Ostem Roxicltromycin 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 6 mg (potency) per kg of body weight per day. This medicine is administered orally in 2 divided doses of 5～8 mg (potency) per kg of body weight per day. 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 occasionally cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If progressive skin rash symptoms appear, such as blisters on the skin or damage to mucous membranes, stop using it immediately. This medication should not be used by individuals allergic to this drug or to macrolide antibiotics. Additionally, individuals taking certain medications like terfenadine, astemizole, cisapride, or pimozide should not use this medication. Patients taking ergots or midazolam should avoid this medication as it may cause peripheral vascular spasm, limb ischemia, or sensory abnormalities. Caution is required for patients with liver dysfunction or elderly individuals. Caution should be exercised when used with other antibiotics as resistance may occur. Furthermore, this drug may affect the heart, so patients with prolonged QT interval or those at risk of arrhythmias need close monitoring by a doctor when taking this medication. Use cautiously in patients with myasthenia gravis as it may worsen symptoms. Rarely, this medication can induce allergic reactions or anaphylactic shock, and if any adverse symptoms appear, administration should be stopped immediately and appropriate medical treatment should be sought. Various side effects such as liver dysfunction, digestive disorders, diarrhea, pseudomembranous colitis, pneumonia, neurological issues, taste and smell disturbances, skin rashes etc., have been reported; therefore, it is essential to consult with healthcare providers if symptoms occur. Long-term use of this medication may lead to resistant bacteria, so it should only be used for the minimum required duration, and regular tests are necessary if liver function is impaired. No special dosage adjustments are needed for patients with reduced kidney function. Women who are pregnant or may become pregnant should consult a doctor before use as it could affect the fetus. Breastfeeding mothers should avoid using this drug or discontinue breastfeeding as it may transfer in small amounts to breast milk. Elderly patients can use this medication without special dosage adjustments, but attention should be paid to side effects such as dizziness or visual disturbances. Dizziness or visual impairments may occur while taking this medication, so care should be taken when operating machinery or driving. This drug may interact with other medications, so inform healthcare providers of any other medications being taken, especially heart-related drugs or certain antihistamines or antibiotics.

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, elevated serum bilirubin, loss of appetite, nausea, vomiting, upper abdominal discomfort, dyspepsia, abdominal pain, abdominal distention, diarrhea, colitis due to pseudomembrane, loose stools, hemorrhagic colitis, blood in stool, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disturbance, ageusia, smell disturbance, anosmia, erythema multiforme, purpura, secondary infections due to overgrowth of non-susceptible pathogens, transient hearing loss, hearing impairment, visual disturbances, blurred vision, conjunctival injection, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication should be stored in a tightly sealed container to prevent air or moisture exposure, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer time.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle