Medication info
Amoculzen Tablet 625mg (Amoxicillin-Potassium Clavulanate (4:1))

Amoculzen Tablet 625mg (Amoxicillin-Potassium Clavulanate (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
White or nearly white oblong film-coated tablet
Packaging
60 tablets/PTP [60 tablets (4 tablets/PTP x 15)]
Approval status
Active

MFDS item code 201907294 · Approved 2019.10.17 · Insurance code 057600320

Summary

Main use
Treatment of respiratory and genitourinary infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing 40 kg or more should take 250 mg of amoxicillin/125 mg of clavulanate orally three times a day every 8 hours. In the case of severe or respiratory infections, the dose may be increased to 500 mg/125 mg once. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 ~ 500 mg of amoxicillin every 12 hours by mouth.
Child dose
Administered in the same manner as for adults and children aged 12 years or older or weighing 40 kg or more, and adjusted similarly in cases of renal impairment.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

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

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

This drug is effective against a variety of bacteria including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Neisseria gonorrhoeae, etc. It is primarily used for respiratory infections such as acute and chronic bronchitis, pneumonia, and empyema. It is also utilized for urinary tract infections such as cystitis and urethritis, as well as for the treatment of sexually transmitted infections such as gonorrhea and pelvic inflammatory disease. It is effective for furuncles, abscesses, soft tissue infections, wound infections, osteomyelitis, and dental infections. Therefore, this drug is widely used for the treatment of various diseases caused by bacterial infections.

How to take

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take 250 mg of amoxicillin/125 mg of clavulanate orally three times a day every 8 hours. In the case of severe or respiratory infections, the dose may be increased to 500 mg/125 mg once. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 ~ 500 mg of amoxicillin every 12 hours by mouth.

Child dose

Administered in the same manner as for adults and children aged 12 years or older or weighing 40 kg or more, and adjusted similarly in cases of renal impairment.

Precautions

This drug is a beta-lactam antibiotic and belongs to the penicillin group. Therefore, it should not be used by individuals who are allergic to its components or have a history of hypersensitivity reactions to beta-lactam drugs. In particular, it should not be administered to those who have previously experienced hypersensitivity reactions such as anaphylaxis, severe skin reactions, or shock. Also, caution should be exercised in patients with certain viral infections, such as infectious mononucleosis or lymphocytic leukemia, as the risk of side effects such as rash may increase. Individuals with liver function issues or who have had jaundice or liver dysfunction from this drug or penicillin in the past should inform their physician before administration as there is a risk of recurrence. Patients with liver disorders or moderate to severe kidney dysfunction may need dosage adjustments since the blood concentration of this drug may increase. Those with allergic tendencies or individuals with symptoms of bronchial asthma, urticaria, or rashes should exercise caution during administration; patients who have difficulty with oral intake, the elderly, or those in poor overall condition also require caution. During treatment with this drug, gastrointestinal symptoms such as diarrhea, abdominal pain, nausea, and vomiting may occur; if symptoms are severe or persistent, a consultation with a physician is necessary. Liver function abnormalities may also occur, so liver function should be monitored during and after treatment, especially in elderly patients over 60 years and males. Rarely, hypersensitivity reactions such as skin rash, itching, and severe skin reactions may occur; if these symptoms occur, administration should be discontinued, and medical personnel should be notified immediately. This drug has been reported to cause various adverse reactions such as blood cell decrease, tendency for bleeding, neurological symptoms (dizziness, headache, seizures, etc.), and renal dysfunction; if any abnormal symptoms are suspected, prompt consultation with medical personnel is essential. The use of antibiotics may disrupt the intestinal bacterial balance, potentially leading to infections such as stomatitis or candidiasis, so caution is necessary. There is also a risk of bleeding due to vitamin K deficiency; therefore, coagulation status should be monitored during long-term use. This drug may interact with other medications, so if any other medications are being taken, this must be reported, especially when used with anticoagulants, anti-inflammatory drugs, or certain antibiotics as caution is needed. Women who are pregnant or breastfeeding should carefully consider the potential effects of this drug on the fetus or infant, and it is especially advisable to avoid administration during the first three months of pregnancy. Children, particularly those under 12 years old or weighing less than 40 kg, should not generally use this drug as there is limited experience with its use in this population. Elderly patients may experience side effects more easily due to decreased physical functions; therefore, dosage and intervals should be adjusted, and their condition monitored. During this drug's administration, it may affect some clinical test results, so it is essential to inform medical personnel of its usage before undergoing such tests. In cases of overdose, symptoms such as vomiting, diarrhea, abdominal pain, drowsiness, and rash may occur; in severe cases, renal failure or seizures may develop, so immediate medical assistance should be sought. This drug should be stored in a sealed container to prevent moisture at a temperature below 25 degrees Celsius, and it is important to adhere to the prescribed duration and dosage as instructed by a physician.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions (anaphylaxis, anaphylactic shock, hypotension), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, drug reaction (DRESS)), respiratory issues (bronchospasm, dyspnea, laryngeal edema), liver issues (jaundice, hepatitis, cholestasis

Mild side effects

Diarrhea, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, acute pancreatitis, candidiasis, colitis without blood, itching, erythema multiforme, skin rash, symptoms of serum sickness (measles-like rash, arthralgia, edema, lymphadenopathy), hematological abnormalities (reversible leukopenia, thrombocytopenia, hemolytic anemia, anemia, eosinophilia

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

Storage

This drug should be stored in a sealed container to prevent moisture and kept in a dry place below 25 degrees Celsius. Proper storage helps maintain the drug's efficacy over a longer period.

Appearance and packaging

Appearance

White or nearly white oblong film-coated tablet

Package unit

60 tablets/PTP [60 tablets (4 tablets/PTP x 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.