Medication info
Hikra Tablet 625mg (Amoxicillin Hydrate, Potassium Clavulanate (4:1))

Hikra Tablet 625mg (Amoxicillin Hydrate, Potassium Clavulanate (4:1))

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

MFDS item code 201403632 · Approved 2014.08.05 · Insurance code 649102420

Summary

Main use
Treatment of various bacterial infections including respiratory and urogenital infections
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years and older or weighing 40 kg or more: administer 250 mg/125 mg of amoxicillin/clavulanate orally three times a day every 8 hours. In cases of severe infections or respiratory infections, the dosage can be increased to 500 mg/125 mg. In cases of kidney impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 10 to 30 mL/min: Administer 250 to 500 mg of amoxicillin every 12 hours.
Child dose
Children aged 12 years and older or weighing 40 kg or more: administer 250 mg/125 mg of amoxicillin/clavulanate orally three times a day every 8 hours, same as for adults. For children with kidney impairment,

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of various bacterial infections including 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 used to treat infections caused by various types of bacteria. It is effective for respiratory infections such as acute and chronic bronchitis and pneumonia, as well as for the treatment of empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also used to treat urinary infections such as cystitis, urethritis, and pyelonephritis, as well as pelvic infections and sexually transmitted infections such as gonorrhea. It is effective against skin abscesses, pyogenic infections, soft tissue infections, and wound infections, and is utilized in the treatment of osteomyelitis and dental infections. It helps improve various bacterial infections.

How to take

Adult dose

Adults and children aged 12 years and older or weighing 40 kg or more: administer 250 mg/125 mg of amoxicillin/clavulanate orally three times a day every 8 hours. In cases of severe infections or respiratory infections, the dosage can be increased to 500 mg/125 mg. In cases of kidney impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 10 to 30 mL/min: Administer 250 to 500 mg of amoxicillin every 12 hours.

Child dose

Children aged 12 years and older or weighing 40 kg or more: administer 250 mg/125 mg of amoxicillin/clavulanate orally three times a day every 8 hours, same as for adults. For children with kidney impairment,

Precautions

This drug is a beta-lactam antibiotic combining amoxicillin and clavulanate. First, this drug should not be used in patients who are allergic to beta-lactam drugs or have experienced hypersensitivity reactions. Particularly, caution is needed if there is a history of severe allergies such as anaphylaxis, Stevens-Johnson syndrome, or shock. Moreover, it should be avoided in patients with infectious mononucleosis or lymphocytic leukemia due to an increased risk of rash. Patients with a history of liver dysfunction or jaundice caused by this drug or penicillin should also avoid its use due to the risk of recurrence. Patients with impaired liver function or severe kidney disease should use it cautiously, as the drug may remain in the body for longer periods. Allergic individuals, the elderly, and patients with poor nutritional status also need to be careful. Gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting may occur, and in severe cases, serious adverse reactions such as pseudomembranous colitis or acute pancreatitis may develop; thus, if such symptoms appear, the drug should be discontinued immediately, and medical advice should be sought. This medication can stress the liver, so if symptoms of liver dysfunction occur, it should be reported to a healthcare provider immediately, and rare cases of skin rash, hives, or severe allergic reactions might occur, requiring immediate discontinuation of the drug if symptoms arise. Blood abnormalities such as leukopenia or thrombocytopenia have been reported rarely, thus regular blood tests may be necessary during long-term use. It should be used cautiously in early pregnancy and during pregnancy, and if nursing, it should be noted that the baby may experience side effects such as diarrhea or skin rashes; therefore, administration should be discontinued if any abnormal symptoms arise. This drug may interact with other medications, so healthcare providers should be informed, especially when used in conjunction with anticoagulants, gout medications, or antibiotics. In case of overdose, symptoms such as vomiting, diarrhea, rash, drowsiness, or convulsions may occur, and immediate medical attention should be sought if such symptoms are observed. Lastly, this drug should be stored in a dry place at or below 25 degrees Celsius and should only be taken under the guidance of a healthcare professional or pharmacist.

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, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin abnormalities, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and very severe reactions

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, acid reflux, loose stools, dry mouth, candidiasis, hemorrhagic colitis, itching, erythema multiforme, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), vesiculobullous dermatitis, acute generalized exanthematous pustulosis, eosinophilia, angioedema, serum sickness syndrome, hypersensitivity

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

Storage

This drug should be stored in a tightly sealed container to prevent moisture and should be kept in a dry place at or below 25 degrees Celsius. Proper storage will maintain the stability of the drug's components and its effectiveness for a longer duration.

Appearance and packaging

Appearance

White or almost white rectangular film-coated tablets

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.