Medication info
Roxamin Tablet (Roxithromycin)

Roxamin Tablet (Roxithromycin)

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

MFDS item code 200402722 · Notified 2004.06.12 · Insurance code 621802020

Summary

Main use
Treatment of respiratory and ENT, skin, dental, 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. Adjust the dose as appropriate according to age and symptoms.
Child dose
Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight per day. Administer this medicine orally at 5~8mg (potency) per kg of body weight per day in 2 divided doses. The dose according to body weight is as follows. Children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 2.5mL per dose twice daily before meals (for suspension only). Children weighing 12~23Kg: Take 50mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 5mL per dose twice daily before meals (for suspension only). Children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 10mL per dose twice daily before meals (for suspension only).

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and ENT, skin, dental, 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 infections caused by various bacteria. It is effective for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia, and is also used for genital infections and sexually transmitted diseases, except for gonorrhea. Additionally, it applies to infections around the ears and nose such as otitis media and sinusitis, as well as skin and soft tissue infections including folliculitis, boils, and soft tissue infections. It is also used for infection prevention in case of contact with meningococcal meningitis patients and is suitable for the treatment of pericoronitis and periodontitis. This medication acts on a wide range of bacteria, including various strains, effectively improving 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. Adjust the dose as appropriate according to age and symptoms.

Child dose

Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight per day. Administer this medicine orally at 5~8mg (potency) per kg of body weight per day in 2 divided doses. The dose according to body weight is as follows. Children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 2.5mL per dose twice daily before meals (for suspension only). Children weighing 12~23Kg: Take 50mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 5mL per dose twice daily before meals (for suspension only). Children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or 10mL per dose twice daily before meals (for suspension only).

Precautions

This medication may cause severe skin reactions, so if symptoms such as blisters or mucosal damage occur, it should be discontinued immediately. It should not be used by those who are allergic to it or are currently taking certain medications. Patients with poor liver function or elderly patients should use it cautiously and be aware of resistance issues when used with other antibiotics. As it may affect the heart, patients with heart disease or those taking certain medications should consult a doctor before use. This medication may worsen muscle weakness symptoms; caution is needed if such symptoms are present. Rarely, severe allergic reactions, blood abnormalities, hepatitis, gastrointestinal problems, etc., may occur, so if symptoms appear, it is essential to inform medical personnel immediately. If severe diarrhea or abdominal pain occurs, it may indicate pseudomembranous colitis, so the medication should be stopped immediately, and the patient should go to the hospital. If symptoms such as difficulty breathing or coughing occur, the medication should be stopped, and appropriate treatment should be received. Dizziness, drowsiness, taste or smell abnormalities, and visual disturbances may occur, so caution is advised when driving or operating machinery. This medication can increase the concentration of other drugs metabolized by the liver, posing risks such as cardiac arrhythmia, so it should not be taken with certain medications. Pregnant or nursing women should consult a doctor before use as it may affect the fetus or infant.

Side effects

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular rash, 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, abdominal discomfort, dyspepsia, stomach pain, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, blood in stool, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, dysgeusia, ageusia, dysosmia, anosmia, erythema multiforme, purpura, superinfection due to an overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival hyperemia, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, 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 that is well-ventilated, and it is best to keep it at room temperature between 1°C and 30°C. This helps maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

White round film-coated tablet

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.