Medication info
Roxitil Tablet 150 mg (Roxithromycin)

Roxitil Tablet 150 mg (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 199700809 · Notified 1997.07.29 · Insurance code 670300400

Summary

Main use
Treatment of respiratory, ear, nose and throat, and dental infections; treatment of skin and nongonococcal genital infections; prevention of meningococcal disease
Who takes it
Adults · Children
Adult dose
Adults: Administer roxithromycin 150㎎ (potency) orally per dose 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 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 in 2 divided oral doses. Doses according to body weight are as follows. Children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (pediatric tablets or granules only); take 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 or granules only); take 5mL per dose twice daily before meals (suspension only). Children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (pediatric tablets or granules only); take 10mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose and throat, and dental infections; treatment of skin and nongonococcal genital infections; prevention of meningococcal disease

  • Pharyngitis
  • acute bronchitis
  • tonsillitis
  • bacterial pneumonia
  • respiratory infections
  • genitourinary infections
  • sexually transmitted diseases
  • otitis media
  • sinusitis
  • folliculitis
  • boils
  • carbuncles
View approved original text

This medication is used to treat various infections caused by different bacteria. It is effective against respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and bacterial pneumonia, including Mycoplasma pneumonia. Additionally, it is used for genitourinary infections except for those caused by gonorrhea. It is also utilized for infections of the ears and sinuses such as otitis media and sinusitis, and for skin and soft tissue infections such as folliculitis, boils, and cellulitis. It is also used for the prevention of infection in patients who have been in contact with meningococcal meningitis patients, as well as in the treatment of dental-related infections such as pericoronitis and periodontitis. Thus, it is widely used for the treatment of various bacterial infections.

How to take

Adult dose

Adults: Administer roxithromycin 150㎎ (potency) orally per dose 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 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 in 2 divided oral doses. Doses according to body weight are as follows. Children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (pediatric tablets or granules only); take 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 or granules only); take 5mL per dose twice daily before meals (suspension only). Children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (pediatric tablets or granules only); take 10mL per dose twice daily before meals (suspension only).

Precautions

This medication can rarely cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms such as blistering or mucosal lesions develop, administration should be stopped immediately. Individuals allergic to this medication or to macrolide antibiotics should not use it. Furthermore, caution should be taken when co-administering certain medications (terfenadine, astemizole, cisapride, pimozide) as this may pose risks. Co-administration with ergots may lead to severe side effects such as peripheral vascular spasm or limb ischemia. Patients with impaired liver function, elderly patients, and those taking certain antibiotics should be administered this medication with caution. This medication can affect the electrical activity of the heart, so individuals at risk of arrhythmias should be particularly careful. Rarely, severe allergic reactions such as anaphylactic shock can occur, and if symptoms develop, administration should be stopped immediately and appropriate treatment sought. Some patients have reported symptoms such as hepatitis, nausea, diarrhea, abdominal pain, skin rashes, and abnormal symptoms in the ears and eyes. Long-term use of this medication can lead to other infections, so the condition should be closely monitored, and if diarrhea or abdominal pain worsens, consultation with a physician is necessary. This medication can increase the concentrations of several drugs metabolized by the liver, hence increasing the risk of side effects, so consult a doctor if co-administering with certain medications. Women who are pregnant or may become pregnant should consult a physician before using this medication, as it may affect the fetus. If breastfeeding, this medication is known to transfer in small amounts to breast milk, so it is advised to avoid use if possible or to discontinue breastfeeding. Dizziness or visual disturbances may occur, so caution is needed when operating machinery or driving. Finally, keep this medication out of reach of children and do not transfer it to another container.

Side effects

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised pustular exanthema, 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, increased serum bilirubin, loss of appetite, nausea, vomiting, gastric discomfort, dyspepsia, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, watery stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, taste disturbance, ageusia, olfactory disturbance, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, hearing impairment, visual impairment, blurred vision, conjunctival injection, general 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 is susceptible to the effects of air and moisture, so it should be stored in a tightly sealed container. It is also better to store it at a normal indoor temperature rather than in excessively hot or cold places.

Appearance and packaging

Appearance

White round film-coated tablet

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.