Medication info

Aroxine 150 mg (Roxithromycin)

Prescription medicationTabletOralExpired
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Ari Pharmaceutical Co., Ltd.
Appearance
Round, white, film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201906826 · Approved 2019.09.25

This product's status changed to Expired on 2024.09.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, otorhinolaryngologic, dental, skin, and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
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 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 drug is administered orally at 5~8mg (potency) per kg of body weight daily in 2 divided doses. The doses according to body weight are as follows. Children usually 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).

Ingredients

Manufacturer
Ari Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is effective against various bacterial infections. The main indications include pharyngitis, acute bronchitis, tonsillitis, and respiratory infections such as bacterial and mycoplasma pneumonia. It is also used for treating genital infections and sexually transmitted diseases (excluding gonorrhea), otitis media, and sinusitis. It is effective against skin and soft tissue infections such as folliculitis, furuncles, carbuncles, soft tissue infections, lymphangitis, paronychia, subcutaneous abscess, hidradenitis, excoriated acne, and infectious granulomas. It is used for infection prevention in patients who have been in contact with meningococcal meningitis cases, and also for treating pericoronitis and periodontal disease. Overall, it is a useful medication for the treatment and prevention of various bacterial infectious diseases.

How to take

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 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 drug is administered orally at 5~8mg (potency) per kg of body weight daily in 2 divided doses. The doses according to body weight are as follows. Children usually 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).

Precautions

This medication can, in rare cases, cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If skin rashes progress to blistering or mucosal damage, discontinue use immediately. Persons allergic to this drug or macrolide antibiotics should not use it, and patients taking certain medications (terfenadine, astemizole, cisapride, pimozide, ergots, mizolastine) should also not take this drug. Patients with liver impairment or the elderly should use this drug cautiously, and caution should be taken regarding potential drug interactions when taken with other antibiotics. Additionally, this drug can prolong the QT interval, representing electrical signals of heartbeats, so patients with heart diseases or those taking certain antiarrhythmic drugs should be particularly careful. This drug may worsen symptoms of myasthenia gravis; therefore, patients with such conditions should consult with medical personnel before use. Users may experience various side effects during use, such as allergic reactions, blood abnormalities, liver function abnormalities, gastrointestinal issues, respiratory symptoms, neurological issues, sensory abnormalities, and skin rashes. Any symptoms should be promptly reported to medical personnel. This medication may cause superinfection due to intestinal microbiota imbalance, so the patient’s condition should be periodically monitored during prolonged use. Pregnant or nursing women should carefully consider the potential impact on the fetus or infant when taking this drug and, if nursing, it is recommended to avoid use or to stop nursing if possible. This drug can elevate the blood concentration of other medications metabolized in the liver, leading to heart issues, so it is essential to consult with medical personnel when taking it alongside certain medications. Lastly, this medication should be stored out of the reach of children and should not be transferred to other containers.

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, gastric discomfort, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, dysosmia, anosmia, erythema multiforme, purpura, superinfection by resistant pathogens, temporary hearing loss, auditory impairment, vision impairment, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, menstrual irregularities, inflammation of the 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 closed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1°C and 30°C. Storing it this way will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Round, white, 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.