Medication info

Kyungbocefprazole Dry Syrup (Cefprozil Hydrate)

Prescription medicationSyrupOral
Ingredient · strength
Cefprozil Hydrate›5g / 100g
Manufacturer / importer
Kyungbo Pharmaceutical Co., Ltd.
Appearance
Pink powdered syrup
Packaging
Bottle - 150 milliliters/bottle
Approval status
Active

MFDS item code 202100550 · Notified 2021.01.19

Summary

Main use
Treatment of respiratory infections (such as otitis media), skin and soft tissue infections, and urinary tract 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 needed 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 every 12 hours [or 500mg (potency) every 24 hours], or 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> Treatment is generally given 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 and administration 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 medicine is removed by hemodialysis, so administer it after hemodialysis is completed. 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, and for acute sinusitis, administer 7.5mg per kg of body weight every 12 hours. However, for moderate or more severe infections requiring a higher dose, administer 15mg per kg of body weight every 12 hours.

Ingredients

Manufacturer
Kyungbo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory infections (such as otitis media), skin and soft tissue infections, and urinary tract infections

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

This medication is used for various infections including upper respiratory infections such as pharyngitis, tonsillitis, otitis media, and acute sinusitis. It is also effective for secondary bacterial infections of acute bronchitis and exacerbation of chronic bronchitis. It is used for skin and soft tissue infections, particularly for staphylococcal and streptococcal infections, and for the treatment of abscesses that require drainage. Furthermore, it is utilized for simple urinary tract infections, especially cystitis. This medication is effective against the causative pathogens for each disease, and tailored treatment can be provided through susceptibility testing if necessary. Therefore, it is used for the treatment of upper and lower respiratory infections, skin infections, and urinary tract infections.

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 needed 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 every 12 hours [or 500mg (potency) every 24 hours], or 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> Treatment is generally given 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 and administration 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 medicine is removed by hemodialysis, so administer it after hemodialysis is completed. 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, and for acute sinusitis, administer 7.5mg per kg of body weight every 12 hours. However, for moderate or more severe infections requiring a higher dose, administer 15mg per kg of body weight every 12 hours.

Precautions

This medication is a cephalosporin antibiotic and should not be administered to patients with a history of allergy to this class of drugs. Patients with hypersensitivity to penicillin or other drugs should use it with caution, and dosage should be adjusted while often checking kidney function in patients with impaired renal function or severe condition. Patients with gastrointestinal diseases, especially a history of colitis, should also use it cautiously. While taking this medication, gastrointestinal adverse reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur, and hypersensitivity reactions such as liver dysfunction or skin rashes and urticaria may also occur. Central nervous system symptoms such as dizziness, headaches, and drowsiness have been reported rarely, along with potential kidney dysfunction, so care is necessary. Patients with impaired kidney function particularly require dosage adjustments, and as this medication may provoke seizures, use should be immediately discontinued if any unusual symptoms occur. Caution is needed as the combination of this medication with other cephalosporins, aminoglycosides, and diuretics may increase renal toxicity. Pregnant or breastfeeding women should only use this medication when necessary, and caution is advised as the effects on nursing infants are unknown. Safety in infants under 6 months has not been established; therefore, use should be avoided. Elderly patients may also have decreased kidney function, so dosage adjustments may be necessary. This medication may affect some clinical test results; therefore, caution should be taken in interpreting test results. In case of overdose, as it is excreted through the kidneys, patients with impaired kidney function may be able to remove the drug through hemodialysis, etc. Lastly, this medication may lead to the emergence of resistant bacteria with long-term use; hence, it should only be administered for the minimum required duration while closely monitoring the patient's condition.

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 nephropathy
  • 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 should be stored in a sealed container to protect it from exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained and it can be used safely.

Appearance and packaging

Appearance

Pink powdered syrup

Package unit

Bottle - 150 milliliters/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.