Medication info
Cephrozime Tablet 250 mg (Cefprozil)

Cephrozime Tablet 250 mg (Cefprozil)

Prescription medicationTablet
Ingredient · strength
Cefprozil Hydrate›250mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Oval film-coated tablet with a light yellow color
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201800569 · Approved 2018.01.30 · Insurance code 693902780

Summary

Main use
Treatment of upper and lower respiratory tract infections, urinary tract infections, and skin and soft tissue infections
Who uses it
Adults · Children
Adult dosage
○ Adults (13 years and older) 1) For upper respiratory tract infections, including pharyngitis and tonsillitis, 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, which are lower respiratory tract infections, administer 500mg (potency) of this medicine 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 depending on 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 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 medicine is removed by hemodialysis, so administer it after hemodialysis is completed.
Children's dosage
○ Children (2~12 years): For upper respiratory tract infections, including pharyngitis and tonsillitis, administer 7.5mg (potency) per Kg of body weight every 12 hours. ○ Children (2~12 years): 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, an upper respiratory tract infection, 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 or more severe infections requiring a higher dose, administer 15mg per Kg of body weight every 12 hours.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of upper and lower respiratory tract infections, 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
  • acute bacterial exacerbations of chronic bronchitis
  • skin and soft tissue infections
  • simple skin and soft tissue infections
  • abscess
  • uncomplicated urinary tract infections
View approved original text

This drug is used for the treatment of various types of infections such as upper respiratory tract infections, lower respiratory tract infections, skin and soft tissue infections, and uncomplicated urinary tract infections. It is effective for upper respiratory tract infections, including pharyngitis, tonsillitis, otitis media, and acute sinusitis; for lower respiratory tract infections, it is used for secondary bacterial infections of acute bronchitis and acute exacerbations of chronic bronchitis. It is utilized in the treatment of simple skin infections and postoperative abscesses, as well as uncomplicated urinary tract infections (including cystitis). This drug is suitable for treating patients with mild to moderate infections caused by susceptible strains and optimal treatment is achieved through susceptibility testing of the causative bacteria when necessary. Therefore, it is widely used in the treatment of infections caused by various bacteria.

Dosage and Administration

Adult dosage

○ Adults (13 years and older) 1) For upper respiratory tract infections, including pharyngitis and tonsillitis, 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, which are lower respiratory tract infections, administer 500mg (potency) of this medicine 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 depending on 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 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 medicine is removed by hemodialysis, so administer it after hemodialysis is completed.

Children's dosage

○ Children (2~12 years): For upper respiratory tract infections, including pharyngitis and tonsillitis, administer 7.5mg (potency) per Kg of body weight every 12 hours. ○ Children (2~12 years): 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, an upper respiratory tract infection, 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 or more severe infections requiring a higher dose, administer 15mg per Kg of body weight every 12 hours.

Precautions

This drug is a cephalosporin antibiotic and should not be administered to patients with a known allergy to cephalosporins. It should be used with caution in patients with a history of allergy to penicillin or other drugs, especially in patients with diminished renal function or severe illnesses, who should have their renal status closely monitored before and during treatment. In patients with impaired renal function, the serum concentration of this drug may increase, thus requiring a dosage reduction; caution is also needed in patients with a history of gastrointestinal diseases, particularly colitis. Adverse gastrointestinal reactions such as diarrhea, nausea, vomiting, and abdominal pain may occur while taking this drug, and liver function test results may elevate. Allergic reactions such as skin rash or urticaria may occur, typically within a few days after administration and rapidly resolve after discontinuation of the drug. Central nervous system side effects such as dizziness, headache, drowsiness have been reported rarely, and seizures may occur in rare cases, so particular caution should be exercised in patients with impaired renal function. Blood tests may show changes such as decreased white blood cell count, increased eosinophils, or elevated renal function parameters. Use with other cephalosporins or diuretics may increase renal toxicity, and caution should be exercised when combining. It should only be used in pregnant women when absolutely necessary, and nursing mothers should be cautious as this drug is excreted in small amounts into breast milk. Safety in infants under 6 months of age has not been established, thus caution is warranted regarding use. Elderly patients may experience decreased renal function, thus requiring dosage adjustments. This drug may affect the results of certain tests, so patients should inform their physicians or pharmacists during testing. In cases of overdose, since it is eliminated through the kidneys, patients with impaired renal function may require hemodialysis. This drug is not associated with carcinogenic or mutagenic risks, and no reproductive function impairment was noted in animal studies.

Side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • AST elevation
  • ALT elevation
  • ALP elevation
  • bilirubin elevation
  • cholestatic jaundice
  • rash
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  • urticaria
  • dizziness
  • hyperactivity
  • headache
  • anxiety
  • insomnia
  • confusion
  • drowsiness
  • seizures
  • leukopenia
  • eosinophilia
  • BUN elevation
  • serum creatinine elevation
  • diaper rash
  • superinfection
  • pruritus of the genitals
  • vaginitis
  • anaphylaxis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • serum sickness reaction
  • fever
  • renal failure
  • toxic nephropathy
  • aplastic anemia
  • hemolytic anemia
  • hemorrhage
  • prolonged prothrombin time
  • positive Coombs test
  • LDH elevation
  • pancytopenia
  • neutropenia
  • agranulocytosis
  • thrombocytopenia

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

Storage

This drug should be stored in a tightly sealed container that blocks light, and it is best kept at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

Oval film-coated tablet with a light yellow color

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.