Medication info

Setroc Tablet (Cefuroxime Axetil)

Prescription medicationTabletOralExpired
Ingredient · strength
Cefuroxime Axetil›300.72mg / 1 tablet
Manufacturer / importer
Samik Pharmaceutical Co., Ltd.
Appearance
White to off-white rectangular film-coated tablet
Packaging
100 tablets (10 tablets/PTP × 10)
Approval status
Expired

MFDS item code 201903235 · Approved 2019.05.20

This product's status changed to Expired on 2024.05.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory infections, genitourinary infections (e.g., gonorrhea), skin infections, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, it should be taken after meals. Adults and children aged 12 years and older Most infections: Administer 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by organisms with reduced susceptibility: Administer 500mg twice daily. Urinary tract infections: Administer 250mg twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg twice daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medication should be administered for 7~10 days. Patients with renal impairment ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg twice daily) 10 - 29 mL/min/1.73m2: Administer the standard single dose every 24 hours < 10 mL/min/1.73m2: Administer the standard single dose every 48 hours Patients receiving hemodialysis: Administer an additional standard single dose at the end of each dialysis session
Child dose
Infants and children under 12 years of age, most infections: Administer 125mg per dose, twice daily. Otitis media in children 2 years of age and older, severe infections: Administer 250mg per dose, twice daily. Infants and children under 12 years of age, Lyme disease: Administer 250mg per dose, twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medication should not be divided; therefore, it is not appropriate for treating patients who cannot swallow tablets, such as young infants and children.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Otitis media
  • sinusitis
  • tonsillitis
  • pharyngitis
  • acute bronchitis
  • chronic bronchitis
  • pneumonia
  • pyelonephritis
  • cystitis
  • urethritis
  • boil infections
  • impetigo
View approved original text

This medication contains cefuroxime, which has a strong antibacterial effect against various strains. It is effective against upper respiratory infections such as otitis media, sinusitis, tonsillitis, and pharyngitis, and is widely used for the treatment of lower respiratory infections such as acute and chronic bronchitis and pneumonia. It is also helpful for urinary tract infections such as pyelonephritis, cystitis, and urethritis, and can be safely used to treat skin and soft tissue infections like boils and impetigo. It is suitable for the treatment of gonorrhea and early Lyme disease, making it widely applicable to various infectious diseases. It is stable against beta-lactamases and shows efficacy against strains resistant to ampicillin and amoxicillin. This medication is very useful for the treatment of infections.

How to take

Adult dose

For optimal absorption, it should be taken after meals. Adults and children aged 12 years and older Most infections: Administer 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by organisms with reduced susceptibility: Administer 500mg twice daily. Urinary tract infections: Administer 250mg twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg twice daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medication should be administered for 7~10 days. Patients with renal impairment ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg twice daily) 10 - 29 mL/min/1.73m2: Administer the standard single dose every 24 hours < 10 mL/min/1.73m2: Administer the standard single dose every 48 hours Patients receiving hemodialysis: Administer an additional standard single dose at the end of each dialysis session

Child dose

Infants and children under 12 years of age, most infections: Administer 125mg per dose, twice daily. Otitis media in children 2 years of age and older, severe infections: Administer 250mg per dose, twice daily. Infants and children under 12 years of age, Lyme disease: Administer 250mg per dose, twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. This medication should not be divided; therefore, it is not appropriate for treating patients who cannot swallow tablets, such as young infants and children.

Precautions

This medication should not be used in patients with hypersensitivity to cephalosporin antibiotics. It should be used with caution in patients with a history of hypersensitivity to penicillin or other beta-lactam antibiotics, or who have allergies in themselves or in their family. Patients with severely impaired kidney function, those who have difficulty taking medications orally, elderly patients, and patients with poor overall status should be closely monitored as vitamin K deficiency symptoms may occur. While using this medication, mild and transient side effects may occur; however, serious allergic reactions or severe skin reactions can occur, and symptoms should be closely observed. Gastrointestinal symptoms such as headache, dizziness, diarrhea, nausea, and abdominal pain may also frequently occur, so if these symptoms worsen, consult a healthcare professional. During antibiotic use, excessive overgrowth of Candida or other resistant bacteria may occur; therefore, caution is needed with long-term use. If severe diarrhea or persistent abdominal pain occurs, immediately suspect pseudomembranous colitis, discontinue treatment, and inform a healthcare professional. This medication may cause dizziness; therefore, caution is needed when driving or operating machinery. Pregnant or breastfeeding women should only take this medication under a doctor's supervision when necessary, as it may affect the baby during breastfeeding. It is advisable not to use this medication in infants under 3 months of age as safety has not been established. Elderly patients are at higher risk of adverse reactions due to decreased physiological function, so dosage and administration interval should be adjusted, and their condition should be closely monitored. This medication may affect certain clinical test results, so patients should inform healthcare professionals about taking this medication during tests. In cases of overdose, serious side effects such as seizures may occur, and immediate medical attention is required; blood dialysis or peritoneal dialysis can lower drug concentration. This medication should be kept out of reach of children and stored tightly sealed in the original container to maintain the quality of the medication.

Side effects

  • Candida overgrowth
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • granulocytopenia
  • erythrocytopenia
  • hemoglobin decrease
  • hematocrit decrease
  • hemolytic anemia
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  • skin rash
  • urticaria
  • itching
  • drug fever
  • serum sickness
  • anaphylaxis
  • facial swelling
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • seizures
  • anxiety
  • restlessness
  • mental confusion
  • hallucinations
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • indigestion
  • constipation
  • appetite loss
  • membranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • abnormal chest X-ray
  • interstitial pneumonia
  • eosinophilic lung infiltration
  • transient increase in liver enzymes
  • jaundice
  • hepatitis
  • elevated BUN
  • acute renal failure
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B deficiency
  • ear pain
  • perioral paresthesia
  • sensation of tongue numbness
  • pharyngeal disorders
  • xerostomia
  • palpitations
  • eczema
  • DRESS syndrome
  • shock symptoms
  • malaise
  • oral abnormalities
  • wheezing
  • tinnitus
  • sweating
  • Conn's syndrome

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

Storage

This medication should be stored in a tightly sealed container to prevent air ingress and kept in a cool place below 25 degrees Celsius to ensure effectiveness.

Appearance and packaging

Appearance

White to off-white rectangular film-coated tablet

Package unit

100 tablets (10 tablets/PTP × 10)

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.