Sama Cefprozil Dry Syrup 125mg/5mL (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 necessary for moderate or severe infections). 2) For bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500 mg (potency) of this medicine per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250 mg (potency) of this medicine 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 medicine every 24 hours. <Duration of administration> Treatment is generally administered 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. Since some of this medicine is removed by hemodialysis, administer it after the hemodialysis session.

Child dose

○ Children (2～12 years) 1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight every 12 hours. 2) 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 among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours; for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. For moderate or severe infections 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 certain patients. First, patients with a history of allergic reactions to cephalosporin antibiotics should not use this medication. Additionally, this medication contains lactose and should not be administered to patients with genetic issues that prevent lactose digestion. Patients with a history of penicillin or other drug allergies should be cautious when using this medication. Especially, patients with impaired kidney function may require dosage adjustments and regular monitoring of kidney function. Patients with gastrointestinal diseases or a history of colitis should also be administered this medication with caution. Various side effects may occur from taking this medication, including gastrointestinal disturbances, liver function abnormalities, rashes, hives, dizziness, headaches, and allergic reactions. If severe allergic reactions occur, administration should be stopped immediately, and medical attention should be sought. Long-term use of this medication may lead to the emergence of resistant bacteria or other infections; therefore, it is important to minimize the treatment duration. When used in conjunction with other antibiotics or diuretics, renal toxicity may increase, so caution is necessary. Pregnant or breastfeeding women should use this medication only when necessary, and breastfeeding mothers should consider the potential effects on the infant. This medication should be avoided in infants under 6 months of age due to undefined safety. Elderly individuals may have reduced kidney function and may require dosage adjustments. This medication can affect certain clinical test results, so it is important to inform the healthcare provider about its use during testing. In the event of an overdose, since the drug is excreted through the kidneys, patients with compromised kidney function may require hemodialysis. Lastly, while there is no evidence that this medication causes carcinogenicity, mutagenicity, or reproductive dysfunction, it should be used only in clinically necessary situations.

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

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, avoid storing the medication in places that are too hot or too cold, and it is best to keep it at room temperature between 1°C and 30°C.

Appearance

Pink powdered syrup

Package unit

100 milliliters/bottle, 150 milliliters/bottle