Medication info
Amocra Tablet 625 mg (Amoxicillin-Clavulanic Acid Potassium (4:1))

Amocra Tablet 625 mg (Amoxicillin-Clavulanic Acid Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
White or almost white rectangular film-coated tablet
Packaging
60 tablets (4 tablets/PTP packaging x 15)
Approval status
Active

MFDS item code 199200514 · Notified 1992.04.02 · Insurance code 646800880

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing 40 kg or more should take amoxicillin/clavulanic acid potassium 250 mg/125 mg per dose, taken orally three times a day, every 8 hours. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance as follows: - Creatinine clearance 10 to 30 mL/min: 250 to 500 mg of amoxicillin every 12 hours.
Child dose
Administered in the same manner as for adults and children over 12 years or weighing over 40 kg, but the dosage is reduced in case of renal impairment.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)

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

This medication is effective against various bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli, and works against beta-lactamase producing strains as well. It is used to treat respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. Additionally, it is effective for urinary infections such as cystitis, urethritis, and pyelonephritis, as well as for pelvic infections and gonorrhea. It can also be used for skin infections, abscesses, soft tissue infections, and wound infections, and is suitable for the treatment of osteomyelitis and dental infections. Thus, it is widely used for various infections to improve the condition.

How to take

Adult dose

Adults and children over 12 years or weighing 40 kg or more should take amoxicillin/clavulanic acid potassium 250 mg/125 mg per dose, taken orally three times a day, every 8 hours. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance as follows: - Creatinine clearance 10 to 30 mL/min: 250 to 500 mg of amoxicillin every 12 hours.

Child dose

Administered in the same manner as for adults and children over 12 years or weighing over 40 kg, but the dosage is reduced in case of renal impairment.

Precautions

This drug is a beta-lactam antibiotic, and should not be used in patients who have had hypersensitivity reactions to penicillin or cephalosporin drugs. Patients with viral diseases such as infectious mononucleosis or lymphocytic leukemia are at higher risk of developing rashes when taking this medication. Patients with a history of liver dysfunction or jaundice may have worsened liver function or recurrence of symptoms when taking this drug, so it should be administered with caution. Patients with liver impairment may require caution as their liver function can deteriorate further, and those with moderate to severe kidney impairment may retain the drug in their body longer, leading to side effects, thus requiring dosage interval adjustments. Patients with allergies may easily develop allergic reactions such as hives or rashes, so caution is necessary. Elderly patients or those in poor general condition, and patients who have difficulty with oral intake may be at increased risk of bleeding due to vitamin K deficiency, necessitating careful observation. Gastrointestinal side effects such as diarrhea, nausea, vomiting, and abdominal pain may occur when taking this drug; in severe cases, serious colitis such as pseudomembranous colitis may develop, so if symptoms are severe, stop taking the medication immediately and consult a doctor. Increased liver enzyme levels or rare symptoms of liver abnormalities such as hepatitis and jaundice may occur, so regular liver function tests are necessary. Skin rashes, itching, and in severe cases, serious skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if any skin abnormalities arise, stop taking the drug immediately and follow your physician's instructions. Blood tests may reveal rare abnormalities such as leukopenia, thrombocytopenia, or anemia, so blood tests are advisable for long-term users. Central nervous system effects can include anxiety, agitation, drowsiness, seizures, and are particularly risky in patients with poor kidney function or high-dose usage. Patients with kidney problems may experience acute renal failure or hematuria, requiring regular kidney function tests. This medication may disturb the intestinal bacterial balance, leading to fungal infections like candidiasis; if symptoms arise, inform your doctor. Bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B complex deficiency may also occur rarely, so caution is necessary. This medication is important to administer for only the minimum duration to prevent the emergence of resistant bacteria, and if used for extended periods, careful observation is required. Patients with a severe allergic reaction history to penicillin-class drugs should be particularly cautious, and after administration, serious reactions such as anaphylactic shock may occur, necessitating immediate emergency measures. If diarrhea occurs during or after antibiotic use, the possibility of pseudomembranous colitis should be considered, and the doctor should be consulted immediately. This drug may interact with other medications, so especially when taken with anticoagulants, allopurinol, or antibiotics, consult a physician or pharmacist. Pregnant women or women who may become pregnant should avoid taking this drug during the first trimester of pregnancy; caution is also necessary for breastfeeding mothers as it may affect the infant. It is not recommended for children under 12 years old or those weighing less than 40 kg. Elderly patients may exhibit side effects more readily due to diminished physical function, so dosage and intervals should be adjusted accordingly and administered with caution. During the course of this drug, it may affect the results of certain clinical tests, so inform the healthcare provider about the medication during tests. In case of overdose, gastrointestinal disturbances, renal failure, and central nervous system abnormalities may occur; stop taking the medication immediately and seek appropriate treatment at a medical institution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, significant decrease in urine output

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
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  • abdominal pain
  • abdominal distension
  • constipation
  • colonic pain
  • gastric acid elevation
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-related colitis
  • increased AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • vesicular exfoliative dermatitis

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

Storage

This medication should be kept in a tightly closed container to prevent moisture and stored in a cool, dry place below 25 degrees Celsius. Proper storage will maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White or almost white rectangular film-coated tablet

Package unit

60 tablets (4 tablets/PTP packaging 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.

Questions about this medicine

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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.