Cephran Tablet (Cefprozil Hydrate)

Adult dosage

○ Adults (13 years and older) 1) For upper respiratory tract infections, including pharyngitis and tonsillitis, administer 500mg (potency) of cefprozil per dose 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 lower respiratory tract infections, including bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis, administer 500mg (potency) of this medicine per dose 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 administer 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 treatment> Treatment is usually given for about 10 days. However, for pharyngitis/tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic), treatment should be given for 10 days or longer. For uncomplicated cystitis, treatment is given for about 7 days. ○ Patients with renal impairment 1) For a creatinine clearance of 30～120mL/min, administer according to the standard dosage and 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.

Children's dosage

○ Children (2～12 years) For upper respiratory tract infections, including pharyngitis and tonsillitis, administer 7.5mg (potency) per Kg of body weight every 12 hours. For uncomplicated skin and soft tissue infections, administer 20mg (potency) per Kg of body weight every 24 hours. ○ Infants and children (6 months～12 years) For upper respiratory tract infections, including otitis media, 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 or more severe infections requiring an increased dose, administer 15mg per Kg of body weight every 12 hours.

This medication, as a cephalosporin antibiotic, should not be administered to certain patients. For example, it should not be used in patients with a history of allergy to cephalosporin antibiotics. Caution is required when administering to patients with a history of allergy to penicillin or other medications, as about 10% of penicillin-allergic patients may show cross-reactivity with this drug. Patients with severe conditions or known or suspected renal impairment should have their renal function assessed before administration, and careful monitoring and testing are necessary during treatment. These patients may have elevated or prolonged drug levels in the blood, which may require dosage adjustments. Patients with gastrointestinal diseases, especially those with a history of colitis, should also be cautious. While taking this medication, gastrointestinal symptoms such as diarrhea, nausea, vomiting, and abdominal pain may occur. Liver function test results may increase, and in rare cases, cholestatic jaundice may occur. Hypersensitivity reactions such as skin rashes or urticaria may occur, particularly reported more frequently in children. These reactions usually appear within a few days of starting treatment and resolve within 2-3 days after discontinuation of the drug. Central nervous system symptoms such as dizziness, headache, and insomnia have been reported rarely, and seizures may occur, necessitating special caution in renal impairment patients. Blood tests may show decreased white blood cell counts or increased eosinophils, as well as elevated renal function parameters. This medication can increase renal toxicity when used in conjunction with other cephalosporin antibiotics, aminoglycoside antibiotics, or diuretics, so careful monitoring is required during co-administration. Use during pregnancy should only be considered when necessary, and caution is required when administering to nursing mothers as the effects on infants are not known. Safety and efficacy in infants under 6 months of age have not been established, and caution is needed for newborns as the drug may remain in their bodies longer. Elderly patients may require dosage adjustments as renal function may decline. To prevent the development of resistant bacteria during antibiotic use, susceptibility testing should be done, and treatment should be limited to the necessary minimum duration. If diarrhea occurs during treatment, the possibility of pseudomembranous colitis should be considered, and appropriate treatment is necessary in severe cases. In case of overdose, the drug can be removed from patients with renal impairment through hemodialysis. Some studies have shown that this drug does not cause mutagenicity or reproductive dysfunction, but long-term carcinogenic testing has not yet been conducted.

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

This medication is sensitive to light, so it should be stored in a tightly sealed container that blocks light. Additionally, it is important to store it at a temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance

Pale orange, oblong, film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle