Medication info
Roxin Tablet (Roxithromycin)

Roxin Tablet (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
SAMSUNG PHARMACEUTICAL CO., LTD.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199700429 · Notified 1997.07.31 · Insurance code 642300580

Summary

Main use
Treatment of respiratory, ear, nose, dental, genital, and skin infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
(Tablets) 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 increased or decreased as appropriate according to age and symptoms.
Child dose
(Pediatric tablets)(Granules)(Suspension) Children: The mean 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 (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).

Ingredients

Manufacturer
SAMSUNG PHARMACEUTICAL CO., LTD.

Efficacy & effects

Treatment of respiratory, ear, nose, dental, genital, and skin infections; prevention of meningococcal infection

  • Pharyngitis
  • acute bronchitis
  • tonsillitis
  • bacterial pneumonia
  • mycoplasma pneumonia
  • genital infections
  • sexually transmitted diseases
  • otitis media
  • sinusitis
  • folliculitis
  • boils
  • carbuncles
View approved original text

This medication is effective in treating various infections caused by multiple types of bacteria. It is used for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It is also used for treating infections and sexually transmitted diseases, excluding gonococcal infections of the genital tract. This medication is effective for infections around the ear and nose, such as otitis media and sinusitis, as well as skin and soft tissue infections such as folliculitis, boils, and soft tissue infections. It can be used to prevent infections in cases of contact with meningococcal meningitis patients, and it also helps in treating periodontal infections. Overall, it is used to treat and prevent various bacterial infections.

How to take

Adult dose

(Tablets) 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 increased or decreased as appropriate according to age and symptoms.

Child dose

(Pediatric tablets)(Granules)(Suspension) Children: The mean 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 (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).

Precautions

This medication can cause serious skin reactions, so if symptoms such as blisters or mucosal damage appear, use should be stopped immediately. Additionally, individuals allergic to this medication or similar class antibiotics should not take it, and caution should be exercised when taken with specific medications, as there may be risks. Patients with poor liver function or the elderly need to be particularly cautious when using this medication, and when used alongside certain antibiotics, antibiotic resistance issues should also be considered. This medication may affect heart rhythm, so patients with heart disease or those taking related medications should use it with caution. Rarely, this medication can worsen symptoms of muscle weakness; therefore, patients with myasthenia gravis should take caution. During administration, various side effects such as allergic reactions, gastrointestinal disturbances, liver dysfunction, respiratory problems, and neurological symptoms may occur, and if such symptoms arise, immediate consultation with healthcare professionals is necessary. This medication should only be used for the minimum duration necessary to prevent the emergence of resistant bacteria, and patients with liver dysfunction require regular monitoring. Patients with impaired kidney function do not generally require dose adjustments; however, in children, strict adherence to dosing and duration is necessary. This medication can interact with other drugs; therefore, if currently taking any medications, it is important to inform healthcare professionals, especially when used in conjunction with heart-related medications, certain antihistamines, antifungals, etc. Women who are pregnant or may become pregnant should carefully evaluate the risks and benefits of this medication before using it, and breastfeeding mothers should avoid administration or discontinue breastfeeding. In the elderly, the retention time of this medication in the body may be prolonged, but generally, dose adjustments are not necessary. Using this medication may result in symptoms such as dizziness or blurred vision, so care should be taken when operating machinery or driving. Finally, this medication should be kept out of reach of children, and transferring it to other containers could adversely affect its quality.

Side effects

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, discomfort in the upper abdomen, abdominal pain, abdominal bloating, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paresthesia, paralysis, dysgeusia, ageusia, olfactory disturbances, anosmia, erythema multiforme, purpura, superinfection due to excessive growth of non-susceptible pathogens, transient hearing loss, hearing impairment, visual disturbances, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucosa, hallucinations, confusion

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air from entering, and it is safe to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.