Medication info
Roxodrine Tablet 150 mg (Roxithromycin)

Roxodrine Tablet 150 mg (Roxithromycin)

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

MFDS item code 199701950 · Notified 1997.12.12 · Insurance code 649400560

Summary

Main use
Treatment of respiratory, ear, nose and throat, dental, skin, and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
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
Children: The average dose used in clinical trials was 6mg (potency) per kg of body weight daily. Administer 5~8mg (potency) per kg of body weight daily orally in 2 divided doses. The dose according to body weight is as follows. Children weighing 6~11Kg: Take 25mg (potency) per dose twice daily before meals (for pediatric tablets and granules only); 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); 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); take 10mL per dose twice daily before meals (for suspension only).

Ingredients

Manufacturer
Youngil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose and throat, dental, 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
  • carbuncles
View approved original text

This medication is effective for various respiratory infections including pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It is also used for otitis media and sinusitis, and helps in treating genital infections and sexually transmitted diseases other than those caused by gonococcus. In terms of skin infections, it shows efficacy against various inflammatory diseases such as folliculitis, boils, carbuncles, soft tissue infections, and lymphangitis. Additionally, it is used for the prevention of infections in individuals who have been in contact with patients with meningococcal meningitis. It can also be utilized for dental diseases such as pericoronitis and periodontal disease. Thus, it is utilized in the treatment of various infections, improving symptoms.

How to take

Adult dose

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

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

Precautions

This medication may cause serious skin reactions; if symptoms like blistering or rash occur, discontinue use immediately. Patients with allergies to this medication or other antibiotics in the same class should not use it. Patients taking certain medications such as terfenadine, astemizole, cisapride, pimozide, ergoline alkaloids, or mizolastine should not take this medication. Patients with impaired liver function or the elderly should use this medication with particular caution, and care should be taken when used in combination with other antibiotics due to potential resistance issues. This medication can affect heart rhythm, so patients with heart conditions or those taking specific antiarrhythmic medications should consult a physician before use. Patients with myasthenia gravis may experience worsening symptoms, thus caution is needed when taking this medication. Allergic reactions or shock may occur; if any unusual symptoms arise, discontinue use immediately and inform healthcare personnel. Various side effects, including liver function abnormalities, gastrointestinal issues, respiratory difficulties, neurological problems, sensory abnormalities, and skin rashes may occur; symptoms should be closely monitored. Prolonged use may lead to the development of resistant strains, so it should be used for the minimum necessary period, and condition should be continuously monitored during treatment. Patients with liver function impairment may require regular liver function tests and dosage adjustments. This medication is not significantly excreted through the kidneys, so no dosage adjustments are typically needed for patients with kidney impairment. For children, strict adherence to dosage and duration is required, and overdose should be avoided. Due to numerous drug interactions, inform healthcare personnel if any medications are being taken. Women who are pregnant or may become pregnant should use this medication only if the benefits are deemed to outweigh the risks, and nursing mothers should avoid use or discontinue breastfeeding while on this medication. Elderly patients may experience prolonged drug retention times, though dosage adjustments are generally not necessary. Symptoms such as dizziness or blurred vision may occur, requiring caution when operating machinery or driving. This medication should be stored in a secure location out of reach of children, and it is advisable not to transfer it into other containers.

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, increased serum bilirubin, loss of appetite, nausea, vomiting, gastric discomfort, gastric pain, 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, taste disturbance, ageusia, olfactory disturbance, anosmia, erythema multiforme, purpura, secondary infection due to the overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, 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 closed container to prevent exposure to air or moisture. It is best to keep the medication at room temperature, between 1 to 30 degrees Celsius, away from excessive heat or cold.

Appearance and packaging

Appearance

White round tablet

Package unit

30 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.