Dongkwang Roxithromycin Tablet

Adult dose

Adults: Administer 150㎎ (potency) of roxithromycin orally twice daily, in the morning and evening before meals. For pneumonia, administer 300mg (potency) once daily before breakfast. The dose may be adjusted 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. Administer 5～8mg (potency) per kg of body weight per day 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 (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 can rarely cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms of progressive skin rash such as blistering or mucosal damage occur, discontinue the medication immediately. Patients allergic to this drug or similar classes of antibiotics should not use this medication. Additionally, patients currently taking specific medications (terfenadine, astemizole, cisapride, pimod zid, ergot alkaloids, mizolastine) should not take this medication. Patients with poor liver function or elderly patients should use this drug cautiously, and when used with other antibiotics, attention should be paid to resistance issues. This drug can affect electric signals related to heartbeats, hence patients with heart disease or those taking specific medications should exercise caution. Myasthenia gravis patients may experience exacerbation of symptoms. This medication may rarely cause severe allergic reactions such as anaphylactic shock, so if any abnormal symptoms occur during use, discontinue the medication immediately and consult healthcare personnel. Additionally, various side effects such as hepatitis, gastrointestinal disturbances, diarrhea, pneumonia, and neurological symptoms have been reported, so careful monitoring of symptoms is necessary. Long-term use of this medication may reduce beneficial gut bacteria and lead to other infections, therefore patient conditions should be continuously evaluated. Patients with impaired liver function should undergo regular liver function tests and dosage adjustments may be necessary. In patients with poor renal function, dosage adjustment is usually not required. Particularly for children, care should be taken not to exceed the recommended dose and duration. This medication may interact with some drugs, so if you are taking other medications, be sure to inform your healthcare provider. Pregnant women or women who could become pregnant should use this medication with caution, weighing the benefits and risks for the fetus. Nursing mothers should discontinue breastfeeding when taking this medication as it may be transmitted in small amounts in breast milk. Elderly patients can be administered the same doses as general adults, but as the drug's half-life may be extended, their conditions should be monitored. This medication can cause dizziness, blurred vision, and other symptoms, so caution is required when operating machinery or driving. Finally, keep this medication out of the reach of children and do not transfer it to another container, as this is important for maintaining the quality of the drug.

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, anorexia, nausea, vomiting, epigastric discomfort, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray findings, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disturbance, ageusia, olfactory disturbance, anosmia, polymorphous erythema, purpura, superinfection due to excessive growth of non-susceptible microorganisms, temporary hearing loss, hearing impairment, visual impairment, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, away from direct sunlight and at normal room temperature. Avoid placing it in warm or excessively cold areas, and always close the lid tightly when not in use.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle