Medication info
Fleming Tablets 625mg (Amoxicillin·Clavulanate Potassium)

Fleming Tablets 625mg (Amoxicillin·Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)라이트팜텍
Appearance
White or almost white oval film-coated tablets
Packaging
40 tablets/box [4 tablets/PTPX10]
Approval status
Active

MFDS item code 201906638 · Approved 2019.09.23 · Insurance code 690301700

Summary

Main use
Treatment of respiratory and genitourinary infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years or older or weighing 40 kg or more, take amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe or respiratory infections, it can be increased to 500 mg/125 mg per dose. For patients with kidney impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dose adjustment required
Child dose
For children under 12 years or weighing less than 40 kg, the dosage should be reduced in the same manner.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

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

  • 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 types of bacteria. It is used for respiratory infections such as pneumonia, bronchitis, sinusitis, otitis media, and genitourinary infections such as cystitis, urethritis, and pyelonephritis. It is also effective for treating pelvic infections, gonorrhea, boil and abscess, soft tissue infections, wound infections, osteomyelitis, and dental infections. By treating a variety of bacterial infections, it helps improve symptoms. Therefore, this medication is widely used for the treatment of various infectious diseases.

How to take

Adult dose

For adults and children aged 12 years or older or weighing 40 kg or more, take amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe or respiratory infections, it can be increased to 500 mg/125 mg per dose. For patients with kidney impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dose adjustment required

Child dose

For children under 12 years or weighing less than 40 kg, the dosage should be reduced in the same manner.

Precautions

This medication contains amoxicillin and clavulanate potassium as part of the beta-lactam antibiotic class. It should not be used in patients with a history of allergic reactions to these ingredients or similar penicillin antibiotics. Administration is contraindicated in those with a history of severe hypersensitivity reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock. Additionally, it should be avoided in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as there is an increased risk of rash. Patients with liver dysfunction or a history of jaundice also require caution due to the risk of recurrence. Patients with impaired liver function or severe kidney dysfunction will require dose adjustments and administration interval modifications. Those with allergic tendencies should also use this medication cautiously. Elderly patients, malnourished individuals, and those with gastrointestinal disorders accompanied by vomiting or diarrhea should exercise caution when using this medication. This medication may cause gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain. In severe cases, serious side effects such as pseudomembranous colitis may occur, and if symptoms arise, patients should immediately stop using the medication and consult a doctor. Symptoms of liver dysfunction have also been reported, particularly in men over 60 years of age or with long-term use, necessitating regular liver function tests. Rarely, severe skin reactions or hypersensitivity reactions such as anaphylactic shock may occur; if symptoms such as skin rash, itching, or difficulty breathing occur, administration should be stopped immediately and emergency treatment sought. Blood abnormalities, kidney function impairment, and central nervous system adverse reactions have also been reported, so patients should be vigilant for symptoms. This medication may interact with other drugs, so especially in patients taking anticoagulants, certain antibiotics, anti-inflammatory drugs, or anticonvulsants, it is essential to inform their physician or pharmacist. It is advisable to avoid use during the first three months of pregnancy and, during pregnancy or breastfeeding, to consider the benefits versus risks carefully before administering. Pediatric use is recommended only for children over 12 years of age or weighing over 40 kg, as there is insufficient data for younger children, requiring caution. Elderly individuals may have an increased risk of side effects due to declining physical functions, thus requiring careful dose and administration interval adjustments. This medication may affect the results of certain clinical tests, such as glucose tests, so it is crucial to inform the healthcare provider conducting the tests. In case of overdose, gastrointestinal symptoms, renal failure, and seizures may occur, and immediate medical attention is necessary for appropriate treatment. It should be stored in a sealed container to avoid moisture. It is important to maintain a cool temperature between 1 and 25 degrees Celsius while storing. This will safely preserve the effectiveness of the medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rashes, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or trouble breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden onset

Mild side effects

Diarrhea, pseudomembranous colitis, indigestion, stomatitis, gastritis, glossitis, darkening of the tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, hyperacidity, soft stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, bloody stools, gastrointestinal adverse reactions, hepatitis, elevations of AST, ALT, ALP, LDH, serum bilirubin, itching, erythema multiforme, dermatitis, eosinophilia, systemic symptoms associated with drug reactions

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

Storage

This medication is contained in a sealed container to prevent moisture. It is important to maintain a cool temperature between 1 and 25 degrees Celsius during storage. This way, the effectiveness of the medication can be safely preserved.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

40 tablets/box [4 tablets/PTPX10]

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.