Medication info
Roxithromycin Tablet (Roxithromycin)

Roxithromycin Tablet (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Allico Pharmaceutical Co., Ltd.
Appearance
Biconvex white round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200400873 · Notified 2004.07.07 · Insurance code 656000270

Summary

Main use
Treatment of respiratory, ear, nose, and periodontal infections; skin and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
Adults: The usual dose is 150 mg (potency) of roxithromycin orally twice daily, in the morning and evening before meals. For pneumonia, administer 300 mg (potency) once daily before breakfast. The dose may be adjusted according to age and symptoms.
Child dose
Children: The average dose used in clinical trials was 6 mg (potency) per kg of body weight per day. Administer 5–8 mg (potency) per kg of body weight per day orally in 2 divided doses. Children weighing 6–11 Kg: Take 25 mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or take 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 take 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 take 10mL per dose twice daily before meals (for suspension only).

Ingredients

Manufacturer
Allico Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose, and periodontal infections; skin and genital infections; prevention of meningococcal infection

  • pharyngitis
  • acute bronchitis
  • tonsillitis
  • bacterial pneumonia
  • mycoplasma pneumonia
  • reproductive infections
  • sexually transmitted diseases
  • otitis media
  • sinusitis
  • folliculitis
  • boils
  • carbuncle
View approved original text

This medication is used to treat various bacterial and mycoplasma infections. It is effective against respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It is also used to treat reproductive infections other than gonorrhea, sexually transmitted diseases, otitis media, and sinusitis. It helps with various infectious diseases such as folliculitis, boils, soft tissue infections, and paronychia. It is also used to prevent infections in patients who have been in contact with Neisseria meningitidis. It is applicable for dental-related infections such as pericoronitis and periodontitis. Overall, it is used to improve various bacterial infections.

How to take

Adult dose

Adults: The usual dose is 150 mg (potency) of roxithromycin orally twice daily, in the morning and evening before meals. For pneumonia, administer 300 mg (potency) once daily before breakfast. The dose may be adjusted according to age and symptoms.

Child dose

Children: The average dose used in clinical trials was 6 mg (potency) per kg of body weight per day. Administer 5–8 mg (potency) per kg of body weight per day orally in 2 divided doses. Children weighing 6–11 Kg: Take 25 mg (potency) per dose twice daily before meals (for pediatric tablets and granules only), or take 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 take 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 take 10mL per dose twice daily before meals (for suspension only).

Precautions

This medication can rarely cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms such as blistering of the skin or mucosal damage occur, discontinue use immediately. Patients allergic to this drug or to macrolide antibiotics, those taking certain cardiac medications (terfenadine, astemizole, cisapride, pimocard), ergot alkaloids, or mizolastine should not use this medication. Patients with impaired liver function or elderly patients should use this medication with caution, and when used with other antibiotics, be aware of resistance issues. This medication can prolong the QT interval of cardiac electrical signals, so patients with congenital long QT syndrome or at risk of arrhythmias, or those taking certain antiarrhythmic medications should be particularly cautious. Patients with myasthenia gravis may experience exacerbation of symptoms due to this medication, requiring careful monitoring. This medication can rarely cause severe allergic reactions such as anaphylactic shock, so if symptoms appear, discontinue use immediately and seek appropriate treatment. Adverse effects may include liver function abnormalities, gastrointestinal issues (nausea, vomiting, diarrhea, abdominal pain, etc.), severe colitis, pneumonia, neurological symptoms (headache, dizziness, drowsiness), alterations in taste and smell, and skin rashes. Consult healthcare professionals if abnormal symptoms occur. Use of this medication may lead to infections due to a reduction in beneficial intestinal bacteria, so symptoms should be monitored closely. Strict adherence to dosing is required for children, as overdose may affect bone growth. This medication has many interactions with other drugs, especially cardiac medications, anticoagulants, immunosuppressants, sedatives, and heart medications, so caution is necessary when taken together. Women who are pregnant or may become pregnant should carefully consider the risks and benefits before using this medication, and breastfeeding mothers should avoid using it or discontinue breastfeeding. Elderly patients may experience prolonged half-life of the drug in the body, but general dose adjustments are not required. This medication may cause dizziness or vision disturbances, so caution is required when driving or operating machinery. Finally, this medication should be stored out of the reach of children and not transferred to other containers for safety.

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, elevated serum bilirubin, loss of appetite, nausea, vomiting, epigastric discomfort, abdominal pain, abdominal cramps, 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, taste disturbance, ageusia, smell disturbance, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual impairment, blurred vision, ocular congestion, 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 should be stored in a tightly sealed container to prevent air exposure and kept at room temperature that is neither too hot nor too cold. Storing it this way can maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Biconvex white round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 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.