Medication info

Amoracillin 375 mg (Amoxicillin-Clavulanate Potassium (2:1))

Prescription medicationTablet경구Expired
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
하이플생명과학(주)
Appearance
White or almost white oval film-coated tablet
Packaging
100 tablets/PTP (10 tablets x 10)
Approval status
Expired

MFDS item code 201900330 · Approved 2019.01.22

This product's status changed to Expired on 2024.01.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(Respiratory infections, urinary infections) treatment and soft tissue infection improvement
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years and older or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg per dose, taken orally 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. For patients with renal impairment, dosing should be adjusted according to creatinine clearance. - Creatinine clearance 10 – 30 mL/min: 250 mg – 500 mg of amoxicillin per dose taken orally every 12 hours. - Creatinine clearance less than 10 mL/min: 250 mg of amoxicillin per dose taken orally every 24 hours, ensuring the dose does not exceed the limit.
Child dose
Children aged 12 years and older or weighing 40 kg or more are included, but separate dosing for younger children is not clearly mentioned. In children with renal impairment, the same dosing adjustments should be made.

Ingredients

Manufacturer
하이플생명과학(주)

Efficacy & effects

(Respiratory infections, urinary infections) treatment and soft tissue infection improvement

  • Acute and chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
  • pelvic infections
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, pneumonia, empyema, and lung abscess, as well as upper respiratory infections such as tonsillitis, sinusitis, and otitis media. It also treats urinary infections such as cystitis, urethritis, and pyelonephritis, and is indicated for pelvic infections and gonorrhea. It is applied to skin and soft tissue infections including furuncles, abscesses, cellulitis, wound infections, and osteomyelitis. It is also used for treating dental infections, aiding in the treatment of various infections. This medication is effective against multiple strains and improves infection treatment.

How to take

Adult dose

Adults and children aged 12 years and older or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg per dose, taken orally 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. For patients with renal impairment, dosing should be adjusted according to creatinine clearance. - Creatinine clearance 10 – 30 mL/min: 250 mg – 500 mg of amoxicillin per dose taken orally every 12 hours. - Creatinine clearance less than 10 mL/min: 250 mg of amoxicillin per dose taken orally every 24 hours, ensuring the dose does not exceed the limit.

Child dose

Children aged 12 years and older or weighing 40 kg or more are included, but separate dosing for younger children is not clearly mentioned. In children with renal impairment, the same dosing adjustments should be made.

Precautions

This medication is a penicillin class antibiotic and should not be used in certain patients. Patients who have previously experienced allergic reactions to any of its components or beta-lactam antibiotics should not be administered this medication. Additionally, patients with viral infections such as 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 due to this medication or penicillin should also be cautious as there is a risk of recurrence. Patients with impaired liver function should use this medication cautiously as it may worsen liver function. Patients with moderate to severe kidney impairment may need to adjust the dosing interval as the medication may remain in the body longer, increasing the risk of side effects. Patients with allergic tendencies or those prone to symptoms such as bronchial asthma, rash, or urticaria should also be cautious. Patients who have difficulty in oral ingestion, the elderly, and those in poor general condition need observation due to the risk of bleeding, such as vitamin K deficiency. Patients with severe gastrointestinal diseases like vomiting or diarrhea may not absorb the medication properly. Taking this medication may cause gastrointestinal adverse effects such as diarrhea, dyspepsia, vomiting, and abdominal pain. In particular, serious enteritis, such as pseudomembranous colitis, may occur rarely, so if abdominal pain or severe diarrhea occurs, the medication should be stopped immediately and a doctor should be consulted. Liver function test values may temporarily increase, and hepatitis or cholestatic jaundice may rarely occur. Adverse reactions are reported to be more common in the elderly and males, and the risk may increase with prolonged administration. Skin rashes, itching, and, in severe cases, serious skin reactions such as Stevens-Johnson syndrome have been rarely reported. If these symptoms occur, the medication must be stopped immediately. Hematological abnormalities such as leukopenia, thrombocytopenia, and anemia may occur rarely in blood tests. Central nervous system symptoms may include rare occurrences of headache, dizziness, and seizures, so caution is warranted if any abnormal symptoms arise. This medication is excreted through the kidneys, so patients with reduced kidney function require dose adjustments, and overdose may result in renal failure or interstitial nephritis. In the event of overdose, medication should be stopped immediately and treatment should be administered according to the symptoms, and if necessary, the medication can be removed by dialysis. Women who are pregnant or may become pregnant are advised to avoid this medication, especially during the first trimester. Those who are breastfeeding should also be cautious as side effects may occur in the baby. This medication may interact with other drugs, so it is important to inform your doctor or pharmacist of any medications you are taking. Particular caution is required when used with medications that affect blood coagulation due to the risk of bleeding. When administering antibiotics, it is essential to use for the necessary duration to prevent the emergence of resistant bacteria, and regular checks of liver and kidney function and blood condition should be conducted during long-term use. If allergy symptoms or severe side effects appear after taking the medication, immediate consultation with a specialist is necessary. This medication should be stored in a sealed container to prevent moisture, and kept in a cool, dry place at or below 25 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent spoilage.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, anaphylaxis, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, severe allergic reactions, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice)

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
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  • abdominal pain
  • abdominal bloating
  • constipation
  • colicky pain
  • hyperacidity
  • loose stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • severe colitis with bloody stools
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • skin reactions
  • angioedema
  • serum sickness-like syndrome

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

Storage

This medication is stored in a sealed container to prevent moisture and should be kept in a cool, dry place at or below 25 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

Package unit

100 tablets/PTP (10 tablets 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.