Medication info
Cefutil Tablet 250 mg (Cefuroxime Axetil)

Cefutil Tablet 250 mg (Cefuroxime Axetil)

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

MFDS item code 201800609 · Approved 2018.01.31 · Insurance code 640903600

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 12 years of age and older — most infections: Administer 250mg per dose 2 times daily. Adults and 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: Administer 500mg per dose 2 times daily. Adults and children 12 years of age and older — urinary tract infections: Administer 250mg per dose 2 times daily. Adults and children 12 years of age and older — uncomplicated gonorrhea: Administer 1g as a single dose. Adults and children 12 years of age and older — Lyme disease: Administer 500mg per dose 2 times daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. Patients with renal impairment: Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, reducing the dose of cefuroxime as follows is recommended. ≥ 30 mL/min/1.73m2 (T1/2 1.4 - 2.4 hours): No dosage adjustment required (standard dose: 125mg-500mg per dose 2 times daily) 10 - 29 mL/min/1.73m2 (T1/2 4.6 hours): Administer the standard single dose every 24 hours < 10 mL/min/1.73m2 (T1/2 16.8 hours): Administer the standard single dose every 48 hours Patients receiving hemodialysis (T1/2 2 - 4 hours): 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 2 times daily. Children 2 years of age and older — otitis media, severe infections: Administer 250mg per dose 2 times daily. Infants and children under 12 years of age — Lyme disease: Administer 250mg per dose 2 times daily for 14 days (10~21 days). Infants under 3 months of age: There is insufficient experience with use. Not suitable for treating patients who cannot swallow tablets, such as young infants and children.

Ingredients

Manufacturer
Ilhwa 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
  • pyoderma
View approved original text

Cefuroxime is an antibiotic with a broad antibacterial effect against various bacteria, especially effective against many resistant strains as it works stably against beta-lactamase. This medication is used not only for upper respiratory infections such as otitis media, sinusitis, and tonsillitis but also for lower respiratory infections including acute and chronic bronchitis, and pneumonia. It is also effective in treating urogenital infections such as pyelonephritis, cystitis, and urethritis as well as skin and soft tissue infections such as furunculosis, pyoderma, and impetigo. It is utilized in the treatment of acute uncomplicated gonococcal urethritis and gonococcal cervicitis and is employed in the early treatment of Lyme disease. Thus, Cefuroxime is widely used for the treatment of various infections, contributing to the recovery of patients' health.

How to take

Adult dose

For optimal absorption, take after meals. Adults and children 12 years of age and older — most infections: Administer 250mg per dose 2 times daily. Adults and 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: Administer 500mg per dose 2 times daily. Adults and children 12 years of age and older — urinary tract infections: Administer 250mg per dose 2 times daily. Adults and children 12 years of age and older — uncomplicated gonorrhea: Administer 1g as a single dose. Adults and children 12 years of age and older — Lyme disease: Administer 500mg per dose 2 times daily for 14 days (10~21 days). For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. Patients with renal impairment: Cefuroxime is primarily eliminated by the kidneys. To compensate for delayed elimination in patients with significantly impaired renal function, reducing the dose of cefuroxime as follows is recommended. ≥ 30 mL/min/1.73m2 (T1/2 1.4 - 2.4 hours): No dosage adjustment required (standard dose: 125mg-500mg per dose 2 times daily) 10 - 29 mL/min/1.73m2 (T1/2 4.6 hours): Administer the standard single dose every 24 hours < 10 mL/min/1.73m2 (T1/2 16.8 hours): Administer the standard single dose every 48 hours Patients receiving hemodialysis (T1/2 2 - 4 hours): 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 2 times daily. Children 2 years of age and older — otitis media, severe infections: Administer 250mg per dose 2 times daily. Infants and children under 12 years of age — Lyme disease: Administer 250mg per dose 2 times daily for 14 days (10~21 days). Infants under 3 months of age: There is insufficient experience with use. Not suitable for treating patients who cannot swallow tablets, such as young infants and children.

Precautions

This medication should not be administered to patients with hypersensitivity to cephalosporin antibiotics. Patients with a history of allergies to penicillins or other beta-lactam antibiotics should use it with caution. Caution is also necessary for individuals with bronchial asthma or a tendency to develop allergic symptoms such as skin rashes and urticaria. Patients with severely impaired kidney function should be particularly careful when using this drug. Patients who cannot take oral medications, those receiving parenteral nutrition, elderly patients, and those in poor general condition may show symptoms of vitamin K deficiency, and careful monitoring is needed. When using this medication, hypersensitivity reactions may occur, such as skin rashes, urticaria, itching, fever, serum sickness, and anaphylaxis, and if symptoms arise, medical personnel should be notified immediately. Commonly observed symptoms include headache, dizziness, diarrhea, nausea, abdominal pain, skin rash, itching, thrombocytopenia, leukopenia, vomiting, dyspepsia, constipation, loss of appetite, abdominal bloating, fever, cough, dyspnea, transient increase in liver enzymes, symptoms of vitamin K deficiency, symptoms of vitamin B deficiency, ear pain, peripheral sensation changes around the mouth, tongue numbness, dysphagia, dry mouth, palpitations, eczema, and Churg-Strauss syndrome. Prolonged use may lead to problems caused by excessive proliferation of Candida species or non-susceptible strains, necessitating discontinuation of use if symptoms occur. Diarrhea occurring during or after antibiotic use may indicate the possibility of pseudomembranous colitis, and if there are severe abdominal pains or persistent diarrhea, treatment should be stopped immediately and further evaluation is required. Pregnant women should only use this medication if absolutely necessary, as its safety has not been established, and nursing mothers should also be cautious as the drug can be transmitted through breast milk. The safety of this drug has not been established in children, especially infants under 3 months of age, and due to the strong bitter taste when crushed, syrup formulation is recommended. Elderly patients can develop adverse reactions more easily due to declining body function, so dosage and administration intervals should be adjusted, and careful observation is required. This medication may cause dizziness when driving or operating machinery, thus caution is needed. In cases of overdose, seizures may occur and immediate medical assistance should be sought, with hemodialysis or peritoneal dialysis available to lower drug concentration. Store this medication out of reach of children, and keep it sealed in the original container.

Side effects

  • Candida overgrowth
  • 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
  • anorexia
  • colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • chest X-ray abnormalities
  • transient increase in liver enzymes
  • jaundice
  • hepatitis
  • elevated BUN
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • otalgia
  • perioral paresthesia
  • tongue numbness
  • pharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • DRESS syndrome
  • shock symptoms
  • malaise
  • oral abnormalities
  • wheezing
  • fecal incontinence
  • tinnitus
  • sweating
  • Cornelia de Lange syndrome

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

Storage

Store this medication in a tightly sealed container that is well-ventilated and should preferably be kept at room temperature between 1 to 30 degrees Celsius. This storage condition helps to maintain the drug's effectiveness for longer.

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.