Saipro Tablet (Cefprozil Hydrate)

Adult dosage

○ 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 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 drug per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) of this drug 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 drug every 24 hours. <Duration of administration> Administration is usually 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 regimen above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose at the same interval as the standard regimen. However, some of this drug is removed by hemodialysis, so administer it after hemodialysis is completed.

Children's dosage

○ Children (2～12 years) Children (2～12 years): For 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): For 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) Infants and children (6 months～12 years): For otitis media among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours. Infants and children (6 months～12 years): For acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. Infants and children (6 months～12 years): For moderate to severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

This drug is a cephalosporin antibiotic and should not be administered to certain patients. Particularly, patients with a history of hypersensitivity to cephalosporins should not use this medication. Patients with allergies to penicillin or other beta-lactam antibiotics should use this medication with caution due to the possibility of cross-reactivity. Patients with severe illness or those with kidney function issues should assess renal function before administration and closely monitor it during treatment. In cases of renal impairment, drug concentration may increase, necessitating dose adjustments. Patients with gastrointestinal diseases, especially a history of colitis, must use this drug carefully. Caution is also advised for those allergic to the dye components included in this drug. Various adverse reactions such as gastrointestinal disturbances, liver function abnormalities, skin rashes, central nervous system symptoms, etc., may occur when taking this medication. Special care should be taken in children, as allergic reactions have been reported more frequently. Seizures may occur, so patients with impaired kidney function should properly adjust the dosage, and if seizures appear, administration should be stopped immediately. This drug may increase nephrotoxicity when used in conjunction with other antibiotics or diuretics, so caution is necessary when combined. Additionally, when used with certain medications, the concentration of this drug in the body may increase. Pregnant and nursing women should only use this drug when absolutely necessary, and caution should be exercised to consider the effects on the baby during breastfeeding. It is advisable to avoid using this medication in infants under 6 months of age, as safety and efficacy have not been established. Elderly patients may require dosage adjustments due to decreased kidney function, and care should be taken as drug metabolism and excretion may vary. This medication may affect the results of some clinical tests, so it should be taken into account when interpreting test results, and in cases of overdose, renal excretion may be compromised, necessitating hemodialysis. Finally, this drug has not been reported to carry any carcinogenic or mutagenic risks, nor has it been associated with reproductive dysfunction.

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

This medication is sensitive to light, so it should be stored in a container that prevents light from entering. Additionally, the medication should be stored at room temperature, ideally maintaining a temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow-orange oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle