Medication info
Cramax Tablet 625 mg (Amoxicillin-Clavulanate Potassium (4:1))

Cramax Tablet 625 mg (Amoxicillin-Clavulanate Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
동성제약(주)
Appearance
White or nearly white oblong film-coated tablet
Packaging
60 tablets/PTP (4 tablets x 15)
Approval status
Active

MFDS item code 201904474 · Approved 2019.06.28 · Insurance code 643203210

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and the genitourinary system (cystitis, gonorrhea)
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years or older or weighing over 40 kg, the recommended dosage is 250 mg/125 mg of amoxicillin/clavulanate potassium taken orally every 8 hours, three times a day. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg at a time. In patients with renal impairment, the dosage should be adjusted according to creatinine clearance.
Child dose
Same as adults and for children aged 12 years or older or weighing over 40 kg, with dosage adjustment in cases of renal impairment.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and the genitourinary system (cystitis, gonorrhea)

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

This medication is effective against various bacterial infections. It is mainly used for respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It is also applicable for genitourinary infections such as cystitis, urethritis, and pyelonephritis, as well as the treatment of gonorrhea and pelvic inflammatory disease. It is effective for skin and soft tissue infections, including boils, abscesses, wound infections, and osteomyelitis. It is also used for dental infections and exhibits broad-spectrum antibacterial action against multiple types of bacteria. Overall, it is used for the treatment of a variety of bacterial infections.

How to take

Adult dose

For adults and children aged 12 years or older or weighing over 40 kg, the recommended dosage is 250 mg/125 mg of amoxicillin/clavulanate potassium taken orally every 8 hours, three times a day. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg at a time. In patients with renal impairment, the dosage should be adjusted according to creatinine clearance.

Child dose

Same as adults and for children aged 12 years or older or weighing over 40 kg, with dosage adjustment in cases of renal impairment.

Precautions

This drug should not be administered to patients with hypersensitivity to penicillin-type drugs, as it is a beta-lactam antibiotic. Precautions are necessary for patients with infectious mononucleosis or lymphocytic leukemia due to the increased risk of rash. It should also be avoided in patients with liver dysfunction or a history of liver disease caused by this drug or penicillin. In patients with impaired liver function or moderate to severe renal impairment, dosage and administration intervals should be adjusted to prevent increased drug levels. Patients with allergic tendencies or frequent episodes of bronchial asthma, skin rashes, and those with gastrointestinal symptoms such as vomiting or diarrhea should use this drug cautiously. Gastrointestinal side effects such as diarrhea, abdominal pain, and vomiting may occur, and in severe cases, pseudomembranous colitis or intestinal hemorrhage may develop; if symptoms arise, discontinue use immediately. Abnormal liver function symptoms have also been reported, so regular liver function tests are required for the elderly or those on long-term therapy. Serious allergic reactions such as skin rash, urticaria, and anaphylaxis may occur rarely, so if unusual symptoms arise, drug administration should be stopped immediately, and medical attention sought. Various abnormal reactions such as hematological abnormalities, renal dysfunction, and central nervous system symptoms have also been reported, necessitating careful observation of the patient's condition. This drug may interact with other medications, so it is essential to inform healthcare professionals of any ongoing medications, particularly when used with anticoagulants, probenecid, or allopurinol. Women who are pregnant or breastfeeding should carefully consider the use, and breastfeeding mothers should monitor for side effects in the infant. It is not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients are at increased risk of side effects due to renal and liver function decline, so dosage adjustments and status monitoring are essential. In case of overdose, gastrointestinal symptoms, central nervous system abnormalities, or allergic reactions may occur, necessitating immediate medical attention. This drug should be stored in a special container to prevent moisture, in a cool, dry place at or below 25°C to maintain its effectiveness for an extended period.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, anaphylaxis, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis), angioedema, symptoms of hypotension, acute pancreatitis, pseudomembranous colitis, hemorrhagic colitis, severe colitis with blood in stools, severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, respiratory difficulty, asthma attacks, bronchospasm

Mild side effects

Diarrhea, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, anorexia, abdominal pain, bloating, constipation, colonic discomfort, acid reflux, soft stools, dry mouth, candidiasis, colitis without blood in stools, increased AST, ALT, ALP, LDH, serum bilirubin, hepatitis, skin itching, erythema multiforme, hematological abnormalities (reversible leukopenia, thrombocytopenia, anemia, etc.), vaginal itching, increased secretion, anxiety

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

Storage

This drug should be stored in a special container to prevent moisture, ideally in a cool and dry place, at or below 25°C. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

White or nearly white oblong film-coated tablet

Package unit

60 tablets/PTP (4 tablets x 15)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.