Medication info
Lopesin Tablet (Roxithromycin)

Lopesin Tablet (Roxithromycin)

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

MFDS item code 199700833 · Notified 1997.12.03 · Insurance code 643100230

Summary

Main use
Treatment of respiratory, ear, nose, and dental infections; treatment of skin and nongonococcal genital infections; prevention of meningococcal disease
Who takes it
Adults · Children
Adult dose
Adults: Administer 150 mg (potency) of roxithromycin orally per dose twice daily, before breakfast and dinner. For pneumonia, administer 300 mg (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 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. The doses by body weight are as follows: - Children usually weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 2.5 mL per dose twice daily before meals (suspension only). - Children weighing 12–23 kg: Take 50 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 5 mL per dose twice daily before meals (suspension only). - Children weighing 24–40 kg: Take 100 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 10 mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Bionex Co., Ltd.

Efficacy & effects

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

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

This medication is effective for treating various respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and bacterial pneumonia. It is also used for the treatment of urogenital infections and sexually transmitted infections except for gonococcal infections. It can be used for the treatment of otitis media and sinusitis, as well as for various skin and soft tissue infections, such as folliculitis, boils, soft tissue infections, and purulent paronychia. It is also used for infection prevention when in contact with patients with meningococcal meningitis. Finally, it is beneficial for the treatment of periapical periodontitis and periodontal disorders. Therefore, this medication is used to effectively treat a variety of bacterial infections.

How to take

Adult dose

Adults: Administer 150 mg (potency) of roxithromycin orally per dose twice daily, before breakfast and dinner. For pneumonia, administer 300 mg (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 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. The doses by body weight are as follows: - Children usually weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 2.5 mL per dose twice daily before meals (suspension only). - Children weighing 12–23 kg: Take 50 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 5 mL per dose twice daily before meals (suspension only). - Children weighing 24–40 kg: Take 100 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 10 mL per dose twice daily before meals (suspension only).

Precautions

This medication may rarely cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If any progressive skin rash symptoms appear, such as blistering or damage to mucous membranes, discontinue use immediately. This medication should not be used in patients with hypersensitivity to macrolide antibiotics or those taking certain medications. Specifically, it should not be administered to those taking terfenadine, astemizole, cisapride, pimodidine, ergot alkaloids, or mizolastine. Caution should also be exercised when used in patients with impaired liver function or the elderly, and resistance issues should be monitored when used in combination with other antibiotics. Additionally, this medication can affect the heart's electrical signals, so caution is needed for patients with congenital heart disease or a risk of arrhythmias. Patients with myasthenia gravis may experience worsening symptoms, so special care is needed. This medication can cause various side effects including allergic reactions, blood abnormalities, liver dysfunction, gastrointestinal disturbances, serious colitis, respiratory issues, neurological symptoms, sensory disturbances, and skin rashes. If abdominal pain or diarrhea worsens, discontinue use immediately and consult healthcare professionals. This medication should not be used in combination with certain drugs, as it may interfere with the metabolism of other drugs in the liver, increasing blood concentrations and potentially causing serious side effects such as cardiac arrhythmias. Extra caution is needed when used with anticoagulants such as warfarin, as the risk of bleeding may increase. Women who are pregnant, or may become pregnant, should consult a healthcare provider before using this medication, as it may affect the fetus. When breastfeeding, this medication may transfer in small amounts into breast milk, so it is advisable to avoid use or discontinue breastfeeding if possible. The half-life of this medication may be prolonged in the elderly, but general dosage adjustments are not usually necessary. Symptoms such as dizziness or blurred vision may occur during treatment, so caution is needed when operating machinery or driving. Finally, this medication should be kept out of reach of children and should not be transferred to another container.

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, discomfort in the upper abdomen, dyspepsia, abdominal pain, abdominal distension, diarrhea, hemorrhagic colitis, bloody stools, pseudomembranous colitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, taste disorder, ageusia, olfactory disorder, anosmia, erythema multiforme, purpura, secondary infections due to supergrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual disturbances, 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 should be stored in a tightly sealed container to protect it from air and moisture. It is best stored at room temperature, not too hot or too cold.

Appearance and packaging

Appearance

Biconvex white round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

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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.