Medication info
Amoxazene 375 mg (Amoxicillin and Clavulanate Potassium)

Amoxazene 375 mg (Amoxicillin and Clavulanate Potassium)

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

MFDS item code 200700469 · Notified 2007.01.11 · Insurance code 649401330

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and genitourinary (cystitis, gonorrhea) infections.
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing 40 kg or more should take Amoxicillin/Clavulanate Potassium at a dose of 250 mg/125 mg three times a day, every 8 hours. For severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, adjust dosages according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed.
Child dose
For children aged 12 years or older or weighing 40 kg or more, the same dosage as adults is administered. In children with renal impairment, the dosage should be reduced in the same manner.

Ingredients

Manufacturer
영일제약(주)

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia) and genitourinary (cystitis, gonorrhea) infections.

  • 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 various infectious diseases by effectively acting against a wide range of bacteria. It is effective for respiratory infections such as acute and chronic bronchitis, pneumonia, otitis media, and sinusitis, as well as urinary tract infections including cystitis, urethritis, and pyelonephritis. It is also used in the treatment of gonorrhea, pelvic infections, boils, soft tissue infections, wound infections, osteomyelitis, and dental-related infections. This is a medication that helps restore the health of patients by being used for such a wide range of bacterial infections.

How to take

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take Amoxicillin/Clavulanate Potassium at a dose of 250 mg/125 mg three times a day, every 8 hours. For severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, adjust dosages according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed.

Child dose

For children aged 12 years or older or weighing 40 kg or more, the same dosage as adults is administered. In children with renal impairment, the dosage should be reduced in the same manner.

Precautions

This drug is a beta-lactam antibiotic and should not be used in patients who have had hypersensitivity reactions to penicillin or cephalosporin drugs. In particular, patients with infectious mononucleosis or lymphocytic leukemia are at a higher risk of skin rashes when taking this medication and should be cautious. Patients who have had liver dysfunction or jaundice due to this medication or penicillin in the past are advised not to take it due to the risk of recurrence. Patients with impaired liver function should use this medication with caution, as it may worsen liver function. Patients with moderate to severe renal impairment need dose adjustments and interval adjustments, as the drug can remain in the body for a long time, increasing the risk of side effects. Patients with allergic constitution or frequent symptoms of bronchial asthma, skin rashes, or hives should be cautious, as hypersensitivity reactions may occur when taking this medication. Patients in poor nutritional status or unable to take orally, elderly patients, etc., may be at risk of bleeding due to vitamin K deficiency and should be cautious. Patients with severe vomiting or diarrhea due to gastrointestinal diseases should also be careful, as the absorption of the drug may not occur properly. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, abdominal pain; if severe diarrhea or blood in stools occurs, the medication should be stopped immediately and the doctor consulted. Liver function abnormalities may occur rarely, particularly in elderly patients over 60 years of age and males, so liver function tests are necessary during long-term administration. Rarely, skin rashes, hives, and severe skin reactions such as Stevens-Johnson syndrome can occur, and if rashes develop, the use of the medication should be stopped immediately. Blood tests may show abnormalities such as leukopenia, thrombocytopenia, and anemia, so regular blood tests are recommended for long-term use. Central nervous system side effects may rarely include headaches, dizziness, and seizures; caution is required in patients with renal impairment or those receiving high doses. Severe renal impairment may lead to acute renal failure or nephritis, necessitating regular renal function tests. During the intake of this drug, there is a risk of bleeding due to vitamin K deficiency, so if bleeding symptoms appear, the doctor should be notified immediately. Patients taking anticoagulants may experience increased bleeding risk when interacting with this drug, so frequent blood coagulation tests are necessary. Avoid administration during pregnancy, especially in the first three months, and use with caution in women of childbearing age. While breastfeeding, the drug may be transmitted into breast milk and may cause diarrhea or skin rashes in infants, necessitating cessation of the medication if any abnormal symptoms occur. It is not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients are at higher risk of side effects due to decreased renal and hepatic function, so dosage and administration intervals should be adjusted while closely monitoring their condition. This medication may affect certain urine test results, so it is important to inform healthcare professionals during testing. In case of overdose, symptoms such as vomiting, diarrhea, abdominal pain, and drowsiness may occur, and in severe cases, renal failure or seizures may occur, so immediate contact with healthcare professionals is necessary. Store in a tightly sealed container in a dry place at temperatures between 1 and 25 degrees Celsius. This storage method maintains the efficacy of the medication and prevents degradation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • rarely gastritis
  • glossitis
  • black hairy tongue
  • occasional nausea
  • vomiting
  • loss of appetite
Show 20 more
  • abdominal pain
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • severe colitis with blood in stools
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme.

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

Storage

This medication should be kept in a tightly sealed container to prevent moisture and stored at a cool temperature between 1 and 25 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets.

Package unit

100 tablets/PTP [(10 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.