Medication info
Axephu Tablet (Sephuroxime Acetil)

Axephu Tablet (Sephuroxime Acetil)

Prescription medicationTabletOral
Ingredient · strength
Cefuroxime Axetil›300.72mg / 1 tablet
Manufacturer / importer
Shinil Pharmaceutical Co., Ltd.
Appearance
White or off-white rectangular film-coated tablets
Packaging
50 tablets (10 tablets/PTP X 5), 100 tablets (10 tablets/PTP X 10)
Approval status
Active

MFDS item code 200502164 · Notified 2005.01.13 · Insurance code 653801970

Summary

Main use
Treatment of respiratory and genitourinary infections, skin and soft tissue infections, gonorrhea, and early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, this medicine should be taken after meals. Adults 1) Most infections: Administer 250mg per dose twice daily. 2) Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: Administer 500mg per dose twice daily. 3) Urinary tract infections: Administer 250mg per dose twice daily. 4) Uncomplicated gonorrhea: Administer 1g as a single dose. 5) Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). 3. Patients with renal impairment Cefuroxime is excreted primarily by the kidneys. To compensate for delayed excretion in patients with significantly impaired renal function, reduction of the cefuroxime dose as described below is recommended. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dose adjustment required (standard dose: 125mg-500mg per dose twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 (hours) 4.6: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 (hours) 16.8: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 (hours) 2 - 4: 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 aged 12 years and older - Most infections: Administer 250mg per dose twice daily. Children aged 12 years and older - Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: Administer 500mg per dose twice daily. Children aged 12 years and older - Urinary tract infections: Administer 250mg per dose twice daily. Children aged 12 years and older - Uncomplicated gonorrhea: Administer 1g as a single dose. Children aged 12 years and older - Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). Children under 12 years of age - Most infections: Administer 125mg per dose twice daily. Otitis media in children aged 2 years and older and severe infections - Administer 250mg per dose twice daily. 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 medicine must not be divided and is therefore not suitable for treating patients who cannot swallow tablets, such as young infants and children.

Ingredients

Manufacturer
Shinil Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication, Cefuroxime, is a broad-spectrum antibiotic that effectively acts against various bacteria. It is used for upper respiratory infections such as otitis media, sinusitis, tonsillitis, and pharyngitis, and for lower respiratory infections like acute and chronic bronchitis, and pneumonia. It is also effective for urogenital infections such as pyelonephritis, cystitis, and urethritis. It is used for skin and soft tissue infections including boils, pyoderma, and impetigo, and is widely applied for the treatment of gonorrhea and early Lyme disease. Cefuroxime demonstrates stable efficacy against strains resistant to beta-lactamases, making it reliable for treating infections. Therefore, this drug is utilized for the treatment of various infections.

How to take

Adult dose

For optimal absorption, this medicine should be taken after meals. Adults 1) Most infections: Administer 250mg per dose twice daily. 2) Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: Administer 500mg per dose twice daily. 3) Urinary tract infections: Administer 250mg per dose twice daily. 4) Uncomplicated gonorrhea: Administer 1g as a single dose. 5) Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). 3. Patients with renal impairment Cefuroxime is excreted primarily by the kidneys. To compensate for delayed excretion in patients with significantly impaired renal function, reduction of the cefuroxime dose as described below is recommended. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dose adjustment required (standard dose: 125mg-500mg per dose twice daily) Creatinine clearance 10 - 29 mL/min/1.73m2, T1/2 (hours) 4.6: Administer the standard single dose every 24 hours Creatinine clearance < 10 mL/min/1.73m2, T1/2 (hours) 16.8: Administer the standard single dose every 48 hours Patients on hemodialysis, T1/2 (hours) 2 - 4: 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 aged 12 years and older - Most infections: Administer 250mg per dose twice daily. Children aged 12 years and older - Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by less susceptible organisms: Administer 500mg per dose twice daily. Children aged 12 years and older - Urinary tract infections: Administer 250mg per dose twice daily. Children aged 12 years and older - Uncomplicated gonorrhea: Administer 1g as a single dose. Children aged 12 years and older - Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). Children under 12 years of age - Most infections: Administer 125mg per dose twice daily. Otitis media in children aged 2 years and older and severe infections - Administer 250mg per dose twice daily. 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 medicine must not be divided and is therefore not suitable for treating patients who cannot swallow tablets, such as young infants and children.

Precautions

This medication should not be used in patients who have hypersensitivity to cephalosporin antibiotics. It should be used cautiously in patients with a history of hypersensitivity to penicillin or other beta-lactam antibiotics, patients with allergies, patients with severe renal impairment, patients who are unable to take it orally, elderly patients, or those in poor general condition. Mild adverse reactions such as headache, dizziness, diarrhea, nausea, and skin rash may occur while using this drug, and rarely serious skin reactions or interstitial pneumonia and renal impairment may occur, so careful observation is required. To prevent antibiotic-resistant bacteria, it is important to check the susceptibility of the infecting bacteria and to use the medication for only the necessary minimum duration. Allergic reactions or shock symptoms may arise during administration, thus patients' conditions should be closely monitored and administration should be stopped immediately if any abnormal symptoms occur. This drug may cause excessive growth of fungi such as Candida, and prolonged use may lead to clostridium difficile-associated diarrhea due to the proliferation of resistant bacteria, so if diarrhea occurs, inform healthcare personnel. This medication can cause dizziness, so caution is needed when driving or operating machinery. If pregnant or breastfeeding, consultation with a physician is essential before administration, especially during the early stages of pregnancy. It is advisable not to use this drug in infants younger than 3 months, as its safety has not been established, and for children, a syrup formulation is recommended due to its bitter taste. Elderly patients are at risk of bleeding due to decreased renal function and vitamin K deficiency, so dosage and intervals should be adjusted, and they should be closely monitored. This medication can affect certain clinical test results, so inform healthcare personnel during testing, and overdose may cause side effects such as seizures, requiring immediate treatment. Finally, this drug should be kept out of reach of children, stored in its original container, and should not be transferred to another container as this may result in diminished quality or misuse.

Side effects

  • Candida overgrowth
  • eosinophilia
  • positive Coombs test
  • thrombocytopenia
  • leukopenia
  • granulocytopenia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • hemolytic anemia
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  • skin rash
  • urticaria
  • itching
  • drug fever
  • serum sickness
  • anaphylaxis
  • facial swelling
  • lymphadenopathy
  • arthralgia
  • headache
  • dizziness
  • convulsions
  • anxiety
  • restlessness
  • mental confusion
  • hallucinations
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • membranous colitis
  • abdominal bloating
  • fever
  • cough
  • shortness of breath
  • chest X-ray abnormality
  • interstitial pneumonia
  • eosinophilic lung infiltration
  • temporary increase in 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 complex deficiency
  • otalgia
  • perioral sensory disturbance
  • sensation of tongue numbness
  • pharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • Churg-Strauss syndrome
  • DRESS syndrome
  • shock symptoms
  • malaise
  • oral abnormalities
  • wheezing
  • tinnitus
  • sweating

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

Storage

This medication should be stored in a tightly closed container that is well-ventilated and at a cool temperature below 25 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a long time.

Appearance and packaging

Appearance

White or off-white rectangular film-coated tablets

Package unit

50 tablets (10 tablets/PTP X 5), 100 tablets (10 tablets/PTP X 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.