Medication info
Fleming Tablet 375mg (Amoxicillin/Clavulanate Potassium)

Fleming Tablet 375mg (Amoxicillin/Clavulanate Potassium)

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

MFDS item code 201906639 · Approved 2019.09.23 · Insurance code 690301710

Summary

Main use
Treatment of respiratory and urogenital infections
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing more than 40 kg: Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally three times a day every 8 hours. For severe and respiratory infections, the dose can be increased to 500 mg/125 mg once. In patients with renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance over 30 mL/min: No adjustment needed.
Child dose
For children under 12 years of age or weighing less than 40 kg, dose should be reduced according to the same method as in adults.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Treatment of respiratory and urogenital infections

  • Acute and chronic bronchitis
  • lobar and bronchial pneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
  • pelvic infections
  • gonorrhea
View approved original text

This medication is used for the treatment of various bacterial infections. It is effective for respiratory infections such as acute and chronic bronchitis, lobar and bronchial pneumonia, empyema, as well as tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections including cystitis, urethritis, and pyelonephritis, as well as pelvic infections and gonorrhea. It is widely utilized for skin and soft tissue infections such as boils, abscesses, wound infections, as well as osteomyelitis and dental infections. It has broad antibacterial activity, improving various infectious diseases.

How to take

Adult dose

Adults and children over 12 years or weighing more than 40 kg: Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally three times a day every 8 hours. For severe and respiratory infections, the dose can be increased to 500 mg/125 mg once. In patients with renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance over 30 mL/min: No adjustment needed.

Child dose

For children under 12 years of age or weighing less than 40 kg, dose should be reduced according to the same method as in adults.

Precautions

This medicine is a beta-lactam antibiotic and should not be administered to patients with allergies or hypersensitivity to penicillins or cephalosporins. Especially, patients with concomitant viral infections such as infectious mononucleosis or lymphocytic leukemia are at increased risk of rash and require caution. Patients with a history of liver dysfunction or jaundice should avoid use due to the risk of relapse. Patients with impaired liver function or severe renal disease may have accumulation of the drug in their body, thus the dosing interval should be adjusted or used with caution. Patients with allergic tendencies or symptoms of bronchial asthma, urticaria also require caution. Patients experiencing severe vomiting or diarrhea, and elderly patients with poor nutritional status should be observed for the risk of bleeding due to vitamin K deficiency. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain, which can be alleviated by taking it with meals. There may be signs of liver function abnormality, thus regular liver function tests are required during prolonged use. Rarely, serious adverse reactions can occur such as skin rashes, anaphylaxis, blood disorders, and kidney dysfunction, and if any symptoms appear, immediate consultation with medical personnel is necessary. If severe diarrhea or abdominal cramps occur during or after antibiotic use, immediately discontinue administration and seek appropriate treatment. This medication may interact with other drugs, thus when taken with anticoagulants or other antibiotics, it should be taken according to the instructions of a healthcare professional. Women in early pregnancy or nursing should carefully consider the use of this medication and observe for any abnormal symptoms in the baby while breastfeeding. Use in children, especially those under 12 years of age or weighing less than 40 kg is not recommended due to limited experience. Elderly patients may have an increased risk of adverse reactions due to decreased renal and liver function, thus should use with adjusted doses and intervals carefully. Overdose may result in gastrointestinal disorders, acute kidney failure, and seizures, thus immediate cessation and proper emergency treatment are necessary. This medication should be stored in a tightly sealed container to avoid moisture and should be kept in a cool place between 1 and 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, Stevens-Johnson syndrome, shock, severe allergic reactions, severe skin adverse reactions, blisters, desquamation, mucosal pain in the mouth/eyes, respiratory issues, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), severe malaise, liver abnormalities (jaundice)

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • bloating
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  • constipation
  • colonic pain
  • hyperacidity
  • soft stool
  • dry mouth
  • pseudomembranous colitis
  • candidiasis
  • blood in stool
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • decreased urine output
  • renal failure
  • interstitial nephritis
  • hematuria
  • mucosal candidiasis
  • vaginal itching
  • increased secretions
  • nervousness
  • anxiety
  • behavioral changes
  • drowsiness
  • insomnia
  • hyperactivity

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

Storage

This medication is contained in a specially sealed container to prevent moisture. When stored, it should be kept in a cool place at a temperature between 1 and 25 degrees Celsius.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

100 tablets/box [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.