Medication info

Roxithromycin Suspension

Prescription medicationSuspensionOralApproval withdrawn
Ingredient · strength
Roxithromycin›1000mg / 100mL
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
A red syrupy suspension with strawberry flavor contained in an aluminum foil (for export only) or an opaque plastic bottle.
Packaging
500mL/bottle
Approval status
Approval withdrawn

MFDS item code 200201405 · Notified 2002.11.16 · Insurance code 671801441

This product's status changed to Approval withdrawn on 2025.12.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, ear, nose, and dental infections, and skin and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
Adults: Administer 150㎎ (potency) of roxithromycin per dose orally 2 times 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 patients: The average dose used in clinical trials was 6 mg (potency) per kg of body weight per day. This medicine is administered orally in 2 divided doses of 5–8 mg (potency) per kg of body weight per day. The dosage according to body weight is as follows. Children weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only); 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); 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); take 10 mL per dose twice daily before meals (suspension only). Shake the suspension well before use. (Suspension only)

Ingredients

Manufacturer
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose, and dental infections, and skin 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
  • furuncles
View approved original text

This medication is used to treat various infections caused by different bacteria. Specifically, it is effective against respiratory infections such as pharyngitis, tonsillitis, acute bronchitis, and bacterial pneumonia. It is also used to treat genital infections and sexually transmitted diseases, excluding gonococcal infections, and can be used for otitis media and sinusitis. For skin infections, it treats various inflammatory conditions such as folliculitis, boils, cellulitis, and purulent paronychia. It can also be taken to prevent infection if exposed to meningitis bacteria, and it helps in the treatment of periodontal diseases such as pericoronitis and periodontitis. This medication is thus utilized for the treatment and prevention of bacterial infections in a wide range.

How to take

Adult dose

Adults: Administer 150㎎ (potency) of roxithromycin per dose orally 2 times 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 patients: The average dose used in clinical trials was 6 mg (potency) per kg of body weight per day. This medicine is administered orally in 2 divided doses of 5–8 mg (potency) per kg of body weight per day. The dosage according to body weight is as follows. Children weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only); 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); 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); take 10 mL per dose twice daily before meals (suspension only). Shake the suspension well before use. (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 or skin rashes such as blisters or mucosal damage appear, use should be immediately discontinued. This medication should not be used by individuals who have allergic reactions to it or similar antibiotics. It should also be avoided by those taking specific medications like terfenadine, astemizole, cisapride, pimozide, ergot alkaloids, or mizolastine due to potential risks. Patients with impaired liver function or the elderly should use it with greater caution, and care must be taken regarding resistance issues when used with other antibiotics. Additionally, because this medication can affect heart rhythm, patients with heart diseases or electrolyte imbalances should be careful. Serious allergic reactions such as anaphylactic shock can occur, so immediate discontinuation of medication and seeking medical attention is necessary if symptoms like fever, rash, or breathing difficulties arise. Liver or blood abnormalities may occur, and gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea may appear. In particular, severe diarrhea or abdominal pain may indicate pseudomembranous colitis, and immediate consultation with a doctor is required. This medication may affect the ears and eyes, potentially causing temporary hearing impairment or blurred vision. Pregnant women or those who could become pregnant should carefully consider using this medication, as it could impact the fetus, and breastfeeding women should avoid use or stop breastfeeding, as the drug may be excreted in breast milk. Dizziness or visual disturbances may occur, so caution is advised when operating machinery or driving while on this medication. This medication should be kept out of reach of children, and transferring it to other containers should be avoided as it may lead to quality degradation or accidents.

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, increased serum bilirubin, loss of appetite, nausea, vomiting, gastric discomfort, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, bloody stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, anosmia, loss of smell, erythema multiforme, purpura, secondary infections caused by the overgrowth 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 is sensitive to light; it should be stored in a special container that prevents light penetration. Additionally, the medication should be stored at room temperature between 15°C and 25°C to maintain its effectiveness.

Appearance and packaging

Appearance

A red syrupy suspension with strawberry flavor contained in an aluminum foil (for export only) or an opaque plastic bottle.

Package unit

500mL/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.