Medication info
Amocle 375 mg (Amoxicillin and Clavulanate Potassium)

Amocle 375 mg (Amoxicillin and Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White or nearly white oval film-coated tablets
Packaging
100 tablets/box [(10 tablets/PTP x 10)], 80 tablets/box [(8 tablets/PTP x 10)]
Approval status
Active

MFDS item code 201401379 · Approved 2014.03.26 · Insurance code 669905950

Summary

Main use
Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children 12 years or older or weighing 40 kg or more should take amoxicillin/clavulanate potassium as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours. In case of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. For a creatinine clearance of 10-30 mL/min, use 250 mg/125 mg every 12 hours.
Child dose
Children under 12 years or those weighing less than 40 kg should be dosed in a reduced manner using the same method.

Ingredients

Manufacturer
대한뉴팜(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 infections caused by various bacteria. It is effective for respiratory infections such as acute and chronic bronchitis, lobar pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. Additionally, it is used to treat urogenital infections such as cystitis, urethritis, and pyelonephritis, as well as sexually transmitted diseases like gonorrhea and pelvic inflammatory disease. It is also effective for skin and soft tissue infections such as furuncles, abscesses, and soft tissue infections, as well as osteomyelitis and dental infections. This drug can respond to various pathogens including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, and Neisseria gonorrhoeae, making it widely utilized. Therefore, it is very useful for the treatment of various bacterial infections.

How to take

Adult dose

Adults and children 12 years or older or weighing 40 kg or more should take amoxicillin/clavulanate potassium as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours. In case of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. For a creatinine clearance of 10-30 mL/min, use 250 mg/125 mg every 12 hours.

Child dose

Children under 12 years or those weighing less than 40 kg should be dosed in a reduced manner using the same method.

Precautions

This drug, being a penicillin class antibiotic, should not be used in certain patients. For example, it should not be administered to patients with allergies or hypersensitivity reactions to its components or beta-lactam drugs. Additionally, caution is needed for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as they are at a higher risk for rash. Patients with a history of liver dysfunction or jaundice should also avoid using this drug, as symptoms may recur. Patients with impaired liver function or moderate to severe kidney function impairment may experience increased drug concentrations, so dosing intervals should be adjusted or used with caution. Patients with allergic constitutions, those unable to take the drug orally, and the elderly may be at risk for bleeding due to vitamin K deficiency, so caution is advised. This drug can cause various gastrointestinal side effects, and serious intestinal conditions such as diarrhea or pseudomembranous colitis may occur, so usage should be discontinued immediately if symptoms appear. Abnormal liver function tests or hepatitis and cholestatic jaundice may occur, with the elderly and males particularly advised to use it cautiously and avoid long-term use. Skin itching or rashes, in severe cases severe reactions like Stevens-Johnson syndrome may occur, so drug use should be stopped immediately if such symptoms arise. Blood-related abnormalities such as leukopenia, thrombocytopenia, and anemia may rarely occur, so symptom observation is necessary. Central nervous system symptoms such as dizziness, convulsions, and confusion may also rare occur, and patients with impaired kidney function are at risk for acute renal failure. This drug may interact with other medications, so particularly patients taking anticoagulants, anti-inflammatory drugs, or oral contraceptives should consult a doctor. Pregnant or breastfeeding women may find the use of this drug to be risky, and should always consult a physician before use, especially during the first three months of pregnancy. It is not recommended for children under 12 years or those weighing less than 40 kg. The elderly may experience side effects more easily due to decreased physiological function, so dosages and intervals should be adjusted and used carefully. In case of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, and in severe cases renal failure or convulsions may occur, so immediate medical attention is required. This drug should be stored in a dry place below 25 degrees Celsius and if any adverse reactions occur during usage, immediate consultation with a professional is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rashes, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough + fever, respiratory problems, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden onset

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal distension
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  • constipation
  • colitis
  • hyperacidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • blood in stools
  • nausea with high-dose administration
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • elevated serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis

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

Storage

This drug should be kept in a tightly sealed container to prevent moisture from entering, and it is important to maintain a cool temperature between 1 and 25 degrees during storage. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP x 10)], 80 tablets/box [(8 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.