Medication info

Cramox 500 mg (Amoxicillin-Clavulanate Potassium (7:1))

Prescription medicationTablet경구Expired
Ingredient · strength
Amoxicillin Hydrate›437.5mg / 1 tabletDilute Potassium Clavulanate›107.76mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White or almost white oblong film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Expired

MFDS item code 201903644 · Approved 2019.05.31

This product's status changed to Expired on 2024.05.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary genital system (cystitis, gonorrhea)
Who takes it
Adults
Adult dose
For severe infections and respiratory infections in adults, take 2 tablets orally every 12 hours, twice a day. In patients with kidney impairment, the dosage may be reduced depending on the degree of kidney function. In cases of severe kidney impairment (glomerular filtration rate below 30 mL/min), this medication should not be administered.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary genital 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 used for the treatment of various infections caused by a wide range of bacteria. It is effective for the treatment of respiratory infections such as acute or chronic bronchitis, lobar pneumonia and bronchopneumonia, empyema and lung abscess, tonsillitis, sinusitis, and otitis media. It is also used for urinary infections such as cystitis, urethritis, and pyelonephritis, and is helpful in the treatment of pelvic infections and gonorrhea. It is useful for the treatment of skin and soft tissue infections such as boils, abscesses, soft tissue infections, and wound infections, as well as osteomyelitis. Lastly, it is also used for dental infections to improve various bacterial infections.

How to take

Adult dose

For severe infections and respiratory infections in adults, take 2 tablets orally every 12 hours, twice a day. In patients with kidney impairment, the dosage may be reduced depending on the degree of kidney function. In cases of severe kidney impairment (glomerular filtration rate below 30 mL/min), this medication should not be administered.

Precautions

This drug is a beta-lactam antibiotic and should not be used in patients with a history of hypersensitivity to penicillin or cephalosporins. Patients with infectious mononucleosis or lymphocytic leukemia should be careful as there is a higher risk of rash when taking this medication. Patients who have previously experienced jaundice or liver function impairment due to this drug or penicillin should avoid its use due to the risk of recurrence. Caution should be exercised in patients with impaired liver function or moderate to severe kidney impairment, as drug concentration may increase. Patients with allergies, the elderly, and those in poor general health should be careful due to the risk of bleeding from vitamin K deficiency. Patients with severe vomiting or diarrhea may not absorb the medication properly, which could reduce effectiveness. This medication can affect the gastrointestinal system, potentially causing symptoms such as diarrhea, vomiting, and abdominal pain. If significant gastrointestinal discomfort occurs, discontinue use immediately and consult a physician. Abnormal liver function tests or symptoms of hepatitis and jaundice may rarely occur, necessitating liver function assessments during prolonged use. Severe skin reactions, such as rashes, hives, or in severe cases, Stevens-Johnson syndrome, can occur, and immediate discontinuation is required if symptoms appear. Rarely, abnormalities in blood tests, such as leukopenia and thrombocytopenia, can occur; thus, monitoring is necessary if adverse symptoms present. Rarely, central nervous system effects like agitation, anxiety, confusion, and seizures have been reported, requiring caution in patients with poor kidney function or those taking high doses. Acute kidney damage may occur; hence regular kidney function tests should be performed, and the medication should be discontinued if any abnormalities are found. During treatment, symptoms of vitamin K deficiency or fungal infections such as candidiasis may arise, requiring consultation with a doctor if symptoms develop. Antibiotic use may disturb intestinal bacterial balance, potentially decreasing the effectiveness of oral contraceptives; this should be communicated to patients. Use should be avoided during pregnancy, especially in the first three months, and caution is warranted during breastfeeding as adverse reactions may occur in the infant. Not recommended for children under 12 years of age or weighing under 40 kg. Elderly patients may experience more noticeable adverse reactions due to changes in kidney and liver function; dosage and administration intervals should be adjusted and monitored. This medication may affect some clinical test results, such as urine glucose tests, necessitating precaution during testing. Overdosage may lead to primarily gastrointestinal and neurological symptoms; immediate cessation of use and appropriate treatment is required. This drug should be stored in a dry place below 25 degrees Celsius, and resistance and changes in liver and kidney function should be carefully observed during long-term administration.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe allergic reactions
  • severe rash accompanied by high fever
  • blisters
  • skin peeling
Show 12 more
  • pain in oral/ocular mucosa
  • severe skin reactions
  • breathing problems
  • yellowing of the skin or eyes (jaundice)
  • liver abnormalities (jaundice)
  • sudden and severe headache
  • lightning-like headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • severe neurological symptoms.

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal distension
Show 27 more
  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • colitis
  • bloody stools
  • itching
  • erythema multiforme
  • dermatitis
  • mucosal candidiasis
  • vaginal itching
  • increased discharge
  • restlessness
  • anxiety
  • behavior changes
  • confusion
  • drowsiness
  • insomnia
  • hyperactivity
  • dizziness
  • headache
  • lethargy
  • taste disturbances
  • bleeding time and prothrombin.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to keep the medication in a cool, dry place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

White or almost white oblong film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 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.

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.