Prosezil Tablet 250 mg (Cefprozil Hydrate)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 500mg (potency) of cefprozil every 24 hours as a single dose; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (a dose increase is needed for moderate or more severe infections). 2) For bacterial secondary infection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500mg (potency) of this medicine every 12 hours as a single dose. 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 depending on symptoms. 4) For uncomplicated urinary tract infections, administer 500mg (potency) of this medicine every 24 hours. <Duration of administration> Administration is generally 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) For creatinine clearance of 30～120mL/min, administer according to the standard dosage regimen above. 2) For creatinine clearance of 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 reconstituted, store in a refrigerator and use within 14 days (syrup only).

Child dose

○ Children (2～12 years) — Pharyngitis and tonsillitis among upper respiratory tract infections: Administer 7.5mg (potency)/kg body weight per dose every 12 hours. ○ Children (2～12 years) — Uncomplicated skin and soft tissue infections: Administer 20mg (potency)/kg body weight per dose every 24 hours. ○ Infants and children (6 months～12 years) — Otitis media among upper respiratory tract infections: Administer 15mg/kg body weight every 12 hours. ○ Infants and children (6 months～12 years) — Acute sinusitis: Administer 7.5mg/kg body weight every 12 hours. ○ Infants and children (6 months～12 years) — Acute sinusitis, moderate or more severe infection requiring a dose increase: Administer 15mg/kg body weight every 12 hours.

This medication is a cephalosporin antibiotic and should be avoided in certain patients. It should not be used in patients with a history of allergies to cephalosporin antibiotics. Caution is also needed in patients with allergies to penicillin or other drugs, as there may be cross-reactivity among beta-lactam antibiotics. In severely ill patients or those with impaired kidney function, renal function should be assessed before administration and careful monitoring should continue during treatment. Kidney impairment may lead to elevated blood levels of this medication, necessitating a reduction in dosage. Patients with a history of gastrointestinal disorders, particularly colitis, should also use caution. While taking this medication, gastrointestinal adverse reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur. Hepatic dysfunction, rash, urticaria, and other hypersensitivity reactions can also arise, so any symptoms should be reported immediately. CNS symptoms such as dizziness, headache, and insomnia have been reported rarely, and patients with renal impairment may experience seizures, so caution is advised. This medication may increase nephrotoxicity when used with other cephalosporin or aminoglycoside antibiotics, as well as diuretics, so care should be taken. During pregnancy, it should only be used when absolutely necessary, and nursing mothers should be cautious as this drug is excreted in small amounts in breast milk. Safety and efficacy have not been confirmed for infants under 6 months of age, so its use in this population is not recommended. Elderly patients may have reduced kidney function, so dosage adjustments may be necessary. Prolonged use of this medication may lead to the development of resistant bacteria and the overgrowth of non-susceptible organisms, necessitating the minimization of treatment duration. If diarrhea occurs after antibiotic use, the possibility of pseudomembranous colitis should be considered, and if symptoms are severe, immediate consultation with a healthcare professional is required. In the case of overdose, this medication is excreted via the kidneys, necessitating dialysis in patients with renal function impairment. Finally, this medication can affect several clinical test results, so it is important to inform the healthcare provider of its use during testing.

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

This medication may be sensitive to light, so it should be stored in a container that blocks light. The optimal storage temperature is between 1 degree and 30 degrees Celsius at room temperature. Proper storage helps maintain the drug's efficacy and safety.

Appearance

Yellowish-orange oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle