Medication info

Aclast Tablets 625 mg (Amoxicillin-Potassium Clavulanate (4:1))

Prescription medicationTablet경구Expired
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)아리제약
Appearance
This drug is a white or almost white oval film-coated tablet.
Packaging
40 tablets (4 tablets/PTP*10), 60 tablets (6 tablets/PTP*10)
Approval status
Expired

MFDS item code 201906646 · Approved 2019.09.23

This product's status changed to Expired on 2024.09.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections.
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years of age or weighing 40 kg or more: Administer 250 mg/125 mg of Amoxicillin/Potassium Clavulanate orally three times a day every 8 hours, and for severe or respiratory infections, the dose can be increased to 500 mg/125 mg. If the patient has renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment needed.
Child dose
For children weighing less than 40 kg, the dosage should be reduced based on creatinine clearance in the same manner.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections.

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

This drug is used for the treatment of various infections caused by a wide range of bacteria. It is effective for treating respiratory infections such as acute and chronic bronchitis, lobar and bronchial pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also utilized for urinary tract infections such as cystitis, urethritis, and pyelonephritis. Additionally, it is used for sexually transmitted diseases like pelvic infections and gonorrhea, as well as skin and soft tissue infections including boils, abscesses, soft tissue cellulitis, and wound infections. Furthermore, it shows excellent efficacy in treating osteomyelitis and dental infections. Therefore, this drug is used for a broad spectrum of bacterial infections.

How to take

Adult dose

Adults and children over 12 years of age or weighing 40 kg or more: Administer 250 mg/125 mg of Amoxicillin/Potassium Clavulanate orally three times a day every 8 hours, and for severe or respiratory infections, the dose can be increased to 500 mg/125 mg. If the patient has renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment needed.

Child dose

For children weighing less than 40 kg, the dosage should be reduced based on creatinine clearance in the same manner.

Precautions

This drug is a beta-lactam antibiotic and should not be administered to patients who are allergic to penicillin-based drugs. Especially, individuals with a history of anaphylaxis or severe skin reactions should use this drug with caution, as it may pose risks. Additionally, patients with infectious mononucleosis or lymphocytic leukemia are at a higher risk of rashes and should avoid using this drug. Those with a history of liver function issues should also exercise caution, as using this drug can lead to a recurrence of liver impairment. Patients with decreased liver function or moderate to severe renal impairment may experience increased drug concentration and should consult healthcare professionals. Patients with allergic tendencies or those who frequently experience bronchial asthma or skin rashes should also use this drug cautiously. Elderly patients or those in poor general condition need to be careful due to the risk of bleeding from vitamin K deficiency. Gastrointestinal symptoms such as diarrhea, vomiting, or abdominal pain may occur during treatment, and if symptoms are severe, the medication should be stopped immediately and a doctor consulted. If symptoms indicate liver dysfunction or skin rash, hives, or difficulty breathing occur, the administration should be stopped immediately, and treatment should be sought. Prolonged use of this medication may result in the development of resistant bacteria, so it is important to take it only for the necessary duration. Severe diarrhea following antibiotic use may indicate pseudomembranous colitis, and if symptoms are severe, the healthcare provider should be informed immediately. Women who are pregnant or may become pregnant are advised to avoid this medication, especially during the first three months, and caution is necessary for breastfeeding mothers due to the potential for adverse reactions in infants. Caution is required when administering this medication to children and the elderly, with particular attention to bleeding tendencies and liver and kidney function. This drug may interact with other medications, so it is essential to inform healthcare professionals about any concurrent medications. In cases of overdose, symptoms such as vomiting, diarrhea, rashes, or convulsions may appear, and immediate medical assistance should be sought. Store in a dry container to prevent moisture and keep below 25 degrees Celsius. Prior to use, a thorough review of allergy history and current health status is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, breathlessness or difficulty breathing, asthma attacks, cough with fever and respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary changes.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
Show 26 more
  • abdominal pain
  • bloating
  • constipation
  • colic
  • gastric hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • colitis
  • bloody stools
  • nausea
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin levels
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • angioedema
  • dermatitis
  • oral edema
  • leukopenia
  • thrombocytopenia.

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

Storage

This drug should be stored in a tightly sealed container to prevent moisture and kept in a cool, dry place below 25 degrees Celsius. This way of storage helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

This drug is a white or almost white oval film-coated tablet.

Package unit

40 tablets (4 tablets/PTP*10), 60 tablets (6 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.