Medication info
Roxemisin 150 mg (Roxithromycin)

Roxemisin 150 mg (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200410904 · Notified 2004.05.13 · Insurance code 643500590

Summary

Main use
Treatment of respiratory, otorhinolaryngologic, 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 orally per dose, twice daily before breakfast and dinner. For pneumonia, administer 300mg (potency) once daily before breakfast. Adjust the dose appropriately according to age and symptoms.
Child dose
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. 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
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication acts effectively against various bacterial infections. It is used to treat respiratory infections such as pharyngitis, acute bronchitis, and tonsillitis, and is also helpful in improving bacterial pneumonia and mycoplasma pneumonia. It is used for genitourinary infections excluding gonorrhea among sexually transmitted diseases, and is effective in treating otitis media and sinusitis. Furthermore, it improves various skin and soft tissue infections such as folliculitis, boils, cellulitis, lymphangitis, paronychia, and acne. It is also used for the prevention of infections when in contact with patients suffering from meningococcal meningitis and is helpful in treating periodontal disease and pericoronal inflammation. Overall, this medication is used to treat and prevent multiple bacterial infections.

How to take

Adult dose

Adults: Administer 150㎎ (potency) of roxithromycin orally per dose, twice daily before breakfast and dinner. For pneumonia, administer 300mg (potency) once daily before breakfast. Adjust the dose appropriately according to age and symptoms.

Child dose

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. 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 may cause severe 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 medication should not be used by patients who are allergic to this drug or macrolide antibiotics, those taking specific drugs (terfenadine, astemizole, cisapride, pimobendan), or those taking ergots or mizolastine. Caution is required for patients with poor liver function, the elderly, and those taking other specific antibiotics. In particular, caution should be used in patients with arrhythmias or taking related medications due to the risk of prolonged QT interval. This medication may worsen myasthenia gravis, so patients with this condition should be careful. During use, there may be occurrences of anaphylactic shock or hypersensitivity reactions, blood abnormalities, liver dysfunction, gastrointestinal issues, severe colitis, pneumonia, neurological symptoms, sensory disorders, skin rashes, and otological or ophthalmological abnormalities, and if any abnormal symptoms arise, consult medical personnel immediately. Moreover, prolonged use of this medication may lead to resistant bacteria, so it is essential to take it for the minimum period necessary after susceptibility testing. Patients with impaired liver function should adjust their dosage while regularly monitoring liver function, while those with poor kidney function do not need dosage adjustment. This medication may interact with other drugs, so it is important to inform medical personnel when taking it with specific heart-related medications, antihistamines, anticoagulants, immunosuppressants, sedatives, or digoxin. Pregnant women or those who may become pregnant should carefully consider the benefits and risks of using this medication, and nursing mothers should avoid administration or cease breastfeeding. No dosage adjustment is required for the elderly, but they should be cautious due to the potential for dizziness or visual disturbances while operating machinery or driving. Finally, this medication should be stored out of reach of children and should not be transferred to 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, dyspepsia, stomach pain, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, blood in stool, pancreatitis, symptoms of membranous colitis, bronchospasm, cough, dyspnea, chest X-ray abnormalities, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste distortion, ageusia, olfactory abnormalities, anosmia, erythema multiforme, purpura, superinfection due to excessive growth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual impairment, blurred vision, conjunctival injection, systemic malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual irregularities, inflammation of oral and vaginal mucous membranes, hallucinations, confusion

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

Storage

This medication should be stored in an airtight container to protect it from air and moisture. It is crucial to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve its effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 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.