Medication info
Hwamo Clej 375mg (Amoxicillin · Clavulanate Potassium)

Hwamo Clej 375mg (Amoxicillin · Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
It is a white or almost white oval film-coated tablet.
Packaging
100 tablets (10 tablets/PTPX10)
Approval status
Active

MFDS item code 201803807 · Approved 2018.09.27

Summary

Main use
Treatment of acute and chronic bronchitis, pneumonia (respiratory infections), and urinary infections such as cystitis.
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing over 40 kg: administer orally as amoxicillin/clavulanate potassium at a dosage of 250 mg/125 mg per dose, three times a day every 8 hours. In severe cases or respiratory infections, the dosage may be increased to 500 mg/125 mg per dose. Renal impairment patients: creatinine clearance above 30 mL/min requires no dosage adjustment. For creatinine clearance between 10 and 30 mL/min, administer once every 12 hours.
Child dose
Children under 12 years or weighing less than 40 kg: administer a reduced dosage similar to adults.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Treatment of acute and chronic bronchitis, pneumonia (respiratory infections), and urinary 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 effective against various bacteria and is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also effective for urinary infections like cystitis, urethritis, and pyelonephritis. Additionally, it helps in the treatment of pelvic infections and gonorrhea, and is used for skin and soft tissue infections such as boils, abscesses, cellulitis, and wound infections. The medication is also applied to the treatment of osteomyelitis and dental infections. It is particularly effective against various resistant strains, making it reliable for treating multiple infectious diseases. Overall, it is used to improve respiratory, urinary, pelvic, skin, and soft tissue infections.

How to take

Adult dose

Adults and children over 12 years or weighing over 40 kg: administer orally as amoxicillin/clavulanate potassium at a dosage of 250 mg/125 mg per dose, three times a day every 8 hours. In severe cases or respiratory infections, the dosage may be increased to 500 mg/125 mg per dose. Renal impairment patients: creatinine clearance above 30 mL/min requires no dosage adjustment. For creatinine clearance between 10 and 30 mL/min, administer once every 12 hours.

Child dose

Children under 12 years or weighing less than 40 kg: administer a reduced dosage similar to adults.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with allergies to penicillin or cephalosporin medications. Particular caution is required for patients with histories of hypersensitivity reactions like anaphylaxis, Stevens-Johnson syndrome, or shock. It is advisable not to use this medication in patients with infectious mononucleosis or lymphocytic leukemia due to the risk of rash. Patients with liver dysfunction or a history of jaundice should be cautious as this medication may worsen liver function. Patients with moderate to severe renal impairment may experience increased drug concentration, necessitating adjustments in dosing intervals. Patients with allergies, those who cannot take medications orally, elderly patients, and those in poor general condition should be monitored closely. Gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting may occur; in severe cases, pseudomembranous colitis may develop, requiring immediate consultation with a physician if symptoms arise. Liver function tests may reveal elevated liver enzymes or symptoms of hepatitis and jaundice, which are rare but more frequently reported in men over 60 years of age. Skin rash, itching, and severe skin reactions may occur, and any symptoms should lead to discontinuation of the medication and following a doctor's recommendations. Blood dyscrasias such as leukopenia, thrombocytopenia, and hemolytic anemia have been reported rarely, so regular blood testing may be required. Central nervous system effects like anxiety, confusion, and seizures may occur, with a higher risk of seizures in patients with renal dysfunction. Rarely, acute renal failure or interstitial nephritis may occur, so kidney function should be monitored. Disruption of normal intestinal flora can lead to fungal infections such as candidiasis, necessitating immediate medical notification if symptoms arise. Bleeding tendencies due to vitamin K deficiency may occur; therefore, signs of bleeding should be monitored closely. This medication carries a risk for resistance development with prolonged use; hence, it is important to take it for the minimum duration necessary. Patients with hypersensitivity reactions to penicillin may experience severe allergic reactions; therefore, past medical history must be verified prior to administration. Anaphylactic shock may occur, so careful monitoring of the patient's condition is essential after administration. If severe diarrhea or abdominal cramping occurs, there is a possibility of pseudomembranous colitis, so medication should be stopped immediately and healthcare providers should be consulted. Administration during pregnancy, especially in the first trimester, should be avoided. During breastfeeding, unusual reactions such as diarrhea or skin rashes may occur in infants; therefore, caution is advised. Children are recommended to take it only if they are 12 years or older or weigh more than 40 kg, as there is limited experience in younger age groups. Elderly patients may exhibit adverse reactions more readily due to declining physiological functions, hence careful dose adjustments should be made while administering the medication. This medication may interact with other drugs, so it is crucial to inform healthcare providers of any other medications in use. In cases of overdose, gastrointestinal symptoms and renal function abnormalities may arise, and immediate healthcare evaluation is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, breathing difficulties, cold sweat, pallor, high fever with severe rash, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, altered consciousness, visual disturbances, paralysis, urination abnormalities.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • anorexia
  • abdominal pain
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  • abdominal distention
  • constipation
  • colonic pain
  • acid reflux
  • loose stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • hematochezia
  • acute pancreatitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • elevated serum bilirubin
  • itching
  • erythema multiforme
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • vesicular exfoliative dermatitis.

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

Storage

This medication should be stored in a sealed container, protected from moisture, and placed in a dry location below 25 degrees Celsius to maintain its efficacy for a longer period.

Appearance and packaging

Appearance

It is a white or almost white oval film-coated tablet.

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.

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.