Medication info
Amoksalina Tablet 625 milligrams (Amoxicillin · Clavulanate Potassium (4:1))

Amoksalina 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
한화제약(주)
Appearance
White or nearly white oblong film-coated tablet
Packaging
60 tablets (4 tablets/PTP X 15)
Approval status
Active

MFDS item code 201501595 · Approved 2015.03.26 · Insurance code 651601810

Summary

Main use
(Respiratory infections, urinary infections) treatment and (skin infections) improvement
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing over 40 kg are administered 250 mg/125 mg of amoxicillin/clavulanate potassium, taken orally three times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg at a time. For those with kidney impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance 10-30 mL/min: administer 250-500 mg at a time every 12 hours.
Child dose
Dosage is administered in the same manner as for adults and children aged 12 years or older or weighing over 40 kg but adjusted downward in cases of renal impairment.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

(Respiratory infections, urinary infections) treatment and (skin infections) improvement

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

This medication is used to treat infections caused by various bacteria. It is effective against respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and lung abscess, as well as tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections like cystitis, urethritis, and pyelonephritis, as well as pelvic infections and gonorrhea treatment. It improves skin and soft tissue infections, boils or abscesses, and wound infections, and is an effective treatment option for osteomyelitis and dental infections. This drug helps treat infections in response to various bacteria, including beta-lactamase producing strains.

How to take

Adult dose

Adults and children aged 12 years or older or weighing over 40 kg are administered 250 mg/125 mg of amoxicillin/clavulanate potassium, taken orally three times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg at a time. For those with kidney impairment, dosage adjustments should be made according to creatinine clearance. - Creatinine clearance 10-30 mL/min: administer 250-500 mg at a time every 12 hours.

Child dose

Dosage is administered in the same manner as for adults and children aged 12 years or older or weighing over 40 kg but adjusted downward in cases of renal impairment.

Precautions

This drug is a beta-lactam antibiotic and should not be used in patients who have had hypersensitivity reactions to this component or penicillin and cephalosporin drugs. Caution is needed in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with a history of liver dysfunction or jaundice should use this drug with caution as symptoms may recur. Those with impaired liver function should use this drug cautiously as it may worsen liver function during administration. Patients with moderate to severe kidney dysfunction may experience elevated blood drug levels, so dosage interval adjustments may be necessary. Caution is needed when administering this drug to individuals with allergic tendencies or family history, as allergic reactions may easily occur. Patients who cannot take oral medications, elderly individuals in poor nutritional states, or patients with poor general condition may show symptoms of vitamin K deficiency, so monitoring is required. Gastrointestinal symptoms like vomiting or diarrhea may lead to insufficient drug absorption, so careful administration is advised. This drug may cause gastrointestinal side effects such as diarrhea, abdominal pain, nausea, vomiting, and rarely severe colitis; if symptoms worsen, discontinue use immediately. Liver function abnormalities may rarely occur, and caution is particularly needed for males over 60 or during long-term therapy. Serious skin reactions such as rash, itching, and in severe cases, Stevens-Johnson syndrome, may occur; if any abnormal symptoms arise, medical attention should be sought immediately. Rarely reported blood reactions include leukopenia and thrombocytopenia, necessitating regular blood tests. Central nervous system symptoms like anxiety, restlessness, and seizures may also rarely occur; caution is necessary upon symptom occurrence. Kidney function may deteriorate rapidly, so regular kidney function tests should be done and any abnormal symptoms reported immediately. This drug can alter gut bacterial balance, leading to fungal infections like candidiasis; consult a doctor if symptoms appear. Hemorrhagic tendencies due to vitamin K deficiency may develop, so any bleeding symptoms must be reported immediately. Women who are pregnant or breastfeeding should use this drug cautiously, considering its potential effects on the fetus or newborn; especially in the first trimester, avoidance is recommended. Breastfeeding mothers should observe for abnormal reactions such as diarrhea or skin rashes in their newborns. It is not recommended for children under 12 years or weighing less than 40 kg. Elderly individuals may experience side effects more easily due to declining bodily functions; thus, careful observation and adjustments to dosage and intervals are necessary. This drug may affect certain clinical test results, so it is essential to inform the healthcare provider of this medication during testing. In case of overdose, gastrointestinal symptoms like vomiting, diarrhea, and abdominal pain may occur; in severe cases, renal failure or seizures may happen, warranting immediate notification of healthcare staff.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • anorexia
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  • abdominal pain
  • abdominal bloating
  • constipation
  • colonic pain
  • acid dyspepsia
  • soft stools
  • xerostomia
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • blood in stool
  • nausea with high doses
  • elevations in AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucocutaneous syndrome
  • toxicity

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

Storage

This medication should be stored in a sealed container to prevent moisture and kept in a dry place below 25 degrees Celsius. This helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

White or nearly white oblong film-coated tablet

Package unit

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.

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.