Medication info
Augmentam 375 mg

Augmentam 375 mg

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
케이엠에스제약(주)
Appearance
White or nearly white oval film-coated tablets
Packaging
30 tablets (6 tablets/Alu-Alu*5)
Approval status
Active

MFDS item code 201501398 · Approved 2015.03.17 · Insurance code 654701590

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections
Who takes it
Adults · Children
Adult dose
Adults and children 12 years and older or weighing 40 kg and above should take 250 mg/125 mg of Amoxicillin/Clavulanate, orally three times a day every 8 hours. In cases of severe infections and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. For patients with renal impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: 250 to 500 mg of Amoxicillin per dose every 12 hours.
Child dose
Children under 12 years of age or weighing less than 40 kg should be dosed cautiously with adjustments in case of renal impairment.

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

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

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

This medication is used to treat infections caused by a variety of bacteria. It is effective for respiratory infections such as acute and chronic bronchitis, lobar and bronchial pneumonia, empyema, as well as tonsillitis, sinusitis, and otitis media. It can also treat urinary infections such as cystitis, urethritis, and pyelonephritis, as well as pelvic infections and sexually transmitted infections like gonorrhea. Additionally, it is used for skin and soft tissue infections, boils and abscesses, wound infections, and osteomyelitis. It is also helpful in the treatment of dental infections. This drug is suitable for the treatment of extensive infections and effectively improves them.

How to take

Adult dose

Adults and children 12 years and older or weighing 40 kg and above should take 250 mg/125 mg of Amoxicillin/Clavulanate, orally three times a day every 8 hours. In cases of severe infections and respiratory infections, the dose can be increased to 500 mg/125 mg per dose. For patients with renal impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: 250 to 500 mg of Amoxicillin per dose every 12 hours.

Child dose

Children under 12 years of age or weighing less than 40 kg should be dosed cautiously with adjustments in case of renal impairment.

Precautions

This medication is a beta-lactam antibiotic and belongs to the penicillin group. It should not be administered to patients who have experienced allergic reactions to this medication or have hypersensitivity to beta-lactam drugs. Care is especially needed for patients with infectious mononucleosis or lymphocytic leukemia as the risk of rash is higher. Patients with a history of liver dysfunction or jaundice should avoid using this medication. Patients with impaired liver function or moderate to severe renal impairment may experience increased drug concentrations, so dosing intervals should be adjusted or used cautiously. Those with allergic predisposition, gastrointestinal disorders, the elderly, or patients receiving parenteral nutrition should also exercise caution. This medication may cause gastrointestinal side effects such as gastrointestinal disturbances, diarrhea, vomiting, and loss of appetite, and in rare cases, severe colitis or acute pancreatitis may occur. Elevated liver enzymes or liver dysfunction reactions have also been reported, particularly in older adults and males. Severe skin reactions may rarely occur, such as rash, urticaria, and in severe cases, Stevens-Johnson syndrome, so use should be discontinued immediately if rashes or itching occur. Hematological side effects such as leukopenia, thrombocytopenia, and anemia may occur infrequently, and renal issues or acute renal failure may also arise, necessitating regular monitoring. This medication may interact with other drugs, so caution is required when taken together with probenecid, anticoagulants, allopurinol, or other antibiotics. Use should be avoided during the first three months of pregnancy, and pregnant or breastfeeding women should use it cautiously after consulting a doctor, as side effects may occur in infants during breastfeeding. Children under the age of 12 or weighing less than 40 kg have limited experience with this medication and are not recommended for use. Elderly patients are at higher risk of side effects due to decreased bodily function, so dosage and administration intervals should be adjusted, and their condition should be closely monitored. In case of overdose, symptoms such as gastrointestinal symptoms, drowsiness, rash, and renal failure may occur, and prompt discontinuation and appropriate treatment are required. This medication should be stored in a dry place at a temperature below 25 degrees Celsius, and regular liver, kidney, and blood function tests are recommended during prolonged use. Finally, when using this medication, it is important to administer it only for the necessary minimum duration after susceptibility tests to prevent the emergence of resistant bacteria.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin sloughing, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes, extreme lethargy, liver abnormalities (jaundice), sudden and very severe headaches, and lightning sensation.

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal bloating
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  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • hematochezia
  • pseudomembranous colitis
  • elevation of AST
  • ALT
  • ALP
  • LDH
  • hepatitis
  • and occasionally cholestatic jaundice
  • pruritus
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • and vesicular exfoliative dermatitis.

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, in a cool place. The ideal temperature range is 1 to 25 degrees Celsius, and it should be kept in a low-humidity and dry environment to maintain the drug's efficacy.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

30 tablets (6 tablets/Alu-Alu*5)

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.