Medication info
Amoxicillin Tablets 625 mg (Amoxicillin Hydrate · Clavulanic Acid Potassium (4:1))

Amoxicillin Tablets 625 mg (Amoxicillin Hydrate · Clavulanic Acid Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Oval film-coated tablet that is white or almost white
Packaging
40 tablets (4 tablets/PTP x 10)
Approval status
Active

MFDS item code 201307131 · Approved 2013.04.30 · Insurance code 671805450

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urogenital system (cystitis, gonorrhea)
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years of age or weighing 40 kg or more should take Amoxicillin/Clavulanic Acid Potassium 250 mg/125 mg orally three times daily every 8 hours. In cases of severe or respiratory infections, the dose can be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance. - For patients with creatinine clearance ≥ 30 mL/min: No adjustment of dosage is needed.
Child dose
Children under 12 years of age or weighing less than 40 kg should be dosed according to adult dosage adjusted downwards.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and urogenital 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 effective against a variety of bacterial infections and is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It also has therapeutic effects on urinary tract infections such as cystitis, urethritis, and pyelonephritis, on sexually transmitted infections such as pelvic inflammatory disease and gonorrhea, as well as on skin and soft tissue infections like boils, abscesses, cellulitis, and wound infections. Additionally, it is utilized for the treatment of osteomyelitis and dental infections, improving a wide range of infectious diseases.

How to take

Adult dose

Adults and children over 12 years of age or weighing 40 kg or more should take Amoxicillin/Clavulanic Acid Potassium 250 mg/125 mg orally three times daily every 8 hours. In cases of severe or respiratory infections, the dose can be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance. - For patients with creatinine clearance ≥ 30 mL/min: No adjustment of dosage is needed.

Child dose

Children under 12 years of age or weighing less than 40 kg should be dosed according to adult dosage adjusted downwards.

Precautions

This medication should not be used in patients who have had specific allergic reactions. Caution must be taken especially in patients who have had hypersensitivity reactions to beta-lactam antibiotics, as the administration of this medication can lead to severe allergic reactions. Patients with poor liver function or moderate to severe kidney impairment should use this medication cautiously, adjusting the dosage and administration interval as it may strain the liver and kidneys. During the course of this medication, gastrointestinal symptoms may occur, such as diarrhea or abdominal pain, which in severe cases can progress to serious conditions like pseudomembranous colitis, necessitating immediate cessation of use and consultation with healthcare professionals if symptoms worsen. Rarely, symptoms of liver dysfunction may also arise, so regular liver function tests should be conducted, and the drug must be stopped if abnormalities are detected. Allergic reactions such as skin rash, itching, or severe skin reactions can occur; if these symptoms arise, the medication should be discontinued and the doctor notified immediately. Blood-related abnormalities such as leukopenia and thrombocytopenia may occur with long-term use, necessitating regular blood tests. Central nervous system symptoms such as dizziness, headaches, and seizures have been rarely reported, particularly in patients with poor kidney function or those on high doses, warranting caution. Pregnant or breastfeeding women should administer this medication only under medical supervision as its safety has not been fully established, and especially during early pregnancy, use should be avoided. This medication can interact with other drugs; therefore, consultation with a doctor or pharmacist is necessary when used in conjunction with anticoagulants, anti-inflammatory drugs, or oral contraceptives. In cases of overdose, gastrointestinal symptoms, impaired kidney function, and central nervous system abnormalities may manifest, requiring immediate medical attention for appropriate treatment. This medication should be stored in a cool, dry place below 25 degrees Celsius, and prior to administration, the allergy history and current medications must be verified.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, Stevens-Johnson syndrome, shock, severe skin adverse reactions, blistering, skin peeling, mucosal pain in the mouth/eyes, difficulty breathing or breathlessness, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
Show 23 more
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • soft stool
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • gastrointestinal adverse reactions
  • AST
  • ALT
  • ALP
  • LDH
  • elevated serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • angioedema
  • dermatitis
  • oral edema
  • reversible leukopenia
  • thrombocytopenia

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

Storage

This medication is contained in special packaging to prevent moisture exposure and should be stored at a cool temperature between 1 to 25 degrees Celsius. Storing it this way helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Oval film-coated tablet that is white or almost white

Package unit

40 tablets (4 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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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.