Medication info

Krasygen Tablet 375 mg

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

MFDS item code 201903758 · Approved 2019.06.05

This product's status changed to Expired on 2024.06.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and the urogenital system (cystitis, gonorrhea)
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years or older or weighing 40 kg or more, amoxicillin/clavulanic acid potassium is administered orally as 250 mg/125 mg, 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 cases of renal impairment, dosages are adjusted based on creatinine clearance. For a creatinine clearance of 10 to 30 mL/min, 250 to 500 mg of amoxicillin is administered orally every 12 hours. For a creatinine clearance of less than 10 mL/min, 250 mg of amoxicillin is administered orally every 24 hours without exceeding the maximum dose. For children, the dosage is adjusted similarly. However, for dental infections, 250 mg of amoxicillin is administered three times a day for 5 days.
Child dose
For children aged 12 years or older or weighing 40 kg or more, the dosage is the same as adults. For children with renal impairment, the dosage should be adjusted similarly.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

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

This medicine is effective against various bacterial infections. It is used for respiratory diseases such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It also has therapeutic effects on urinary tract infections such as cystitis, urethritis, and pyelonephritis. It helps with skin and soft tissue infections, including pelvic infections and gonorrhea, as well as boils, abscesses, cellulitis, and wound infections. It is also used for treating osteomyelitis and dental infections, improving various bacterial infections.

How to take

Adult dose

For adults and children aged 12 years or older or weighing 40 kg or more, amoxicillin/clavulanic acid potassium is administered orally as 250 mg/125 mg, 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 cases of renal impairment, dosages are adjusted based on creatinine clearance. For a creatinine clearance of 10 to 30 mL/min, 250 to 500 mg of amoxicillin is administered orally every 12 hours. For a creatinine clearance of less than 10 mL/min, 250 mg of amoxicillin is administered orally every 24 hours without exceeding the maximum dose. For children, the dosage is adjusted similarly. However, for dental infections, 250 mg of amoxicillin is administered three times a day for 5 days.

Child dose

For children aged 12 years or older or weighing 40 kg or more, the dosage is the same as adults. For children with renal impairment, the dosage should be adjusted similarly.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with hypersensitivity to penicillin components. In particular, it should not be used in patients with a history of severe allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock. It is advisable to avoid administering this drug to patients with infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with a history of liver dysfunction or jaundice from this drug or penicillin should be cautious due to the risk of recurrence. Patients with impaired liver or kidney function may be affected in terms of drug metabolism and excretion, hence careful administration and possible dose adjustment are necessary. Caution is required for patients with a history of allergies or difficulty in oral ingestion, elderly patients, or those in poor overall condition due to the risk of bleeding from vitamin K deficiency. Patients with gastrointestinal diseases accompanied by vomiting or diarrhea should check their condition before administration as drug absorption may be impaired. Gastrointestinal side effects may include diarrhea, gastritis, and vomiting, and if severe diarrhea or abdominal pain occurs, discontinue use immediately. Signs of liver function abnormality have also been reported, and they may occur more frequently in elderly or long-term users, so liver function testing is necessary. Rarely, skin rash, itching, or severe skin reactions may occur, so if unusual symptoms occur, discontinue administration immediately and seek medical advice. Blood tests may show leukopenia or thrombocytopenia, so long-term use necessitates monitoring of blood status. Neurological symptoms such as agitation, anxiety, or seizures may occur rarely, and caution is needed in patients with impaired renal function. Renal damage or acute kidney failure symptoms have also been reported, and regular kidney function tests are recommended. Antibiotic use may lead to dysbiosis or candidiasis, so appropriate measures should be taken if symptoms arise. Symptoms of vitamin K and vitamin B group deficiencies may appear, so it is important to check nutritional status. To prevent the emergence of resistant bacteria, it is advisable to administer only for the necessary duration after sensitivity testing. Patients with a history of penicillin hypersensitivity are at risk for severe allergic reactions, so verification prior to administration is essential. Patients should be closely monitored for status after administration in case of emergencies such as anaphylactic shock. There is a risk of antibiotic-associated pseudomembranous colitis, so if severe diarrhea or abdominal pain occurs, inform medical personnel immediately. Caution is needed when used for more than 14 days as non-sensitive bacteria can proliferate. If liver dysfunction is suspected, testing should be done immediately, and administration should be stopped if necessary. Since renal excretion is the main pathway, dose adjustment is needed in patients with impaired kidney function. Avoid use in suspected infectious mononucleosis cases. If hives, skin rash, or serum sickness symptoms occur, discontinue administration immediately and follow medical guidance. Regular testing of renal function, liver function, and hematopoietic function is necessary for long-term use. Verification of a history of penicillin, cephalosporin, or other allergies is mandatory before administration. Adequate fluid intake and urine output maintenance are important during high-dose administration to prevent acute kidney damage. It is recommended for children over 12 years of age or weighing more than 40 kg. Do not administer during the first three months of pregnancy, and pregnant or breastfeeding women should use it cautiously after consulting a physician. During breastfeeding, if the infant shows symptoms such as diarrhea or skin rashes, administration should be discontinued in case of adverse effects. This drug can interact with other medications, so if taking other drugs, health professionals should be informed. Overdose may result in gastrointestinal symptoms, renal failure, seizures, and immediate medical treatment is required.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • anaphylaxis
  • Stevens-Johnson syndrome
  • shock
  • severe skin reactions
Show 13 more
  • severe rash
  • blisters
  • skin peeling
  • mucosal pain in the mouth/eyes
  • respiratory problems
  • bronchospasm
  • laryngeal edema
  • anaphylactic shock
  • hypotensive symptoms
  • yellowing of the skin or eyes (jaundice)
  • extreme lethargy
  • liver abnormalities
  • sudden and severe

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
Show 22 more
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • colitis with blood-stained stools
  • itching
  • erythema multiforme
  • skin rash
  • serum sickness syndrome
  • systemic symptoms
  • angioedema
  • bronchospasm
  • leukopenia
  • thrombocytopenia
  • anemia
  • thrombocytosis
  • bone marrow suppression

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

Storage

This drug should be kept in a sealed container to avoid moisture, stored in a dry place below 25 degrees Celsius. Proper storage helps maintain the efficacy of the drug for an extended period.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

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

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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.