Medication info

Cepro (Cefprozil Hydrate)

Prescription medicationTabletOralExpired
Ingredient · strength
Cefprozil Hydrate›250mg / 1 tablet
Manufacturer / importer
Medika Korea Co., Ltd.
Appearance
Yellow-orange oblong film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 202003923 · Approved 2020.05.27

This product's status changed to Expired on 2025.05.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory infections, uncomplicated urinary tract infections, and skin and soft tissue infections
Who takes it
Adults · Children
Adult dose
○ Adults (13 years of age 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 (dose escalation 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) of this medicine per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) of this medicine 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 medicine 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 approximately 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30~120mL/min, administer according to the standard dosage and administration described 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 medicine is removed by hemodialysis, so administer it after hemodialysis is complete. Once reconstituted, store refrigerated and use within 14 days (syrup only).
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 per dose every 12 hours. 2) 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; for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. However, for moderate or more severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

Ingredients

Manufacturer
Medika Korea Co., Ltd.

Efficacy & effects

Treatment of respiratory infections, uncomplicated urinary tract infections, and skin and soft tissue infections

  • Upper respiratory tract infections
  • pharyngitis
  • tonsillitis
  • otitis media
  • acute sinusitis
  • lower respiratory tract infections
  • secondary bacterial infections of acute bronchitis
  • exacerbation of bacterial symptoms in chronic bronchitis
  • uncomplicated skin and soft tissue infections
  • abscesses
  • uncomplicated urinary tract infections
  • cystitis.
View approved original text

This medication is used for the treatment of various types of infections. It is effective for upper respiratory tract infections such as pharyngitis, tonsillitis, otitis media, and acute sinusitis. For lower respiratory tract infections, it is used in the treatment of secondary bacterial infections caused by acute bronchitis and exacerbation of acute bacterial symptoms in chronic bronchitis. Additionally, it helps treat uncomplicated skin and soft tissue infections and post-surgical abscesses, and is also used for uncomplicated urinary tract infections, particularly cystitis. Thus, it is used to treat mild to moderate infections caused by various bacteria.

How to take

Adult dose

○ Adults (13 years of age 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 (dose escalation 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) of this medicine per dose every 12 hours. 3) For uncomplicated skin and soft tissue infections, administer 250mg (potency) of this medicine 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 medicine 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 approximately 7 days. ○ Patients with renal impairment 1) If creatinine clearance is 30~120mL/min, administer according to the standard dosage and administration described 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 medicine is removed by hemodialysis, so administer it after hemodialysis is complete. Once reconstituted, store refrigerated and use within 14 days (syrup only).

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 per dose every 12 hours. 2) 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; for acute sinusitis, administer 7.5mg per Kg of body weight every 12 hours. However, for moderate or more severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

Precautions

This medication is a cephalosporin antibiotic and should not be administered to certain patients. Patients with hypersensitivity to cephalosporins may experience severe allergic reactions when using this medication and should avoid it. Patients with a history of allergy to penicillin or other drugs should also use this medication with caution, especially since there may be a cross-allergy between beta-lactam antibiotics. In severely ill patients or those with kidney function issues, renal function status must be verified prior to administration, and careful monitoring should continue during treatment. Patients with poor kidney function may have drug concentrations remaining in the body for longer periods, increasing the risk of side effects, so the total daily dosage of this medication should be reduced. Patients with gastrointestinal diseases, particularly a history of colitis, should also exercise caution when using this medication. Common gastrointestinal-related side effects include diarrhea, nausea, vomiting, and abdominal pain. There have been rare reports of elevated liver enzyme levels indicating liver dysfunction and cholestatic jaundice, so liver health should be carefully monitored. Skin rashes or urticaria may occur more frequently, particularly in children, and if such symptoms appear, the medication should be discontinued. CNS symptoms such as dizziness, headaches, insomnia, and drowsiness have been reported infrequently, and in severe cases, seizures may occur, requiring caution. Blood tests may show changes such as leukopenia or eosinophilia, and kidney function-related test values may also be elevated. This medication, when used with other cephalosporin antibiotics or specific diuretics, may increase renal toxicity; therefore, careful monitoring is required when used together. It should only be used during pregnancy when absolutely necessary, and breastfeeding mothers should be cautious as this medication is secreted in small amounts into breast milk, the effects on infants are not fully known. The safety of this medication in infants under 6 months of age has not been established, so it is advisable not to use it in this age group. Elderly patients may have reduced kidney function, therefore the medication dosage may need to be adjusted, and even if kidney function appears normal, drug clearance may be reduced. During the use of this medication, serious intestinal diseases such as pseudomembranous colitis may occur, so if diarrhea symptoms appear, immediate consultation with healthcare professionals is necessary. In case of overdose, removal of the drug may be possible through hemodialysis depending on kidney function, requiring prompt emergency intervention. Lastly, it is important to conduct susceptibility testing to prevent the emergence of resistant bacteria and to administer the drug for only the minimum necessary duration.

Side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated bilirubin levels
  • rash
  • urticaria
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  • dizziness
  • hyperactivity
  • headache
  • anxiety
  • insomnia
  • confusion
  • drowsiness
  • seizures
  • decreased white blood cell count
  • increased eosinophils
  • elevated BUN
  • elevated serum creatinine
  • diaper rash
  • superinfection
  • genital itching
  • vaginitis
  • anaphylaxis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • serum sickness reaction
  • fever
  • renal failure
  • toxic kidney disease
  • aplastic anemia
  • hemolytic anemia
  • bleeding
  • prolonged prothrombin time
  • positive Coombs test
  • elevated LDH
  • pancytopenia
  • neutropenia
  • agranulocytosis
  • thrombocytopenia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. It should also be stored at a temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow-orange oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.