Medication info
Cefprozil 250 mg (Cefprozil Hydrate)

Cefprozil 250 mg (Cefprozil Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Cefprozil Hydrate›250mg / 1 tablet
Manufacturer / importer
Geonil Pharmaceutical Co., Ltd.
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200500500 · Notified 2005.02.28 · Insurance code 646800780

Summary

Main use
Treatment of respiratory infections (e.g., pharyngitis), urinary tract infections, and skin and soft tissue infections
Who takes it
Adults · Children
Adult dose
○ Adults (13 years and older)\n1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer cefprozil hydrate 500mg (potency) per dose every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (an increase in dose is necessary for moderate or more severe infections).\n2) For bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500mg (potency) of this drug per dose every 12 hours.\n3) 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 the symptoms.\n4) For uncomplicated urinary tract infections, administer 500mg (potency) of this drug every 24 hours.\n<Duration of administration>\nTreatment 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.\n○ Patients with renal impairment\n1) If creatinine clearance is 30~120mL/min, administer according to the standard dosage and regimen above.\n2) If creatinine clearance is 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.\nOnce reconstituted, store refrigerated and use within 14 days (for syrup only).
Child dose
○ Children (2~12 years)\nFor pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours.\nFor uncomplicated skin and soft tissue infections, administer 20mg (potency) per Kg of body weight per dose every 24 hours.\n○ Infants and children (6 months~12 years)\nFor otitis media among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours.\nFor acute sinusitis among upper respiratory tract infections, administer 7.5mg per Kg of body weight every 12 hours.\nFor moderate or more severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

Ingredients

Manufacturer
Geonil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory infections (e.g., pharyngitis), urinary tract infections, and skin and soft tissue infections

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

This drug is used to treat various mild and moderate infections caused by susceptible strains. It is effective for upper respiratory infections including pharyngitis, tonsillitis, otitis media, and acute sinusitis, especially against pathogens such as Group A beta-hemolytic streptococci, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. For lower respiratory infections, it is used for secondary bacterial infections of acute bronchitis and acute bacterial exacerbations of chronic bronchitis. Additionally, it is effective for uncomplicated skin and soft tissue infections and the treatment of postoperative abscesses. Finally, this drug is also used for uncomplicated urinary tract infections, such as cystitis. Thus, this drug is widely used for the treatment of various infections.

How to take

Adult dose

○ Adults (13 years and older)\n1) For pharyngitis and tonsillitis among upper respiratory tract infections, administer cefprozil hydrate 500mg (potency) per dose every 24 hours; for acute sinusitis, administer 250mg (potency) or 500mg (potency) every 12 hours (an increase in dose is necessary for moderate or more severe infections).\n2) For bacterial superinfection of acute bronchitis or bacterial exacerbation of chronic bronchitis among lower respiratory tract infections, administer 500mg (potency) of this drug per dose every 12 hours.\n3) 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 the symptoms.\n4) For uncomplicated urinary tract infections, administer 500mg (potency) of this drug every 24 hours.\n<Duration of administration>\nTreatment 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.\n○ Patients with renal impairment\n1) If creatinine clearance is 30~120mL/min, administer according to the standard dosage and regimen above.\n2) If creatinine clearance is 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.\nOnce reconstituted, store refrigerated and use within 14 days (for syrup only).

Child dose

○ Children (2~12 years)\nFor pharyngitis and tonsillitis among upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours.\nFor uncomplicated skin and soft tissue infections, administer 20mg (potency) per Kg of body weight per dose every 24 hours.\n○ Infants and children (6 months~12 years)\nFor otitis media among upper respiratory tract infections, administer 15mg per Kg of body weight every 12 hours.\nFor acute sinusitis among upper respiratory tract infections, administer 7.5mg per Kg of body weight every 12 hours.\nFor moderate or more severe infections requiring a dose increase, administer 15mg per Kg of body weight every 12 hours.

Precautions

This drug is a cephalosporin antibiotic and should be avoided in certain patients. It should not be used in patients who have had an allergic reaction to cephalosporin antibiotics. Patients who have allergies to penicillin or other drugs should use this drug with caution, as there may be cross-reactivity between beta-lactam antibiotics. Patients with severe illnesses or impaired renal function should carefully check renal status before administration and reduce the dosage if necessary. Poor renal function may cause the drug to remain in the body for a long time, leading to side effects. Patients with gastrointestinal diseases, especially those with a history of colitis, should also use this drug with caution. This drug contains a dye called Tartrazine, and patients who have had allergic reactions to this component should be cautious. Common gastrointestinal disturbances such as diarrhea, nausea, vomiting, and abdominal pain may occur while taking this drug. There have also been reports of allergic reactions such as liver function abnormalities, skin rashes, and itching. Rarely, central nervous system symptoms such as dizziness, headaches, insomnia, drowsiness, changes in blood levels, or renal function abnormalities may occur. In case of a severe allergic reaction or seizure, discontinue the medication immediately and visit a hospital. Long-term use of this drug may lead to the development of resistant bacteria or overgrowth of other bacteria, so it should only be used for the minimal period necessary. When used in combination with other antibiotics or diuretics, renal toxicity may increase, so caution is advised. Women who are pregnant or nursing should only use this drug if absolutely necessary, and nursing mothers should consider the potential effects on their babies before administration. It is advised not to use in infants under 6 months of age as safety and efficacy have not been established. Elderly patients may require dosage adjustments due to potential renal function decline. This drug may affect the results of certain clinical tests, so caution is needed in interpreting test results. In case of overdose, since it is excreted through the kidneys, patients with impaired renal function may require hemodialysis. Finally, this drug is known to present no risk of carcinogenicity or mutagenicity and does not affect reproductive function.

Side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • increased AST
  • increased ALT
  • increased ALP
  • elevated bilirubin levels
  • cholestatic jaundice
  • rash
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  • urticaria
  • dizziness
  • hyperactivity
  • headache
  • restlessness
  • insomnia
  • confusion
  • drowsiness
  • seizures
  • decreased white blood cell count
  • increased eosinophils
  • elevated BUN
  • increased 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 drug is sensitive to light and should be stored in a container that protects it from light. It is also important to keep the drug at room temperature, between 1 and 30 degrees Celsius, to maintain its effectiveness for an extended period.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablet

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.