Wiprozi Tablet (Cefprozil Monohydrate)

Adult dose

○ Adults (13 years 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 increase 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) 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 administered 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 about 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30～120mL/min, administer according to the standard dosage and administration described above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose at the same intervals as the standard regimen. However, some of this medicine is removed by hemodialysis, so administer it after hemodialysis is completed. Once reconstituted, store refrigerated and use 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. 2) 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; for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. However, for moderate or more severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

This drug, as a cephalosporin antibiotic, should not be administered to certain patients. For example, those with a history of hypersensitivity to cephalosporin antibiotics and those with allergies to soybean oil or peanuts should not use it. Additionally, caution is needed for patients with a history of allergies to penicillin or other drugs, as there may be cross-reactivity with beta-lactam antibiotics. For severe patients or those with impaired kidney function, renal status should be closely evaluated and dosages adjusted as needed. Patients with a history of gastrointestinal diseases or abnormalities in lipid metabolism such as hyperlipoproteinemia, diabetic dyslipidemia, or pancreatitis should be administered the drug cautiously. Caution is also warranted for those allergic to the yellow dye #5 included in this medication. While using this medication, gastrointestinal adverse reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur, as well as elevated liver enzymes, skin rash, and hypersensitivity reactions have been reported. Rarely, central nervous system symptoms, blood test abnormalities, or changes in kidney function may occur, so if any unusual symptoms appear, immediate consultation with medical personnel is advised. In patients with impaired kidney function, the blood concentration of this drug may increase, raising the risk of side effects such as convulsions. Thus, dosage adjustment and monitoring are crucial. If seizures occur, the use of this drug should be discontinued and necessary treatment should be provided. To prevent resistance, it is recommended to use this drug only for the minimum duration required, based on sensitivity testing. Long-term use can cause overgrowth of resistant bacteria, so patient conditions should be closely monitored. If an allergic reaction is suspected, administration should be discontinued immediately, and emergency measures should be taken. Appropriate treatment is necessary if symptoms of pseudomembranous colitis appear. This drug may increase nephrotoxicity when combined with other cephalosporins, aminoglycosides, or diuretics, so careful monitoring is required during combination therapy. Additionally, caution is needed when using probenecid, as it can increase drug concentration. For pregnant or breastfeeding individuals, animal studies have not indicated special risks, but due to a lack of sufficient human studies, it should only be used when absolutely necessary with caution. Safety and efficacy have not been established for infants under 6 months old, and elderly patients may require dosage adjustments due to decreased renal function, which may increase drug concentration. This drug may affect the results of some clinical tests, so this should be considered during testing, and in cases of overdose, the drug is excreted through the kidneys, so patients with impaired renal function can have it removed by dialysis. Finally, this drug is not known to present risks of carcinogenicity or mutagenicity, and it is reported not to affect reproductive function.

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

This drug should be stored in a tightly sealed container that blocks light and kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness over time.

Appearance

Yellowish-orange, oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle