Cephron Tablets (Cefprozil Hydrate)

Adult dose

○ Adults (13 years and older) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, 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 to severe infections). 2) For bacterial secondary infections of acute bronchitis or bacterial exacerbations 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 per dose 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> 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 dosage regimen above. 2) For creatinine clearance of 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. After reconstitution, store in a refrigerator and take within 14 days (for 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. ○ Infants and children (6 months～12 years) - For moderate to severe infections requiring a higher dose, administer 15mg per Kg of body weight every 12 hours.

This medicine is a cephalosporin antibiotic and should not be administered to certain patients. Patients with allergies to cephalosporin antibiotics may experience severe hypersensitivity reactions when using this medicine, hence it should not be administered. Patients with allergies to penicillin or other antibiotics should also use it with caution, especially since cross-reactivity may occur. Patients with impaired renal function or severe illness should carefully monitor kidney status before and during administration and should reduce the dosage if necessary. Patients with a history of gastrointestinal diseases, especially colitis, should also take caution when using this medicine. This medicine contains Yellow No. 5 dye, so it should be administered with caution if there is an allergy to this component. Side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur, and liver function tests may show elevated levels. Allergic reactions such as rashes or urticaria may occur, especially reported more frequently in children, so immediate consultation with healthcare personnel is recommended if symptoms arise. Neurological symptoms such as dizziness, headache, and insomnia may occur rarely, but most are temporary. Decreased white blood cell count, increased eosinophils, and impaired kidney function have been reported, so regular monitoring may be necessary. Prolonged use of this medicine may lead to the development of resistant bacteria, so it is advised to administer it for the minimum required duration. If diarrhea occurs after antibiotic use, the possibility of pseudomembranous colitis should be considered, and healthcare personnel should be notified immediately. Caution is needed when used in combination with other antibiotics or diuretics as renal toxicity may increase, and certain medications may raise blood concentration levels. Pregnant and nursing women should use it only when absolutely necessary, as sufficient research has not been conducted on its effects on the fetus or infant. It should be avoided in infants younger than 6 months as safety has not been established. Elderly patients may require dose adjustment due to decreased kidney function. This medicine may also affect certain clinical test results, so inform the healthcare personnel during tests. In the event of overdose, as it is primarily excreted through the kidneys, patients with impaired kidney function may require hemodialysis. This medicine has a low risk of carcinogenicity or mutagenicity, and no reproductive function impairment has been found in animal studies.

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

This medicine is sensitive to light and should be stored in a closed container that blocks light. The storage temperature should be maintained at room temperature between 1 and 30 degrees.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle