Medication info
Sepactil Tablets (Cefuroxime Axetil)

Sepactil Tablets (Cefuroxime Axetil)

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

MFDS item code 200703345 · Notified 2007.03.22 · Insurance code 645207790

Summary

Main use
Treatment of respiratory infections, genitourinary infections and gonorrhea, skin and soft tissue infections, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, take after meals. Adults and children aged 12 years and older Most infections: 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: 500mg twice daily. Urinary tract infections: 250mg twice daily. Uncomplicated gonorrhea: 1g as a single dose. Lyme disease: 500mg twice daily for 14 days (10~21 days). For treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), administer this medicine for 7~10 days. Patients with renal impairment Creatinine clearance ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2: Administer the standard single dose every 48 hours Patients on 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: 125mg twice daily. Otitis media in children aged 2 years and older, 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. This medicine is not appropriate for treating young children and other patients who cannot swallow tablets.

Ingredients

Manufacturer
Aprogen Biologics Co., Ltd.

Efficacy & effects

Treatment of respiratory infections, genitourinary infections and gonorrhea, skin and soft tissue infections, and early Lyme disease

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

Cefuroxime is a broad-spectrum antibiotic that works effectively against various types of bacteria. It is used to treat upper respiratory infections such as otitis media, sinusitis, tonsillitis, and pharyngitis, as well as lower respiratory infections, including acute and chronic bronchitis and pneumonia. It is also indicated for urinary tract infections like pyelonephritis, cystitis, and urethritis. It is helpful for skin and soft tissue infections such as furunculosis, impetigo, and pyoderma. Additionally, it is used for the treatment of gonorrhea, including acute gonococcal urethritis and gonococcal cervicitis, and for early Lyme disease. Thus, cefuroxime is an effective medication for improving various infections.

How to take

Adult dose

For optimal absorption, take after meals. Adults and children aged 12 years and older Most infections: 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: 500mg twice daily. Urinary tract infections: 250mg twice daily. Uncomplicated gonorrhea: 1g as a single dose. Lyme disease: 500mg twice daily for 14 days (10~21 days). For treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), administer this medicine for 7~10 days. Patients with renal impairment Creatinine clearance ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2: Administer the standard single dose every 48 hours Patients on 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: 125mg twice daily. Otitis media in children aged 2 years and older, 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. This medicine is not appropriate for treating young children and other patients who cannot swallow tablets.

Precautions

This medication should not be used in patients with an allergy to cephalosporin antibiotics. It should be administered cautiously in patients with a history of hypersensitivity to penicillin or other beta-lactam antibiotics, or in those with a family history of allergic conditions. Patients with severely impaired kidney function, those who have difficulty with oral intake, the elderly, or those in poor general condition should also be cautious. During the use of this medication, side effects such as headache, dizziness, diarrhea, nausea, and skin rash may occur, and rarely, serious allergic reactions or skin adverse reactions may appear. Long-term use of this medication can lead to excessive proliferation of Candida species or resistant bacteria, so caution is necessary. If diarrhea persists or abdominal pain worsens, stop taking the medication immediately and consult with a physician. This medication may cause dizziness, so be cautious when driving or operating machinery. Women who are pregnant or nursing should use this medication only if necessary, and caution is advised while nursing due to potential effects on the infant. For infants under 3 months of age, safety has not been established, so use should be avoided. Elderly patients may exhibit increased side effects due to reduced physical function, thus monitoring and adjusting the dose and administration interval is essential. This medication may interact with other drugs, especially diuretics, aminoglycoside antibiotics, probenecid, and antacids, so caution is necessary when used in combination. In cases of overdose, serious side effects such as seizures may occur; seek medical attention immediately. Finally, this medication should be kept out of reach of children and stored sealed in its original container.

Side effects

  • Candidiasis hyperproliferation
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • granulocytopenia
  • anemia
  • hemoglobin decrease
  • hematocrit decrease
  • hemolytic anemia
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  • skin rash
  • urticaria
  • itching
  • drug fever
  • serum sickness
  • anaphylaxis
  • facial edema
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • pseudomembranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • chest X-ray abnormalities
  • transient elevation of liver enzymes
  • jaundice
  • hepatitis
  • increased BUN
  • acute renal failure
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • otalgia
  • perioral sensory abnormalities
  • tongue numbness
  • pharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • DRESS syndrome
  • symptoms of shock
  • malaise
  • oral abnormalities
  • wheezing
  • bowel movement
  • 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 closed container to prevent exposure to air and moisture, and it is best kept at a cool temperature below 25 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

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.