Medication info
Kramox Tablets 375 mg (Amoxicillin Trihydrate, Clavulanate Potassium (2:1))

Kramox Tablets 375 mg (Amoxicillin Trihydrate, Clavulanate Potassium (2:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Oval film-coated tablets, white or almost white
Packaging
100 tablets ((10 tablets/Alu-Alu)x10)
Approval status
Active

MFDS item code 200100908 · Notified 2001.10.12 · Insurance code 651201680

Summary

Main use
(Treatment of respiratory infections and urogenital infections, and improvement of soft tissue infections)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older, or weighing more than 40 kg, should take Amoxicillin/Clavulanate Potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe infection and respiratory infections, the dose may be increased to 500 mg/125 mg per administration. In cases of renal impairment, the dosing regimen must be adjusted based on creatinine clearance. For creatinine clearances of 10-30 mL/min, Amoxicillin should be administered as 250-500 mg every 12 hours.
Child dose
Children aged 12 years or older, or weighing more than 40 kg, should receive the same dosage as adults. For children with renal impairment, dosage should be reduced accordingly.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

(Treatment of respiratory infections and urogenital infections, and improvement of soft tissue infections)

  • Acute and chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
  • pelvic infections
View approved original text

This medication is used to treat various bacterial infections. It is primarily effective against respiratory infections such as acute and chronic bronchitis, lobar and bronchopneumonia, empyema and lung abscesses, tonsillitis, sinusitis, and otitis media. It is also used for urogenital infections like cystitis, urethritis, and pyelonephritis, as well as pelvic infections and gonorrhea. Additionally, it applies to skin and soft tissue infections such as boils, abscesses, and wound infections, osteomyelitis, and dental infections. It is effective against a wide range of effective strains including Staphylococcus, Streptococcus, Escherichia coli, and various resistant strains. Thus, this drug is very useful for treating bacterial infections in various locations.

How to take

Adult dose

Adults and children aged 12 years or older, or weighing more than 40 kg, should take Amoxicillin/Clavulanate Potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe infection and respiratory infections, the dose may be increased to 500 mg/125 mg per administration. In cases of renal impairment, the dosing regimen must be adjusted based on creatinine clearance. For creatinine clearances of 10-30 mL/min, Amoxicillin should be administered as 250-500 mg every 12 hours.

Child dose

Children aged 12 years or older, or weighing more than 40 kg, should receive the same dosage as adults. For children with renal impairment, dosage should be reduced accordingly.

Precautions

This drug contains components belonging to the beta-lactam antibiotic class, particularly in the penicillin category. It should not be administered to patients with allergies to any components of this drug or those who have had hypersensitivity reactions to beta-lactam drugs. Particularly, patients with infectious mononucleosis or lymphocytic leukemia require caution as there is a risk of rash when taking this drug. Patients who have previously experienced jaundice or liver dysfunction due to this drug or penicillin-class medications should avoid administration. Patients with impaired liver function or moderate to severe renal disease must use this drug cautiously, and especially those with decreased kidney function should extend the dosing intervals accordingly. Individuals with allergic predispositions or those prone to symptoms such as bronchial asthma, rashes, and urticaria should exercise caution when using this drug. Patients who have difficulty swallowing, elderly individuals with poor nutritional status, or those who have gastrointestinal diseases causing vomiting or diarrhea may have impeded absorption of the medication, and careful administration is warranted. During treatment, gastrointestinal symptoms such as diarrhea, stomach discomfort, vomiting, and abdominal pain may occur, and especially if severe diarrhea or bloody stools appear, the medication should be stopped immediately and a doctor consulted. This medication may cause liver dysfunction, thus it is advisable to undergo regular liver function tests if taken for an extended period. Rarely, severe skin reactions such as rashes, itching, and in severe cases, Stevens-Johnson syndrome may occur, and any abnormal skin symptoms should prompt immediate cessation of the drug and notification to healthcare professionals. Blood tests may show changes like leukopenia and thrombocytopenia, so if there are unusual symptoms, examinations are necessary. It may affect the central nervous system, causing anxiety, drowsiness, and seizures, hence any unusual symptoms should be taken seriously. This drug is excreted through the kidneys, so dosage adjustment is necessary for patients with reduced kidney function, and in cases of overdose, symptoms such as vomiting, diarrhea, and seizures may occur, requiring immediate medical attention. Use in pregnant or breastfeeding women should be considered with caution, especially during the first three months of pregnancy where use is generally discouraged. During lactation, the drug may pass into breast milk, potentially causing diarrhea or skin rashes in the infant, so caution is necessary. This drug can have interactions when taken with certain medications, hence it is essential to inform healthcare providers about other medications being taken, particularly with anticoagulants, anti-inflammatory agents, and other antibiotics requiring caution.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rashes, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin adverse reactions, asthma attacks, respiratory distress accompanying cough and fever, respiratory problems, jaundice, profound lethargy, liver abnormalities (jaundice), sudden and very severe headache, lightning bolt headaches, seizures, and confusion

Mild side effects

Diarrhea, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, bloating, constipation, colonic pain, acid reflux, soft stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, bloody stools, itching, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, reversible leukopenia, thrombocytopenia, hemolytic anemia, anemia, thrombocytopenic purpura, eosinophilia, leukemia, agranulocytosis

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

Storage

This medication is stored in a tightly sealed container to prevent moisture exposure. Additionally, it should be kept in a dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Oval film-coated tablets, white or almost white

Package unit

100 tablets ((10 tablets/Alu-Alu)x10)

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.

Questions about this medicine

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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.