranous colitis, hematochezia, abdominal pain, diarrhea, nausea, vomiting, gastric and abdominal discomfort, cirrhosis, loss of appetite, abdominal pain, dyspepsia, chest pain, thirst, altered taste, stomatitis, glossitis, abdominal bloating, constipation, dysphagia, gastrointestinal bleeding, oral mucosal pain, intestinal perforation, anemia, leukopenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, petechiae, ecchymosis, prolonged prothrombin time, reversible bone marrow suppression, lymphocytopenia, neutropenia, elevated ESR, insomnia, dizziness, headache, seizures, tremors, paresthesia, peripheral nervous disorders, visual disturbances, diplopia, neglect, nystagmus, auditory disturbances, tinnitus, hearing loss, hallucinations, drowsiness, nervousness, sleep disturbances, confusion, anxiety, depression, restlessness, epiphany, delusion, seizures, nightmares, paranoia, disorientation, attention deficit, memory impairment, delirium, suicidal ideation, suicide, perceptual disturbances, olfactory dysfunction, balance disorders, ataxia, aphasia, heaviness in the head, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, arthralgia, myalgia, muscle weakness, myositis, weakness, elevated CPK, elevated myoglobin, rhabdomyolysis, pharyngitis, dyspnea, bronchospasm, allergic pneumonia, nosebleed, stridor, fever, cough, interstitial pneumonia, cerebral thrombosis, pulmonary edema, tachycardia, hypertension, hypotension, palpitations, vasodilation, circulatory collapse, prolonged QT interval, ventricular tachycardia, dysuria, frequency of urination, urinary retention, anuria, polyuria, hematuria, urinary storage, pyuria, diabetes, proteinuria, alkaline urine, vaginitis, vaginal candidiasis, increased vaginal discharge, pruritus of the female external genitalia, menstrual irregularities, uterine cramps, female genital rashes, pain, irritation, burning sensation, hypoglycemic symptoms, limb pain, fatigue, fever, aortic aneurysm, aortic dissection, heart valve regurgitation, heart valve insufficiency

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

Storage

Store this drug in a tightly closed container that is well-ventilated and ideally at room temperature between 1 to 30 degrees Celsius. This way, the medication can maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

White to slightly yellowish 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.