Medication info

RomaWin Tablet 150 mg (Roxithromycin)

Prescription medicationApproval withdrawn
Ingredient · strength
Roxithromycin›Strength being verified
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201804511 · Approved 2018.11.14

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory, ear, nose and throat, and dental infections, and genital and skin infections; prevention of meningococcal infection
Who uses it
Adults
Adult dosage
Adults: Administer roxithromycin 150㎎ (potency) orally twice daily, before breakfast and dinner. For pneumonia, administer 300mg (potency) once daily before breakfast. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose and throat, and dental infections, and genital and skin infections; prevention of meningococcal infection

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

This medicine is effective against various bacteria, including Streptococcus, Streptococcus pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, and Bordetella pertussis. It is mainly used for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It can also be used for the treatment of genital infections and sexually transmitted diseases, excluding those caused by Neisseria gonorrhoeae. It helps treat various infections such as ear and sinus inflammation, folliculitis, and various skin infections, cellulitis, and purulent paronychia. It is also used for infection prevention in cases of contact with patients with meningococcal meningitis. Additionally, it is effective in treating oral infections such as periapical inflammation and periodontitis. Overall, this medicine helps prevent and treat various bacterial infections.

Dosage and Administration

Adult dosage

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

Precautions

This medication may rarely cause severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. If symptoms such as blistering of the skin or mucosal damage occur, discontinue use immediately. This medication should not be used in patients with allergies to macrolide antibiotics or those taking certain medications. Specifically, it is important to avoid concurrent use with terfenadine, astemizole, cisapride, pizotifen, ergot alkaloids, or mizolastine. Caution is required in patients with impaired liver function, elderly patients, and when used with other antibiotics. This medication may affect cardiac electrical signals, so patients with heart disease or prolonged QT intervals should consult a physician before use. This medication may cause allergic reactions, liver function abnormalities, gastrointestinal disturbances, and rarely serious pneumonia or neurological symptoms. If any unusual symptoms occur, notify healthcare professionals immediately. The treatment duration should be the minimum necessary period after confirming the bacterial susceptibility, and patients with liver dysfunction should undergo regular liver function tests. This medication may interact with multiple drugs, so anyone currently taking other medications should inform healthcare professionals, especially when taking heart-related medications or those metabolized in the liver. Pregnant women or those who may become pregnant should consult a physician thoroughly before using this medication because it may affect the fetus. If breastfeeding, it is advisable to avoid taking this medication or stop breastfeeding if possible. Dizziness or visual disturbances may occur, so care should be taken when driving or operating machinery. Lastly, this medication should be kept out of the reach of children and not 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, increased AST, increased ALT, increased ALP, elevated serum bilirubin, loss of appetite, nausea, vomiting, dyspepsia, 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 numbness, paralysis, dysgeusia, ageusia, olfactory disturbance, anosmia, erythema multiforme, purpura, superinfection due to overgrowth of resistant pathogens, temporary hearing loss, auditory impairment, vision disorder, blurred vision, conjunctival injection, generalized malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, nasal bleeding, 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 should be stored in a tightly closed container to prevent air or moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

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.

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.