Sama Roxithromycin Tablet

Adult dose

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

Child dose

Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight daily. Administer this medicine orally in 2 divided doses of 5～8mg (potency) per kg of body weight daily. The doses according to body weight are 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 cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; therefore, if symptoms such as blisters or mucosal damage occur, usage should be discontinued immediately. Individuals allergic to this drug or macrolide antibiotics, as well as those taking certain heart disease medications or ergot alkaloids such as mizolastine, should not use it. Caution is needed for patients with impaired liver function or the elderly, and consultation with a physician is essential for those with heart conditions or taking related medications, as it could affect heart rhythms. This drug may worsen myasthenia gravis; therefore, caution is advised in individuals with this condition. While using this medication, various side effects such as allergic reactions, blood disorders, liver function abnormalities, gastrointestinal issues, severe diarrhea or abdominal pain, breathing difficulties, neurological symptoms, gustatory and olfactory disturbances, hearing loss, and vision disturbances may occur, so immediate consultation with healthcare professionals is necessary if symptoms arise. Particularly, severe diarrhea accompanied by bleeding may be a sign of pseudomembranous colitis, requiring caution. This drug can interfere with the metabolism of other medications in the liver, raising blood drug concentrations, thereby increasing the risk of side effects when taken with certain medications; thus, it is crucial to inform the physician. Women who are pregnant or may become pregnant should carefully consider the necessity and risks of treatment, as administration may affect the fetus; for those breastfeeding, it is advisable to discontinue breastfeeding. In the elderly, the drug's half-life may be prolonged, though dosage adjustments are generally not necessary. This medication may cause dizziness or visual disturbances, so caution is advised when operating machinery or driving. Finally, it should be stored out of reach of children, and it is safer to avoid transferring the medication to another container.

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, elevated AST, elevated ALT, elevated ALP, increased serum bilirubin, anorexia, nausea, vomiting, epigastric discomfort, gastric pain, 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 paralysis, paralysis, dysgeusia, ageusia, olfactory disturbances, loss of smell, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, temporary deafness, hearing impairment, visual disturbances, 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 contact with air or moisture, and it is important to keep it in a cool room away from direct sunlight.

Appearance

White round tablet

Package unit

30 tablets, 300 tablets (bottle)