Medication info

Genupharm Roxithromycin Tablet (Roxithromycin)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
White, round, film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202003199 · Approved 2020.04.29

This product's status changed to Approval withdrawn on 2024.11.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections (respiratory, genital, skin, etc.); prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
(Tablets) 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. Adjust the dose as appropriate according to age and symptoms.
Child dose
(Pediatric tablets)(Granules)(Suspension) 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. For children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 2.5mL per dose twice daily before meals (suspension only). For children weighing 12~23Kg: Take 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 5mL per dose twice daily before meals (suspension only). For children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 10mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

Treatment of infections (respiratory, genital, skin, etc.); prevention of meningococcal infection

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

This medication is used to treat infections caused by various bacteria. Major indications include respiratory infections such as pharyngitis, acute bronchitis, and tonsillitis, as well as bacterial pneumonia and mycoplasma pneumonia. It is also effective for non-gonococcal genital infections and sexually transmitted diseases, otitis media, and sinusitis. For skin infections, it is utilized in the treatment of folliculitis, boils, carbuncles, and various inflammations and abscesses, and is used for preventing infections in contacts of Neisseria meningitidis. It is used in the treatment of dental conditions such as pericoronitis and periodontitis. Thus, this drug is used for a wide range of bacterial infection treatments.

How to take

Adult dose

(Tablets) 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. Adjust the dose as appropriate according to age and symptoms.

Child dose

(Pediatric tablets)(Granules)(Suspension) 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. For children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 2.5mL per dose twice daily before meals (suspension only). For children weighing 12~23Kg: Take 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 5mL per dose twice daily before meals (suspension only). For children weighing 24~40Kg: Take 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only); take 10mL per dose twice daily before meals (suspension only).

Precautions

This drug may cause serious skin reactions; therefore, if symptoms such as blisters or progressive rashes appear, usage should be stopped immediately. Individuals allergic to this drug or similar antibiotic classes should not use it. Serious side effects may occur when taken with certain medications, so if you are currently taking any other medications, you must inform your healthcare provider. Patients with impaired liver function or the elderly require special caution when using this drug, and care must be taken regarding resistance issues when used with other antibiotics. As this can affect the heart, patients with heart disease or those taking certain antiarrhythmic medications should consult their doctors. Myasthenia gravis patients should use this cautiously as symptoms may worsen. An allergic reaction could lead to shock; therefore, any abnormal symptoms must be immediately reported to healthcare professionals. This medication can affect the liver or blood; if unusual symptoms occur, discontinue use immediately and seek hospital care. Gastrointestinal side effects such as abdominal pain, diarrhea, and vomiting may occur; particularly if symptoms of hemorrhagic colitis are suspected, treatment should be stopped immediately. If severe diarrhea occurs during the use of this drug, it may be indicative of pseudomembranous colitis, so inform healthcare professionals right away. If respiratory symptoms or lung issues arise, stop taking the medication and receive appropriate treatment. Neurological side effects such as dizziness, drowsiness, and headaches can occur, so caution is advised while driving or operating machinery. There may be a change in taste or smell. This drug can rarely cause severe skin diseases, thus monitoring for skin changes is essential. While using antibiotics, other infections may arise; therefore, changes in symptoms should be monitored closely. Transient hearing impairment or dizziness may occur. Women who are pregnant or may become pregnant should consult with their doctor before using this drug, and it's advisable to stop breastfeeding if currently breastfeeding. Children's dosages and duration of use should be strictly adhered to, and overdosing should be avoided. This medication has many drug interactions, so if you are taking other medicines, you must inform your healthcare provider. This drug 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 reaction, 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, abdominal discomfort, 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 paralysis, paralysis, dysgeusia, ageusia, olfactory dysfunction, anosmia, erythema multiforme, purpura, superinfection due to an overgrowth of resistant microorganisms, transient hearing loss, auditory impairment, visual impairment, blurred vision, conjunctival injection, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal hemorrhage, 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 well-closed container to prevent air from entering, away from direct sunlight, and ideally at room temperature. Room temperature is typically defined as between 15 to 25 degrees Celsius.

Appearance and packaging

Appearance

White, round, film-coated tablet

Package unit

Bottle - 30 tablets/bottle, 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.