Medication info
Asikra Tablet 375 mg (Amoxicillin Trihydrate · Potassium Clavulanate (2:1))

Asikra Tablet 375 mg (Amoxicillin Trihydrate · Potassium Clavulanate (2:1))

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

MFDS item code 201506649 · Approved 2015.09.21 · Insurance code 657805660

Summary

Main use
Treatment of bacterial infections such as respiratory and urogenital infections
Who takes it
Adults · Children
Adult dose
For adults and children over 12 years or weighing more than 40 kg, administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg at a time. For those with renal impairment, dosage should be adjusted according to creatinine clearance. For creatinine clearance of 10-30 mL/min, administer amoxicillin at the amount of 250-500 mg orally every 12 hours. For clearance of 10 mL/min or less, administer amoxicillin at the amount of 250 mg orally every 24 hours, ensuring the total dose does not exceed.
Child dose
For children under 12 years of age or weighing less than 40 kg, administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of renal impairment, adjust the dosage to match that of adults.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment of bacterial infections such as respiratory and urogenital infections

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

This medication is effective against various bacterial infections. It is used to treat respiratory infections such as acute and chronic bronchitis, lobar and bronchopneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also effective for urinary tract infections such as cystitis, urethritis, and pyelonephritis. Additionally, it is utilized for the treatment of sexually transmitted infections such as pelvic inflammatory disease and gonorrhea. It improves infections related to boils, abscesses, soft tissue infections, wound infections, osteomyelitis, and dental infections. This medication is useful for treating bacterial infections in various locations.

How to take

Adult dose

For adults and children over 12 years or weighing more than 40 kg, administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg at a time. For those with renal impairment, dosage should be adjusted according to creatinine clearance. For creatinine clearance of 10-30 mL/min, administer amoxicillin at the amount of 250-500 mg orally every 12 hours. For clearance of 10 mL/min or less, administer amoxicillin at the amount of 250 mg orally every 24 hours, ensuring the total dose does not exceed.

Child dose

For children under 12 years of age or weighing less than 40 kg, administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of renal impairment, adjust the dosage to match that of adults.

Precautions

This medication should not be used in patients who have had a hypersensitivity reaction to certain components or beta-lactam antibiotics. In particular, caution is advised in patients with infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with liver dysfunction or a history of jaundice should also use this medication cautiously as symptoms may recur. Care should be taken when administering to patients with liver disease, as liver function may deteriorate. In patients with moderate or severe renal impairment, dosing intervals should be adjusted due to the risk of increased drug concentration. Patients with allergic tendencies, those unable to take the drug orally, the elderly, and immunocompromised individuals should be cautious as they may experience vitamin K deficiency symptoms. Patients with gastrointestinal diseases may be affected in drug absorption, so observation is necessary. This medication can cause gastrointestinal adverse reactions such as diarrhea, vomiting, and abdominal pain, and in severe cases, pseudomembranous colitis or acute pancreatitis can occur, necessitating immediate discontinuation of use if symptoms occur. Symptoms of liver dysfunction may also rarely appear, especially in the elderly and males, so regular liver function tests are necessary. Serious hypersensitivity reactions such as skin rashes, urticaria, or anaphylaxis may occur, and if any abnormal symptoms appear, discontinue use immediately and follow the physician's instructions. Blood-related adverse reactions such as leukopenia, thrombocytopenia, and anemia may rarely occur, requiring blood tests. Central nervous system adverse reactions such as agitation, anxiety, and seizures may occur rarely, so caution is needed. Regular renal function tests should be performed as this medication can affect kidney function. Long-term use of this medication may lead to the development of resistant bacteria, so administering only for the necessary minimum period is important. Women who are pregnant or breastfeeding are restricted from using this medication, especially during the first three months of pregnancy. During breastfeeding, infants may experience odd reactions such as diarrhea or skin rashes, necessitating discontinuation of use if any abnormal symptoms occur. Dosage and administration intervals should be adjusted with caution for children and the elderly, as their responses may differ. This medication may interact with other drugs; therefore, consultation with a professional is required, especially when used with anticoagulants, anti-inflammatory drugs, and other antibiotics. In cases of overdose, gastrointestinal symptoms and central nervous system abnormalities may occur, necessitating immediate visit to a medical facility for proper treatment. Store in a sealed container to avoid moisture, and it is important to take the medication exactly as directed by a doctor.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest discomfort, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever accompanied by severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and very severe reactions.

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
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • candidiasis
  • colitis due to antibiotics
  • acute pancreatitis
  • elevation of AST
  • ALT
  • ALP
  • LDH
  • elevated serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • vesicular desquamation.

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

Storage

This medication should be stored in a sealed container to protect it from moisture. Additionally, it should be kept in a cool, dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

100 tablets (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

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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.