Medication info
Amiklan Tablet 375 mg (Amoxicillin Hydrate, Clavulanate Potassium) (2:1)

Amiklan Tablet 375 mg (Amoxicillin Hydrate, Clavulanate Potassium) (2:1)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
White or nearly white oval film-coated tablets
Packaging
100 tablets (10 tablets/PTP × 10)
Approval status
Active

MFDS item code 201208110 · Approved 2012.11.13 · Insurance code 654004080

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urogenital (cystitis, gonorrhea) infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing over 40 kg should be administered amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times daily every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg at a time. For patients with renal impairment, the dosage is adjusted based on creatinine clearance; for those with a clearance of 10-30 mL/min, administer 250-500 mg at a time every 12 hours.
Child dose
Children aged 12 years or older or weighing over 40 kg should receive the same dosage as adults. For pediatric patients with renal impairment, the dosage should be reduced similarly.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

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

This medication is effective against various bacterial infections, particularly used for respiratory diseases such as acute and chronic bronchitis, pneumonia, and empyema. Additionally, it is applicable for urinary tract infections like cystitis, urethritis, and pyelonephritis. It is effective in treating pelvic infections and gonorrhea, and is also used for skin and soft tissue infections such as boils, abscesses, cellulitis, and wound infections. It is utilized for osteomyelitis and dental infections, helping to improve a variety of infectious diseases.

How to take

Adult dose

Adults and children aged 12 years or older or weighing over 40 kg should be administered amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times daily every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg at a time. For patients with renal impairment, the dosage is adjusted based on creatinine clearance; for those with a clearance of 10-30 mL/min, administer 250-500 mg at a time every 12 hours.

Child dose

Children aged 12 years or older or weighing over 40 kg should receive the same dosage as adults. For pediatric patients with renal impairment, the dosage should be reduced similarly.

Precautions

This drug is a beta-lactam antibiotic and should not be administered to patients with allergies to penicillin. Those with a history of severe allergic reactions such as anaphylaxis or Stevens-Johnson syndrome should be cautious as using this drug may be risky. Patients with viral infections, such as infectious mononucleosis or lymphocytic leukemia, are at higher risk for adverse effects like rash and should avoid using this drug. Patients with a history of liver dysfunction or jaundice should also be cautious due to the risk of recurrence. Those with compromised liver function or severe kidney impairment may have elevated drug concentrations and should use it cautiously with adjusted dosing intervals. Patients with allergies, the elderly, or those with poor nutritional status may also have an increased risk of side effects. Gastrointestinal side effects may include diarrhea, vomiting, and abdominal pain; if severe diarrhea or abdominal pain occurs, stop using the medication immediately and consult a physician. Liver function abnormalities may occur, so regular liver function tests should be conducted during long-term use. Rarely, severe skin reactions such as rashes, itching, or Stevens-Johnson syndrome can occur, and if any abnormal symptoms arise, usage should be discontinued immediately. Blood dyscrasias such as leukopenia, anemia, and thrombocytopenia have been reported, so caution is necessary for patients with bleeding tendencies. Neurological side effects such as headaches, dizziness, and seizures may occur occasionally, particularly in patients with renal impairment. It is advisable to avoid use during the first three months of pregnancy, and nursing mothers should be cautious as side effects may affect infants. This drug may interact with other medications, so patients taking other drugs should consult with their physician or pharmacist. In cases of overdose, gastrointestinal symptoms and renal function abnormalities may occur, and immediate contact with a healthcare facility for appropriate treatment is necessary. This drug should be stored in a dry place below 25 degrees Celsius, and it is crucial to check for allergy history and liver and kidney function status prior to 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 rashes, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, lightning pain

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
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  • abdominal pain
  • bloating
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • colitis
  • itching
  • erythema multiforme
  • angioedema
  • dermatitis
  • oral edema
  • reversible leukopenia
  • thrombocytopenia
  • hemolytic anemia
  • anemia
  • thrombocytopenic purpura
  • eosinophilia
  • leukemia
  • agranulocytosis
  • lymphocytic disorders

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

Storage

This drug should be kept in a sealed container to prevent moisture exposure and stored in a dry place below 25 degrees Celsius to maintain efficacy. Caution should be taken as performance may deteriorate in high humidity or elevated temperatures.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

100 tablets (10 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.