Medication info
Medikra Tablet 375 mg (Amoxicillin · Clavulanate Potassium (2:1))

Medikra Tablet 375 mg (Amoxicillin · Clavulanate Potassium (2:1))

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

MFDS item code 201309266 · Approved 2013.09.10 · Insurance code 646003690

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)
Who takes it
Adults · Children
Adult dose
Amoxicillin/Clavulanate Potassium should be taken as 250 mg/125 mg orally three times daily every 8 hours. In cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg at a time. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10-30 mL/min: Take 250-500 mg orally every 12 hours. - Creatinine clearance
Child dose
Pediatric patients aged 12 years and older or weighing 40 kg or more are given the same dosage as adults. If renal impairment is present in a child, the dosage is adjusted accordingly.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

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

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

This medicine is effective in treating various bacterial infections. It is used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and lung abscess. It is also effective for upper respiratory infections such as tonsillitis, sinusitis, and otitis media. It is utilized for urinary tract infections such as cystitis, urethritis, pyelonephritis, and pelvic inflammatory disease, as well as gonorrhea. It is used for treating skin and soft tissue infections, furuncles, abscesses, and wound infections, and it is also effective for bone infections such as osteomyelitis and dental infections. Thus, this drug is used to treat a variety of bacterial infections.

How to take

Adult dose

Amoxicillin/Clavulanate Potassium should be taken as 250 mg/125 mg orally three times daily every 8 hours. In cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg at a time. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10-30 mL/min: Take 250-500 mg orally every 12 hours. - Creatinine clearance

Child dose

Pediatric patients aged 12 years and older or weighing 40 kg or more are given the same dosage as adults. If renal impairment is present in a child, the dosage is adjusted accordingly.

Precautions

This medication is a beta-lactam antibiotic and belongs to the penicillin class. Patients with a history of allergies to this medication's components or beta-lactam drugs should not take this medication. In particular, patients with viral infections such as infectious mononucleosis or lymphocytic leukemia are at a higher risk of developing rashes when taking this medication. Patients with a history of liver dysfunction or jaundice should use this medication with caution, as it may worsen liver function. Patients with moderate to severe renal impairment may experience increased serum concentrations of this medication, necessitating adjustments to dosing intervals and amounts. Patients with allergic constitutions or those who have experienced symptoms such as bronchial asthma, rash, or urticaria should use this medication cautiously. Patients who have difficulty swallowing, the elderly, and those in poor general condition may also experience vitamin K deficiency, requiring attention. Gastrointestinal symptoms may include diarrhea, nausea, vomiting, abdominal pain, and loss of appetite, and serious problems such as pseudomembranous colitis or acute pancreatitis may rarely occur. Symptoms of liver dysfunction include elevated liver enzyme levels, hepatitis, cholestatic jaundice, particularly occurring more frequently in males over 60 or with long-term use. Skin symptoms such as itching or rashes may occur, and in severe cases, serious skin reactions like Stevens-Johnson syndrome can develop, requiring immediate discontinuation of the medication. Hematological abnormalities such as leukopenia, thrombocytopenia, and anemia are rarely reported, and caution is needed due to the risk of bleeding. Central nervous system effects may include anxiety, restlessness, drowsiness, headaches, and seizures, particularly in patients with renal impairment who are at an increased risk of seizures. Acute renal failure or interstitial nephritis may occur, thus regular monitoring of kidney function is necessary. This medication can affect the intestinal microbiota, leading to conditions such as candidiasis, so appropriate measures must be taken if symptoms arise. There is a risk of bleeding due to vitamin K deficiency, especially in the elderly or with long-term use. This drug has many drug interactions, so caution is warranted when taken with anticoagulants, probenecid, allopurinol, disulfiram, etc. Women who are pregnant or breastfeeding should use this medication with caution, and it is advisable to avoid use during the first trimester of pregnancy. Use in children under 12 years of age or weighing less than 40 kg is not recommended due to limited experience. In case of overdose, gastrointestinal symptoms, renal failure, and seizures may occur; treatment should be stopped immediately and appropriate care should be provided. This medication should be stored in a dry place below 25 degrees Celsius, and if any unusual reactions occur during use, consult a physician immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions (anaphylaxis, angioedema, anaphylactic shock, hypotension), high fever with severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, serious skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, vesiculobullous dermatitis, acute generalized exanthematous pustulosis), difficulty or shortness of breath, asthma

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, acid reflux, loose stools, dry mouth, acute pancreatitis, candidiasis, colitis, blood in stool, itching, erythema multiforme, dermatitis, serum sickness symptoms (fever, rash, arthralgia, edema, lymphadenopathy), angioedema, bronchospasm, eosinophilia, systemic symptoms, mucosal candidiasis, vaginitis itching

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, and it is best kept at a cool temperature between 1 and 25 degrees Celsius. This will help maintain the drug's effectiveness for longer.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

80 tablets/box [8 tablets/PTP×10], 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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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.