Medication info
Asikra Tablet 625 mg (Amoxicillin Trihydrate · Clavulanic Acid Potassium (4:1))

Asikra Tablet 625 mg (Amoxicillin Trihydrate · Clavulanic Acid Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White or almost white, oblong film-coated tablet
Packaging
60 tablets (4 tablets/PTP x 15)
Approval status
Active

MFDS item code 201307132 · Approved 2013.04.30 · Insurance code 657805130

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/clavulanic acid potassium at a dose of 250 mg/125 mg, three times a day every 8 hours orally. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. Adjust the dosage for patients with renal impairment according to their creatinine clearance. For creatinine clearance of 10 to 30 mL/min, take 250
Child dose
For children aged 12 years or older or weighing 40 kg or more, follow the same dosage as adults. In children with renal impairment, reduce dosage based on creatinine clearance using the same method.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

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

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

This medication is effective against various types of bacteria and is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and tonsillitis. It is also suitable for urinary tract infections including cystitis, urethritis, and pyelonephritis. It is utilized in the treatment of pelvic infections and sexually transmitted infections such as gonorrhea, and is effective in treating abscesses, boils, soft tissue infections, and wound infections. Additionally, it can be used for infections around the bones or teeth, such as osteomyelitis or dental infections. Its broad-spectrum antibacterial action helps in the treatment of various infectious diseases.

How to take

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take amoxicillin/clavulanic acid potassium at a dose of 250 mg/125 mg, three times a day every 8 hours orally. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. Adjust the dosage for patients with renal impairment according to their creatinine clearance. For creatinine clearance of 10 to 30 mL/min, take 250

Child dose

For children aged 12 years or older or weighing 40 kg or more, follow the same dosage as adults. In children with renal impairment, reduce dosage based on creatinine clearance using the same method.

Precautions

This medication contains antibiotics from the penicillin class and clavulanic acid, and should not be used in certain patients. For instance, patients with a history of allergic reactions to this medication or beta-lactam antibiotics, those with infectious mononucleosis or lymphocytic leukemia, or those with a history of liver dysfunction or jaundice due to this medication or penicillin should not take it. Patients with impaired liver function or severe kidney disease should use this medication cautiously, and those with allergic constitutions, elderly patients, or patients in poor nutritional status should also exercise caution. Furthermore, patients exhibiting gastrointestinal symptoms such as vomiting or diarrhea may not absorb the medication properly and should take care. This medication may cause gastrointestinal side effects including diarrhea, vomiting, and abdominal pain, and in rare cases may lead to severe colitis or pancreatitis; therefore, if symptoms worsen, the medication should be stopped immediately, and medical advice sought. Symptoms of liver dysfunction have also been reported, requiring regular liver function tests, especially for elderly male patients or those taking it for more than 14 days. Allergic reactions may present as skin rashes, itching, and in severe cases, Stevens-Johnson syndrome or anaphylactic shock can occur, necessitating immediate cessation of the medication and emergency treatment. Blood-related side effects such as leukopenia, anemia, and thrombocytopenia may occur rarely, requiring examination if abnormal symptoms arise. Central nervous system side effects include rare occurrences of headache, dizziness, and seizures, with a risk of kidney damage in patients with poor renal function, necessitating regular monitoring. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist of any concurrent medications. Pregnant or breastfeeding women should consult their doctor before using this medication, and especially during the first trimester of pregnancy, use should be avoided. In children under 12 years or weighing less than 40 kg, experience is limited, and use is not recommended. Elderly patients, due to decreased body function, bear a higher risk of side effects and should be monitored closely with adjusted dosage and administration intervals. In the case of overdose, gastrointestinal disturbances, drowsiness, rashes, and in severe cases, seizures or shock may occur, thus immediate discontinuation and appropriate treatment are required. This medication should be stored in a tightly sealed container to prevent moisture ingress; hence, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness and prevent degradation.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory symptoms accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urinary retention

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • abdominal distension
  • constipation
  • colonic pain
  • acid reflux
  • clay-colored stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • dry mouth
  • severe colitis with bloody stools
  • elevation of AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • skin and mucosal syndrome

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

Storage

This medication is stored in a tightly sealed container to prevent moisture ingress. Therefore, it should be stored in a place that is dry and has low humidity, maintaining a temperature below 25 degrees Celsius. Proper storage ensures the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White or almost white, oblong film-coated tablet

Package unit

60 tablets (4 tablets/PTP x 15)

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.