Medication info
Roxatop Tablet (Roxithromycin)

Roxatop Tablet (Roxithromycin)

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

MFDS item code 200402476 · Notified 2004.12.04 · Insurance code 670100340

Summary

Main use
Treatment of respiratory, ear, and nasal infections and skin, genital, and dental infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
(Tablets) Adults: Roxithromycin 150㎎ (potency) per dose is administered orally twice daily, in the morning and evening before meals. For pneumonia, 300mg (potency) is administered once daily before breakfast. The dose may be adjusted according to age and symptoms.
Child dose
(Pediatric tablets)(Granules)(Suspension) Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight daily. This drug is administered orally in 2 divided doses of 5~8mg (potency) per kg of body weight daily; doses according to body weight are as follows. Children usually 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). 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). 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
Pharmgen Science Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, and nasal infections and skin, genital, and dental infections; prevention of meningococcal infection

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

This medication is effective for treating infections caused by various bacteria. It is primarily used for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It also helps in treating urogenital infections excluding gonorrhea and sexually transmitted diseases. It can be prescribed for inflammation of the ear and sinuses such as otitis media and sinusitis. It is effective for treating various skin and soft tissue infections including folliculitis, boils, cellulitis, and purulent paronychia. It is used for infection prevention in cases of contact with patients with meningococcal meningitis and 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

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

Child dose

(Pediatric tablets)(Granules)(Suspension) Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight daily. This drug is administered orally in 2 divided doses of 5~8mg (potency) per kg of body weight daily; doses according to body weight are as follows. Children usually 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). 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). 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 medication can rarely cause serious skin reactions, so it should be discontinued immediately if blisters appear on the skin or mucous membrane damage occurs. Patients allergic to antibiotics of the same class or those taking certain cardiac and neurological medications should not use this drug. Patients with poor liver function or elderly patients should use this medication cautiously, and care should be taken for possible drug interactions if used with other antibiotics. This medication may affect heart rhythm, so individuals with heart disease or those taking specific medications should consult a physician. Patients with myasthenia gravis should be cautious as this medication may exacerbate symptoms. While using, allergic reactions, blood disorders, liver function abnormalities, gastrointestinal issues, respiratory problems, neurological symptoms, sensory disturbances, skin rashes, hearing issues may appear, so if any abnormal symptoms occur, discontinue use immediately and consult a healthcare professional. Long-term use may increase the risk of resistant bacteria and recurrent infections, so it should only be used for the necessary minimum duration. Patients with impaired liver function should have regular liver function tests and adjust the dosage accordingly. For children, the established dosage and duration should be adhered to, and care should be taken not to overdose. This medication can interact with other drugs, and side effects may occur when taken with certain medications, so it is crucial to inform the healthcare provider of any medications being taken. Pregnant or nursing women should consult a physician before using this medication as it may affect the fetus or baby. Elderly patients may have a prolonged elimination half-life of the drug, but generally, dosage adjustment is not required. Dizziness or blurred vision may occur, so caution should be taken when driving or operating machinery while taking this medication.

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, blood in stool, pseudomembranous colitis, bronchospasm, cough, shortness of breath, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, paresthesia of the tongue, paralysis, taste disturbances, ageusia, olfactory disturbances, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, dizziness, visual impairment, blurred vision, conjunctival injection, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual disorders, inflammation of oral and vaginal mucous membranes, hallucinations, confusion

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress and kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets, 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.

Questions about this medicine

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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.