Medication info
Roxithromycin 150 mg Tablet

Roxithromycin 150 mg Tablet

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

MFDS item code 201702610 · Approved 2017.05.26 · Insurance code 693902480

Summary

Main use
Treatment of respiratory, ear, nose, and throat, and dental infections; treatment of skin and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
Adults: The usual dose of roxithromycin is 150㎎ (potency) orally twice daily, in the morning and evening before meals. For pneumonia, administer 300mg (potency) once daily before breakfast. The dose may be adjusted as appropriate according to age and symptoms.
Child dose
Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight daily. This medicine is administered orally in 2 divided doses of 5~8mg (potency) per kg of body weight daily. The doses according to body weight are 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
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

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

This medication is used to treat various bacterial infections. It is primarily effective against respiratory infections such as pharyngitis, acute bronchitis, and tonsillitis, as well as bacterial pneumonia and mycoplasma pneumonia. It is also used for genitourinary infections and sexually transmitted diseases, otitis media, and sinusitis. It is used to treat various skin and soft tissue infections, for example, folliculitis, boils, cellulitis, and paronychia. Additionally, it helps prevent infections when in contact with patients with meningococcal meningitis. It is also used for the treatment of periodontal disease and pericoronitis, contributing to the improvement of infections in patients.

How to take

Adult dose

Adults: The usual dose of roxithromycin is 150㎎ (potency) orally twice daily, in the morning and evening before meals. For pneumonia, administer 300mg (potency) once daily before breakfast. The dose may be adjusted as appropriate according to age and symptoms.

Child dose

Children: The mean dose used in clinical trials was 6mg (potency) per kg of body weight daily. This medicine is administered orally in 2 divided doses of 5~8mg (potency) per kg of body weight daily. The doses according to body weight are 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 can cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If progressive skin rash symptoms such as blistering or mucosal damage occur, discontinue use immediately. This drug should not be used in patients who are allergic to this medication or other antibiotics in the same class. Serious side effects may occur when taken with specific medications, so it is essential to inform your doctor of any current medications. Patients with poor liver function or elderly patients need to exercise more caution when using this drug. Since this medication may affect heart rhythms, patients with arrhythmias or at risk for heart disease should consult a doctor before administration. This medication may worsen myasthenia gravis, so it should be used with caution in patients with this condition. Rarely, an allergic reaction may cause shock; therefore, inform healthcare personnel immediately if any abnormal symptoms occur. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea may occur; if severe diarrhea or abdominal pain occurs, discontinue the medication immediately. Serious intestinal diseases like pseudomembranous colitis may occur during the use of this medication, so inform healthcare personnel if persistent diarrhea or bleeding occurs. Discontinue use and seek appropriate treatment if symptoms such as shortness of breath or coughing arise. Neurological symptoms such as dizziness, drowsiness, and headaches may occur, requiring caution when driving or operating machinery. This medication may increase blood concentrations of other drugs metabolized in the liver, causing side effects, so inform your doctor of any other medications you are taking. Women who are pregnant or may become pregnant should consult their doctor before use, as this medication may affect the fetus. During breastfeeding, the medication may be transmitted in small amounts through breast milk, so it's advisable to consider stopping breastfeeding or other alternatives if possible. In children, dosage and duration of treatment must be strictly adhered to, and overdosing should be avoided. This medication should be stored out of reach of children and transferred to other containers should be avoided.

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, upper abdominal discomfort, dyspepsia, gastric pain, abdominal pain, abdominal distension, diarrhea, hemorrhagic colitis, hematochezia, pseudomembranous colitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, olfactory disturbance, anosmia, erythema multiforme, purpura, superinfection with non-susceptible pathogens, transient hearing loss, auditory impairment, visual impairment, blurred vision, conjunctival injection, generalized fatigue, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nosebleeds, menstrual abnormalities, inflammation of oral and vaginal mucosa, hallucinations, confusion

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. To maintain the drug's effectiveness, it is best to store it in a cool room away from direct sunlight.

Appearance and packaging

Appearance

White round film-coated 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.