Medication info
Romycin Tablet 150 mg (Roxithromycin)

Romycin Tablet 150 mg (Roxithromycin)

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

MFDS item code 199700870 · Notified 1997.10.10

Summary

Main use
Treatment of respiratory, ear, nose and throat, dental, skin, and nongonococcal genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
(Tablets) Adults: Administer 150 mg (potency) of roxithromycin orally per dose twice daily, before breakfast and dinner. For pneumonia, administer 300 mg (potency) once daily before breakfast. Adjust the dose appropriately 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 5–8 mg (potency) per kg of body weight per day orally in 2 divided doses. Children usually weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 2.5 mL per dose twice daily before meals (suspension only). Children weighing 12–23 kg: Take 50 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 5 mL per dose twice daily before meals (suspension only). Children weighing 24–40 kg: Take 100 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 10 mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Daewoo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose and throat, dental, 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
  • furunculosis
  • abscess
  • carbuncle
View approved original text

This medication is used to treat infections caused by various bacteria. The main indications include respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and Mycoplasma pneumonia. It is also effective in treating genital infections and sexually transmitted diseases, excluding infections caused by gonorrhea. This medication is used for the treatment of various skin infections including furunculosis, abscess, cellulitis, and lymphangitis, as well as otitis media and sinusitis. It is beneficial in preventing infections in patients who have been in contact with meningococcal meningitis.

How to take

Adult dose

(Tablets) Adults: Administer 150 mg (potency) of roxithromycin orally per dose twice daily, before breakfast and dinner. For pneumonia, administer 300 mg (potency) once daily before breakfast. Adjust the dose appropriately 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 5–8 mg (potency) per kg of body weight per day orally in 2 divided doses. Children usually weighing 6–11 kg: Take 25 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 2.5 mL per dose twice daily before meals (suspension only). Children weighing 12–23 kg: Take 50 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 5 mL per dose twice daily before meals (suspension only). Children weighing 24–40 kg: Take 100 mg (potency) per dose twice daily before meals (pediatric tablets and granules only), or take 10 mL per dose twice daily before meals (suspension only).

Precautions

This drug may cause severe blistering skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, so it should be discontinued immediately if symptoms such as blisters or mucosal damage occur. Patients with hypersensitivity to this medication or those taking specific drugs, particularly terfenadine, astemizole, cisapride, pimozide, ergot alkaloids, or mizolastine, should not use this medication. Patients with impaired liver function or the elderly should use this medication with caution, and there may be issues with resistance if used with certain other antibiotics. This drug can prolong the QT interval related to heart rhythm, so patients with congenital long QT syndrome or a risk of arrhythmias should consult a doctor before use. Patients with myasthenia gravis should use this medication cautiously as it may exacerbate symptoms. This medication can cause various side effects, including allergic reactions, blood abnormalities, liver dysfunction, gastrointestinal symptoms, respiratory issues, neurological symptoms, sensory disorders, skin reactions, auditory and visual disturbances, so if any unusual symptoms appear, you should notify your healthcare provider immediately. Especially in cases of diarrhea, abdominal pain, or bloody stools, serious intestinal conditions such as pseudomembranous colitis may arise, and the medication should be discontinued immediately and medical attention sought. Long-term use of this medication may lead to the development of resistant bacteria or new infections, so it should be used for the minimum necessary duration, and the patient's condition should be monitored continuously. Patients with liver impairment should undergo regular liver function tests and dosage adjustments may be necessary, while patients with poor kidney function do not require dosage adjustment. Excessive dosages in children should be avoided, and the prescribed dosages and durations must be adhered to. This drug can interact with other medications, especially heart-related drugs, antihistamines, antibiotics, anticoagulants, immunosuppressants, and sedatives, so it is essential to consult a doctor or pharmacist when co-administering. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this medication, and breastfeeding mothers should ideally avoid its use or stop breastfeeding. The elderly may experience a prolonged half-life of this medication, but generally, dosage adjustments are not necessary. While taking this medication, dizziness, visual disturbances, and blurred vision may occur, requiring caution when driving or operating machinery. Lastly, this medication should be stored out of reach of children and should not be transferred to other containers to ensure safety and maintain quality.

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, discomfort in the upper abdomen, stomach pain, abdominal pain, abdominal bloating, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue numbness, paralysis, taste disorder, ageusia, olfactory disorder, anosmia, erythema multiforme, purpura, superinfection due to excessive growth of non-susceptible pathogens, transient hearing loss, auditory disability, visual disturbances, blurred vision, conjunctival injection, generalized 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 should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Doing so will help preserve the medication's efficacy and safety over time.

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.