Medication info
Roxasine Tablet (Roxithromycin)

Roxasine Tablet (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
HuTechs Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 199700106 · Notified 1997.08.04 · Insurance code 649100210

Summary

Main use
Treatment of respiratory, otorhinolaryngological, and dental infections, and skin and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
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. Adjust the dose as appropriate according to age and symptoms.
Child dose
Children: The average dose used in clinical trials was 6mg (potency)/kg of body weight daily. Administer 5~8mg (potency)/kg of body weight daily orally 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 (pediatric tablets and granules only), or 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), or 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), or 10mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
HuTechs Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, otorhinolaryngological, and dental infections, and 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
  • boils
  • carbuncles
View approved original text

This medication is used to treat various bacterial infections. It is mainly effective for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It is also used for infections like otitis media and sinusitis, and helps treat various skin infections such as folliculitis, boils, soft tissue infections, and paronychia. This medication is also used in cases of genital infections and excluding gonococcal infections among sexually transmitted diseases. It is effective for dental-related infections such as infectious necrosis or periodontal disease, and used for preventive purposes in cases of contact with patients with meningococcal meningitis. This drug is utilized to improve various infections.

How to take

Adult dose

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. Adjust the dose as appropriate according to age and symptoms.

Child dose

Children: The average dose used in clinical trials was 6mg (potency)/kg of body weight daily. Administer 5~8mg (potency)/kg of body weight daily orally 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 (pediatric tablets and granules only), or 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), or 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), or 10mL per dose twice daily before meals (suspension only).

Precautions

This medication may cause severe skin reactions; discontinue use immediately if symptoms such as skin blisters or mucosal damage occur. Individuals allergic to this drug or similar antibiotics should not take it. It can be dangerous when taken with certain medications, so inform your healthcare provider about any current medications you are taking. Patients with impaired liver function or the elderly should use the medication with caution, and those with heart disease should consult a doctor as it may affect heart rhythm. Patients with muscle weakness symptoms should be careful as this drug may exacerbate symptoms. If you experience allergic reactions or shock symptoms, stop taking the medication and inform healthcare personnel immediately. Consult a doctor if gastrointestinal symptoms such as vomiting, diarrhea, or abdominal pain worsen, particularly if hemorrhagic diarrhea appears, as prompt treatment is necessary. This drug may affect liver and kidney functions, so regular monitoring may be required. Symptoms such as dizziness or drowsiness may occur, so exercise caution when driving or operating machinery. If you are pregnant or breastfeeding, consult your doctor before using this medication and it is advisable to suspend breastfeeding while taking the drug. When administering this medication to children, strict adherence to dosage and duration is necessary, and it should be kept out of reach of children. Finally, this medication should only be used for the shortest duration necessary and should be taken according to the physician's instructions to prevent the emergence of resistant bacteria.

Side effects

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, loss of appetite, nausea, vomiting, gastric discomfort, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, bronchospasm, cough, respiratory difficulty, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, dysosmia, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-sensitive pathogens, transient hearing loss, auditory 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

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature at room temperature, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 200 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.