Medication info

Roxacin M Tablet (Ofloxacin)

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

MFDS item code 201803421 · Approved 2018.08.22

This product's status changed to Expired on 2023.08.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, ear, eye, genitourinary, and intestinal infections; skin and soft tissue infections; and leprosy
Who uses it
Adults
Adult dosage
For adults, the usual dosage is 300~600 mg of ofloxacin in 2~3 divided doses daily. For Hansen's disease, the dosage is 400~600 mg of this medication in 2~3 divided doses daily. In principle, it should be used in combination with other antileprosy drugs. Adjust the dosage appropriately according to age and symptoms.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This drug is effective for treating complicated skin and soft tissue infections caused by various bacteria, as well as acute and chronic otitis media, bacterial sinusitis, community-acquired pneumonia, and acute exacerbations of chronic obstructive pulmonary disease. It is also used for urinary tract infections, prostatitis, epididymitis, gonococcal and non-gonococcal urethritis, and helps in the treatment of gastrointestinal infections, including bacterial dysentery and gastroenteritis. In females, it is used for treating pelvic inflammatory disease, intrauterine infections, and Bartholin's gland inflammation, and is effective against eye conditions such as blepharitis, stye, dacryocystitis, and corneal ulcer. It is also used in combination therapy for Hansen's disease, and fluoroquinolone antibiotics, including this drug, should be used cautiously when there are no other treatment options available for certain infections. Overall, this medication is widely used for the treatment of various bacterial infections.

Dosage and Administration

Adult dosage

For adults, the usual dosage is 300~600 mg of ofloxacin in 2~3 divided doses daily. For Hansen's disease, the dosage is 400~600 mg of this medication in 2~3 divided doses daily. In principle, it should be used in combination with other antileprosy drugs. Adjust the dosage appropriately according to age and symptoms.

Precautions

This drug may cause tendon-related diseases such as tendinitis and tendon rupture, so usage should be stopped immediately if these symptoms appear. Peripheral neuropathy or central nervous system symptoms may also occur, so careful monitoring is needed if sensory abnormalities or neurological symptoms arise. Patients with myasthenia gravis may experience worsening symptoms with this drug, so it should not be administered to them. This drug is used only for specific bacterial infections and should only be used when there are no other treatment options available. Elderly patients, those with reduced kidney function, and individuals taking corticosteroids are at higher risk for tendon rupture, so extra caution is necessary. During treatment with this drug, care should be taken to avoid strong sunlight or ultraviolet exposure, and treatment should be stopped immediately if skin rashes or photosensitivity reactions develop. Because of the risk of seizures, patients with a history of seizures or central nervous system disorders must consult a healthcare professional before using this drug. This drug may affect liver and kidney function, so regular monitoring is necessary with prolonged use. Care should be taken when driving or operating machinery, as dizziness or drowsiness may occur. Diabetic patients who require blood sugar control should closely monitor any changes in blood sugar levels while taking this drug, and immediate treatment should be sought if hypoglycemic symptoms arise. It is safer for pregnant or potentially pregnant women and nursing mothers to avoid taking this drug. Children and adolescents during growth have not had the safety of this drug established, so it should not be used in this population. There may be interactions with other medications, so any current medications should be reported, especially when using anticoagulants, hypoglycemic agents, and some antacids. In the case of overdose, immediate medical attention should be sought, and this drug is not removed by hemodialysis, so caution is needed. This drug should be stored in a cool, dry place, and kept out of the reach of children.

Side effects

Tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, exacerbation of myasthenia gravis, anaphylactic shock, anaphylactoid reactions, rash, itching, erythema, edema, fever, warmth, photosensitivity reactions, hematuria, acute renal failure, nephrolithiasis, 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, diarrhea, nausea, vomiting, gastric and abdominal discomfort, cirrhosis, appetite loss, gastric and abdominal pain, dyspepsia, chest pain, thirst, taste disturbance, stomatitis, glossitis, abdominal distension, constipation, dysphagia, gastrointestinal hemorrhage, oral mucosal pain, intestinal perforation, anemia, leukopenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, petechiae and ecchymosis, prolonged prothrombin time, reversible bone marrow suppression, lymphopenia, neutropenia, elevated ESR, insomnia, dizziness, headache, seizures, tremors, paresthesia, sensory disturbances, sensory reduction, diplopia, neglect, nystagmus, tinnitus, hearing loss, hallucinations, drowsiness, hypersensitivity, sleep disorders, confusion, anxiety, depression, agitation, hyperesthesia, disorientation, attention deficit, memory impairment, delirium, suicidal ideation, suicide, perceptual disturbances, olfactory disturbances, equilibrium disturbances, ataxia, aphasia, heaviness of the head, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Leal syndrome, arthralgia, myalgia, muscle weakness, myositis, rhabdomyolysis, 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, storage urine, pyuria, diabetes, proteinuria, alkaline urine, vaginitis, vaginal candidiasis, increased vaginal discharge, pruritus of the external female genitalia, menstrual irregularities, uterine cramps, female genital rash, pain, irritation, burning sensation, symptoms of hypoglycemia, limb pain, malaise, fever, aortic aneurysm, aortic dissection, heart valve regurgitation, heart valve insufficiency

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering. It is recommended to store it at room temperature, between 1 to 30 degrees Celsius. This helps to maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White to light yellow 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.