Medication info

Aclast Tablet 375 mg (Amoxicillin-Potassium Clavulanate (2:1))

Prescription medicationTablet경구Expired
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)아리제약
Appearance
It is an oval film-coated tablet that is white or almost white.
Packaging
100 tablets/box[(10 tablets/PTP*10)], 96 tablets/box[(8 tablets/PTP*12)], 80 tablets/box[(8 tablets/PTP*10)]
Approval status
Expired

MFDS item code 202008262 · Approved 2020.11.26

This product's status changed to Expired on 2025.11.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urogenital (cystitis, gonorrhea) infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or more or weighing more than 40 kg should take Amoxicillin/Potassium Clavulanate as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours and may be increased to 500 mg/125 mg for severe or respiratory infections. In cases of renal impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed -
Child dose
For children under 12 years of age or weighing less than 40 kg, dosage should be adjusted similarly.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia) and urogenital (cystitis, gonorrhea) 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 drug is effective against various bacterial infections. It is used to treat respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It also has efficacy against urinary tract infections such as cystitis, urethritis, and pyelonephritis. It is effective for sexually transmitted diseases such as pelvic infections and gonorrhea, and helps treat boils, abscesses, soft tissue infections, and osteomyelitis. It is also used to treat dental infections, thus used to improve various bacterial infections.

How to take

Adult dose

Adults and children aged 12 years or more or weighing more than 40 kg should take Amoxicillin/Potassium Clavulanate as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours and may be increased to 500 mg/125 mg for severe or respiratory infections. In cases of renal impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed -

Child dose

For children under 12 years of age or weighing less than 40 kg, dosage should be adjusted similarly.

Precautions

This drug is a beta-lactam antibiotic and should not be administered to patients allergic to this drug's ingredients or those allergic to penicillin or cephalosporins. In particular, patients with infectious mononucleosis or lymphocytic leukemia are at higher risk of rash when taking this medication and should exercise caution. Patients with a history of liver dysfunction or jaundice caused by this drug or penicillin should avoid use as there is a possibility of recurrence. Caution should be exercised with patients who have poor liver function or moderate to severe kidney impairment as drug concentrations may increase. Patients with allergic predispositions or those who have difficulty swallowing, elderly patients, and those in poor overall condition should be cautious due to the risk of bleeding from vitamin K deficiency. Patients with severe vomiting or diarrhea due to gastrointestinal diseases may have reduced drug absorption. If symptoms like diarrhea, abdominal pain, or bloody stools occur while taking this drug, discontinue immediately and consult a doctor. Symptoms of liver dysfunction may appear during administration or after discontinuation, so liver function tests are necessary with prolonged use. Allergic reactions such as skin rash, itching, and in severe cases Stevens-Johnson syndrome or anaphylactic shock may occur, thus it is essential to inform medical personnel immediately if unusual symptoms appear. Blood abnormalities such as leukopenia and thrombocytopenia may rarely occur, so blood tests are recommended for long-term use. Central nervous system symptoms such as anxiety, confusion, and seizures have been reported rarely, necessitating caution in patients with impaired renal function or those receiving high doses. Avoid use during the first three months of pregnancy, and in cases of pregnancy or breastfeeding, administration should only occur after consulting a doctor. Use is recommended only for children over 12 years of age or those weighing more than 40 kg, and caution should be taken in the elderly due to a higher likelihood of side effects from decreased physical function. This drug has many interactions with other medications and should be used cautiously, especially with anticoagulants, allopurinol, disulfiram, etc., as it may decrease the effectiveness of oral contraceptives. In case of overdose, symptoms such as vomiting, diarrhea, abdominal pain, drowsiness, and seizures may occur, necessitating immediate notification to medical personnel and appropriate treatment. This drug should be stored in a closed container to avoid moisture exposure and kept in a dry location at temperatures below 25 degrees to maintain its effectiveness.

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, high fever with severe rash, blisters, skin peeling, pain of oral/eye mucosa, severe skin reactions, shortness of breath or breathing difficulties, asthma attack, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
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  • abdominal pain
  • abdominal distension
  • constipation
  • colic
  • gastric acid increase
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • bloody stools
  • gastrointestinal adverse reactions
  • increase in AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • angioedema
  • serum sickness syndrome

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

Storage

This drug should be stored in a sealed container to avoid moisture exposure. Additionally, it should be kept in a dry location at temperatures below 25 degrees to maintain its effectiveness.

Appearance and packaging

Appearance

It is an oval film-coated tablet that is white or almost white.

Package unit

100 tablets/box[(10 tablets/PTP*10)], 96 tablets/box[(8 tablets/PTP*12)], 80 tablets/box[(8 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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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.