Medication info
Myungmoon Amoclan Tablet 625 Milligrams (Amoxicillin - Clavulanate Potassium (4:1))

Myungmoon Amoclan Tablet 625 Milligrams (Amoxicillin - Clavulanate Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White or almost white, oblong film-coated tablet
Packaging
60 tablets / PT[ (4 tablets/PT * 15) ]
Approval status
Active

MFDS item code 202002096 · Approved 2020.03.25 · Insurance code 649807610

Summary

Main use
Treatment of respiratory infections (bronchitis, pneumonia), urogenital infections (cystitis, gonorrhea)
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years old or weighing more than 40 kg: Administer Amoxicillin/Clavulanate potassium 250 mg/125 mg once, orally, three times a day every 8 hours. In cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg once. In cases of renal impairment, the dosage is adjusted according to creatinine clearance. - Creatinine clearance 10 - 30 mL/min: Administer 250 - 500 mg of Amoxicillin every 12 hours.
Child dose
Children over 12 years old or weighing more than 40 kg follow the same dosage as adults. Children with renal impairment should have their dosages adjusted in the same manner.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Treatment of respiratory infections (bronchitis, pneumonia), urogenital infections (cystitis, gonorrhea)

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

This drug is used in the treatment of various infections caused by different bacteria. It is effective for respiratory infections such as acute and chronic bronchitis, lobar and bronchial pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections such as cystitis, urethritis, and pyelonephritis, as well as for pelvic infections and gonorrhea. It is effective for skin infections such as boils, abscesses, soft tissue infections, wound infections, and severe osteomyelitis. Additionally, it is used in dentistry to improve overall bacterial infections. This drug is particularly effective against various resistant strains, including those producing beta-lactamase, making it useful for treating a variety of infections.

How to take

Adult dose

Adults and children over 12 years old or weighing more than 40 kg: Administer Amoxicillin/Clavulanate potassium 250 mg/125 mg once, orally, three times a day every 8 hours. In cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg once. In cases of renal impairment, the dosage is adjusted according to creatinine clearance. - Creatinine clearance 10 - 30 mL/min: Administer 250 - 500 mg of Amoxicillin every 12 hours.

Child dose

Children over 12 years old or weighing more than 40 kg follow the same dosage as adults. Children with renal impairment should have their dosages adjusted in the same manner.

Precautions

This drug, as a beta-lactam antibiotic, should not be used in patients with a history of hypersensitivity to penicillin-based drugs. It is contraindicated especially in patients with a history of severe allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock. Caution is advised in patients with concurrent viral infections such as infectious mononucleosis or lymphocytic leukemia, as there may be an increased risk of rash. Patients with a history of liver dysfunction or jaundice may have a recurrence risk when taking this drug, and it is advisable not to use it. In patients with liver impairment, careful use is necessary as liver function may deteriorate, and those with moderate or severe renal impairment should adjust the administration interval to prevent excessively high blood concentrations. Caution is needed for patients with allergic tendencies or symptoms like bronchial asthma, rashes, or hives. For patients who have difficulty taking orally, those in poor nutritional status, or elderly patients, careful use is required to prevent bleeding risks due to vitamin K deficiency. In cases of gastrointestinal diseases with vomiting or diarrhea, sufficient drug absorption may not occur. This drug may cause various gastrointestinal side effects such as indigestion, diarrhea, vomiting, and abdominal pain, so if symptoms are severe, immediate discontinuation and consultation with a physician are mandatory. Symptoms of liver dysfunction may also occur, particularly in older adults over 60 years and men. Severe skin reactions such as skin rashes, hives, and in severe cases Stevens-Johnson syndrome may occur; if abnormal symptoms arise, immediate discontinuation of the drug is necessary. Hematological side effects such as leukopenia, thrombocytopenia, and anemia have been rarely reported, and neurological abnormalities may occasionally occur, such as headache, seizures, or confusion. Renal function may rapidly deteriorate, so patients with kidney disease require regular check-ups. The balance of intestinal flora may be disrupted, which may lead to infections like candidiasis or stomatitis. The tendency for bleeding due to vitamin K deficiency and symptoms of vitamin B complex deficiency may also rarely occur, necessitating caution during prolonged use. This drug should only be used for the minimum required duration to prevent the emergence of resistant bacteria, and caution is required for patients with a history of hypersensitivity as serious allergic reactions may occur. Anaphylactic shock may occur, thus monitoring the patient is necessary after administration, and emergency measures should be prepared. If diarrhea occurs during or after antibiotic use, the possibility of pseudomembranous colitis should be considered, and the drug should be discontinued immediately with medical consultation. Long-term use may lead to the risk of resistant bacteria proliferation, so when used for more than 14 days, the patient's condition should be carefully monitored. This drug is excreted via the kidneys, so dosage adjustments are necessary for those with decreased renal function. It should be avoided during the first three months of pregnancy, and during breastfeeding, any adverse effects in infants should be monitored, leading to discontinuation if abnormal symptoms are noted. It is not recommended for children under 12 years or weighing less than 40 kg. In the elderly, adverse reactions may occur more frequently due to decreased physiological function, necessitating careful dosage adjustments and administration intervals. This drug may affect certain clinical test results, so it is important to inform medical personnel about its use during tests. In cases of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, and in severe cases, renal failure or seizures may arise, necessitating immediate visit to a medical facility. The storage condition should be in a dry place at or below 25 degrees Celsius to maintain the drug's effectiveness, and consultation with medical professionals is required for any interacting medications during use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, painful mucosa of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing + fever, breathing problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • indigestion
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • bloating
  • constipation
  • colonic pain
  • hyperacidity
  • soft stool
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • colitis
  • rarely nausea
  • AST
  • ALT
  • ALP
  • LDH elevation
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • dermatitis
  • angioedema
  • serum sickness
  • hypersensitivity vasculitis
  • acute generalized rash with pustules

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

Storage

This drug should be kept in a tightly sealed container to prevent moisture, stored in a dry place at or below 25 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer duration.

Appearance and packaging

Appearance

White or almost white, oblong film-coated tablet

Package unit

60 tablets / PT[ (4 tablets/PT * 15) ]

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.