Medication info
Gumentin 375 mg Tablet

Gumentin 375 mg Tablet

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

MFDS item code 200203496 · Notified 2002.06.25 · Insurance code 663600040

Summary

Main use
Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children 12 years and older or weighing 40 kg or more: Administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, adjust based on creatinine clearance. - Creatinine clearance above 30 mL/min: No adjustment necessary.
Child dose
Administered in the same manner as adults and children aged 12 years and older or weighing 40 kg or more, but dosage may be reduced in cases of renal impairment.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)

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

This medication is effective against various bacterial infections. It is used to treat respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It is also good for urogenital infections such as cystitis, urethritis, and pyelonephritis. It is used to treat infections in various areas, including gonorrhea, pelvic infections, abscesses, soft tissue infections, wound infections, osteomyelitis, and dental infections. It is effective against a variety of bacteria, especially beta-lactamase producing strains, providing a broad spectrum of treatment. This medicine effectively treats various bacterial infections.

How to take

Adult dose

Adults and children 12 years and older or weighing 40 kg or more: Administer amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg orally 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, adjust based on creatinine clearance. - Creatinine clearance above 30 mL/min: No adjustment necessary.

Child dose

Administered in the same manner as adults and children aged 12 years and older or weighing 40 kg or more, but dosage may be reduced in cases of renal impairment.

Precautions

This medication, as a beta-lactam antibiotic, should not be administered to patients with hypersensitivity to penicillins or cephalosporins. In particular, patients with viral infections such as infectious mononucleosis or lymphocytic leukemia are at a higher risk of rashes, and caution should be exercised when using this medication. It is advisable to avoid administration in patients with a history of liver dysfunction or jaundice due to the risk of recurrence. Patients with impaired liver function or moderate to severe renal impairment may have increased drug concentrations, so dosage intervals should be adjusted and used with caution. Patients with allergic tendencies, those receiving parenteral nutrition, elderly individuals, and those in poor general condition may show symptoms of vitamin K deficiency, hence caution is needed. Patients with severe vomiting or diarrhea due to gastrointestinal disorders may not absorb the drug properly. This medication can cause side effects such as diarrhea, vomiting, and abdominal pain in the gastrointestinal tract, and in severe cases, it may lead to serious colitis such as pseudomembranous colitis, requiring immediate cessation of use upon symptom onset. Abnormal liver function has been reported rarely, so periodic liver function tests during and after treatment are advisable. Rarely, serious hypersensitivity reactions such as skin rashes, itching, and in severe cases, Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, necessitating immediate discontinuation of use if symptoms like rash or difficulty breathing arise. Blood disorders such as leukopenia, thrombocytopenia, and anemia may occur, so regular blood tests are needed. Central nervous system side effects have been reported rarely, including headaches, dizziness, and seizures, with an increased risk of seizures in patients with poor kidney function. Kidney-related issues, such as acute renal failure or interstitial nephritis, may develop, thus regular monitoring of renal function is necessary. Antibiotic use may alter the normal gut flora, leading to conditions like stomatitis or candidiasis, requiring appropriate treatment if symptoms appear. Rarely, bleeding tendencies and vitamin B complex deficiency symptoms due to vitamin K deficiency have been reported, hence caution is necessary. It is advisable to administer this medication only for the required duration after susceptibility testing to prevent the emergence of resistant bacteria, as prolonged use increases the risk of side effects. Severe hypersensitivity reactions may lead to anaphylactic shock, thus the patient's condition should be closely monitored after administration, with readiness for emergency intervention. Antibiotic-associated pseudomembranous colitis may occur, so if diarrhea or abdominal pain is severe, the medication should be immediately discontinued and appropriate treatment should be obtained. This medication can affect liver and kidney function, so cautious observation is necessary for elderly patients or those with underlying diseases. Avoid use in the first three months of pregnancy, and pregnant or nursing women should use it carefully after consulting a physician. It is not recommended for children under 12 years of age or those weighing less than 40 kg. Potential interactions may occur with other medications, so inform the healthcare provider of any other medications being taken, especially anticoagulants or certain antibiotics that may require caution when co-administered. In case of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may appear, and in severe cases, renal failure or seizures may occur, thus immediate medical assistance is necessary. Store in a dry place below 25 degrees, and do not arbitrarily discontinue or adjust the dosage.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, Stevens-Johnson syndrome, shock, severe rash, blisters, skin peeling, oral mucosal pain, ocular mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes, jaundice, generalized malaise, sudden and severe headache, lightning headache

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 bloating
  • constipation
  • colonic pain
  • gastric hyperacidity
  • thin stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • bloody stools
  • gastrointestinal adverse reactions
  • elevation of AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • toxic epidermal necrolysis
  • vesicular rash

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

Storage

This medication should be kept in a sealed container to prevent moisture and stored in a cool place maintaining a temperature between 1 and 25 degrees. Proper storage helps to maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

100 tablets/box [(10 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.