Ceprozen Tablet (Cefprozil Monohydrate)

Adult dose

○ Adults (13 years and older) 1) For upper respiratory tract infections, including pharyngitis and tonsillitis, administer cefprozil 500mg (potency) every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (dose increases are necessary for moderate or more severe infections). 2) For lower respiratory tract infections, including bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis, administer 500mg (potency) of this medicine every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) of this medicine 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) of this medicine every 24 hours. <Duration of administration> 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, treatment is given for about 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30～120mL/min, administer according to the standard dosage regimen above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose at the standard dosing interval. However, some of this medicine is removed by hemodialysis, so administer it after hemodialysis is completed. Once dissolved, refrigerate and take within 14 days (syrup only).

Child dose

○ Children (2～12 years) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours. 1) For 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) For otitis media among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours, and for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. For acute sinusitis with moderate or greater severity requiring an increased dose, administer 15mg per Kg of body weight every 12 hours.

This medicine is a cephalosporin antibiotic and should be avoided in certain patients. Patients who have had hypersensitivity reactions to cephalosporins should not take this medication. Patients with a history of allergies to penicillin or other drugs should be cautious when using this medicine. Particularly, about 10% of individuals with penicillin allergies may also show allergic reactions to this medication, so careful administration is necessary. Patients with severe conditions or renal function impairment must have their kidney function assessed before administration, and dosage adjustments should be made if needed. Patients suspected of having renal impairment require careful clinical observation and examination. Patients with gastrointestinal diseases, especially a history of colitis, should be cautious when using this medicine. Gastrointestinal adverse reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur while taking this medication, so symptoms should be monitored closely. Abnormal liver function, hypersensitivity, central nervous system symptoms (dizziness, headache, drowsiness, etc.), blood abnormalities, and renal function changes have also been reported as side effects, and if any abnormal symptoms occur, immediate consultation with a healthcare provider is required. The combination of this medicine with other cephalosporin antibiotics or certain diuretics may increase kidney toxicity, so careful observation is necessary when administered together. It should only be used during pregnancy when necessary, and nursing women should use this medicine cautiously, as it is excreted in small amounts into breast milk. It is best to avoid using this medication in infants under 6 months of age as safety and efficacy have not been sufficiently established. Elderly patients may need dosage adjustments due to the potential for renal function decline. When using this medicine, susceptibility testing should be performed to prevent the emergence of resistant bacteria, and it is important to administer it for the minimum necessary duration. Additionally, if diarrhea occurs after antibiotic use, the possibility of pseudomembranous colitis should be considered, and appropriate measures should be taken. In cases of overdose, the drug is eliminated through the kidneys, and renal function impaired patients may need hemodialysis.

• Diarrhea
• nausea
• vomiting
• abdominal pain
• increased AST
• increased ALT
• increased ALP
• increased bilirubin levels
• rash
• urticaria

This medicine is sensitive to light and should be stored in a container that prevents light exposure. Additionally, it is important to maintain the storage temperature at room temperature, between 1 and 30 degrees Celsius, to ensure the drug's effectiveness and safety.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle