Medication info

Roxidine Tablets (Roxithromycin)

Prescription medicationTabletOralExpired
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202001962 · Approved 2020.03.19

This product's status changed to Expired on 2025.03.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, middle ear, periodontal, genital, and skin infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
Adults: Take 150㎎ (potency) of roxithromycin 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. This medicine is administered orally in 2 divided doses of 5~8mg (potency) per Kg of body weight per day. 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), or 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), or 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), or 10mL per dose twice daily before meals (for suspension only).

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

Treatment of respiratory, middle ear, periodontal, genital, and skin infections; prevention of meningococcal infection

  • Pharyngitis
  • acute bronchitis
  • tonsillitis
  • bacterial pneumonia
  • Mycoplasma pneumonia
  • genitourinary infections
  • sexually transmitted diseases
  • otitis media
  • sinusitis
  • folliculitis
  • furuncles
  • carbuncles
View approved original text

This medication is used to treat infections caused by various types of bacteria. It is primarily effective against Streptococcus, Streptococcus pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, and Bordetella pertussis, among other pathogens. It is used to treat respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and Mycoplasma pneumonia. It is also effective against genitourinary infections excluding gonorrhea, sexually transmitted diseases, otitis media, and sinusitis. It helps treat various infectious diseases of the skin such as folliculitis, furuncles, and soft tissue infections. It is used for infection prevention in patients in contact with Neisseria meningitidis meningitis and is also applied in the treatment of periodontal conditions like pericoronal inflammation and periodontitis.

How to take

Adult dose

Adults: Take 150㎎ (potency) of roxithromycin 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. This medicine is administered orally in 2 divided doses of 5~8mg (potency) per Kg of body weight per day. 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), or 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), or 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), or 10mL per dose twice daily before meals (for suspension only).

Precautions

This medication can rarely cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If there are symptoms such as blistering of the skin or progressive skin rash with mucosal damage, discontinue the medication immediately. This medication should not be used by individuals who are allergic to this medication or to macrolide antibiotics, those taking certain heart-related medications, and those on ergots or mizolastine. Caution is required in patients with impaired liver function, elderly patients, and those taking this medication with specific antibiotics. In particular, caution should be exercised in patients with congenital heart rhythm abnormalities or those taking certain antiarrhythmic medications, as this medication may affect heart rhythms. Severe allergic reactions such as anaphylaxis can rarely occur, so if any unusual symptoms occur during the use of the medication, it should be stopped immediately and medical consultation sought. This medication may affect the liver and digestive system; if hepatitis symptoms or abdominal pain and diarrhea occur, discontinue use and inform your physician immediately. This medication may cause hearing loss or dizziness in some patients, and visual disturbances have also been reported. Care should be taken when driving or operating machinery. Additionally, this medication is highly likely to interact with other medications, so inform healthcare professionals of any other medications being taken. Women who are pregnant or breastfeeding should carefully consider the effects of this medication on the fetus or baby when using it, and it is recommended to either avoid use while breastfeeding or stop breastfeeding. For children, the prescribed doses and durations must be strictly adhered to, and overdosing should be avoided. Lastly, this medication should be stored out of reach of children and not transferred to other containers for safety.

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, increased AST, increased ALT, increased ALP, elevated serum bilirubin, loss of appetite, nausea, vomiting, discomfort in the upper abdomen, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, bloody stool, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, olfactory disturbances, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, hearing impairment, visual disturbances, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal hemorrhage, menstrual irregularities, oral and vaginal mucosal inflammation, hallucinations, confusion

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or humidity and should be kept at room temperature between 1 degree and 30 degrees Celsius. Avoid direct sunlight and do not store in excessively hot or cold places.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 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.