Medication info
Gloksin Tablets (Roxithromycin)

Gloksin Tablets (Roxithromycin)

Prescription medicationTabletOral
Ingredient · strength
Roxithromycin›150mg / 1 tablet
Manufacturer / importer
Kips Biopharma Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201206968 · Approved 2012.09.27 · Insurance code 693200720

Summary

Main use
Treatment of respiratory, ear, nose, throat, and dental infections; skin and nongonococcal 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. The dose may be adjusted 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
Kips Biopharma Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose, throat, and dental infections; 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
  • boils
  • abscesses
View approved original text

This medication is used to treat various types of bacterial infections. It is effective for respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, bacterial pneumonia, and mycoplasma pneumonia. It also helps in the treatment of genital infections and sexually transmitted diseases excluding gonorrhea. It is used for infections of the ear and nasal areas, such as otitis media and sinusitis. The drug is effective for a variety of skin conditions as well, including folliculitis, boils, abscesses, cellulitis, and perionychia. Additionally, it is used to prevent meningococcal infections and treat periodontal disease, contributing to the overall treatment of 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. The dose may be adjusted 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 rarely cause serious skin conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If progressive rashes appear, such as blistering of the skin or mucosal damage, stop taking this medication immediately. This medication should not be used by individuals who are allergic to this drug or similar classes of antibiotics, or by those taking certain medications. Patients with impaired liver function or the elderly should be cautious when using this medication. This medication may prolong the QT interval related to heart rhythm, requiring caution in those with heart diseases or in those taking certain medications. Additionally, it may exacerbate muscle disorders known as myasthenia gravis, so patients with this history should be cautious. Although rare, severe allergic reactions or anaphylactic shock may occur; thus, if any unusual symptoms arise during treatment, medical consultation is required. Gastrointestinal side effects may include decreased appetite, nausea, vomiting, abdominal pain, and diarrhea, especially severe diarrhea accompanied by bleeding, necessitating immediate discontinuation. This medication may rarely cause pneumonia, hepatitis, blood abnormalities, neurological symptoms, taste and smell disturbances, hearing impairments, and auditory disabilities. Long-term use may carry the risk of resistant bacteria and superinfections, so continual monitoring of the patient's condition is necessary. This drug may interfere with the metabolism of other medications in the liver, potentially raising blood levels of certain drugs, necessitating caution when combined with other medications. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of using this medication, and those who are breastfeeding should either avoid its use or discontinue breastfeeding. Symptoms such as dizziness or blurred vision may occur, so caution is advised when driving or operating machinery. This medication should be kept out of reach of children, and changing the storage container should be avoided as it can adversely affect the product's quality.

Side effects

Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, 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, discomfort in the upper abdomen, abdominal pain, abdominal distension, diarrhea, membranous colitis, loose stools, hemorrhagic colitis, pancreatitis, bronchospasm, cough, dyspnea, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, olfactory disturbances, loss of smell, erythema multiforme, purpura, secondary infections due to overgrowth of non-susceptible pathogens, temporary hearing loss, auditory impairment, visual disturbances, blurred vision, conjunctival injection, generalized 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 sealed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way will help ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 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.