Cefazoline Dry Syrup (Cefprozil Hydrate)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 500 mg (potency) of cefprozil per dose every 24 hours; for acute sinusitis, administer 250 mg (potency) or 500 mg (potency) every 12 hours (dose escalation is required for moderate to severe infections). 2) For bacterial secondary infection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500 mg (potency) of this drug per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250 mg (potency) of this drug per dose every 12 hours [or 500 mg (potency) every 24 hours], or administer 500 mg (potency) every 12 hours according to symptoms. 4) For uncomplicated urinary tract infections, administer 500 mg (potency) of this drug 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. Also, 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 regimen above. 2) If creatinine clearance is 29mL/min or less, administer 50% of the standard dose at the standard dosing interval. However, some of this drug is removed by hemodialysis, so administer it after hemodialysis is completed.

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. ○ Infants and children (6 months～12 years) For moderate to severe infections requiring dose escalation, administer 15mg per kg of body weight every 12 hours.

This medication should be used in the minimum amount possible, keeping the aspartame content below the World Health Organization’s recommended maximum daily dose of 40mg/kg. This medication is a cephalosporin antibiotic and should not be administered to patients with a history of specific allergies. Especially, patients who have had hypersensitivity reactions to other cephalosporin antibiotics or have genetic issues such as lactase deficiency should not use it. It should be administered cautiously to patients with a history of allergies to penicillin or other medications, those with impaired renal function or suspected kidney disease, and those with a history of gastrointestinal diseases. Patients with reduced renal function should have their dose of this medication reduced, and renal function should be monitored before and during treatment. When taking this medication, gastrointestinal adverse reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur. Hypersensitivity reactions may also occur, such as liver function abnormalities, rashes, and hives, and central nervous system symptoms like dizziness, headaches, and insomnia have been reported infrequently. There may also be adverse reactions related to renal function or blood, so caution is necessary. Long-term use of this medication may lead to the development of resistant bacteria or overgrowth of non-sensitive bacteria; thus, the treatment period should be minimally limited and patients should be carefully monitored. If an allergic reaction occurs, administration should be stopped immediately and emergency measures should be taken. This medication can increase nephrotoxicity when used in conjunction with other cephalosporin antibiotics, aminoglycoside antibiotics, and diuretics, so caution is needed when used in combination. Additionally, when used with probenecid, this medication's concentration in the body may increase. Pregnant women should only use this medication when absolutely necessary, and when administering to breastfeeding women, careful judgment should be made considering the effects on the baby. It is best not to use in infants younger than 6 months, as safety and efficacy have not been established. For elderly patients, dosage adjustments may be necessary considering potential renal function decline. This medication can affect test results, so it is vital to inform the doctor during blood or urine tests. In cases of overdose, this medication is excreted via the kidneys; thus, in patients with impaired renal function, the drug can be removed through hemodialysis. This medication does not present a risk of carcinogenicity or mutagenicity, and no reproductive dysfunction was found in animal experiments.

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

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, to ensure safe storage, it is important to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

<For Internal Use> Pink powdered syrup

Package unit

[For Internal Use] 100mL/bottle, 150mL/bottle