Medication info
Hwamocle Tablets 625mg (Amoxicillin·Clavulanic Acid Potassium)

Hwamocle Tablets 625mg (Amoxicillin·Clavulanic Acid Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
White or almost white oval film-coated tablet
Packaging
40 tablets (4 tablets/PTP x 10)
Approval status
Active

MFDS item code 201508548 · Approved 2015.12.31 · Insurance code 684501330

Summary

Main use
Treatment of respiratory and urogenital infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years or older or weighing 40 kg or more should take Amoxicillin/Clavulanate Potassium at a dosage of 250 mg/125 mg three times a day every 8 hours orally. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment required.
Child dose
Children aged 12 and older or weighing 40 kg or more should be administered the same dosage as adults. Children with renal impairment should have their dosage reduced as in adults.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Treatment of respiratory and urogenital infections

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

This drug is effective against various bacteria including Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli. It is used for respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It is also helpful for urinary infections like cystitis, urethritis, pyelonephritis, pelvic infections, and gonorrhea. Additionally, it is effective in treating skin and soft tissue infections, osteomyelitis, and dental infections. It is a medication used to improve bacterial infections in multiple areas.

How to take

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take Amoxicillin/Clavulanate Potassium at a dosage of 250 mg/125 mg three times a day every 8 hours orally. In cases of severe or respiratory infections, the dosage may be increased to 500 mg/125 mg. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment required.

Child dose

Children aged 12 and older or weighing 40 kg or more should be administered the same dosage as adults. Children with renal impairment should have their dosage reduced as in adults.

Precautions

This drug is a beta-lactam antibiotic and should not be administered to patients with a history of hypersensitivity to penicillins or cephalosporins. Special caution is required for patients with infectious mononucleosis or lymphocytic leukemia, as they are at a higher risk of rash. Those with a history of liver function impairment or jaundice due to this drug or penicillin should not be re-administered as symptoms may reappear. Patients with impaired liver function or severe renal impairment should use the drug with caution as drug concentrations can increase. Caution is also needed for those with allergic constitutions, who have difficulty taking medication orally, the elderly, or patients in poor overall condition. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain, and in severe cases, pseudomembranous colitis may occur. Therefore, if diarrhea or abdominal pain worsens, use should be immediately discontinued. Symptoms of liver dysfunction have also been reported; prolonged use may require liver function testing, especially in men over 60 years of age. Rarely, severe hypersensitivity reactions such as skin rash, urticaria, anaphylactic shock may occur; if rash or difficulty breathing appears, medication use should be immediately stopped and medical attention sought. Hematological abnormalities such as leukopenia, anemia, and thrombocytopenia may occur, requiring blood tests during long-term administration. Central nervous system symptoms such as agitation, anxiety, confusion, and convulsions have been rarely reported, so if any abnormal symptoms occur, they should be reported immediately. This drug is excreted through the kidneys, so dosage adjustment is necessary for patients with decreased renal function, and adequate hydration is recommended. Additionally, this drug may interact with other medications, and caution is needed when used in combination with anticoagulants, other antibiotics, or anti-inflammatory drugs. Use should be avoided in the first three months of pregnancy, and pregnant or nursing women should consult a doctor before administration. During breastfeeding, caution is needed as side effects may occur in the infant. For children, it is recommended to use only those aged 12 years or older or weighing 40 kg or more; for the elderly, due to decreased body function, there's an increased risk of side effects, so dosing and intervals should be adjusted cautiously. This drug requires proper storage and should be stored in a cool, dry place below 25 degrees Celsius. In case of overdose, symptoms such as vomiting, diarrhea, and convulsions may occur, so administration should be stopped immediately and necessary emergency treatment should be received.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination abnormalities

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
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • AST elevation
  • ALT elevation
  • ALP elevation
  • LDH elevation
  • serum bilirubin elevation
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis

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

Storage

This drug is contained in a sealed container that can block moisture and air and should be stored at a cool temperature between 1 and 25 degrees. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

Package unit

40 tablets (4 tablets/PTP x 10)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.