Medication info
Roxitem Tablets (Roxithromycin)

Roxitem Tablets (Roxithromycin)

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

MFDS item code 201502237 · Approved 2015.04.15 · Insurance code 057000260

Summary

Main use
Treatment of infections (including respiratory, skin, and genital infections), prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
(Tablets) 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. The dose may be adjusted according to age and symptoms.
Child dose
(Pediatric tablets)(Granules)(Suspension) Children: The average dose used in clinical trials was 6mg (potency) per Kg of body weight per day. Administer 5~8mg (potency) per Kg of body weight per day orally in 2 divided doses. Doses by 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
The U Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of infections (including respiratory, 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 a variety of bacterial infections. It is effective for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and pneumonia, and is also used for genitourinary infections excluding sexually transmitted diseases. It also helps in the treatment of ear and sinus infections such as otitis media and sinusitis, as well as skin infections like folliculitis, boils, and soft tissue infections. It can be used for infection prevention in patients who have been in contact with individuals with meningococcal meningitis. Suitable for dental-related infections such as periodontitis and pericoronitis. Overall, it is effective for the treatment and prevention of various types of bacterial infections.

How to take

Adult dose

(Tablets) 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. The dose may be adjusted according to age and symptoms.

Child dose

(Pediatric tablets)(Granules)(Suspension) Children: The average dose used in clinical trials was 6mg (potency) per Kg of body weight per day. Administer 5~8mg (potency) per Kg of body weight per day orally in 2 divided doses. Doses by 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 severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. If you experience blistering on the skin or mucosal damage, discontinue use immediately. Individuals allergic to other antibiotics in the same class should not take this medication. Avoid co-administration with certain heart medications or allergy medications, as this may increase the risk of heart problems. Patients with impaired liver function or the elderly should exercise caution when using this medication, and regular liver function tests are recommended. Individuals with irregular heartbeats or risk of QT prolongation should also use this medication with caution. Patients with myasthenia gravis may experience worsening symptoms with this medication and should use it cautiously. This medication can cause a variety of side effects including allergic reactions, liver dysfunction, gastrointestinal issues, respiratory diseases, and neurological symptoms, so if any unusual symptoms occur, consult a healthcare professional immediately. Particularly, if diarrhea or abdominal pain worsens, it could indicate a serious bowel condition like pseudomembranous colitis. This medication may interact with other drugs, increasing the blood concentrations of certain medications and the risk of side effects, so always inform your doctor of any other medications you are taking. Women who are pregnant or might become pregnant should use this medication with caution, and nursing mothers should discontinue breastfeeding. Dizziness or blurred vision may occur, so caution is advised when driving or operating machinery. Keep out of reach of children and do not transfer the medication to another container for safety.

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, discomfort in the stomach, abdominal pain, abdominal bloating, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, numbness of the tongue, paralysis, taste disturbance, ageusia, olfactory disturbance, hyposmia, erythema multiforme, purpura, overgrowth of non-sensitive pathogens, superimposed infections, transient hearing loss, hearing impairment, visual impairment, blurred vision, conjunctival injection, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of the oral and vaginal mucosa, hallucinations, confusion

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius. Avoid storing in extremely hot or cold conditions.

Appearance and packaging

Appearance

White round film-coated tablets

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.