Medication info
Elproxim Tablet (Cefuroxime Axetil)

Elproxim Tablet (Cefuroxime Axetil)

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

MFDS item code 201903572 · Approved 2019.05.30 · Insurance code 052401420

Summary

Main use
Treatment of respiratory tract infections, genitourinary infections and gonorrhea, and skin and soft tissue infections and Lyme disease
Who takes it
Adults · Children
Adult dose
To ensure optimal absorption, take after meals. Adults and children 12 years and older Most infections: 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility: 500mg twice daily. Urinary tract infections: 250mg twice daily. Uncomplicated gonorrhea: a single dose of 1g. Lyme disease: 500mg twice daily for 14 days (10~21 days). Patients with renal impairment Cefuroxime is excreted primarily by the kidneys. To compensate for delayed excretion in patients with significant renal impairment, the cefuroxime dose should be reduced as follows. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dosage adjustment required (standard dose: 125mg-500mg 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 undergoing hemodialysis, T1/2 (hours) 2 - 4: Administer an additional standard single dose at the end of each dialysis session
Child dose
Infants and children under 12 years, most infections: 125mg twice daily. Children 2 years and older, otitis media or severe infections: 250mg twice daily. Infants and children under 12 years, Lyme disease: 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. This medicine should not be divided and is therefore not suitable for patients who cannot swallow tablets, such as infants and young children.

Ingredients

Manufacturer
Intro Bio Pharma Co., Ltd.

Efficacy & effects

Treatment of respiratory tract infections, genitourinary infections and gonorrhea, and skin and soft tissue infections and 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 is effective against various types of bacteria. It is used for the treatment of upper respiratory infections such as otitis media, sinusitis, tonsillitis, and pharyngitis. It is also effective for lower respiratory infections such as acute and chronic bronchitis and pneumonia. It can also treat urinary tract infections such as pyelonephritis, cystitis, and urethritis, and is used for skin and soft tissue infections such as abscesses, impetigo, and furuncles. In the case of gonorrhea, it is applied to the treatment of simple acute gonococcal urethritis and gonococcal cervicitis, and it also helps in the treatment of early Lyme disease. This drug has strong resistance to beta-lactamase, so it effectively treats infections caused by strains resistant to ampicillin and amoxicillin.

How to take

Adult dose

To ensure optimal absorption, take after meals. Adults and children 12 years and older Most infections: 250mg twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or suspected infections caused by organisms with low susceptibility: 500mg twice daily. Urinary tract infections: 250mg twice daily. Uncomplicated gonorrhea: a single dose of 1g. Lyme disease: 500mg twice daily for 14 days (10~21 days). Patients with renal impairment Cefuroxime is excreted primarily by the kidneys. To compensate for delayed excretion in patients with significant renal impairment, the cefuroxime dose should be reduced as follows. Creatinine clearance ≥ 30 mL/min/1.73m2, T1/2 (hours) 1.4 - 2.4: No dosage adjustment required (standard dose: 125mg-500mg 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 undergoing hemodialysis, T1/2 (hours) 2 - 4: Administer an additional standard single dose at the end of each dialysis session

Child dose

Infants and children under 12 years, most infections: 125mg twice daily. Children 2 years and older, otitis media or severe infections: 250mg twice daily. Infants and children under 12 years, Lyme disease: 250mg twice daily for 14 days (10~21 days). There is insufficient experience with use in infants under 3 months of age. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. This medicine should not be divided and is therefore not suitable for patients who cannot swallow tablets, such as infants and young children.

Precautions

This drug is a cephalosporin antibiotic and should not be used in patients with a history of allergy to drugs in this class. Patients with a history of allergy to penicillin or other beta-lactam antibiotics, those prone to allergic reactions such as bronchial asthma, skin rashes, urticaria, patients with severe renal impairment, patients who have difficulty swallowing or in elderly patients, and patients in poor general condition should be given this drug with caution. Various adverse reactions, ranging from mild symptoms to serious side effects, may occur when using this drug, so if symptoms such as rash, urticaria, fever, difficulty breathing, or severe skin reactions occur, immediate consultation with a healthcare professional is necessary. Also, symptoms like headache, dizziness, indigestion, diarrhea, and nausea may commonly occur, so caution is needed. Long-term use of this drug can lead to excessive growth of Candida or an increase in harmful bacteria in the intestines, so if these symptoms occur, the treatment should be discontinued. If diarrhea worsens or abdominal pain persists during or after antibiotic use, it may indicate pseudomembranous colitis, and immediate notification to a healthcare professional is required. This drug can cause dizziness, so caution is needed when driving or operating machinery. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of this drug if administration is necessary, and caution should also be exercised if breastfeeding. It is advisable to avoid using this drug in infants under 3 months of age as safety has not been established, and for children, syrup form is recommended due to its bitterness. In elderly patients, the risk of bleeding due to impaired renal function and vitamin K deficiency is higher, so doses and intervals should be adjusted and their condition closely monitored. This drug can worsen renal impairment when used in conjunction with other diuretics or aminoglycoside antibiotics, so caution is advised, and absorption may decrease when combined with antacids or other gastric acid suppressants, so it is preferable to take it with meals. Additionally, it may reduce the effectiveness of oral contraceptives, so caution is necessary when used together. In case of overdose, seizures may occur, so immediate medical assistance should be sought, and the drug concentration can be reduced by hemodialysis or peritoneal dialysis. Lastly, this drug should be stored out of reach of children and kept in its original container as transferring to another container poses risks of misuse or quality degradation.

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
  • dyspepsia
  • constipation
  • loss of appetite
  • pseudomembranous 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 kidney failure
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • vitamin K deficiency symptoms
  • vitamin B group deficiency symptoms
  • otalgia
  • perioral sensory disturbances
  • tongue numbness
  • pharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • Kounis syndrome
  • shock symptoms
  • malaise
  • oral abnormalities
  • wheezing
  • stool abnormalities
  • tinnitus
  • sweating

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

Storage

This drug should be stored in a tightly sealed container to prevent air exposure, and it is best to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and ensure its safe use.

Appearance and packaging

Appearance

White rectangular film-coated tablets

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.