Dongsung Roxithromycin Tablet

Adult dose

(Tablets) Adults: Administer roxithromycin 150 mg (potency) per dose orally twice daily, in the morning and evening before meals. For pneumonia, administer 300 mg (potency) once daily before breakfast. Adjust the dose appropriately according to age and symptoms.

Child dose

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

This medication may cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms such as blistering of the skin or mucosal damage occur, immediate discontinuation of the medication is required. Patients with an allergy to this medication or macrolide antibiotics, or those taking certain heart-related medications (terfenadine, astemizole, cisapride, pimobendan) should not use this medication. Caution is necessary for patients with poor liver function, the elderly, and those taking other antibiotics. Those with heart rhythm abnormalities or risks of arrhythmia should have an ECG when taking this medication. This medication can exacerbate myasthenia gravis, so it should be used cautiously in patients with this history. Rarely, rapid allergic reactions such as anaphylactic shock may occur; therefore, if abnormal symptoms arise, discontinue use immediately and consult a healthcare professional. Gastrointestinal side effects may include decreased appetite, nausea, vomiting, and diarrhea. If severe abdominal pain or hemorrhagic diarrhea occurs, discontinue use immediately. This medication can cause serious intestinal diseases such as membranous colitis; therefore, if persistent diarrhea or bleeding occurs, notify healthcare professionals immediately. Respiratory symptoms such as bronchospasm or interstitial pneumonia may occur, so if breathing difficulties or severe coughing worsen, discontinue use. Neurological side effects may include drowsiness, headache, and dizziness, requiring caution when driving or operating machinery. This medication may cause taste or smell abnormalities in some patients, and skin reactions such as rash or purpura may rarely occur. Using this medication for an extended period may lead to the emergence of resistant bacteria or risks of reinfection, thus requiring regular evaluation of the patient’s condition. This medication can interact with various drugs, especially with heart-related medications, anticoagulants, immunosuppressants, and sedatives. Therefore, it is essential to consult with healthcare professionals when using them together. Women who are pregnant or may become pregnant should carefully assess the necessity of treatment due to potential effects on the fetus. If breastfeeding, they should avoid using the medication or discontinue breastfeeding. In the elderly, dosage adjustments are not necessary; however, careful observation considering physical status is required. This medication may cause dizziness or visual disturbances, so it is advisable to avoid driving or operating hazardous machinery while taking it. Lastly, keep this medication out of reach of children and ensure it is not transferred to other containers.

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, shock, anaphylactic shock, fever, rash, allergic skin reactions, 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, abdominal discomfort, dyspepsia, stomach pain, abdominal pain, abdominal bloating, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, shortness of breath, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, hyposmia, anosmia, erythema multiforme, purpura, superinfection due to excessive growth of non-susceptible pathogens, temporary hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival injection, general malaise, weakness, palpitation, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of the oral and vaginal mucosa, hallucinations, delirium

Store this medication in a tightly closed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle