Medication info
Amoxicil Tablets 625 mg (Amoxicillin-Clavulanate Potassium (4:1))

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

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

MFDS item code 201309814 · Approved 2013.10.20 · Insurance code 657202620

Summary

Main use
Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
For Amoxicillin/Clavulanate Potassium, administer 250 mg/125 mg orally per dose, three times a day every 8 hours. In cases of severe and respiratory infections, the dose may be escalated to 500 mg/125 mg per dose. In cases of renal impairment, the dosage must be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: administer 250 mg/125 mg or 500 mg/125 mg every 12 hours.
Child dose
For children aged 12 years or older or weighing 40 kg or more, the same dosage as adults should be administered: Amoxicillin/Clavulanate Potassium 250 mg/125 mg per dose, taken orally three times a day every 8 hours. In cases of severe and respiratory infections, dosing may need to be adjusted.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)

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

This medication is used to treat various bacterial infections. It treats pulmonary diseases such as acute and chronic bronchitis, lobar pneumonia, empyema, and lung abscess, and is also effective for tonsillitis, sinusitis, and otitis media. Additionally, it is used for urinary infections like cystitis, urethritis, pyelonephritis, as well as pelvic infections and gonorrhea. It applies to various external infections including skin and soft tissue infections, boils and abscesses, wound infections, and bone infections such as osteomyelitis and dental infections. It shows therapeutic effects against a wide range of bacterial infections and helps improve infections.

How to take

Adult dose

For Amoxicillin/Clavulanate Potassium, administer 250 mg/125 mg orally per dose, three times a day every 8 hours. In cases of severe and respiratory infections, the dose may be escalated to 500 mg/125 mg per dose. In cases of renal impairment, the dosage must be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: administer 250 mg/125 mg or 500 mg/125 mg every 12 hours.

Child dose

For children aged 12 years or older or weighing 40 kg or more, the same dosage as adults should be administered: Amoxicillin/Clavulanate Potassium 250 mg/125 mg per dose, taken orally three times a day every 8 hours. In cases of severe and respiratory infections, dosing may need to be adjusted.

Precautions

This drug is a beta-lactam antibiotic and belongs to the penicillin class. Patients with a history of allergic reactions to this drug's components or hypersensitivity to beta-lactam drugs should not use it. Particularly, it is advisable to avoid use in patients with infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with liver function problems should also be cautious as liver dysfunction may recur upon use. Patients with poor liver function or renal impairment may have increased drug concentrations, thus dosing intervals may need to be adjusted or used cautiously. Patients with allergies, those receiving non-oral nutrition, the elderly, and patients in poor overall condition should also be cautious of possible side effects like vitamin deficiency when using this drug. Gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, and vomiting may occur, and in severe cases, pseudomembranous colitis or acute pancreatitis may develop, necessitating immediate discontinuation upon symptom occurrence. Rarely, abnormal liver symptoms such as elevated liver enzymes, hepatitis, and cholestatic jaundice may appear, particularly in the elderly and males. Skin rashes, itching, and severe skin reactions (such as Stevens-Johnson syndrome) may occur, and medication should be discontinued immediately if abnormalities arise. Blood tests may occasionally reveal leukopenia, thrombocytopenia, or hemolytic anemia, so regular blood tests may be required. CNS adverse responses like agitation, anxiety, confusion, and convulsions can also rarely occur, so caution is needed if symptoms arise. Rapid deterioration of kidney function may also occur, hence regular kidney function tests should be conducted, and medication should be discontinued if abnormalities are found. This drug can disrupt the intestinal bacterial balance, leading to fungal infections like candidiasis, so appropriate measures are needed if symptoms occur. There may be a tendency for bleeding due to vitamin K deficiency when using this drug, so caution is needed if bleeding symptoms are present. When used with anticoagulants, the risk of bleeding may increase, requiring frequent checks of coagulation status and dosage adjustments. There are numerous potential interactions with other drugs, so any medications currently being taken should be disclosed to medical personnel. Use of this drug should be avoided during the first three months of pregnancy, and administration to pregnant or nursing women should be done cautiously under a physician's judgment. It is not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients may experience side effects more readily due to reduced kidney and liver function, so care should be taken with the dosage and administration intervals. In cases of overdose, symptoms such as vomiting, diarrhea, abdominal pain, drowsiness, rash, etc. may occur, and in severe instances, emergency treatment may be required. This medication should be stored in a sealed container to prevent moisture ingress and kept at a cool temperature between 1 and 25 degrees Celsius to maintain its efficacy and safety over time.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, peeling skin, mucous membrane pain in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanying cough and fever, respiratory issues, jaundice of skin or eyes, extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • appetite loss
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  • abdominal pain
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated enteritis
  • severe colitis with hematochezia
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • skin rash
  • dermatitis
  • blood

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

Storage

This drug is kept in a sealed container to prevent moisture ingress, and it should be stored at a cool temperature between 1 and 25 degrees Celsius. This helps maintain the drug's effectiveness and safety for a long time.

Appearance and packaging

Appearance

White or nearly 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.