Medication info

Amoclduo Tablet 500mg (Amoxicillin · Clavulanate Potassium)

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Amoxicillin Hydrate›437.5mg / 1 tabletDilute Potassium Clavulanate›107.76mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White or almost white rectangular film-coated tablet
Packaging
100 tablets (10 tablets/PTP packaging x 10)
Approval status
Approval revoked

MFDS item code 201900231 · Approved 2019.01.17

This product's status changed to Approval revoked on 2023.10.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory infections (bronchitis, pneumonia), urinary infections (cystitis, urethritis)
Who takes it
Adults
Adult dose
For adults with severe infections and respiratory infections, take 2 tablets orally, twice daily, every 12 hours. Dosage may be adjusted according to the degree of renal function in renal impairment patients. Severe renal impairment patients (glomerular filtration rate below 30 mL/min) should not receive this medication.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Treatment of respiratory infections (bronchitis, pneumonia), urinary infections (cystitis, urethritis)

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

This medication is an antibiotic effective against various bacterial infections, targeting several pathogens including Staphylococcus aureus, Escherichia coli, and Streptococcus pneumoniae. It is used to treat respiratory infections such as acute and chronic bronchitis, pneumonia, and empyema, as well as urinary tract infections such as cystitis, urethritis, and pyelonephritis. It also treats pelvic inflammatory disease, gonorrhea, and skin and soft tissue infections such as abscesses and cellulitis, as well as osteomyelitis and dental infections, thereby improving bacterial infections in various parts of the body. Therefore, this medication is used to treat a variety of infections caused by different types of bacteria.

How to take

Adult dose

For adults with severe infections and respiratory infections, take 2 tablets orally, twice daily, every 12 hours. Dosage may be adjusted according to the degree of renal function in renal impairment patients. Severe renal impairment patients (glomerular filtration rate below 30 mL/min) should not receive this medication.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with allergies to penicillins or cephalosporins. Special caution is needed in cases with a history of hypersensitivity reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock. It is recommended to avoid this medication in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia due to an increased risk of rash. Patients with a history of liver dysfunction or jaundice associated with this medication or penicillin should avoid its use. Those with impaired liver function may experience further worsening of liver function when taking this medication, so caution is needed. In patients with moderate to severe renal impairment, drug concentrations may increase, necessitating adjustment of dosing intervals. Patients with allergies or symptoms like asthma or urticaria should be cautious as there is a higher risk of side effects. Patients who have difficulty in oral intake, elderly patients, or those in poor general condition may have an increased risk of bleeding due to vitamin K deficiency, so monitoring is necessary. Patients with gastrointestinal symptoms such as vomiting or diarrhea may not absorb the medication sufficiently. During treatment with this medication, if unusual symptoms such as diarrhea, abdominal pain, rash, itching, or shortness of breath occur, immediate consultation with a physician is advised. Particularly, severe colitis symptoms, including pseudomembranous colitis, may occur, warranting caution regarding diarrhea and abdominal pain. Symptoms indicating liver dysfunction, such as jaundice or hepatitis, may arise during long-term use; thus, regular liver function tests are required. Allergic reactions leading to skin rashes, urticaria, angioedema, or anaphylactic shock can rarely occur, so preparedness for emergencies is necessary. Blood tests may show leukopenia, thrombocytopenia, or anemia, making regular blood testing advisable. Central nervous system adverse reactions such as anxiety, confusion, or seizures may occur rarely, requiring monitoring if neurological symptoms develop. Kidney function may worsen, and acute renal failure may occur; therefore, regular checks on renal function are essential. Like other antibiotics, this medication may affect the normal gut flora, resulting in phenomena such as candidiasis. Symptoms of vitamin K and B complex deficiency may occur rarely, so nutritional status should be monitored closely. Due to numerous drug interactions, patients taking other medications should consult with their physician or pharmacist. Special caution is required when combined with anticoagulants, gout medications, or other antibiotics. Women who are pregnant or may become pregnant should avoid use except in special cases, and those who are breastfeeding should also be cautious, as side effects may occur in the infant. It is not recommended for children under 12 years of age or those weighing less than 40 kg due to limited experience. Elderly patients have a higher risk of side effects due to decreased bodily functions, thus should use the medication cautiously, adjusting the dosage and intervals. This medication may affect some clinical test results such as urine sugar tests, so it is advisable to inform healthcare providers before testing. In case of overdose, symptoms such as vomiting, diarrhea, rash, or seizures may occur, requiring immediate notification to healthcare providers for appropriate treatment. This medication should be stored in a dry place below 25 degrees Celsius, and regular kidney, liver, and blood function tests are important during prolonged use.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reaction, asthma attack, respiratory issues with cough and fever, jaundice with skin or eyes turning yellow, severe malaise, liver abnormalities (jaundice), sudden and severe headache, lightning-type headache

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, dark tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, discolored stool, dry mouth, candidiasis, antibiotic-associated colitis, elevation in AST, ALT, ALP, LDH, serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, angioedema, serum sickness, hypersensitivity vasculitis, acute generalized exanthematous pustulosis

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool and dry place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

White or almost white rectangular film-coated tablet

Package unit

100 tablets (10 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.