JRLoxithromycin Tablets (Loxithromycin)

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 6mg (potency) per Kg of body weight daily. This medicine is administered orally at 5～8mg (potency) per Kg of body weight daily in 2 divided doses; doses according to body weight are as follows. Children weighing 6～11Kg: 25mg (potency) per dose twice daily before meals (pediatric tablets and granules only); 2.5mL per dose twice daily before meals (suspension only). Children weighing 12～23Kg: 50mg (potency) per dose twice daily before meals (pediatric tablets and granules only); 5mL per dose twice daily before meals (suspension only). Children weighing 24～40Kg: 100mg (potency) per dose twice daily before meals (pediatric tablets and granules only); 10mL per dose twice daily before meals (suspension only).

This medication may cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, although rarely. If any abnormal skin symptoms appear, such as blisters or mucosal lesions, discontinue use immediately. This medication should not be used by patients allergic to macrolide antibiotics or those taking certain medications (terfenadine, astemizole, cisapride, pimethixene, ergot alkaloids, mizolastine). Patients with impaired liver function, elderly patients, and those using it in conjunction with other antibiotics should use it with caution, as there is a risk of cardiac side effects. This medication may worsen the symptoms of myasthenia gravis, so these patients should consult a physician before use. During treatment, various side effects such as allergic reactions, blood disorders, liver function abnormalities, gastrointestinal problems (abdominal pain, diarrhea), pneumonia symptoms, neurological abnormalities, skin rashes, hearing loss may occur, so if any abnormal symptoms appear, consult a doctor immediately. If severe diarrhea or abdominal pain occurs, it may indicate antibiotic-associated colitis, so discontinue use immediately and inform healthcare professionals. This medication should only be used for the minimum duration necessary to prevent the occurrence of resistant bacteria, and patients with impaired liver function may need to undergo regular liver function tests and possibly dose adjustments. Patients with poor kidney function do not require special dose adjustments. In children, excessive doses should be avoided, and recommended doses and duration should be adhered to. This medication may interact with other drugs, so particularly when taken alongside cardiac drugs, antihistamines, anticoagulants, immunosuppressants, and sedatives, one must consult with a physician or pharmacist. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of this medication, and nursing mothers should either avoid taking it or stop breastfeeding. In the elderly, the half-life of the medication may be prolonged, but dose adjustments are not necessary. If dizziness or blurred vision occurs during use, caution should be exercised when driving or operating machinery. This medication should be kept out of reach of children, and transferring it to other containers may not be good for quality maintenance.

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, anorexia, nausea, vomiting, gastric discomfort, dyspepsia, abdominal pain, abdominal distension, diarrhea, membrane colitis, watery stools, hemorrhagic colitis, blood in stools, pancreatitis, bronchospasm, cough, dyspnea, abnormal chest X-ray, interstitial pneumonia, drowsiness, headache, dizziness, tongue paralysis, paralysis, dysgeusia, ageusia, olfactory disturbance, loss of smell, erythema multiforme, purpura, superinfection due to overgrowth of non-susceptible pathogens, transient hearing loss, auditory impairment, visual impairment, blurred vision, conjunctival injection, general malaise, weakness, palpitations, QT prolongation, ventricular tachycardia, arthralgia, epistaxis, menstrual disorder, inflammation of oral and vaginal mucosa, hallucinations, confusion

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle