Medication info

Hankook Farm Bio Roxithromycin Tablet

Prescription medicationTabletOralExpired
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Hankook Farm Bio Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202000091 · Approved 2020.01.07

This product's status changed to Expired on 2025.01.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, otorhinolaryngologic, oral, skin, and nongonococcal 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. Adjust the dose as appropriate according to age and symptoms.
Child dose
(Pediatric tablets) (Granules) (Suspension) Children: The average dose used in clinical trials was 6 mg (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 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
Hankook Farm Bio Co., Ltd.

Efficacy & effects

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

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

This medication is used for various infections caused by multiple bacteria. It is particularly effective for treating respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It is also used for genital infections and sexually transmitted diseases, excluding gonorrhea, and is utilized for the treatment of otitis media and sinusitis. It can be used for soft tissue infections occurring on the skin, such as abscesses, folliculitis, and carbuncles, as well as purulent paronychia and infectious granulomas. It may be taken to prevent infection if in contact with patients with meningococcal meningitis. It is effective for dental infections such as pericoronitis and periodontitis. Thus, it is broadly used for various infectious diseases.

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. Adjust the dose as appropriate according to age and symptoms.

Child dose

(Pediatric tablets) (Granules) (Suspension) Children: The average dose used in clinical trials was 6 mg (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 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, although rarely, cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. If symptoms such as blisters on the skin or damage to mucous membranes occur, the medication should be stopped immediately. Those allergic to similar macrolide antibiotics or taking certain medications (terfenadine, astemizole, cisapride, pimethosine) should not use this medication. Also, those taking ergoline alkaloid medications should avoid this medication, as it may cause symptoms such as vascular spasms or peripheral tingling. Caution is required when used in patients with impaired liver function, elderly individuals, and when used in combination with certain antibiotics. Those with heart rhythm issues should be particularly careful, as this medication may alter the heart's electrical signals, increasing the risk of arrhythmias. This medication can rarely lead to severe allergic reactions or blood abnormalities and may cause gastrointestinal disturbances such as liver dysfunction, digestive issues, or severe diarrhea. If severe abdominal pain or hemorrhagic diarrhea occurs, the medication must be stopped immediately and medical attention sought. Additionally, if severe diarrhea occurs during or after using this medication, it may indicate pseudomembranous colitis, so medication should be stopped at once and a healthcare professional consulted. Respiratory symptoms, neurological symptoms, abnormalities in taste and smell, and transient hearing impairment may occur; it is important to report these symptoms if they arise. This medication may interact with other drugs, particularly those related to heart medications, antihistamines, anticoagulants, immunosuppressants, and sedatives. It is essential to inform a doctor or pharmacist if you are taking such medications. Women who are pregnant or may become pregnant should carefully weigh the risks and benefits of using this medication, and nursing mothers should avoid taking it if possible or stop nursing. Elderly patients may have prolonged drug concentration in the body, although special dosage adjustments are not typically necessary. If dizziness or blurred vision occurs while taking this medication, it is best to avoid driving or operating machinery. Finally, this medication should be kept out of reach of children, and it is advisable not to transfer it 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, elevated serum bilirubin, loss of appetite, nausea, vomiting, upper abdominal discomfort, abdominal pain, abdominal distension, diarrhea, pseudomembranous colitis, loose stools, hemorrhagic colitis, blood in stool, pancreatitis, bronchospasm, cough, dyspnea, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disturbance, ageusia, olfactory disorder, loss of smell, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival injection, malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, 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 sealed container to prevent air from entering, at room temperature between 1 and 30 degrees Celsius. This helps maintain the effectiveness of the medication and prevents deterioration.

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.