Cephrozil Tablets (Cepharozil Hydrate)

Adult dose

○ Adults (13 years of age and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer cefprozil 500mg (potency) every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (dose escalation is required for moderate or more severe infections). 2) For bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500mg (potency) every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) every 12 hours [or 500mg (potency) every 24 hours], or administer 500mg (potency) every 12 hours according to symptoms. 4) For uncomplicated urinary tract infections, administer 500mg (potency) every 24 hours. <Duration of treatment> Treatment is generally given for about 10 days; however, for pharyngitis/tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic), administer for 10 days or longer. For uncomplicated cystitis, administer for approximately 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30～120mL/min, administer according to the standard dose and regimen above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose at the standard dosing interval. However, since some of this medicine is removed by hemodialysis, administer it after hemodialysis is completed.

Child dose

○ Children (2～12 years) — Upper respiratory tract infections, including pharyngitis and tonsillitis: Administer 7.5mg (potency) per Kg of body weight per dose every 12 hours. ○ Children (2～12 years) — Uncomplicated skin and soft tissue infections: Administer 20mg (potency) per Kg of body weight per dose every 24 hours. ○ Infants and children (6 months～12 years) — Upper respiratory tract infections, including otitis media: Administer 15mg per Kg of body weight every 12 hours. ○ Infants and children (6 months～12 years) — Acute sinusitis: Administer 7.5mg per Kg of body weight every 12 hours. However, for infections of moderate or greater severity requiring a higher dose, administer 15mg per Kg of body weight every 12 hours.

This drug is a cephalosporin antibiotic and should not be administered to certain patients. First, patients who have had allergic reactions to cephalosporins should not take this medication. Additionally, patients with allergies to penicillin or other antibiotics should be very cautious when using this drug. Particularly, patients with impaired renal function or suspected kidney disorders should check their renal status thoroughly before administration and may need to reduce the dosage. Caution is also necessary for patients with a history of gastrointestinal diseases, especially colitis. During treatment, gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur. Liver function abnormalities may be observed, so liver enzyme levels should be monitored. Allergic reactions such as skin rashes or hives may occur, especially in children. Central nervous system symptoms such as dizziness, headache, and drowsiness have rarely been reported, and seizures may occur infrequently, so caution is advised. Blood tests may reveal leukopenia or increased eosinophils, and renal function test results may change. Long-term use of this drug may lead to the development of resistant bacteria and excessive growth of non-susceptible organisms, so it is important to use for the necessary duration only. If allergic symptoms occur, administration should be stopped immediately, and appropriate emergency care should be sought. If diarrhea occurs after taking this medication, the possibility of pseudomembranous colitis should be considered, and immediate consultation with a healthcare professional is necessary. Caution is required in combination with other antibiotics or diuretics, as renal toxicity may increase. During pregnancy, it should be used only when essential, and during breastfeeding, caution is advised due to unknown effects on the baby. It should be avoided in infants under 6 months of age, as safety and efficacy have not been established. Elderly patients may require dosage adjustments due to declining renal function. This medication may affect certain clinical test results, so patients should inform healthcare professionals during testing. In case of overdose, since it is excreted via the kidneys, blood dialysis may be necessary for patients with reduced renal function. Lastly, this drug does not carry risks of carcinogenicity or mutagenicity, and reproductive dysfunction was not found in animal studies.

• Diarrhea
• nausea
• vomiting
• abdominal pain
• elevated AST
• elevated ALT
• elevated ALP
• elevated bilirubin levels
• cholestatic jaundice
• rash

This drug may be sensitive to light, so it should be stored in a container that blocks light. Additionally, it is best to store the medication at room temperature, typically between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

Yellowish-orange, oblong, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle