Roxithromycin Tablets (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 mean dose used in clinical trials was 6mg (potency) per Kg of body weight daily. Administer 5～8mg (potency) per Kg of body weight daily orally in 2 divided doses. The dose according to body weight is 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 cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If there are signs of blistering or progressive skin rash with mucosal damage, discontinuation of the drug should occur immediately. This medication should not be used by individuals who are allergic to this drug or macrolide antibiotics, or those taking certain heart condition treatments or other medications. Individuals with compromised liver function or the elderly should exercise caution when using this drug, and care should be taken as resistance may develop when used with other antibiotics. This medication can affect cardiac electrical signal transmission, so individuals with heart disease or electrolyte imbalances should consult a physician before use. Those with myasthenia gravis should be cautious as this drug may exacerbate symptoms. Rarely, serious allergic reactions such as anaphylactic shock may occur; if unusual reactions occur, the drug should be stopped immediately and medical personnel should be notified. Various side effects can occur such as liver dysfunction, gastrointestinal issues, skin rashes, breathing difficulties, and neurological symptoms, so if symptoms arise, consultation with a medical professional is essential. Long-term use of this drug can lead to resistance or the development of other infections, therefore it is important to adhere strictly to the prescribed duration and dosage. Pregnant or breastfeeding women should consult a physician before using this medication as it may affect the fetus or infant, and it is advisable to avoid administration while breastfeeding. Dizziness or blurred vision may occur, thus caution is advised when operating machinery or driving. This medication should be stored out of reach of children and it is safer not to transfer it to another container.

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, elevated AST, elevated ALT, elevated ALP, elevated serum bilirubin, loss of appetite, nausea, vomiting, gastric discomfort, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray findings, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, olfactory disturbances, loss of smell, erythema multiforme, purpura, superinfection due to the overgrowth of non-susceptible pathogens, transient hearing loss, hearing impairment, visual disturbances, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of the oral and vaginal mucosa, hallucinations, confusion

This medication should be stored tightly sealed to protect it from air and moisture exposure. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets per bottle, 300 tablets per bottle