Cefprozil Tablets (Cefprozil Hydrate)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer cefprozil at a dose of 500mg (potency) every 24 hours. For acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (the dose should be increased 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 medicine at a dose of 500mg (potency) every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer this medicine at a dose of 250mg (potency) every 12 hours [or 500mg (potency) every 24 hours], or 500mg (potency) every 12 hours depending on symptoms. 4) For uncomplicated urinary tract infections, administer this medicine at a dose of 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 about 7 days. ○ Patients with renal impairment 1) For a creatinine clearance of 30～120mL/min, administer according to the standard dosage regimen above. 2) For a 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, refrigerate and take within 14 days (for 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 an increased dose, administer 15mg per Kg of body weight every 12 hours.

This drug is a cephalosporin antibiotic and should not be used in certain patients. Patients with a history of allergy to cephalosporin antibiotics can experience severe hypersensitivity reactions, thus should not take this drug. Patients who have had allergies to penicillin or other medications should also be cautious when using this drug. In particular, patients with poor kidney function or severe illness should assess their renal status carefully before administration, and may need to reduce the dosage if necessary. Patients with a history of gastrointestinal diseases, especially colitis, should use this drug cautiously. This drug contains a coloring agent called Yellow No. 5, which may cause allergic reactions in sensitive individuals. While taking this medication, gastrointestinal issues such as diarrhea, nausea, vomiting, and abdominal pain, as well as liver dysfunction, skin rashes, and allergic symptoms like hives may occur. Symptoms of the central nervous system, such as dizziness, headaches, and insomnia, may rarely occur, and renal function should be monitored closely. If seizures or severe allergic reactions occur, immediately stop taking the medication and consult a medical professional. This drug should only be used for the minimum necessary duration to prevent the development of resistance, and caution should be exercised to avoid bacterial overgrowth or superinfection during prolonged use. Caution is also needed when taken with other cephalosporin antibiotics or certain diuretics, as it may increase renal toxicity. During pregnancy, this drug should only be used when absolutely necessary, and during breastfeeding, caution is required as the effects on the infant are unknown. It is advisable not to use this drug in infants under 6 months old as safety has not been established. Elderly patients may have decreased kidney function, possibly requiring adjustment of the dosage. This drug may affect certain clinical test results, so inform healthcare providers before testing. In cases of overdose, since the drug is excreted through the kidneys, blood dialysis may be necessary if renal function is impaired. This drug is not known to pose a risk of carcinogenicity or mutagenicity, and animal studies have shown no effect on reproductive function.

• Diarrhea
• nausea
• vomiting
• abdominal pain
• AST elevation
• ALT elevation
• ALP elevation
• bilirubin elevation
• rash
• urticaria

This drug is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it is important to maintain a room temperature between 1 degree and 30 degrees Celsius when storing the drug. Storing it this way ensures the drug's effectiveness is safely maintained.

Appearance

Oblong, light yellow film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle