Medication info
Roxithromycin Tablets

Roxithromycin Tablets

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Il-Yang Biopharma Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201700478 · Approved 2017.01.25 · Insurance code 696601690

Summary

Main use
Treatment of respiratory, ear, and nose infections; genital, skin, and oral 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. The dose may be adjusted as appropriate 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 5~8mg (potency) per kg of body weight daily orally in 2 divided doses. The dose according to body weight is as follows. Children weighing 6~11Kg: 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 2.5mL per dose twice daily before meals (for suspension only) Children weighing 12~23Kg: 50mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 5mL per dose twice daily before meals (for suspension only) Children weighing 24~40Kg: 100mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 10mL per dose twice daily before meals (for suspension only)

Ingredients

Manufacturer
Il-Yang Biopharma Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, and nose infections; genital, skin, and oral 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 effective against several strains, including those commonly causing infections such as Streptococcus, Pneumococcus, and Meningococcus, and is widely used for respiratory infections like pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and Mycoplasma pneumonia. Additionally, it is effective for non-gonococcal genital infections and sexually transmitted diseases, as well as otitis media and sinusitis. It is also employed in various skin and soft tissue infections such as folliculitis, boils, and soft tissue infections, and provides preventive measures against meningococcal meningitis exposure. It is used for the treatment of dental-related infections such as pericoronitis and periodontitis. This medication is effectively used for the treatment and prevention of various infectious diseases.

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. The dose may be adjusted as appropriate 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 5~8mg (potency) per kg of body weight daily orally in 2 divided doses. The dose according to body weight is as follows. Children weighing 6~11Kg: 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 2.5mL per dose twice daily before meals (for suspension only) Children weighing 12~23Kg: 50mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 5mL per dose twice daily before meals (for suspension only) Children weighing 24~40Kg: 100mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 10mL per dose twice daily before meals (for suspension only)

Precautions

This medication can rarely cause severe skin reactions, therefore, if symptoms such as blistering or worsening skin rash occur, discontinue use immediately. Those allergic to this medication or similar types of antibiotics should not take it, and individuals currently taking certain heart-related medications or drugs that may induce vascular constriction should also avoid using it. Patients with impaired liver function or the elderly should particularly be cautious when using this medication, and care should be taken when using it in conjunction with other antibiotics due to the potential for resistance issues. This medication can affect heart rhythm, so individuals with arrhythmia risk or heart disease must consult a physician before taking it. Patients with muscle weakness disorders must use this medication carefully, as it may exacerbate symptoms. During the use of this medication, symptoms such as allergic reactions, blood abnormalities, liver dysfunction, gastrointestinal issues, severe diarrhea, respiratory distress, and neurological abnormalities may occur, so it is essential to notify a doctor immediately if any symptoms arise. If severe diarrhea or abdominal pain occurs, it could indicate serious intestinal conditions like pseudomembranous colitis, so discontinue use immediately and consult a healthcare professional. This medication may interact with other drugs, so be sure to inform your doctor of any other medications you are taking, especially when using it with heart-related drugs, antihistamines, anticoagulants, or immunosuppressants. Women who are pregnant or may become pregnant should consult with a physician before taking this medication, and breastfeeding mothers are also advised to avoid it. If symptoms such as dizziness or blurred vision appear, activities requiring machinery operation or driving should be avoided. This medication must be stored out of reach of children, and care should be taken not to transfer it to another container as this can affect its quality.

Side effects

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, shock, fever, rash, allergic skin reaction, vascular edema, 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, epigastric discomfort, stomach pain, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, olfactory disturbances, anosmia, erythema multiforme, purpura, secondary infection due to excessive growth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival injection, generalized malaise, asthenia, 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 exposure, and the storage temperature should be kept between 1 to 30 degrees Celsius at room temperature. Proper storage will ensure the medication's effectiveness is maintained safely.

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.

Questions about this medicine

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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.