Medication info
Samsetil Tablets (Cefuroxime Axetil)

Samsetil Tablets (Cefuroxime Axetil)

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

MFDS item code 202001476 · Approved 2020.03.02 · Insurance code 642308340

Summary

Main use
Treatment of respiratory, skin, and soft-tissue infections; genitourinary infections and gonorrhea; early Lyme disease
Who takes it
Adults · Children
Adult dose
For optimal absorption, take after meals. Adults and children aged 12 years or older Most infections: Administer 250mg per dose twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by organisms with low susceptibility: Administer 500mg per dose twice daily. Urinary tract infections: Administer 250mg per dose twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). Patients with renal impairment ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg per dose 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 undergoing 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. Children aged 2 years or older with otitis media or 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). Infants under 3 months of age: There is insufficient experience with use. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. This medicine must not be divided and is therefore not suitable for patients who cannot swallow tablets, such as young infants and children.

Ingredients

Manufacturer
Samsung Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

Cefuroxime is a highly effective antibiotic against various bacteria, used to treat several upper and lower respiratory infections, including otitis media, sinusitis, tonsillitis, acute and chronic bronchitis, and pneumonia. It is also effective for urinary tract infections such as pyelonephritis and cystitis, as well as skin and soft tissue infections like carbuncles and pyoderma. It is used in the treatment of gonorrhea, including gonococcal urethritis and cervicitis, and is useful for early Lyme disease treatment. This drug is resistant to beta-lactamase enzymes, exhibiting excellent bactericidal activity against resistant strains. It is widely used for various infectious diseases, including some strains with complex resistance issues.

How to take

Adult dose

For optimal absorption, take after meals. Adults and children aged 12 years or older Most infections: Administer 250mg per dose twice daily. Severe lower respiratory tract infections, pneumonia, severe infections, or infections suspected to be caused by organisms with low susceptibility: Administer 500mg per dose twice daily. Urinary tract infections: Administer 250mg per dose twice daily. Uncomplicated gonorrhea: Administer 1g as a single dose. Lyme disease: Administer 500mg per dose twice daily for 14 days (10~21 days). Patients with renal impairment ≥ 30 mL/min/1.73m2: No dosage adjustment required (standard dose: 125mg-500mg per dose 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 undergoing 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. Children aged 2 years or older with otitis media or 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). Infants under 3 months of age: There is insufficient experience with use. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), this medicine should be administered for 7~10 days. This medicine must not be divided and is therefore not suitable for patients who cannot swallow tablets, such as young infants and children.

Precautions

This medication is a cephalosporin antibiotic and should not be administered to patients with a known allergy to this class of drugs. Caution should be taken for patients with a history of allergy to penicillin or other beta-lactam antibiotics, those with a familial history or who are predisposed to allergies. Patients with severely impaired renal function, those who cannot take it orally, the elderly, and those in poor systemic condition should also be monitored closely. While using this drug, excessive proliferation of Candida or resistant bacteria in the intestines may occur, thus monitoring is necessary. If gastrointestinal symptoms such as diarrhea or abdominal pain occur, consider the possibility of pseudomembranous colitis and discontinue treatment immediately. Serious skin reactions can occur, so monitor the skin condition and stop use immediately if any abnormal symptoms arise. Caution is advised while driving or operating machinery, as dizziness may occur. This drug may interact with other medications, especially diuretics, certain antibiotics, and antacids, which can affect renal function or drug efficacy, so consulting a specialist is advised. Use during pregnancy or nursing should be decided with caution, particularly considering risks and benefits during early pregnancy. It is not established as safe for infants under 3 months old, and for children, it is advisable to select an appropriate formulation due to potential difficulties with taste. Elderly patients may experience more side effects due to declining physical function, so dosages and intervals should be adjusted and monitored closely. This medication can affect the results of blood tests, so inform healthcare professionals about its usage during testing. In cases of overdose, seizures may occur; seek medical attention immediately for appropriate treatment. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

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
  • diarrhea
  • nausea
  • abdominal pain
  • vomiting
  • dyspepsia
  • constipation
  • loss of appetite
  • membranous colitis
  • abdominal distension
  • fever
  • cough
  • dyspnea
  • abnormal chest X-ray
  • interstitial pneumonia
  • eosinophilic lung infiltration
  • temporary 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 complex deficiency
  • otalgia
  • perioral sensory abnormalities
  • sensation of numbness in the tongue
  • oropharyngeal abnormalities
  • dry mouth
  • palpitations
  • eczema
  • Churg-Strauss syndrome
  • DRESS syndrome
  • discomfort
  • oral abnormalities
  • wheezing
  • tinnitus
  • sweating

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

Storage

Store this medication in a sealed container to prevent exposure to air and moisture, and keep it in a cool place below 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

White to off-white, oval film-coated tablet

Package unit

100 tablets/box [(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.