Medication info

Augmentin Syrup 156.25 mg/5 mL (Amoxicillin - Clavulanate Potassium)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin·Clavulanate Potassium (4:1)›27.031g / 100g
Manufacturer / importer
일성아이에스(주)
Appearance
This is a syrup preparation that dissolves in use and has a whitish powder with a peculiar smell.
Packaging
10 bottles/box [(30 mL/bottle)], 10 bottles/box [(50 mL/bottle)]
Approval status
Active

MFDS item code 198700829 · Notified 1987.07.09 · Insurance code 655401482

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)
Who takes it
Adults · Children
Adult dose
For mild to moderate infections such as recurrent tonsillitis, upper respiratory tract infections, lower respiratory tract infections, urinary tract infections, and skin and soft tissue infections, the recommended dosage is 20 mg/5 mg per kg of body weight divided into 3 doses per day. For severe infections such as upper respiratory infections like otitis media and sinusitis, lower respiratory infections like bronchopneumonia, and urinary tract infections, the dosage is generally 40 mg/10 mg per kg of body weight divided into 3 doses per day. To minimize potential gastrointestinal intolerance, it is recommended to administer it at the beginning of meals.
Child dose
There is insufficient clinical data on the use of the 4:1 syrup in children less than 2 months old. (The precise administration method for children is not specified, but it is administered based on weight in kg.)

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

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

  • 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. It is used for respiratory diseases such as acute and chronic bronchitis, lobar pneumonia and bronchopneumonia, tonsillitis, sinusitis, and otitis media. It is also effective for urinary tract infections like cystitis, urethritis, and pyelonephritis, and helps in treating pelvic infections and gonorrhea. It is used for skin boil infections, abscesses, soft tissue infections, wound infections, as well as osteomyelitis and dental infections. This drug acts on various bacteria, including beta-lactamase producing strains resistant to ampicillin and amoxicillin, treating infections effectively. Therefore, it is effective in improving various symptoms of bacterial infections.

How to take

Adult dose

For mild to moderate infections such as recurrent tonsillitis, upper respiratory tract infections, lower respiratory tract infections, urinary tract infections, and skin and soft tissue infections, the recommended dosage is 20 mg/5 mg per kg of body weight divided into 3 doses per day. For severe infections such as upper respiratory infections like otitis media and sinusitis, lower respiratory infections like bronchopneumonia, and urinary tract infections, the dosage is generally 40 mg/10 mg per kg of body weight divided into 3 doses per day. To minimize potential gastrointestinal intolerance, it is recommended to administer it at the beginning of meals.

Child dose

There is insufficient clinical data on the use of the 4:1 syrup in children less than 2 months old. (The precise administration method for children is not specified, but it is administered based on weight in kg.)

Precautions

This drug is a penicillin-class antibiotic and should not be administered to patients with allergies to specific components or a history of hypersensitivity to beta-lactam drugs. Patients with viral infections such as infectious mononucleosis or lymphocytic leukemia may have an increased risk of skin rash upon taking this drug, so caution is advised. Patients with liver function issues should use this drug carefully as it may cause a recurrence of liver damage. Patients with liver dysfunction or moderate to severe renal impairment may require dosage adjustment and interval adjustment due to increased blood concentration of the drug. Patients with allergic predisposition should be careful as they may experience symptoms such as bronchial asthma, skin rash, or urticaria. Patients with gastrointestinal symptoms such as vomiting or diarrhea may have insufficient drug absorption, so should be administered with caution. Gastrointestinal side effects may include diarrhea, gastritis, vomiting, abdominal pain, and in severe cases may lead to pseudomembranous colitis or acute pancreatitis, so immediate consultation with a doctor is necessary if symptoms occur. Rarely reported are elevated liver enzymes or hepatitis, or jaundice. If signs of liver dysfunction appear, administration should be stopped immediately and medical attention sought. Serious skin reactions such as rashes, itching, or in severe cases, Stevens-Johnson syndrome, may appear, and if any skin abnormalities are noted, medication should be discontinued. Hematological abnormalities such as leukopenia, thrombocytopenia, and anemia can rarely occur, so blood tests are necessary during prolonged treatment. Central nervous system side effects like anxiety, restlessness, or seizures may rarely occur, and immediate medical attention should be sought for any abnormal symptoms. This medication may affect kidney function, so patients with reduced kidney function require regular monitoring and discontinuation upon abnormal signs. This drug may alter gut microbiota and lead to other infections or candidiasis, necessitating appropriate actions if symptoms occur. A tendency for bleeding due to vitamin K deficiency may occur, so caution is required especially with the elderly or with long-term use. It is advisable to avoid administration during the first 3 months of pregnancy, and pregnant or breastfeeding women should consult a doctor before taking it. During breastfeeding, there may be occurrences of diarrhea or allergic responses in infants, so administration should be stopped if abnormal symptoms arise. Usage in infants or newborns (under 2 months) has not been established as safe, so caution is advised. This drug may interact with other medications; consultations with a doctor are especially needed when used with anticoagulants or other antibiotics. In case of overdose, symptoms such as gastrointestinal issues, renal failure, or seizures may occur, and immediate medical care should be sought if symptoms develop. The drug should be shaken well before use, stored refrigerated after preparation, and taken within 7 days.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, clammy skin, pallor, anaphylaxis, erythema multiforme, shock, severe rash with fever, blisters, skin peeling, pain in the oral or eye mucosa, difficulty breathing, asthmatic attacks, respiratory distress accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden severe headaches, seizures.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
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  • abdominal pain
  • bloating
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • hepatitis
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin levels
  • itching
  • erythema multiforme
  • angioedema
  • skin rash
  • thrombocytopenia
  • anemia
  • leukopenia
  • prolonged bleeding time
  • prothrombin

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. The storage temperature should ideally be between 1 and 25 degrees Celsius in a cool place.

Appearance and packaging

Appearance

This is a syrup preparation that dissolves in use and has a whitish powder with a peculiar smell.

Package unit

10 bottles/box [(30 mL/bottle)], 10 bottles/box [(50 mL/bottle)]

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.

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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.