Medication info

Cefusethyl Tablet 250mg (Cefuroxime Axetil)

Prescription medicationTabletOralExpired
Ingredient · strength
Cefuroxime Axetil›300.72mg / 1 tablet
Manufacturer / importer
Ixu Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
50 tablets (10 tablets/PTP × 5)
Approval status
Expired

MFDS item code 201904221 · Approved 2019.06.18

This product's status changed to Expired on 2024.06.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory and genitourinary infections (e.g., gonorrhea), skin and soft tissue infections, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, take after meals. Most infections: Administer 250mg per dose twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility: Administer 500mg per dose twice daily. Urinary tract infections: Administer 250mg per dose twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). For patients with significantly impaired renal function, the cefuroxime dose should be reduced as described below to compensate for delayed elimination. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 1.4 - 2.4 hours: No dose adjustment necessary (standard dose: 125mg-500mg per dose twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 4.6 hours: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 16.8 hours: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 2 - 4 hours: Administer an additional standard single dose at the end of each dialysis session For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days.
Child dose
Children 12 years of age and older, most infections: 250mg twice daily. Children 12 years of age and older, severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by less susceptible organisms: 500mg twice daily. Children 12 years of age and older, urinary tract infections: 250mg twice daily. Children 12 years of age and older, uncomplicated gonorrhea: a single dose of 1g. Children 12 years of age and older, Lyme disease: 500mg twice daily for 14 days (10~21 days). Infants and children under 12 years of age, most infections: 125mg twice daily. Children 2 years of age and older, otitis media or severe infections: 250mg twice daily. Infants and children under 12 years of age, Lyme disease: 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age.

Ingredients

Manufacturer
Ixu Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and genitourinary infections (e.g., gonorrhea), skin and soft tissue infections, and early Lyme disease

  • Otitis media
  • sinusitis
  • tonsillitis
  • pharyngitis
  • acute bronchitis
  • chronic bronchitis
  • pneumonia
  • pyelonephritis
  • cystitis
  • urethritis
  • boils
  • pyoderma
View approved original text

Cefuroxime is an antibiotic effective against a variety of bacteria, mainly used for treating upper and lower respiratory tract infections, urogenital infections, and skin and soft tissue infections. It is particularly effective against respiratory diseases such as otitis media, sinusitis, and pneumonia, as well as urogenital diseases like pyelonephritis and cystitis. It is also used in the treatment of gonorrhea and early Lyme disease. This drug is stable against beta-lactamase and works well against bacteria resistant to ampicillin and amoxicillin. It is a cephalosporin antibiotic that has broad bactericidal activity against various aerobic and anaerobic strains. Cefuroxime is safely and effectively used for treating infections.

How to take

Adult dose

For optimal absorption, take after meals. Most infections: Administer 250mg per dose twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility: Administer 500mg per dose twice daily. Urinary tract infections: Administer 250mg per dose twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). For patients with significantly impaired renal function, the cefuroxime dose should be reduced as described below to compensate for delayed elimination. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 1.4 - 2.4 hours: No dose adjustment necessary (standard dose: 125mg-500mg per dose twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 4.6 hours: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 16.8 hours: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 2 - 4 hours: Administer an additional standard single dose at the end of each dialysis session For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days.

Child dose

Children 12 years of age and older, most infections: 250mg twice daily. Children 12 years of age and older, severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by less susceptible organisms: 500mg twice daily. Children 12 years of age and older, urinary tract infections: 250mg twice daily. Children 12 years of age and older, uncomplicated gonorrhea: a single dose of 1g. Children 12 years of age and older, Lyme disease: 500mg twice daily for 14 days (10~21 days). Infants and children under 12 years of age, most infections: 125mg twice daily. Children 2 years of age and older, otitis media or severe infections: 250mg twice daily. Infants and children under 12 years of age, Lyme disease: 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age.

Precautions

This medication should not be used by individuals with an allergy to cephalosporin antibiotics. Patients with a history of allergy to penicillin or other beta-lactam antibiotics should use it with caution. Caution is also required in individuals prone to allergic symptoms such as bronchial asthma, skin rash, or hives. Special care should be taken when administering to patients with severely impaired renal function. Patients who have difficulty swallowing or elderly patients, as well as those in poor overall health, should be carefully monitored for symptoms of vitamin K deficiency. Mild side effects may occur when using this medication, but they are usually temporary. Serious allergic reactions like skin rash, hives, itching, fever, serum sickness, and anaphylaxis can rarely occur, so any unusual symptoms should be reported to medical personnel immediately. Headaches or dizziness may occur, so caution is needed while driving or operating machinery. Gastrointestinal disturbances such as diarrhea, nausea, and abdominal pain may develop, and if severe diarrhea persists, the medication should be discontinued and a hospital visited. Long-term use can lead to candidiasis or the emergence of resistant strains, so it is advisable to use it for the minimum necessary duration. This drug can affect liver and kidney function, necessitating regular check-ups, and treatment should be halted if any abnormalities arise. The safety of this drug during pregnancy or breastfeeding has not been fully confirmed, so it should be used cautiously when necessary. It is advisable to avoid using it in infants under 3 months of age, as its safety has not been established in this population. Elderly patients may experience side effects more readily due to decreased bodily functions; thus, dosages and intervals should be adjusted, and they should be monitored closely. Co-administration with other drugs may place additional stress on the kidneys, particularly with diuretics or aminoglycoside antibiotics, so it should be administered cautiously. Taking it with acid suppressants may reduce its effectiveness, so it is recommended to take it with meals. This drug can affect the results of blood tests and urine tests, so it is important to inform medical personnel of its use during testing. Overdosing may lead to serious side effects such as seizures, and drug levels can be lowered through hemodialysis or peritoneal dialysis. Keep out of the reach of children, and medications should be stored in their original containers for safety.

Side effects

  • Candidiasis overgrowth
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • granulocytopenia
  • erythropenia
  • hemoglobin decrease
  • hematocrit decrease
  • hemolytic anemia
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  • skin rash
  • urticaria
  • pruritus
  • drug fever
  • serum sickness
  • anaphylaxis
  • angioedema
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • seizures
  • anxiety
  • restlessness
  • mental confusion
  • hallucinations
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • pseudomembranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • chest X-ray abnormalities
  • interstitial pneumonia
  • eosinophilic lung infiltrates
  • transient increase in liver enzymes
  • jaundice
  • hepatitis
  • elevated BUN
  • acute renal failure
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • vitamin K deficiency symptoms
  • vitamin B group deficiency symptoms
  • otalgia
  • perioral paresthesia
  • tongue numbness
  • pharyngeal abnormalities
  • xerostomia
  • palpitations
  • eczema
  • Kounis syndrome
  • discomfort
  • oral abnormalities
  • wheezing
  • fecal incontinence
  • tinnitus
  • sweating

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

Storage

This medication should be stored in a sealed container to prevent air from entering, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage maintains the drug's effectiveness and allows for safe use.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

50 tablets (10 tablets/PTP × 5)

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.