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

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

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

MFDS item code 201500725 · Approved 2015.02.13 · Insurance code 660702770

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia), urogenital (cystitis, gonorrhea), skin, and soft tissue infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 and over or weighing 40 kg or more should take 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times a day every 8 hours. In cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg once. In patients with renal impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 ~
Child dose
Children under 12 years old or weighing less than 40 kg should be administered at a reduced dosage similar to adults.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia), urogenital (cystitis, gonorrhea), skin, and soft tissue infections

  • 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 can treat respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections such as cystitis, urethritis, and pyelonephritis. It is effective for sexually transmitted infections such as pelvic inflammatory disease and gonorrhea, and is useful for treating skin and soft tissue infections such as furuncle, abscess, cellulitis, and wound infections. In addition, it is used for the treatment of osteomyelitis and dental infections. Therefore, this medication is safely and effectively used for the treatment of various bacterial infections.

How to take

Adult dose

Adults and children aged 12 and over or weighing 40 kg or more should take 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times a day every 8 hours. In cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg once. In patients with renal impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 ~

Child dose

Children under 12 years old or weighing less than 40 kg should be administered at a reduced dosage similar to adults.

Precautions

This medication is a beta-lactam antibiotic and should not be used in patients with hypersensitivity to penicillin or those who have previously experienced severe allergic reactions. Precautions are necessary in patients with infectious mononucleosis or lymphocytic leukemia, as there is a higher risk of rash. Caution is also needed in patients with a history of liver dysfunction or jaundice, as the drug may worsen liver function. In patients with moderate to severe renal impairment, dosage adjustment and timing of administration are necessary due to increased drug concentration. Patients with allergic conditions, elderly patients, and those with poor nutritional status should be closely monitored for risk of side effects. Gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain may occur, and in severe cases, pseudomembranous colitis may develop, so patients should consult a physician immediately if symptoms appear. Liver-related abnormalities such as elevated liver enzymes, hepatitis, and cholestatic jaundice have also been reported, necessitating liver function tests during long-term use. Serious skin reactions such as rashes, hives, and in severe cases, Stevens-Johnson syndrome, may occur, requiring immediate discontinuation of the drug if a rash develops. Hematologic abnormalities may include transient leukopenia and thrombocytopenia, necessitating monitoring through blood tests. Central nervous system side effects can include headaches, dizziness, and rarely seizures, with increased risk in patients with reduced renal function. Kidney damage or acute renal failure is rarely reported, highlighting the importance of regular monitoring of renal function. This medication may interact with other drugs, especially caution is warranted when used in conjunction with anticoagulants, probenecid, and allopurinol. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this medication, particularly avoiding it during the first trimester of pregnancy. Pediatric use is recommended for those aged 12 and older or weighing over 40 kg, as there is limited experience in younger patients. Elderly patients may be more prone to side effects due to decreased physical function, thus requiring careful dosage adjustments and timing. In cases of overdose, gastrointestinal symptoms and renal failure, and rarely, seizures may occur, requiring immediate medical attention and appropriate management. This medication should be stored in a sealed container to prevent moisture and kept in a dry place at or below 25 degrees Celsius. It is important to regularly check for resistance and any liver and kidney function abnormalities during prolonged use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions, respiratory problems, jaundice of the skin or eyes, systemic lethargy, liver abnormalities, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances, paralysis, severe neurological symptoms, significantly reduced urine output

Mild side effects

Diarrhea, indigestion, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, soft stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, blood in stool, itching, erythema multiforme, mucocutaneous syndrome, toxic epidermal necrolysis, vesiculobullous dermatitis, acute generalized exanthematous pustulosis, eosinophilia, systemic symptoms accompanied by drug reactions, angioedema, serum sickness-like syndrome, hypersensitivity

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

Storage

This medication should be kept in a sealed container to prevent moisture and stored in a dry place at or below 25 degrees Celsius. Storing in this manner can help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

White or nearly white rectangular film-coated tablet

Package unit

60 tablets/box [4 tablets/PTP×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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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.