Medication info
Vaikra Tablets 375mg (Amoxicillin·Clavulanate Potassium)

Vaikra Tablets 375mg (Amoxicillin·Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
White or almost white oval film-coated tablets
Packaging
100 tablets/box [(10 tablets/PTP×10)]
Approval status
Active

MFDS item code 201707117 · Approved 2017.09.19 · Insurance code 643104400

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years and older or weighing 40 kg or more should take 250 mg of amoxicillin/125 mg of clavulanate potassium three times daily orally at 8-hour intervals. In cases of severe and respiratory infections, the dose may be increased to 500 mg of amoxicillin/125 mg of clavulanate potassium. In patients with renal impairment, the doses should be adjusted based on creatinine clearance. - Creatinine clearance above 30 mL/min: no dose adjustment is necessary.
Child dose
Children aged 12 years and older or weighing 40 kg or more may take the same dose as adults. Other pediatric dosing should be adjusted according to renal function using the same method.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)

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

This medication is used for various bacterial infections. It is effective for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and lung abscess. It is also used for upper respiratory infections such as tonsillitis, sinusitis, and otitis media. It helps treat infections in the urogenital system including cystitis, urethritis, pyelonephritis, pelvic infections, and gonorrhea. It is effective for skin and soft tissue infections including boils, abscesses, and wound infections as well as bone infections such as osteomyelitis. Additionally, it is used for dental infections, improving various bacterial infectious diseases.

How to take

Adult dose

Adults and children aged 12 years and older or weighing 40 kg or more should take 250 mg of amoxicillin/125 mg of clavulanate potassium three times daily orally at 8-hour intervals. In cases of severe and respiratory infections, the dose may be increased to 500 mg of amoxicillin/125 mg of clavulanate potassium. In patients with renal impairment, the doses should be adjusted based on creatinine clearance. - Creatinine clearance above 30 mL/min: no dose adjustment is necessary.

Child dose

Children aged 12 years and older or weighing 40 kg or more may take the same dose as adults. Other pediatric dosing should be adjusted according to renal function using the same method.

Precautions

This medication should not be administered to patients with a history of hypersensitivity to beta-lactam antibiotics, particularly penicillins. Patients with infectious mononucleosis or lymphocytic leukemia are at higher risk of rashes, so caution is necessary. Patients with a history of liver dysfunction or jaundice should also avoid using this medication, as symptoms may recur. Caution should be exercised in patients with liver impairment due to the possibility of worsening liver function. Patients with moderate to severe renal impairment may have elevated blood drug concentrations, requiring adjustment of dosing intervals. Patients with allergies may experience bronchial asthma, rashes, or urticaria, requiring vigilance. Patients exhibiting gastrointestinal symptoms such as vomiting or diarrhea may have inadequate drug absorption, necessitating caution. Gastrointestinal side effects like diarrhea, vomiting, and abdominal pain may occur, and in severe cases, pseudomembranous colitis may occur, meaning any abnormal symptoms warrant immediate consultation with a physician. Liver function abnormalities such as hepatitis or jaundice can occur rarely, so regular liver function tests are advised. Severe allergic reactions such as skin rashes, anaphylaxis, and angioedema may occur, and immediate cessation of administration and notification to healthcare professionals is required upon symptom onset. Hematological abnormalities like leukopenia and thrombocytopenia may occur rarely, needing monitoring through blood tests. Neurological symptoms like dizziness, headaches, and, rarely, seizures may occur, requiring special caution in patients with kidney function impairment. Patients with renal problems are at risk of acute renal failure, necessitating regular monitoring of renal function. During antibiotic use, dysbiosis may occur, leading to conditions like candidiasis; therefore, patients should be alert for symptoms. Vitamin K deficiency may lead to bleeding tendencies, especially in the elderly or those at risk of vitamin deficiency, requiring caution. It is advisable not to use this medication during the first trimester of pregnancy, and breastfeeding mothers should discontinue if adverse symptoms develop in infants. It is not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly patients are at higher risk of adverse reactions due to declining physiological functions, requiring careful dose and interval adjustments. This medication may interact with other drugs, so patients should inform their physician or pharmacist of any concurrent medications. In cases of overdose, gastrointestinal symptoms and renal function deterioration may occur, necessitating prompt medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reactions), severe skin adverse reactions (severe rashes, vesicular exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), respiratory distress with bronchoconstriction, laryngeal edema, anaphylactic shock, jaundice and liver dysfunction symptoms (increased AST, ALT, ALP, LDH, cholestatic jaundice), severe nervous system symptoms

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, black stool, dry mouth, candidiasis, diarrhea with bloody stools, itching, erythema multiforme, dermatitis, hematological abnormalities (leukopenia, thrombocytopenia, hemolytic anemia, anemia, etc.), vaginal itching or burning, increased secretions, anxiety, restlessness, behavioral changes, confusion, drowsiness,

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

Storage

This medication should be stored in a tightly sealed container to prevent moisture entry and at a cool temperature between 1°C and 25°C. Proper storage ensures the medication does not deteriorate and remains safe for use.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP×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.