Medication info

Zagutex Neo Syrup (Amoxicillin Hydrate - Potassium Clavulanate)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
(주)테라젠이텍스
Appearance
A syrup formulation as a white or pale yellow powder that is dissolved before use.
Packaging
50 mL/bottle
Approval status
Active

MFDS item code 201405931 · Notified 2014.12.18 · Insurance code 698502901

Summary

Main use
Effective in treating recurrent acute otitis media and sinusitis in children.
Who takes it
Adults · Children
Adult dose
There is no experience of using this medication in adults. To minimize the possibility of gastrointestinal discomfort, it is administered at the beginning of meals.
Child dose
For pediatric patients over 3 months: Based on an amoxicillin content of 600 mg/5 mL, the dosage is 90 mg/kg/day divided into two doses every 12 hours. Use for 10 days for acute otitis media and 7 days for acute sinusitis.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Effective in treating recurrent acute otitis media and sinusitis in children.

  • Recurrent acute otitis media
  • persistent acute otitis media
  • recurrent acute sinusitis
View approved original text

This medication is effective primarily against major bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is especially used for children under 2 years old or those attending daycare, with recurrent or persistent acute otitis media or acute sinusitis after receiving antibiotic treatment within the last three months. It effectively treats recurrent or persistent acute otitis media and acute sinusitis in pediatric patients with these conditions. Therefore, this drug helps safely treat otitis media and sinusitis in children.

How to take

Adult dose

There is no experience of using this medication in adults. To minimize the possibility of gastrointestinal discomfort, it is administered at the beginning of meals.

Child dose

For pediatric patients over 3 months: Based on an amoxicillin content of 600 mg/5 mL, the dosage is 90 mg/kg/day divided into two doses every 12 hours. Use for 10 days for acute otitis media and 7 days for acute sinusitis.

Precautions

This medication is a penicillin-type antibiotic that contains both amoxicillin and clavulanate for treating bacterial infections. It should not be administered to patients with a hypersensitivity reaction to beta-lactam agents, and caution is necessary for patients with infectious mononucleosis or lymphocytic leukemia due to the risk of rash. Patients with a history of liver dysfunction or jaundice caused by this medication or penicillin should avoid its use due to a risk of recurrence. Since it contains lactose, patients with lactose intolerance or related genetic disorders should not take it. In patients with impaired liver or kidney function, the drug concentration may increase, so careful administration or dosage adjustment is necessary. Patients with an allergic constitution or those who experienced symptoms such as bronchial asthma, rash, or urticaria should use this medication cautiously. Gastrointestinal symptoms may include diarrhea, vomiting, abdominal pain, and in some cases, severe colitis or pancreatitis may occur; therefore, immediate consultation with medical personnel is required if abnormal symptoms arise. Liver function abnormalities may occur, which require increased caution, especially in the elderly or with prolonged use. Rarely, severe skin reactions or hypersensitivity reactions such as anaphylaxis may occur, so if rash, itching, or difficulty breathing occurs, immediate discontinuation and medical treatment are necessary. Blood-related abnormalities, such as leukopenia, anemia, and thrombocytopenia, have been reported, so testing is required if abnormal symptoms appear. It may affect the central nervous system, causing anxiety, restlessness, dizziness, headache, and rarely seizures; caution is needed particularly in patients with poor kidney function. This medication can affect the intestinal microbiome, influencing other infections or drug effectiveness, so monitoring is necessary with prolonged use. Pregnant or breastfeeding individuals should avoid using this medication during early pregnancy due to safety not being fully established and should discontinue if abnormal symptoms occur in infants during nursing. It is not used in infants under 3 months of age as safety and efficacy have not been confirmed. This medication may affect some urine test results, so caution is needed during testing. In cases of overdose, gastrointestinal symptoms, kidney problems, seizures, etc., may occur, so immediate contact with medical personnel for appropriate treatment is essential. This medication should be used according to the prescribed dosage and duration, and should not be discontinued arbitrarily even if symptoms improve during treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, etc.

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, acidity, loose stool, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, bloody stool, itching, erythema multiforme, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, serum sickness-like syndrome symptoms, hypersensitivity vasculitis, bronchospasm, etc.

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 air and moisture from entering. Additionally, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A syrup formulation as a white or pale yellow powder that is dissolved before use.

Package unit

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.

Questions about this medicine

No questions yet.

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.