Medication info

Cefprozil Dry Syrup 125 mg/5 mL (Cefprozil Monohydrate)

Prescription medicationSyrupOral
Ingredient · strength
Cefprozil Hydrate›5000g / 100g
Manufacturer / importer
Geonil Pharmaceutical Co., Ltd.
Appearance
Pink powder syrup
Packaging
60 mL/bottle, 150 mL/bottle
Approval status
Active

MFDS item code 200400419 · Notified 2004.08.26 · Insurance code 646800772

Summary

Main use
Treatment of respiratory infections (such as otitis media), 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, which are 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 necessary for moderate or more severe infections). 2) For bacterial superinfection in acute bronchitis or bacterial exacerbation of chronic bronchitis, which are 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 depending on symptoms. 4) For uncomplicated urinary tract infections, administer 500mg (potency) of this medicine every 24 hours. <Duration of administration> Administration is usually 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 described 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. After reconstitution, store refrigerated and use within 14 days (syrup only).
Child dose
○ Children (2~12 years) For pharyngitis and tonsillitis, which are upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours. ○ Children (2~12 years) 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, which is 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 dose escalation, administer 15mg per Kg of body weight every 12 hours.

Ingredients

Manufacturer
Geonil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory infections (such as otitis media), 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 exacerbation of chronic bronchitis
  • uncomplicated skin and soft tissue infections
  • abscess
  • uncomplicated urinary tract infections
  • cystitis
View approved original text

This medicine is used to treat various mild to moderate infections caused by sensitive strains such as Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is effective for upper respiratory tract infections, including pharyngitis, tonsillitis, and acute sinusitis, and can also be used in the treatment of otitis media. For lower respiratory tract infections, it helps with secondary bacterial infections of acute bronchitis and acute exacerbation of chronic bronchitis. Additionally, it is useful for skin and soft tissue infections, especially in cases requiring drainage of simple skin infections or abscesses. Lastly, it is utilized in the treatment of uncomplicated urinary tract infections, particularly cystitis. This medication effectively treats various bacterial infections and assists in the recovery of patients' health.

How to take

Adult dose

○ Adults (13 years of age and older) 1) For pharyngitis and tonsillitis, which are 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 necessary for moderate or more severe infections). 2) For bacterial superinfection in acute bronchitis or bacterial exacerbation of chronic bronchitis, which are 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 depending on symptoms. 4) For uncomplicated urinary tract infections, administer 500mg (potency) of this medicine every 24 hours. <Duration of administration> Administration is usually 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 described 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. After reconstitution, store refrigerated and use within 14 days (syrup only).

Child dose

○ Children (2~12 years) For pharyngitis and tonsillitis, which are upper respiratory tract infections, administer 7.5mg (potency) per Kg of body weight per dose every 12 hours. ○ Children (2~12 years) 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, which is 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 dose escalation, administer 15mg per Kg of body weight every 12 hours.

Precautions

This medication is a cephalosporin antibiotic and should not be used in certain patients. For example, individuals who have had an allergic reaction to this medication or those with a genetic disorder that prevents lactose digestion should not be administered this drug. Additionally, patients with allergies to penicillin or other medications should use this medicine with caution. Patients with impaired kidney function or gastrointestinal disorders should be carefully monitored when using this medication. Taking this medication may result in gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain, and liver function tests may show elevated levels. Allergic reactions such as skin rashes or hives may occur rarely, so caution is necessary. This drug may affect the central nervous system, leading to dizziness, headaches, or insomnia, and patients with impaired kidney function may be at risk of seizures; therefore, it is important to discontinue use immediately if any unusual symptoms arise. Prolonged use of this medication can lead to the development of resistant bacteria, so it should only be taken for the minimum period as directed by a physician, with close monitoring of the infection status during treatment. If an allergic reaction occurs, discontinue use immediately and seek necessary emergency treatment. Furthermore, if severe diarrhea develops while taking this medication, proper treatment should be sought considering the possibility of pseudomembranous colitis. When used with other antibiotics or diuretics, there may be an increased risk of renal toxicity, so caution is needed. Pregnant or breastfeeding women should only use this medication if absolutely necessary, and it should be used with caution in infants or neonates where safety hasn't been thoroughly established. Elderly patients may require dose adjustment due to the potential for decreased kidney function. This medication is excreted through the kidneys, so in cases of overdose in patients with impaired kidney function, it can be removed via hemodialysis. Finally, this medication is not known to pose a risk of carcinogenicity or mutagenicity and is not known to affect reproductive function.

Side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • elevated AST
  • elevated ALT
  • elevated ALP
  • increased bilirubin level
  • cholestatic jaundice
  • rash
Show 35 more
  • urticaria
  • dizziness
  • hyperactivity
  • headache
  • anxiety
  • insomnia
  • confusion
  • drowsiness
  • seizures
  • decreased white blood cell count
  • increased eosinophils
  • elevated BUN
  • increased serum creatinine
  • diaper rash
  • superinfection
  • pruritus of the genitals
  • vaginitis
  • anaphylaxis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • serum sickness reaction
  • fever
  • renal insufficiency
  • 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 medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink powder syrup

Package unit

60 mL/bottle, 150 mL/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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.