Medication info
Augmentin 625 mg Tablets (Amoxicillin/Clavulanate Potassium (4:1))

Augmentin 625 mg Tablets (Amoxicillin/Clavulanate Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
주식회사더유제약
Appearance
White or almost white oval film-coated tablets
Packaging
40 tablets/box [4 tablets/PTP × 10]
Approval status
Active

MFDS item code 201907725 · Approved 2019.11.05 · Insurance code 057000300

Summary

Main use
Treatment of respiratory and urinary tract infections (bronchitis, pneumonia, etc.) and skin soft tissue infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older 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 dose may be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted as follows based on creatinine clearance. - Creatinine clearance 30 mL/min or more: dosage adjustment
Child dose
Children aged 12 years or older or weighing 40 kg or more should be administered the same dosage as adults. If a reduction is necessary, dosage should be adjusted according to the creatinine clearance as in adults.

Ingredients

Manufacturer
주식회사더유제약

Efficacy & effects

Treatment of respiratory and urinary tract infections (bronchitis, pneumonia, etc.) and skin soft tissue infections

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

This medication is used to treat various bacterial infections. It is effective for respiratory infections such as acute and chronic bronchitis, lobar pneumonia, bronchopneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections such as cystitis, urethritis, and pyelonephritis, as well as for gonorrhea and pelvic inflammatory disease. Skin and soft tissue infections including boils, abscesses, soft tissue infections, and wound infections can be treated, and it is also helpful for osteomyelitis and dental infections. This drug is reliable for treating infections as it is effective against various bacteria, including resistant strains that produce beta-lactamase. Therefore, patients should be aware that this drug is effective for treating various infectious diseases.

How to take

Adult dose

Adults and children aged 12 years or older 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 dose may be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted as follows based on creatinine clearance. - Creatinine clearance 30 mL/min or more: dosage adjustment

Child dose

Children aged 12 years or older or weighing 40 kg or more should be administered the same dosage as adults. If a reduction is necessary, dosage should be adjusted according to the creatinine clearance as in adults.

Precautions

This drug is a beta-lactam antibiotic and should not be administered to patients with hypersensitivity to penicillin or cephalosporin drugs. It should particularly be avoided in patients with infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with liver dysfunction should use this drug with caution as liver dysfunction may occur again. Patients with liver disease or moderate to severe renal impairment may experience increased concentrations of this drug, so dosage and administration intervals need adjustment. Patients with allergic tendencies or those with a history of asthma, urticaria, etc., should use this drug cautiously. Patients who cannot take oral medication, elderly patients, or those in poor general condition should be aware that vitamin K deficiency symptoms may occur. Patients with gastrointestinal diseases accompanied by vomiting or diarrhea may have reduced absorption of the drug; thus, their conditions must be checked before administration. This medication may cause gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain, but gastrointestinal adverse reactions may be alleviated by taking the drug with meals. Liver dysfunction may occur, especially in elderly and male patients, so regular liver function tests are recommended. Rarely, serious skin reactions or hypersensitivity reactions such as anaphylaxis may occur; if rash or itching develops, administration should be stopped immediately and medical advice sought. Blood disorders such as leukopenia or thrombocytopenia may arise, so symptoms should be monitored carefully. Neurological symptoms such as anxiety, drowsiness, and seizures have been reported rarely, and caution is especially needed in patients with renal impairment. Renal dysfunction or symptoms of acute renal failure may occur, so regular renal function testing is recommended. This drug may affect the intestinal microbiota, leading to infections such as stomatitis or candidiasis; if symptoms occur, they should be reported immediately. There may be a risk of bleeding tendency due to vitamin K deficiency; therefore, long-term administration should be confirmed by blood tests. This drug may interact with other medications; especially if taking anticoagulants, antibiotics, or anti-inflammatory drugs, patients should inform their doctor. Use during pregnancy or breastfeeding is restricted, and it is particularly advisable to avoid this drug during the first trimester of pregnancy. If taken by nursing mothers, diarrhea or allergic reactions may occur in infants, so administration should be stopped if any unusual symptoms appear. It is not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients, due to decreased physiological function, are at higher risk for side effects, so careful observation and adjustment of dosage and administration intervals are necessary. In case of overdose, gastrointestinal symptoms, renal failure, seizures, etc., may occur, and immediate cessation of administration and appropriate emergency measures should be taken. This medication should be stored in a cool, dry place below 25 degrees Celsius, and care should be taken not to use it longer than necessary. If any unusual symptoms such as diarrhea, abdominal pain, or skin rash occur during use, immediate consultation with a physician is advised, and if serious reactions like anaphylaxis are suspected, rapid emergency treatment should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme fatigue, liver abnormalities (jaundice), abrupt

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • colitis with bloody stools
  • vomiting episodes
  • elevated levels of AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • angioedema
  • serum sickness syndrome
  • overdose

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

Storage

This medication should be stored in a tightly closed container to prevent moisture, in a cool place between 1 and 25 degrees Celsius. Storing in this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

40 tablets/box [4 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.

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.