Rozycef Tablet 250mg (Cefprozil Hydrate)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer cefprozil 500mg (potency) per dose every 24 hours. For acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (dose escalation is 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 this drug 500mg (potency) per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer this drug 250mg (potency) 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 this drug 500mg (potency) 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 approximately 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30～120mL/min, administer according to the standard dosage and regimen above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose, using the same administration interval as the standard regimen. However, some of this drug is removed by hemodialysis; therefore, administer it after hemodialysis is completed. Once reconstituted, store refrigerated and use within 14 days (syrup only).

Child dose

○ Children (2～12 years) — For pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per kg body weight per dose every 12 hours. ○ Children (2～12 years) — For uncomplicated skin and soft tissue infections, administer 20mg (potency) per kg 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 body weight every 12 hours. ○ Infants and children (6 months～12 years) — For acute sinusitis, administer 7.5mg per kg body weight every 12 hours. ○ Infants and children (6 months～12 years) — For moderate or more severe infections requiring a higher dose, administer 15mg per kg body weight every 12 hours.

This medication is a cephalosporin antibiotic and should not be used in patients with a history of allergy to cephalosporins. It should be administered with caution in patients with a history of allergy to penicillin or other drugs, particularly in patients with impaired kidney function or severe illness, who should have their kidney function closely monitored before and during treatment. The dose should be reduced in patients with or suspected of having renal impairment, and caution is needed in patients with gastrointestinal disorders or allergy to yellow No. 5 dye contained in this medication. Symptoms such as diarrhea, nausea, vomiting, abdominal pain may occur upon administration, and hypersensitivity reactions like liver function abnormalities or skin rashes, urticaria have been reported. Central nervous system symptoms such as dizziness, headache, drowsiness may occur rarely, and renal dysfunction or blood abnormalities may also be observed. If a severe allergic reaction occurs, the administration should be stopped immediately and emergency treatment should be received. This medication should be used for the minimum period necessary to prevent the occurrence of resistant bacteria, and patients should be closely monitored for potential other infections during prolonged use. Caution should be exercised when used concomitantly with other cephalosporin antibiotics, aminoglycosides, and diuretics as renal toxicity may increase. It should only be used in pregnant women if necessary, and caution should be given to nursing mothers as this medication may be excreted in breast milk. It is advisable not to use in infants below 6 months of age as safety and efficacy have not been established. Elderly patients may require dose adjustments due to reduced renal function. This medication is excreted through the kidneys so in cases of overdose, blood dialysis may be needed in patients with compromised renal function. If diarrhea occurs after antibiotic use, the possibility of pseudomembranous colitis should be considered and appropriate treatment should be given. This medication can affect the results of blood tests or urine tests, so it is important to inform healthcare providers during testing.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to store it at room temperature between 1°C and 30°C. Proper storage will maintain the medication's effectiveness for a longer duration.

Appearance

Yellow-orange, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle