Medication info
Roxitrol Tablets (Roxithromycin)

Roxitrol Tablets (Roxithromycin)

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

MFDS item code 201405434 · Approved 2014.11.21 · Insurance code 628800450

Summary

Main use
Treatment of respiratory, otolaryngologic, dental, skin, and genital infections; prevention of meningococcal infection
Who takes it
Adults
Adult dose
Adults: Administer roxithromycin 150㎎ (potency) 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.

Ingredients

Manufacturer
Hewbist Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat upper respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and bacterial and mycoplasma pneumonia. It is also effective for genitourinary infections and sexually transmitted diseases (excluding gonorrhea), as well as for otitis media and sinusitis. It is helpful in treating various skin-related infections such as folliculitis, boils, soft tissue infections, and periungual infections. It is used for infection prevention in cases of contact with patients who have meningococcal meningitis. Additionally, it is utilized for dental infections such as periodontal disease and pericoronal infections. This medication effectively improves various types of bacterial infections.

How to take

Adult dose

Adults: Administer roxithromycin 150㎎ (potency) 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.

Precautions

This medication can occasionally cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which are serious blistering skin reactions. Therefore, if symptoms such as blistering on the skin or mucosal damage occur, treatment should be stopped immediately. This medication should not be used in patients who are allergic to this drug or macrolide antibiotics, in patients currently taking certain medications (terfenadine, astemizole, cisapride, pimodivir, etc.), or in patients who are taking ergots or mizolastine. Use cautiously in patients with impaired liver function or in the elderly, as there may be interactions when used with other antibiotics. Additionally, this medication can prolong the QT interval, which is part of the heart’s electrical signal; special caution is required for patients with heart disease or those taking certain antiarrhythmic medications. Patients with myasthenia gravis should be aware that this medication can worsen their symptoms. While taking this medication, various side effects may occur such as allergic reactions, blood abnormalities, liver function issues, gastrointestinal problems, respiratory symptoms, neurological symptoms, sensory disturbances, and skin rashes, so any unusual symptoms should be reported to a doctor immediately. Particularly, if diarrhea or abdominal pain worsens, it may indicate a serious intestinal condition like pseudomembranous colitis; treatment should be stopped immediately and healthcare professional should be notified. This medication has many drug interactions, and taking it with other drugs may lead to heart problems or changes in drug concentration, so be sure to inform your healthcare provider of any other medications being taken. Women who are pregnant or may become pregnant should carefully consider the potential benefits and risks of using this medication as it might affect the fetus. If breastfeeding, it is recommended to discontinue breastfeeding or avoid use if possible, as this medication can be transmitted in small amounts through breast milk. The elderly may experience a prolonged half-life of this medication, but routine dose adjustments are not necessary. Dizziness or blurring of vision may occur while taking this medication; caution is necessary when driving or operating machinery. Lastly, this medication should be stored 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, 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, olfactory disturbance, anosmia, erythema multiforme, purpura, superinfection due to 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, mucosal inflammation of the mouth and vagina, 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 from entering and kept at room temperature away from direct sunlight. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Biconvex white round tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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.