Medication info
Hikra Tablet 375 mg (Amoxicillin and Clavulanate Potassium)

Hikra Tablet 375 mg (Amoxicillin and Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
A white or almost white oval film-coated tablet.
Packaging
80 tablets/box [8 tablets/PTPX10], 100 tablets/box [10 tablets/PTPX10]
Approval status
Active

MFDS item code 201309345 · Approved 2013.09.13 · Insurance code 649102170

Summary

Main use
Treatment of bacterial infections such as respiratory and urogenital infections.
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 or over or weighing 40 kg or more: Amoxicillin/Clavulanate potassium as 250 mg/125 mg once three times daily at 8-hour intervals. In cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg at once. In patients with renal impairment, dosage will be adjusted according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 mg of Amoxicillin every 12 hours orally.
Child dose
Children aged 12 or over or weighing 40 kg or more should follow the same dosage as adults. Children with renal impairment should have their dosage adjusted accordingly.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of bacterial infections such as 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 medication is effective against a variety of bacterial infections, including Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, and Neisseria gonorrhoeae. It is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, sinusitis, and otitis media, as well as urogenital infections like cystitis, urethritis, and pyelonephritis. Additionally, it is helpful in treating pelvic infections, gonorrhea, abscesses, skin and soft tissue infections, wound infections, osteomyelitis, and dental infections. Due to its broad antibacterial spectrum, it is used to effectively improve infections in various situations.

How to take

Adult dose

Adults and children aged 12 or over or weighing 40 kg or more: Amoxicillin/Clavulanate potassium as 250 mg/125 mg once three times daily at 8-hour intervals. In cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg at once. In patients with renal impairment, dosage will be adjusted according to creatinine clearance. - Creatinine clearance 10 ~ 30 mL/min: 250 mg of Amoxicillin every 12 hours orally.

Child dose

Children aged 12 or over or weighing 40 kg or more should follow the same dosage as adults. Children with renal impairment should have their dosage adjusted accordingly.

Precautions

This medication should not be used in patients with hypersensitivity to beta-lactam antibiotics. Those with a history of allergic reactions like anaphylaxis or severe skin reactions should be especially cautious. It is also advisable to avoid use in patients with specific viral infections like infectious mononucleosis or lymphocytic leukemia due to an increased risk of rash. Patients with a history of liver dysfunction should be careful, as this medication may cause liver damage to recur. Patients with impaired liver function or moderate to severe renal impairment may require adjustments to dosing intervals or doses due to increased drug concentrations. Allergy-prone individuals or patients with gastrointestinal symptoms such as vomiting or diarrhea should use with caution to ensure proper drug absorption. During treatment, gastrointestinal symptoms such as diarrhea, abdominal pain, and vomiting may occur, and in rare cases, serious side effects like hepatitis or severe skin rash may develop. If such symptoms occur, the medication should be immediately discontinued and a physician consulted. Long-term use of this medication may lead to the emergence of resistant bacteria, so it is important to take it only for the minimum duration recommended by a physician. Additionally, in cases of a history of hypersensitivity to penicillin antibiotics, serious allergic reactions such as anaphylactic shock may occur, so patients should be monitored closely after administration. Pregnant or breastfeeding women should use this medication only under the guidance of a physician, as it may have effects on the fetus or infant. It is especially advisable to avoid it during the first trimester of pregnancy. Elderly or pediatric patients may be at higher risk for side effects due to decreased physical function or lack of experience, requiring careful dose adjustments and monitoring. This medication can interact with other drugs, so it is essential to inform the physician or pharmacist of any other medications currently being taken. Caution is especially needed when taken in conjunction with anticoagulants, certain antibiotics, or anti-inflammatory drugs. In the event of overdose, gastrointestinal symptoms, renal impairment, or allergic reactions may manifest, and immediate medical assistance should be sought. Store this medication in a sealed container to prevent moisture, and keep it in a cool place between 1 and 25 degrees Celsius. Care should be taken not to arbitrarily discontinue or extend the duration of use without a physician's direction.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, breathing difficulties, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral or ocular mucosa, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary changes.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • severe colitis with bloody stools
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • 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 medication should be stored in a sealed container to prevent moisture and kept in a cool place between 1 and 25 degrees Celsius. This will help maintain the medication's effectiveness safely.

Appearance and packaging

Appearance

A white or almost white oval film-coated tablet.

Package unit

80 tablets/box [8 tablets/PTPX10], 100 tablets/box [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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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.