Roxityrosin Tablet (Roxithromycin)

Adult dose

(Tablets) Adults: Administer roxithromycin 150㎎ (potency) orally twice daily, in the morning and evening before meals. 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 daily. Administer this medicine orally in 2 divided doses of 5～8mg (potency) per kg of body weight daily. Doses by body weight are as follows: Children weighing 6～11Kg: 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 2.5mL per dose twice daily before meals (suspension only). Children weighing 12～23Kg: 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 5mL per dose twice daily before meals (suspension only). Children weighing 24～40Kg: 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 10mL per dose twice daily before meals (suspension only).

This drug can cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If these symptoms occur, discontinue the use of the medication immediately. Patients who are allergic to antibiotics in the same class or are taking specific medications should not use this drug. Caution is needed for patients with impaired liver function, elderly individuals, and when used with certain antibiotics. It should be used cautiously in patients with heart conditions or those on heart-related medications as it can affect heart rhythm. Patients with a history of muscle disorders should also exercise caution as it can exacerbate those conditions. The medication may cause serious allergic reactions, such as anaphylactic shock, so any unusual symptoms should be reported to medical personnel immediately. It may affect the liver and gastrointestinal system, causing symptoms like hepatitis, nausea, vomiting, and diarrhea, so consult with your healthcare provider if symptoms persist. Specifically, if symptoms of severe enteritis like hemorrhagic colitis appear, the use should be discontinued immediately. If respiratory problems or pneumonia symptoms arise, stop the medication and seek appropriate treatment. Neurological side effects such as dizziness, drowsiness, and headaches may occur, requiring caution while driving or operating machinery. This medication may increase the risk of side effects due to interactions with certain drugs, so it is essential to inform your physician about other medications being taken and to follow their instructions. Pregnant or breastfeeding women should consult a doctor before use as it may affect the fetus or infant. Children must adhere strictly to dosage and duration, avoiding long-term use beyond 10 days. This drug must be stored in a safe place out of reach of children, and transferring to another container should be avoided.

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, shock, fever, rash, allergic skin reactions, angioedema, eosinophilia, agranulocytosis, leukopenia, thrombocytopenia, cholestatic acute hepatitis, hepatocellular acute hepatitis, jaundice, AST elevation, ALT elevation, ALP elevation, serum bilirubin elevation, loss of appetite, nausea, vomiting, gastrointestinal discomfort, gastric pain, abdominal pain, abdominal distention, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, numbness of the tongue, paralysis, dysgeusia, ageusia, smell disturbance, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of resistant pathogens, temporary hearing loss, auditory impairment, vision impairment, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This drug should be stored in a tightly closed container to prevent air or moisture from entering. It is recommended to store it at room temperature, between 1°C and 30°C.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle