Romiroxine Tablet (Roxithromycin)

Adult dose

(Tablets) Adults: Administer roxithromycin 150㎎ (potency) per dose orally twice daily before breakfast and dinner. For pneumonia, administer 300mg (potency) once daily before breakfast. Adjust the dose as appropriate according to age and symptoms.

Child dose

(Pediatric tablets)(Granules)(Suspension) Children: The average dose used in clinical trials was 6mg (potency) per kg of body weight per day. Administer 5～8mg (potency) per kg of body weight per day orally in 2 divided doses. The doses according to body weight are as follows. Children weighing 6～11Kg: Take 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 2.5mL per dose twice daily before meals (suspension only). Children weighing 12～23Kg: Take 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 5mL per dose twice daily before meals (suspension only). Children weighing 24～40Kg: Take 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 10mL per dose twice daily before meals (suspension only).

This medication can rarely cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if symptoms such as skin blistering or mucosal lesions occur, it should be discontinued immediately. This medication should not be used by patients allergic to macrolide antibiotics or those taking certain medications (terfenadine, astemizole, cisapride, pimozide, etc.). Caution is required for patients with impaired liver function, elderly patients, and when used in combination with other specific antibiotics, as it can affect heart rhythm, so patients with heart disease or at risk of arrhythmias should consult their physician. This medication can cause various side effects including allergic reactions, liver dysfunction, gastrointestinal issues, and in rare cases, severe colitis or pneumonia; if any unusual symptoms occur, medical professionals should be notified immediately. For long-term use, it is important to use it only for the necessary duration to prevent antibiotic resistance, and regular checks should be conducted if liver function is impaired. This medication can increase the blood concentration of other drugs metabolized in the liver, which can lead to cardiac side effects or other adverse reactions when used in combination with certain medications, so it is essential to inform healthcare professionals of any other medicines being taken. Women who are pregnant or may become pregnant should use this medication cautiously, and those who are breastfeeding should consider avoiding use or stopping breastfeeding. In elderly patients, dose adjustment is not necessary, but caution is advised while operating machinery or driving due to potential symptoms such as dizziness or blurred vision. This medication should be kept out of reach of children, and transferring to another container should be avoided.

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized rash pustulosis, shock, fever, rash, allergic skin reaction, angioedema, eosinophilia, agranulocytosis, leukopenia, thrombocytopenia, cholestatic acute hepatitis, hepatocellular acute hepatitis, jaundice, elevated AST, elevated ALT, elevated ALP, increased serum bilirubin, loss of appetite, nausea, vomiting, upper abdominal discomfort, stomach pain, abdominal pain, abdominal distension, diarrhea, membrane colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, taste disorder, ageusia, olfactory disorder, anosmia, polymorphous erythema, purpura, superinfection due to overgrowth of resistant pathogens, temporary hearing loss, auditory impairment, visual impairment, blurred vision, conjunctival congestion, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nosebleed, menstrual abnormalities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication should be stored in a tightly sealed container to prevent air exposure and kept at a safe temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle