Roximantin Tablets (Roxithromycin)

Adult dose

Adults: Administer roxithromycin 150㎎ (potency) 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

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

This medication may rarely cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. If symptoms such as blistering of the skin or mucosal damage develop, use of this medication should be discontinued immediately. This medication should not be used in patients who are allergic to macrolide antibiotics or are taking certain medications. In particular, it should not be used with terfenadine, astemizole, cisapride, pizotifen, and ergoline alkaloids. Caution is required when using this medication in patients with poor liver function or in the elderly. Additionally, be careful when used in conjunction with other antibiotics due to potential resistance issues. This medication may affect heart rhythm, so patients with congenital rhythm disturbances or those taking certain heart medications should consult their physician before use. This medication may exacerbate symptoms of myasthenia gravis; therefore, it should be used cautiously in patients with this history. During use, various side effects may occur, including allergic reactions, liver dysfunction, gastrointestinal issues, pneumonia, and neurological abnormalities, so report any unusual symptoms to medical personnel immediately. In particular, if severe diarrhea or abdominal pain occurs, it may indicate pseudomembranous colitis, requiring immediate cessation of the medication and medical attention. This medication can interfere with the metabolism of other drugs in the liver, thereby increasing blood concentrations; therefore, it should not be taken with certain medications. Pregnant or breastfeeding women should use this medication only when necessary and based on a physician's judgment, and it is advisable to discontinue breastfeeding during treatment. No dose adjustment is necessary for the elderly, but dizziness or visual disturbances may occur, so take care when driving or operating machinery. Finally, this medication should be kept out of the reach of children and not transferred to other containers for safety.

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, shock, anaphylactic shock, fever, rash, allergic skin reaction, angioedema, eosinophilia, agranulocytosis, leukopenia, thrombocytopenia, cholestatic acute hepatitis, hepatocellular acute hepatitis, jaundice, elevated AST, elevated ALT, elevated ALP, elevated serum bilirubin, loss of appetite, nausea, vomiting, gastric discomfort, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, blood in stool, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disturbance, ageusia, smell disturbance, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-sensitive pathogens, transient hearing loss, auditory impairment, visual impairments, blurred vision, conjunctival hyperemia, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

Store this medication in a tightly sealed container to avoid exposure to air or moisture. Additionally, avoid storage in places that are too hot or too cold, and it is advisable to keep it at room temperature between 1°C and 30°C.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle