Sefozil Tablets (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; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (dose increases are necessary for moderate to 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 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 standard dosing interval. However, some of this medicine is removed by hemodialysis; therefore, administer it after hemodialysis is completed. Once reconstituted, store in a refrigerator and use within 14 days (syrup formulation only).

Child dose

○ Children (2～12 years) — Pharyngitis and tonsillitis among upper respiratory tract infections: Administer 7.5mg (potency)/Kg of body weight per dose every 12 hours. ○ Children (2～12 years) — Uncomplicated skin and soft tissue infections: Administer 20mg (potency)/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/Kg of body weight every 12 hours. ○ Infants and children (6 months～12 years) — Acute sinusitis: Administer 7.5mg/Kg of body weight every 12 hours. However, for moderate to severe infections requiring a dose increase, administer 15mg/Kg of body weight every 12 hours.

This medication is a cephalosporin antibiotic and should not be administered to patients who have had allergic reactions to specific antibiotics. Patients with allergies to penicillin or other medications should exercise caution when using this medication, and especially those with poor kidney function may require dosage adjustments. Patients with gastrointestinal diseases or allergies to specific colorants should also be given this medication with care. This medication may cause gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain, as well as hypersensitivity reactions like liver function abnormalities, rashes, and hives. Rarely, central nervous system symptoms such as dizziness, headaches, and insomnia may occur, and seizures have been reported, so if these symptoms arise, immediate consultation with a healthcare professional is necessary. Regular testing is required, as blood tests may show decreases in white blood cell counts or increases in kidney function indicators. When using antibiotics, it is important to perform susceptibility tests to prevent the development of resistant bacteria and to use them only for the necessary duration. Long-term use may lead to other infections, so patient conditions should be closely monitored. If an allergic reaction occurs, discontinuation of the medication should be immediate, and emergency care may be necessary in the case of severe reactions. If diarrhea occurs after antibiotic use, the possibility of pseudomembranous colitis should be considered and appropriate treatment should be undertaken. This medication requires dosage adjustments in patients with reduced kidney function, as improper dosages may lead to seizures. When used with other antibiotics or diuretics, watch for increased nephrotoxicity, so careful monitoring is necessary during combined use. During pregnancy, use only when absolutely necessary, and nursing women should administer cautiously as the effects on infants are unknown. Use is not recommended for infants under 6 months of age as safety and efficacy have not been established. Elderly patients may require dosage adjustments due to potentially decreased kidney function. This medication may affect some clinical test results, so it is advisable to inform healthcare providers of this when undergoing tests. In case of overdose, as it is excreted through the kidneys, if kidney function is impaired, dialysis may be required to remove the medication. This medication does not induce carcinogenicity or mutagenicity, and reproductive function abnormalities have not been found in animal studies.

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

This medication may be sensitive to light, so it should be stored in a container that blocks light. Moreover, it is best to keep the medication at room temperature, between 1 and 30 degrees Celsius, to maintain its efficacy and safety.

Appearance

Pale yellow, oblong, film-coated tablets

Package unit

30/bottle, 100/bottle