Medication info

Zacutex Dry Syrup 156.25 mg / 5 mL (Amoxicillin·Clavulanate Potassium)

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Amoxicillin Hydrate›21.6248g / 100gDilute Potassium Clavulanate›5.4062g / 100g
Manufacturer / importer
(주)테라젠이텍스
Appearance
Dry syrup preparation to be dissolved in use, in white to pale yellow powder form
Packaging
50 milliliters / bottle
Approval status
Approval withdrawn

MFDS item code 200201928 · Notified 2002.03.04

This product's status changed to Approval withdrawn on 2025.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of bacterial infections such as respiratory and urinary tract infections
Who takes it
Adults · Children
Adult dose
For mild to moderate infections such as recurrent tonsillitis and other upper respiratory infections, lower respiratory infections, urinary tract infections, and skin and soft tissue infections, take 20 mg/5 mg of amoxicillin/clavulanate potassium per kg of body weight, divided into 3 doses per day. For more severe infections such as otitis media, sinusitis, lower respiratory infections like bronchopneumonia, and severe urinary tract infections, take 40 mg/10 mg of amoxicillin/clavulanate potassium per kg of body weight, divided into 3 doses per day.
Child dose
There is insufficient clinical data regarding the use of the 4:1 syrup in children under 2 months. In cases of renal impairment, appropriate dosage reduction should be made.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment of bacterial infections such as respiratory and urinary tract infections

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

This medication is used to treat various infections caused by different bacteria. It is effective for lung-related infections such as acute and chronic bronchitis, lobar pneumonia, as well as pleurisy, lung abscess, tonsillitis, sinusitis, and otitis media. It is used for treating urinary tract infections such as cystitis, urethritis, pyelonephritis, pelvic infections, and gonorrhea. It is also utilized for skin and soft tissue infections like furuncles, abscesses, soft tissue infections, wound infections, as well as bone infections like osteomyelitis. Additionally, this drug is used for dental infections. Overall, it contributes to the improvement of patients' symptoms as a drug that helps treat various bacterial infections.

How to take

Adult dose

For mild to moderate infections such as recurrent tonsillitis and other upper respiratory infections, lower respiratory infections, urinary tract infections, and skin and soft tissue infections, take 20 mg/5 mg of amoxicillin/clavulanate potassium per kg of body weight, divided into 3 doses per day. For more severe infections such as otitis media, sinusitis, lower respiratory infections like bronchopneumonia, and severe urinary tract infections, take 40 mg/10 mg of amoxicillin/clavulanate potassium per kg of body weight, divided into 3 doses per day.

Child dose

There is insufficient clinical data regarding the use of the 4:1 syrup in children under 2 months. In cases of renal impairment, appropriate dosage reduction should be made.

Precautions

This medication should not be used in patients who have had hypersensitivity reactions to specific components or beta-lactam antibiotics. Especially, patients who have experienced anaphylaxis or severe skin reactions should not be administered this drug. Additionally, patients with infectious mononucleosis or lymphocytic leukemia are at a heightened risk for rash if this drug is used. Patients with a history of liver dysfunction or jaundice should avoid this drug as symptoms may recur. This medication contains lactose, making it unsuitable for patients with lactose intolerance or genetic digestive disorders. Care should be taken when administering this drug to patients with impaired liver function or severe kidney impairment due to the increased risk of side effects from elevated concentrations. Patients with known allergies, those receiving parenteral nutrition, elderly patients, and those in poor overall health should also be administered with caution. Patients exhibiting gastrointestinal symptoms like vomiting or diarrhea may not properly absorb the medication, necessitating careful attention. This drug may cause gastrointestinal adverse reactions such as diarrhea, abdominal pain, vomiting, and in severe cases, conditions like pseudomembranous colitis may occur. Liver function abnormalities may rarely develop, so liver function tests are recommended for prolonged use. Should any skin rashes or itching occur, or if severe skin reactions such as Stevens-Johnson syndrome occur, discontinue use immediately. Hematological adverse reactions such as leukopenia or anemia have been reported, so appropriate testing should be conducted if any abnormal symptoms arise. Neurological symptoms such as anxiety, confusion, and seizures may rarely occur; notify medical personnel if symptoms manifest. Since kidney function may deteriorate, regular examinations are necessary for patients with renal disease. This drug can affect the intestinal bacterial balance, potentially leading to infections like candidiasis. Symptoms of vitamin K deficiency may occur, necessitating caution for patients with a tendency to bleed. It is generally advisable not to use this medication during pregnancy, particularly in the first three months, and care should be exercised during nursing to avoid side effects in infants. Young children, especially newborns under 2 months, should be treated with caution as safety has not been established. Elderly patients, due to declining physical function, are at higher risk for side effects and should have dosage and intervals carefully adjusted with close monitoring. When using this drug, it is essential to discuss any history of allergies and current health status with healthcare professionals and to take the medication exactly as prescribed. Furthermore, because of the potential for drug interactions, it is necessary to inform of any other medications being taken. If any abnormal symptoms appear after taking the medication, seek medical attention immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, breathing difficulties, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
Show 23 more
  • abdominal distension
  • constipation
  • colonic pain
  • acid reflux
  • change in stool color
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • colitis with bloody stools
  • nausea
  • bloody stools
  • increased AST
  • ALT
  • ALP
  • LDH
  • elevated serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its efficacy for an extended period.

Appearance and packaging

Appearance

Dry syrup preparation to be dissolved in use, in white to pale yellow powder form

Package unit

50 milliliters / 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.

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.