Medication info
Roxithromycin Tablets

Roxithromycin Tablets

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

MFDS item code 200202127 · Notified 2002.03.04 · Insurance code 653800390

Summary

Main use
Treatment of respiratory, ENT, and dental infections, genital and skin infections; prevention of meningococcal infections
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 appropriately according to age and symptoms.
Child dose
Children: The average dose used in clinical trials was 6mg (potency) per kg of body weight per day. Administer 5~8mg (potency) per kg of body weight per day 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
Shinil Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat various infections caused by several bacteria. It is effective against respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and bacterial pneumonia or mycoplasma pneumonia. It is also used to treat inflammatory conditions of the ears and nose such as genital infections, sexually transmitted diseases, otitis media, and sinusitis. For skin-related infections, it improves various symptoms such as folliculitis, boils, furuncles, shingles, soft tissue infections, lymphangitis, infectious paronychia, hidradenitis suppurativa, and pustular acne. It also helps in preventing infections when coming into contact with meningitis patients. This medication is used to treat periapical periodontitis and periodontal 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. The dose may be adjusted appropriately according to age and symptoms.

Child dose

Children: The average dose used in clinical trials was 6mg (potency) per kg of body weight per day. Administer 5~8mg (potency) per kg of body weight per day 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 serious skin reactions; therefore, if blisters or severe rashes appear, it should be discontinued immediately. Patients who are allergic to this medication or currently taking certain medications should not use it. Patients with impaired liver function or elderly patients should use this medication with special caution, and care should be taken regarding resistance or side effects if taken with other antibiotics. Patients with heart-related issues or those taking specific heart medications should be cautious as this medication may affect heart rhythm. This medication can rarely worsen muscle weakness symptoms, so patients with myasthenia gravis must be careful. Various side effects such as allergic reactions, blood disorders, liver dysfunction, gastrointestinal issues, pneumonia, neurological symptoms may occur; if symptoms develop, consult a doctor immediately. If diarrhea or abdominal pain worsens, it may indicate pseudomembranous colitis, so stop taking the medication and seek medical attention promptly. This medication may interact with other drugs, so be sure to inform your healthcare provider about any other medications being taken, especially when taken with heart medications, antihistamines, or anticoagulants. Women who are pregnant or breastfeeding should use this medication cautiously and are advised to stop breastfeeding if possible. Elderly patients may have slower drug metabolism; however, dosage adjustments are generally not needed. Symptoms such as dizziness or blurred vision may occur, so caution is advised when operating machinery or driving. This medication should be kept out of 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, gastrointestinal discomfort, stomach pain, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, olfactory disturbance, loss of smell, erythema multiforme, purpura, superinfection due to overgrowth of non-sensitive pathogens, temporary hearing loss, auditory impairment, visual disturbances, blurring of vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucous membranes, 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 from entering, with storage temperatures maintained between 1°C and 30°C at room temperature. Proper storage will safely maintain the medication's effectiveness.

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.

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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.