Romaxacin Tablets (Romefloxacin Hydrochloride)

Adult dosage

1. Administer 100 ～ 200 mg of lomefloxacin orally per dose, 2 ～ 3 times daily. 2. However, for acute exacerbations of chronic obstructive pulmonary disease, including chronic bronchitis, the usual adult dose is 400 mg of this drug orally once daily, with or without food. The duration of administration varies according to the severity of infection, but is usually up to 14 days; treatment should continue for at least 2 days after the symptoms of infection have resolved. 3. Patients with renal impairment 1) In patients with creatinine clearance below 30 mL per minute, administer 400 mg of this drug as the initial dose, followed by 200 mg once daily from the next day. 2) In patients receiving hemodialysis, administer 400 mg of this drug as the initial dose, followed by 200 mg once daily from the next day. 3) Dose adjustment is not necessary in patients with hepatic impairment; adjust according to renal function.

This medication may cause serious side effects such as tendonitis, tendon rupture, peripheral neuropathy, and central nervous system disorders, so it should be discontinued immediately if these symptoms appear. Particularly, patients with severe myasthenia gravis should not use this medication as it may worsen their symptoms. This medication should only be used for certain infections such as acute bacterial rhinosinusitis, acute exacerbation of chronic bronchitis, simple urinary tract infections, and acute otitis media when there are no other treatment methods available. Elderly patients, patients with reduced renal function, organ transplant recipients, and those who are taking corticosteroids should exercise caution as they have a higher risk of tendon rupture, and concomitant use should be avoided. Allergic reactions may occur, presenting as rashes, urticaria, and itching, and in severe cases, anaphylactic shock may occur, so if symptoms appear, treatment must be stopped immediately and proper care should be sought. Severe inflammation of the skin or exfoliative dermatitis, and significant skin reactions such as Stevens-Johnson syndrome may occur; thus, if there are abnormal symptoms, immediate consultation with a physician is necessary. It may affect renal and liver function, so patients with kidney or liver diseases need careful monitoring. Gastrointestinal side effects may include abdominal pain, diarrhea, vomiting, and in severe cases, pseudomembranous colitis may occur, requiring cessation of the medication if symptoms worsen. Neuropsychiatric effects such as confusion, depression, hallucinations, and seizures may also occur, and if these symptoms occur, medical personnel should be informed immediately. Respiratory symptoms such as shortness of breath, cough, and fever require stopping the medication immediately and seeking appropriate treatment. Blood abnormalities can occur, such as leukopenia and anemia, so regular blood testing may be necessary. Musculoskeletal side effects like myalgia, arthralgia, and tendon rupture can arise, and any pain or discomfort should be reported immediately. This medication may cause photosensitivity reactions, so strong sunlight or UV exposure should be avoided, and if symptoms develop, use should be discontinued. Dizziness or visual disturbances may occur, necessitating caution during driving or operating machinery. Diabetic patients may experience fluctuations in blood sugar levels, necessitating regular monitoring of blood sugar, and immediate treatment should be available if hypoglycemia occurs. Pregnant or potentially pregnant women, nursing mothers, and adolescents under 18 years of age should not use this medication. As this medication is excreted through the kidneys, elderly patients or those with impaired kidney function need careful dosage adjustments and usage considerations. There may be interactions with other medications, so it is essential to inform healthcare providers about any ongoing medications, particularly when used with non-steroidal anti-inflammatory drugs, anticoagulants, or antacids.

• Tendinitis
• tendon rupture
• peripheral neuropathy
• central nervous system effects
• worsening of myasthenia gravis
• anaphylactic shock
• anaphylactoid reaction
• rash
• hives
• erythema

This medication is sensitive to light and should be stored in a container that blocks light, ideally at room temperature. Avoid storing in extremely hot or cold places, and keep in a cool place away from direct sunlight.

Appearance

White rectangular coated tablet

Package unit

In-house packaging unit