Haeroksin Tablet (Roxithromycin)

Adult dose

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

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. Usually, for children weighing 6～11Kg: take 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or take 2.5mL per dose twice daily before meals (for suspension only). For children weighing 12～23Kg: take 50mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or take 5mL per dose twice daily before meals (for suspension only). For children weighing 24～40Kg: take 100mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or take 10mL per dose twice daily before meals (for suspension only).

This medication can rarely cause serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If any of these symptoms or signs appear, discontinue use immediately. This medication should not be used by individuals allergic to it or to macrolide antibiotics. It should also be avoided by individuals taking specific medications such as terfenadine, astemizole, cisapride, pimodidine, ergot alkaloids, or mizolastine. Caution is required when used by patients with compromised liver function or elderly patients, and attention should be paid to potential resistance issues when used with other antibiotics. There may be an increased risk of prolonged QT interval in patients with heart issues or those taking specific medications, thus requiring special caution. This medication can exacerbate myasthenia gravis, so individuals with this condition should inform their physician. During treatment, symptoms such as allergic reactions, blood abnormalities, liver dysfunction, gastrointestinal issues, respiratory symptoms, neurological symptoms, sensory abnormalities, skin reactions, and auditory and visual impairments can occur, and in case of any symptoms, consult a healthcare professional immediately. Severe diarrhea or abdominal pain may suggest pseudomembranous colitis, warranting immediate discontinuation and treatment. This medication interacts with various drugs metabolized in the liver, which may increase the risk of cardiac abnormalities or other side effects when taken with certain medications, thus it is advisable not to co-administer. Pregnant or potentially pregnant women should carefully consider the risks and benefits of this medication, and if breastfeeding, should avoid use or stop breastfeeding if necessary. Dizziness or blurred vision may occur, so caution is advised when driving or operating machinery. Keep this medication out of reach of children and do not transfer it to other containers for safety purposes.

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 cramps, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, olfactory disturbances, hyposmia, erythema multiforme, purpura, secondary infections due to overgrowth of non-sensitive pathogens, transient hearing loss, hearing impairment, vision disturbances, blurred vision, conjunctival hyperemia, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal hemorrhage, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication should be stored in a sealed container to prevent air or moisture from entering. It is best to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

For domestic use: white, round, film-coated tablets; for export: white, round, biconvex coated tablets.

Package unit

30 tablets/bottle, 500 tablets/bottle