Prosepf Tablet (Cefprozil Monohydrate)

Adult dose

○ Adults (13 years and older) 1) For upper respiratory tract infections, including pharyngitis and tonsillitis, administer cefprozil 500mg (potency) per dose every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (a dose increase is required for moderate to severe infections). 2) For bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis, both 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 about 7 days. ○ Patients with renal impairment 1) For creatinine clearance of 30～120mL/min, administer according to the standard dose and regimen above. 2) For creatinine clearance of 29mL/min or less, administer 50% of the standard dose at the standard dosing intervals. However, some of this drug is removed by hemodialysis, so administer it after hemodialysis is completed.

Child dose

○ 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. ○ Children (2～12 years): 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 otitis media, an upper respiratory tract infection, 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 acute sinusitis with moderate to severe infection requiring a dose increase, administer 15mg per kg of body weight every 12 hours.

This medication is a cephalosporin antibiotic and should not be administered to patients who have had hypersensitivity reactions to cephalosporin drugs. Patients with a history of allergy to penicillin or other drugs should use this medication with caution, and especially those with impaired renal function or severe illness should closely monitor renal status before and during use. For patients with decreased renal function, the drug concentration may increase and the dose should be reduced; caution is also necessary for patients with a history of gastrointestinal diseases, particularly colitis. Symptoms such as diarrhea, nausea, vomiting, abdominal pain, hepatic dysfunction, skin rash, hives may occur during treatment, so patients should report any unusual symptoms immediately. Rarely, central nervous system symptoms such as dizziness, headache, insomnia, and drowsiness have been reported, and seizures may occur, so patients with impaired renal function should be particularly careful. Changes in white blood cell counts or renal function tests may occur, thus regular blood tests and renal function tests are necessary. When this medication is taken with other cephalosporin antibiotics, aminoglycoside antibiotics, or diuretics, renal toxicity may increase, so caution should be exercised during co-administration. Pregnant women should use this medication only if absolutely necessary, and breastfeeding mothers should use it cautiously as some of it may be excreted in breast milk. Safety in infants under 6 months has not been established, so the use should be avoided. Elderly patients may have decreased renal function, which may require dose adjustment. During treatment with this medication, results of certain blood and urine tests may be affected, and this should be considered in the interpretation of test results. In case of overdose, the drug can be removed by hemodialysis, so dosing should be strictly adhered to. Finally, it is important to administer this medication only for the minimum duration necessary after susceptibility testing to prevent the development of resistant bacteria, and careful patient monitoring is essential during prolonged use.

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

This medication is sensitive to light and should be stored in a container that protects it from light. Additionally, it is recommended to store the medication at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

Light orange rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle