Sama Cefprozil Tablets

Adult dose

○ Adults (13 years or 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 needed 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 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> Treatment is generally administered 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, since some of this drug is removed by hemodialysis, administer it after hemodialysis is completed. Once reconstituted, store refrigerated and use within 14 days (syrup only).

Child dose

○ Children (2～12 years) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours. 2) 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) For otitis media among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours; for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. However, for moderate to severe infections requiring dose escalation, administer 15mg per Kg of body weight every 12 hours.

This medication is a cephalosporin antibiotic and should not be used in patients with a history of hypersensitivity to this class of drugs. Caution is necessary as there may be cross-allergic reactions in patients with a history of allergies to penicillin or other medications. For patients with impaired renal function or suspected renal impairment, the blood concentration of this drug may increase, so renal function should be assessed before administration, and dosage may need to be adjusted. Care should be taken when using this medication in patients with gastrointestinal disorders, particularly those with a history of colitis, and those allergic to the yellow No. 5 dye included in this drug. Gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur when taking this medication, and hypersensitivity reactions such as liver dysfunction, skin rash, and urticaria have also been reported. Central nervous system symptoms such as dizziness, headache, and drowsiness may occur rarely, and seizures have also been reported rarely. Because this medication may affect kidney function, regular kidney-related tests should be performed, and administration should be stopped immediately if seizures occur. Caution is advised when this drug is used with other antibiotics or diuretics, as nephrotoxicity might increase. During pregnancy, this medication should only be used when absolutely necessary, and nursing mothers should be cautious regarding its potential effects on the baby. The safety of this drug in infants under 6 months has not been established, so its use is discouraged. In elderly patients, renal function may be reduced, necessitating dosage adjustments. During antibiotic administration, there is a risk of resistant bacteria developing and an overgrowth of non-sensitive bacteria, so it is important to monitor the duration of treatment and sensitivity. In case of overdose, primarily eliminated through the kidneys, hemodialysis may be necessary. If diarrhea occurs after taking this medication, immediate consultation with medical personnel is advised to consider the possibility of pseudomembranous colitis.

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

This medication is sensitive to light; it should be stored in a container that does not allow light to enter. Additionally, the medication should be stored at room temperature between 1°C and 30°C for safe use.

Appearance

Yellowish-orange, oblong film-coated tablets

Package unit

30 tablets, 100 tablets (bottle)