Medication info
Amocra Tablet 375 mg (Amoxicillin - Clavulanate Potassium)

Amocra Tablet 375 mg (Amoxicillin - Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White or almost white oval film-coated tablets
Packaging
100 tablets (10 tablets/PTPX10)
Approval status
Active

MFDS item code 201401087 · Approved 2014.03.11 · Insurance code 073001670,625800090

Summary

Main use
Treatment of acute and chronic bronchitis, pneumonia (respiratory infections), and urinary tract infections such as cystitis
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years or older or weighing 40 kg or more, the dosage for Amoxicillin/Clavulanate Potassium is 250 mg/125 mg orally every 8 hours three times a day. In cases of severe respiratory infections, it may be increased to 500 mg/125 mg orally per dose. In patients with renal impairment, the dosage should be adjusted based on creatinine clearance.
Child dose
For children aged 12 years or older or weighing 40 kg or more, the dosage for Amoxicillin/Clavulanate Potassium is 250 mg/125 mg orally every 8 hours three times a day. In case of renal impairment, dosage adjustments are necessary.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Treatment of acute and chronic bronchitis, pneumonia (respiratory infections), and urinary tract infections such as cystitis

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

This medication is used to effectively treat infections caused by various bacteria. It is effective against respiratory infections including acute and chronic bronchitis, pneumonia, and lung abscess; as well as tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections such as cystitis, urethritis, pyelonephritis, and sexually transmitted infections like gonorrhea and pelvic inflammatory disease. It treats infections of the skin and soft tissues, boils, abscesses, and wound infections, and is effective against osteomyelitis and dental infections. This drug improves the patient's infection status against various pathogens including several types of resistant bacteria. Overall, this medication is used for the treatment of a wide range of bacterial infections.

How to take

Adult dose

For adults and children aged 12 years or older or weighing 40 kg or more, the dosage for Amoxicillin/Clavulanate Potassium is 250 mg/125 mg orally every 8 hours three times a day. In cases of severe respiratory infections, it may be increased to 500 mg/125 mg orally per dose. In patients with renal impairment, the dosage should be adjusted based on creatinine clearance.

Child dose

For children aged 12 years or older or weighing 40 kg or more, the dosage for Amoxicillin/Clavulanate Potassium is 250 mg/125 mg orally every 8 hours three times a day. In case of renal impairment, dosage adjustments are necessary.

Precautions

This drug is a beta-lactam antibiotic belonging to the penicillin class and should be avoided in certain patients. First, it should not be administered to patients with a history of severe allergic reactions to this drug or beta-lactam medications. Such reactions include anaphylaxis, Stevens-Johnson syndrome, and shock. Caution is advised when administering this drug to patients with viral infections such as infectious mononucleosis or lymphocytic leukemia due to an increased risk of rash. Patients with a history of jaundice or liver dysfunction due to this drug or penicillin should also avoid administration due to the risk of recurrence. Patients with impaired liver function should use this drug carefully as it can worsen liver function. Patients with moderate to severe renal impairment should adjust the dosing intervals accordingly due to increased drug concentration. Patients with a history of allergies or a family history should be cautious as they may be at risk for allergic reactions. Patients in poor nutritional status, elderly patients, or those with gastrointestinal disorders accompanied by vomiting or diarrhea may have insufficient absorption of the drug and should use it with caution. This medication may cause gastrointestinal side effects such as abdominal discomfort, diarrhea, and vomiting, and in severe cases, serious conditions such as pseudomembranous colitis may occur. Abnormal liver function symptoms have also been reported, especially in the elderly and male patients. Such symptoms may appear during treatment or after cessation, requiring careful monitoring. Serious skin reactions such as rashes, itching, or, in severe cases, Stevens-Johnson syndrome may occur; if unusual symptoms develop, the medication should be discontinued immediately and a healthcare professional should be consulted. Blood-related adverse reactions such as leukopenia, anemia, and thrombocytopenia may rarely occur, necessitating regular blood tests during prolonged use. Central nervous system side effects may rarely include anxiety, confusion, and seizures, with increased risk in patients with renal impairment or high doses. Patients with impaired renal function may suffer acute renal failure or interstitial nephritis, thus requiring regular monitoring and testing. This drug may alter the gut microbiota and induce conditions like candidiasis or stomatitis, so appropriate measures should be taken if symptoms appear. Bleeding tendencies or symptoms of vitamin K and vitamin B deficiencies may also occur, so caution is advised. To prevent the emergence of resistant bacteria, it is preferable to administer this drug only for the minimum necessary duration as determined by susceptibility testing. Severe allergic reactions can occur, so it is vital to closely observe the patient's condition after administration and prepare for emergency situations. Antibiotic-associated pseudomembranous colitis may occur; if severe diarrhea or abdominal pain develops, the drug should be discontinued immediately and medical advice sought. Long-term use beyond 14 days should be approached with special caution due to the possibility of overgrowth of resistant bacteria. Liver function test values may fluctuate, so patients with liver impairment should use it with caution. Since it is primarily excreted through the kidneys, dose adjustment is necessary for patients with renal impairment. In cases suspected of infectious mononucleosis, it is advisable to avoid this medication. If symptoms such as urticaria, skin rash, or serum sickness develop, the drug should be stopped immediately and appropriate medical guidance followed. Long-term administration requires regular monitoring of renal, hepatic, and hematological functions. Before using this medication, any history of allergies to penicillin or cephalosporins must be confirmed. In cases of high-dose administration, sufficient hydration and urine output should be maintained to prevent renal damage. Use in children, especially those under 12 years old or weighing less than 40 kg, is not recommended due to limited experience. It is ideally avoided during the first trimester of pregnancy, and caution is warranted during breastfeeding as adverse effects may occur in infants. This medication may interact with other drugs, so any concurrent medications should be disclosed to a healthcare provider. Overdose may cause gastrointestinal symptoms, renal failure, and seizures; in such instances, seek immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin adverse reactions, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, abnormal liver function (jaundice), sudden and severe

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, appetite loss, abdominal pain, abdominal distension, constipation, colonic pain, gastric acid reflux, soft stools, dry mouth, elevated AST, ALT, ALP, LDH, increased serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, mucous membrane syndrome, toxic epidermal necrolysis, bullous pemphigoid, acute generalized exanthematous pustulosis, eosinophilia, angioedema,

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

Storage

This medication should be stored in a tightly closed container to protect it from moisture, preferably in a cool and dry place below 25 degrees Celsius. Doing so will help maintain the drug's efficacy over time.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

100 tablets (10 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.

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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.