Medication info
Roximycin Tablet (Roxithromycin)

Roximycin Tablet (Roxithromycin)

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

MFDS item code 199700945 · Notified 1997.10.11 · Insurance code 642701260

Summary

Main use
Treatment of respiratory, ear, nose and throat, dental, skin, and genital infections; prevention of meningococcal infection
Who takes it
Adults · Children
Adult dose
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 appropriately according to age and symptoms.
Child dose
Children: The mean dose used in clinical trials was 6mg (potency) per Kg of body weight per day. Administer this drug orally at 5~8mg (potency) per Kg of body weight per day 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 (pediatric tablets and granules only), or 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), or 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), or 10mL per dose twice daily before meals (suspension only).

Ingredients

Manufacturer
Dongwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is an antibiotic that effectively suppresses various bacteria such as Streptococcus, Streptococcus pneumoniae, Neisseria meningitidis, Neisseria gonorrhoeae, Bordetella pertussis, Corynebacterium diphtheriae, and Clostridium perfringens. It is primarily used for the treatment of respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. This medication is also effective for genital infections other than gonorrhea, as well as otitis media and sinusitis. Additionally, it is helpful in the treatment of skin and soft tissue infections such as folliculitis, furuncles, carbuncles, and soft tissue infections. Furthermore, it is used for infection prevention in cases of contact with patients suffering from meningococcal meningitis, as well as for the treatment of dental-related infections such as pericoronitis and periodontitis. It is effective in treating and preventing various bacterial infections.

How to take

Adult dose

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 appropriately according to age and symptoms.

Child dose

Children: The mean dose used in clinical trials was 6mg (potency) per Kg of body weight per day. Administer this drug orally at 5~8mg (potency) per Kg of body weight per day 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 (pediatric tablets and granules only), or 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), or 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), or 10mL per dose twice daily before meals (suspension only).

Precautions

This medication can rarely cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If symptoms such as skin rash, blisters, or mucous membrane damage occur, discontinue use immediately. Patients with allergies to this medication or similar types of antibiotics should not take it. It is also important to inform of any currently taken medications, as serious side effects may occur when taken with certain drugs. Patients with impaired liver function or the elderly should use this medication cautiously and may need liver function tests. This medication may affect heart rhythms; therefore, patients with heart diseases or those taking specific antiarrhythmic medications should exercise caution. This medication can exacerbate symptoms of myasthenia gravis, so caution is advised for patients with this condition. If any adverse symptoms such as allergic reactions, fever, rash, blood abnormalities, liver issues, gastrointestinal symptoms, or respiratory difficulties occur during treatment, inform healthcare professionals immediately. Long-term use may risk the emergence of resistant bacteria and co-infections, so continuous monitoring of the condition is necessary. Women who are pregnant or may become pregnant should carefully consider the risks and benefits before taking this medication, and nursing mothers should avoid its use or stop breastfeeding. Dizziness or blurred vision may occur; hence caution is needed when driving or operating machinery. 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 eruptive pustulosis
  • shock
  • fever
  • rash
  • allergic skin reactions
  • angioedema
  • eosinophilia
  • agranulocytosis
Show 54 more
  • 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
  • gastric pain
  • abdominal pain
  • abdominal distension
  • diarrhea
  • pseudomembranous colitis
  • loose stools
  • hemorrhagic colitis
  • bloody stools
  • pancreatitis
  • bronchospasm
  • cough
  • dyspnea
  • abnormal chest X-ray findings
  • interstitial pneumonia
  • drowsiness
  • headache
  • dizziness
  • tongue numbness
  • paralysis
  • dysgeusia
  • ageusia
  • olfactory disturbances
  • loss of smell
  • erythema multiforme
  • purpura
  • visual impairment
  • blurred vision
  • conjunctival injection
  • generalized malaise
  • weakness
  • palpitations
  • QT interval prolongation
  • ventricular tachycardia
  • arthralgia
  • epistaxis
  • menstrual irregularities
  • inflammation of oral and vaginal mucosa
  • hallucinations
  • confusion
  • hearing loss
  • auditory impairment

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

Storage

Store this medication in a tightly closed container to prevent air or moisture ingress. It is best stored at room temperature, meaning at a normal room temperature that is not too hot or cold.

Appearance and packaging

Appearance

White, round film-coated tablets that are convex on both sides

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.

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.