Medication info
Amoclara 625 mg (Amoxicillin and Clavulanate Potassium)

Amoclara 625 mg (Amoxicillin and Clavulanate Potassium)

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

MFDS item code 201908434 · Approved 2019.12.16 · Insurance code 060500450

Summary

Main use
Treatment of various bacterial infections, such as respiratory and urogenital infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing 40 kg or more should take 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times a day every 8 hours. In cases of severe or respiratory infections, dosage can be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance. - For creatinine clearance above 30 mL/min: no dosage adjustment is necessary.
Child dose
Administered in the same manner as adults and children aged 12 years or older or weighing 40 kg or more. In cases of renal impairment, dosage should be appropriately reduced based on creatinine clearance.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment of various bacterial infections, such as respiratory and urogenital infections

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

This medication is effective against various bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli. It is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, tonsillitis, sinusitis, and otitis media. It is also helpful in treating urogenital infections like cystitis, urethritis, pyelonephritis, and sexually transmitted diseases like gonorrhea. It is effective for skin infections like boils, abscesses, soft tissue infections, and wound infections, as well as for treating osteomyelitis and dental infections. This medication is suitable for various infection diseases and can be tailored to the site of infection based on the patient's condition.

How to take

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times a day every 8 hours. In cases of severe or respiratory infections, dosage can be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance. - For creatinine clearance above 30 mL/min: no dosage adjustment is necessary.

Child dose

Administered in the same manner as adults and children aged 12 years or older or weighing 40 kg or more. In cases of renal impairment, dosage should be appropriately reduced based on creatinine clearance.

Precautions

This drug is a beta-lactam antibiotic and should not be used in patients with a history of hypersensitivity to penicillin or cephalosporin antibiotics. Patients with infectious mononucleosis or lymphocytic leukemia are at higher risk of rash and should avoid this medication. Patients with a history of liver dysfunction or jaundice should also be cautious as there is a risk of recurrence upon using this medication. Patients with impaired liver function or moderate to severe renal impairment may have elevated drug concentrations and should adjust the dosing intervals or use the drug carefully. Patients with allergic tendencies or symptoms like bronchial asthma, rashes, or hives should be cautious as hypersensitivity reactions may occur with this medication. If there are gastrointestinal disorders such as vomiting or diarrhea, drug absorption may decrease, so the dosing status should be carefully monitored. This medication may cause gastrointestinal side effects such as diarrhea, nausea, vomiting, and in severe cases, pseudomembranous colitis or acute pancreatitis may occur, so if symptoms appear, seek immediate medical attention. Symptoms of liver dysfunction have also been reported, especially in the elderly and males, so liver function tests are necessary during long-term use. Serious skin reactions like rashes, Stevens-Johnson syndrome, or anaphylactic shock may occur infrequently, so if any abnormal symptoms occur, discontinue use immediately and seek medical help. Blood-related abnormalities such as leukopenia, anemia, and thrombocytopenia have been rarely reported, so be vigilant for symptoms of bleeding or infection. Central nervous system abnormalities may be rare and could include anxiety, agitation, confusion, headache, and seizures, so notify healthcare providers if neurological symptoms appear. This medication is excreted through the kidneys, so it should be administered carefully in patients with decreased kidney function, and regular kidney function tests are necessary. During treatment with this drug, there is a risk of bleeding due to vitamin K deficiency, so be aware of bleeding symptoms. Pregnant women or those who may become pregnant should avoid use unless under specific circumstances, and nursing mothers should be cautious as diarrhea or hypersensitivity may occur in infants. Children, especially those under 12 years old or weighing less than 40 kg, have limited experience with this drug and it is not recommended. In elderly patients, there is an increased risk of side effects due to decreased physiological functions, so doses and intervals should be adjusted carefully and monitored. This medication may interact with other drugs, so consult healthcare providers when using it with anticoagulants, probenecid, allopurinol, disulfiram, etc. In cases of overdose, gastrointestinal symptoms, renal failure, and seizures may occur, so seek medical intervention immediately, and if necessary, the drug can be removed through dialysis. This medication should be stored in a dry place at temperatures below 25 degrees Celsius, and always consult healthcare providers to comply with the appropriate dosage and administration before use.

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. Severe rash with high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions. Yellowing of the skin or eyes (jaundice), feeling extremely fatigued, liver abnormality (jaundice). Sudden and extremely severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, serious neurological symptoms.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
Show 22 more
  • abdominal pain
  • abdominal bloating
  • constipation
  • colicky pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • increased serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • angioedema
  • toxic epidermal necrolysis
  • fever

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

Storage

This medication should be kept in a tightly closed container to prevent moisture, and stored in a cool and dry place, i.e., at a temperature below 25 degrees Celsius. Doing so will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

40 tablets/box [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.

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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.