Sefprozil Dry Syrup (Sefprozil Hydrate 125mg (potency) / 5mL)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 500mg (potency) of cefprozil per dose every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (increase the dose 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 per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) of this medicine per dose 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, 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 dosing intervals as the standard regimen. However, some of this medicine is removed by hemodialysis, so administer it after hemodialysis is complete. Once reconstituted, refrigerate 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) 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) — Otitis media among upper respiratory tract infections: 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 moderate or more severe infections requiring a dose increase, administer 15mg per kg of body weight every 12 hours.

This drug is adjusted to use the minimum amount of aspartame possible, limited to below the WHO recommended daily intake. The aspartame contained in this drug is broken down into phenylalanine in the body; therefore, it should not be administered to patients with phenylketonuria, a genetic disorder that requires restriction of phenylalanine. Patients who have had allergic reactions to cephalosporin antibiotics should not use this drug, and it should be used cautiously in patients who have a history of allergy to penicillin or other beta-lactam drugs. In cases of severe renal impairment or suspicion thereof, the dosage of this drug should be adjusted, and kidney function should be monitored frequently, and caution should be taken in patients with gastrointestinal disorders or specific dye allergies. Gastrointestinal symptoms such as diarrhea, nausea, vomiting, and abdominal pain may occur during treatment with this drug, and liver function tests may show increased values. Rarely, hypersensitivity reactions such as rash and urticaria may occur, and central nervous system symptoms such as dizziness, headache, and drowsiness have also been reported. In patients with impaired kidney function, blood levels of the drug may rise, leading to seizures; if such symptoms occur, discontinue use immediately. When used with other antibiotics or diuretics, there is a risk of increased nephrotoxicity, so caution is required; also, co-administration with drugs that affect drug excretion should be careful. This drug should be used in pregnant or breastfeeding women only when necessary, and it should be administered cautiously especially in breastfeeding cases when the effects on the baby are unknown. It is advisable not to use this drug in infants younger than 6 months as safety and efficacy have not been established. Elderly patients may need dosage adjustment due to a potential decrease in kidney function. During treatment with this drug, some blood tests or urine test results may be affected, thus caution is needed in interpreting test results. In case of overdose, as it is primarily excreted through the kidneys, patients with impaired kidney function may require dialysis to remove the drug from the bloodstream. This drug has no risk of carcinogenicity or mutagenicity and has been confirmed not to cause reproductive effects in animal testing.

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

This drug is sensitive to light, so it should be stored in a container that does not allow light to enter. Furthermore, it is recommended to store the drug at room temperature, between 1 to 30 degrees Celsius.

Appearance

White to yellowish powder syrup

Package unit

30g / 60mL