Cephprozil Dry Syrup (Cephprozil Hydrate)

Adult dose

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 (an increased dose is required 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 500mg (potency) per dose of this drug every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) per dose 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> Usually administer 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 same intervals as the standard regimen. However, some of this drug is removed by hemodialysis, so administer it after hemodialysis is completed. After reconstitution, store in a refrigerator and use within 14 days (syrup only).

Child dose

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)—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. However, for moderate or more severe infections requiring an increased dose, administer 15mg per Kg of body weight every 12 hours.

This medication is a cephalosporin antibiotic and should not be administered to patients with a history of certain allergies. It is particularly contraindicated for patients who have had hypersensitivity reactions to cephalosporin antibiotics. Caution is advised when administering to patients with allergies to penicillin or other drugs, as cross-allergic reactions may occur. In cases of severe illness or impaired renal function, renal function should be thoroughly evaluated and monitored before and during treatment. Patients with renal impairment should have their doses reduced; otherwise, elevated drug concentrations in the blood may increase the risk of adverse effects. Patients with gastrointestinal diseases, especially a history of colitis, should use this medication cautiously. This medication may cause gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain. Liver function abnormalities may lead to elevated liver enzyme levels, and rarely cholestatic jaundice may occur. Allergic reactions such as rashes or hives may develop, particularly in children. Central nervous system side effects such as dizziness, headache, insomnia, and drowsiness may occasionally occur, and cases of seizures have been reported. Hematological abnormalities such as leukopenia or eosinophilia may occur, and markers of renal function, including BUN and creatinine, may increase. Diaper rashes, genital pruritus, and vaginitis may also occur. To prevent the emergence of resistant bacteria, susceptibility testing should be performed and this medication should be used only for the minimal necessary duration. Prolonged use may result in excessive proliferation of non-susceptible bacteria, necessitating close monitoring of the patient's condition. If allergic symptoms arise, administration should be discontinued immediately, and in severe cases, emergency treatment may be required. Diarrhea occurring after antibiotic use may suggest the possibility of pseudomembranous colitis, and in severe cases, professional treatment may be necessary. Adjustment of doses in patients with renal impairment is essential to prevent seizure risks. Caution is advised when this medication is used alongside other cephalosporins, aminoglycoside antibiotics, and diuretics, as they may increase nephrotoxicity. Combined use with probenecid may reduce the excretion of this medication, increasing its serum concentration. It should be used in pregnant women only when absolutely necessary, as the safety for the fetus has not been fully established. Caution is necessary when nursing, as the drug may be excreted in small amounts into breast milk and affect the infant. The safety of this medication in infants under 6 months has not been established, and accumulation of the drug in the body may occur in neonates. Elderly patients may require dose adjustments due to decreased renal function leading to increased drug concentrations. This medication may affect the results of certain clinical tests, so care should be taken when interpreting test results. In cases of overdose, this medication is primarily excreted through the kidneys; therefore, patients with decreased renal function may require hemodialysis to remove the drug. This medication is known not to cause carcinogenicity, mutagenicity, or reproductive toxicity; however, research on long-term administration is lacking.

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

This medication should be stored in a tightly closed container to prevent air or moisture ingress. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Pink powdered syrup

Package unit

75g/150mL