Medication info
Nuclear Tablet 625 mg (Amoxicillin·Clavulanate Potassium (4:1))

Nuclear Tablet 625 mg (Amoxicillin·Clavulanate Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
White or nearly white oval film-coated tablet
Packaging
40 tablets (4 tablets/PTP packaging x 10)
Approval status
Active

MFDS item code 201402831 · Approved 2014.06.25 · Insurance code 645304910

Summary

Main use
(Respiratory, Urinary) Treatment of infections and improvement of soft tissue inflammation
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium at 250 mg/125 mg orally once, three times a day every 8 hours. For severe infections and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. In cases of renal impairment, adjust the dose according to creatinine clearance. - Creatinine clearance above 30 mL/min: no need for dose adjustment.
Child dose
For children under 12 years or weighing less than 40 kg: reduce dosage in the same manner.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

(Respiratory, Urinary) Treatment of infections and improvement of soft tissue inflammation

  • 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 for various bacterial infections. It is used for various respiratory diseases such as acute and chronic bronchitis, pneumonia, empyema, and lung abscess. It is also suitable for treating urinary tract infections such as cystitis, urethritis, and pyelonephritis. It is effective for treating sexually transmitted diseases such as pelvic inflammatory disease and gonorrhea, and is also used for skin and soft tissue infections such as boils, abscesses, soft tissue inflammation, and wound infections. It is also helpful in treating osteomyelitis and dental infections. It is safely used to improve various types of infections.

How to take

Adult dose

Adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium at 250 mg/125 mg orally once, three times a day every 8 hours. For severe infections and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. In cases of renal impairment, adjust the dose according to creatinine clearance. - Creatinine clearance above 30 mL/min: no need for dose adjustment.

Child dose

For children under 12 years or weighing less than 40 kg: reduce dosage in the same manner.

Precautions

This medication is a beta-lactam antibiotic containing amoxicillin and clavulanate potassium, used to treat bacterial infections. This medication should not be administered to patients with an allergy or history of hypersensitivity to beta-lactam antibiotics. Patients with viral infections such as infectious mononucleosis or lymphocytic leukemia should use this medication with caution as the risk of rash may increase. Patients who have previously experienced liver dysfunction or jaundice due to this medication or penicillin-class drugs should avoid use due to the risk of recurrence. Patients with impaired liver function should be administered this medication carefully, as liver function may deteriorate. Patients with moderate to severe renal impairment may experience increased drug concentration in the body; therefore, dosing intervals or doses should be adjusted. Patients with allergic constitution or those who easily show symptoms like bronchial asthma, skin rashes, or hives should use this medication with caution. Patients who have difficulty taking orally, those with poor nutritional status, or the elderly may exhibit symptoms of vitamin K deficiency, thus requiring monitoring. Patients with gastrointestinal symptoms such as vomiting or diarrhea should be careful as the absorption of the medication may be insufficient. Gastrointestinal adverse effects such as diarrhea, nausea, vomiting, abdominal pain, and appetite loss may occur, and in severe cases, serious adverse effects such as pseudomembranous colitis or acute pancreatitis may also arise. There may be changes in liver function, so it is recommended for individuals over 60 years old or males to undergo regular liver function tests. Rarely, hypersensitivity reactions such as skin rashes, itching, and severe skin reactions may occur, and if these symptoms appear, discontinue use immediately and consult a doctor. Rare reports of abnormalities in blood tests such as leukopenia, thrombocytopenia, or anemia have been noted; if any unusual symptoms occur, testing is necessary. Central nervous system side effects such as anxiety, confusion, drowsiness, headache, and rarely seizures may occur; caution should be observed if symptoms develop. Kidney function worsening or acute renal failure may occur, so it is important to regularly monitor kidney function. Like other antibiotics, this medication may disrupt the balance of intestinal flora, leading to infections like candidiasis or stomatitis. Rarely, bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B complex deficiency may appear. This medication should be used for the minimum duration necessary to prevent the development of resistant bacteria, and regular monitoring of liver, kidney, and blood function is required during prolonged use. If there is a history of hypersensitivity to penicillin-class drugs, it is essential to inform healthcare professionals before use. It is advisable to avoid use during the first three months of pregnancy, and caution is required during breastfeeding as diarrhea or skin rashes may occur in infants. Not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly individuals, due to decreased bodily functions, have a higher risk of adverse effects; therefore, dosage and administration intervals should be adjusted and used cautiously. During the use of this medication, it may affect urine glucose test results, thus care should be taken during testing. In case of overdose, gastrointestinal symptoms, electrolyte imbalance, drowsiness, and rashes may occur; therefore, contact a medical institution immediately and receive appropriate treatment. Store in a closed container to prevent moisture absorption, and keep in a cool place between 1 degree and 25 degrees Celsius. By storing this way, the medication's effectiveness can be maintained for a long time.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweating, pallor, severe allergic reactions (including anaphylaxis and anaphylactic shock), high fever with severe rash, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome), difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever,

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, appetite loss, abdominal pain, abdominal bloating, constipation, colonic pain, acid reflux, loose stools, xerostomia, candidiasis, colitis accompanied by bloody stools, itching, erythema multiforme, drug reaction (DRESS), angioedema, serum sickness, hypersensitivity vasculitis, acute generalized exanthematous pustulosis, dyspnea with bronchospasm, laryngeal edema, hypotension, reversible leukopenia

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

Storage

This medication should be stored in a tightly sealed container to prevent moisture, and the temperature should be kept in a cool place between 1 and 25 degrees Celsius. This way of storage can maintain the medication's efficacy for a longer duration.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablet

Package unit

40 tablets (4 tablets/PTP packaging 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.

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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.