Roxydron Tablet (Roxithromycin)

Adult dose

Adults: Administer 150㎎ (potency) of roxithromycin per dose 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

Children: The average dose used in clinical trials was 6mg (potency) per kg of body weight daily. Administer 5～8mg (potency) per kg of body weight daily in 2 divided oral doses. 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 cause serious skin problems such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; therefore, if symptoms such as blisters or mucosal damage appear, it should be discontinued immediately. This medication must not be used by patients who are allergic to it or similar antibiotics, or by patients taking certain medications. In particular, caution should be exercised in elderly patients or those with heart problems or liver impairment. When co-administering with other antibiotics, attention should be paid to drug interactions. Additionally, it may affect heart rhythms, so patients with heart conditions or those on related medications should be cautious. During the use of this medication, allergic reactions, fever, skin rashes, blood abnormalities, liver dysfunction, indigestion, diarrhea, pneumonia symptoms, and neurological abnormalities may occur; therefore, it is essential to consult a physician if such symptoms arise. In particular, severe diarrhea, abdominal pain, and diarrhea accompanied by bleeding may indicate pseudomembranous colitis; therefore, it is important to discontinue use quickly and seek medical attention. Caution is needed for patients with impaired liver function, and dosage may need to be adjusted while regularly monitoring liver function tests. No specific dosage adjustment is needed for patients with renal impairment. In children, dosage and duration of administration must be strictly adhered to, and care should be taken to avoid overdose. This medication interacts significantly with other drugs, and side effects may worsen when taken with specific medications; thus, it is crucial to inform the physician or pharmacist about all medications currently being taken and seek advice. Pregnant women or those who may become pregnant should only use this medication after thoroughly considering its risks and benefits, and nursing mothers should either avoid it or stop breastfeeding while taking it. Elderly patients may experience prolonged drug half-life, but generally, no dosage adjustment is necessary. If dizziness, vision disturbances, or blurred vision occurs while taking this medication, it is safer to avoid driving or operating machinery. Finally, this medication should be stored out of reach of children, and it is safer and better for quality maintenance not to transfer it to other containers.

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, abdominal discomfort, stomach pain, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disorder, ageusia, olfactory disorder, anosmia, erythema multiforme, purpura, transient hearing loss, hearing impairment, visual impairment, blurred vision, conjunctival hyperemia, generalized malaise, fatigue, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

Bottle packaging - 300 tablets/bottle, bottle packaging - 30 tablets/bottle