Medication info
Roxside Tablet (Roxithromycin)

Roxside Tablet (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
White, round film-coated tablets, pink round film-coated tablets (for export)
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 199703432 · Notified 1997.08.11 · Insurance code 649500560

Summary

Main use
Treatment of respiratory, ear, nose, 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. The dose may be adjusted according to age and symptoms.
Child dose
Children: The average 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. Doses by body weight are as follows: Children weighing 6~11Kg: 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 2.5mL per dose twice daily before meals (suspension only). Children weighing 12~23Kg: 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 5mL per dose twice daily before meals (suspension only). Children weighing 24~40Kg: 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 10mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Unimed Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose, 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 used to treat respiratory infections such as pharyngitis, tonsillitis, and bronchitis, and bacterial pneumonia and mycoplasma pneumonia. It is also effective for inflammation of the ears and sinuses, such as otitis media and sinusitis. It is indicated for the treatment of various skin and soft tissue infections, including folliculitis, furuncles, and soft tissue infections, as well as for infections of the nails and the treatment of abscesses. Additionally, it can be used for infections caused by pathogens other than gonococcus among genital infections and sexually transmitted diseases. It may also be used to prevent infection after contact with patients suffering from meningococcal meningitis, and it is used to treat inflammatory diseases around the teeth, such as pericoronitis and periodontitis. Overall, it is used effectively for the treatment of various bacterial infections.

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. The dose may be adjusted according to age and symptoms.

Child dose

Children: The average 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. Doses by body weight are as follows: Children weighing 6~11Kg: 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 2.5mL per dose twice daily before meals (suspension only). Children weighing 12~23Kg: 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 5mL per dose twice daily before meals (suspension only). Children weighing 24~40Kg: 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or 10mL per dose twice daily before meals (suspension only).

Precautions

This medication can cause serious skin reactions, so it should be discontinued immediately if symptoms such as blisters on the skin or damage to mucous membranes occur. Those with allergies to antibiotics of a similar class or those taking certain medications (such as terfenadine, astemizole, etc.) should not use this medication. Patients with poor liver function, the elderly, and those with certain heart conditions should use this medication with caution, paying attention to resistance issues and cardiac rhythm when taken with other antibiotics. Rarely, it may cause severe allergic reactions, blood disorders, hepatitis, gastrointestinal disturbances, or pneumonia, so any symptoms should be reported to a doctor immediately. If severe diarrhea occurs during or after treatment, it may indicate pseudomembranous colitis, and the medication should be stopped immediately, and medical attention sought. This medication can increase the blood concentration of other drugs metabolized in the liver, potentially causing heart-related side effects, so care should be taken to avoid concomitant use with certain medications. Women who are pregnant or may become pregnant should consult a doctor before using this medication, and nursing mothers should consider stopping breastfeeding while taking it. Dizziness or blurred vision may occur, so caution is needed when operating machinery or driving. This medication should be stored out of reach of children, and transferring it to other containers should be avoided.

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, abdominal 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, altered taste, ageusia, altered smell, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of resistant pathogens, transient hearing loss, auditory impairment, vision impairment, 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 may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to store the medication at room temperature between 1 to 30 degrees Celsius. This helps maintain the medication's efficacy for a longer time.

Appearance and packaging

Appearance

White, round film-coated tablets, pink round film-coated tablets (for export)

Package unit

30 tablets/bottle, 100 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.