Medication info

Amoxicillin Neo Syrup (Amoxicillin Hydrate - Clavulanic Acid Potassium)

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

MFDS item code 201507078 · Notified 2015.10.08 · Insurance code 651601921

Summary

Main use
Treatment of recurrent acute otitis media and acute sinusitis.
Who takes it
Adults · Children
Adult dose
There is no experience with this medication in adults. This medication is administered at the beginning of meals to minimize the possibility of gastrointestinal discomfort.
Child dose
Children over 3 months: Based on the amoxicillin content (600 mg/5 mL), the dosage is 90mg/kg/day divided into 12-hour intervals, with treatment duration of 10 days for acute otitis media and 7 days for acute sinusitis.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Treatment of recurrent acute otitis media and acute sinusitis.

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

This medication is effective against major bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, especially including beta-lactamase-producing strains. It is primarily used to treat recurrent or persistent acute otitis media and acute sinusitis in children. It is suitable for children under 2 years old or children attending daycare who have received antibiotics for these conditions within the last 3 months. It helps improve and treat symptoms of infection in patients with these conditions.

How to take

Adult dose

There is no experience with this medication in adults. This medication is administered at the beginning of meals to minimize the possibility of gastrointestinal discomfort.

Child dose

Children over 3 months: Based on the amoxicillin content (600 mg/5 mL), the dosage is 90mg/kg/day divided into 12-hour intervals, with treatment duration of 10 days for acute otitis media and 7 days for acute sinusitis.

Precautions

This medication is a penicillin class antibiotic and should not be administered to certain patients. For example, patients who have had a hypersensitivity reaction to the ingredients of this medication or to beta-lactam antibiotics should not use it. Additionally, it should be avoided in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as there is a higher risk of rash. Patients with a history of liver dysfunction or jaundice should be cautious while using this medication as it may worsen symptoms. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with liver impairment should use this medication with caution as it may worsen liver function. Patients with severe renal impairment may need to adjust the dosing interval as serum drug concentration may increase. Patients with allergic constitutions, risk of vitamin K deficiency, or gastrointestinal diseases accompanied by vomiting or diarrhea should also exercise caution. During the course of this medication, side effects such as diarrhea, vomiting, skin rash, and abnormalities in liver function may occur, and if symptoms are severe, immediate consultation with a physician is advised. Severe gastrointestinal symptoms such as pseudomembranous colitis may occur, so if there is abdominal pain or frequent diarrhea, the medication should be stopped and medical personnel notified. If hypersensitivity occurs with itching, hives, severe skin rashes, difficulty breathing, the medication should be stopped immediately and emergency treatment sought. This medication may affect liver and kidney function, so regular testing is required during long-term use. Also, there may be interactions with other medications, so it is essential to inform medical personnel if any other medications are being taken. It is advisable not to use this medication during pregnancy, especially in the first trimester, and caution should be taken during breastfeeding as side effects may occur in the baby. The safety of this medication has not been established for infants under 3 months of age, so it should not be used in this population. When taking the medication, the exact dosing and duration per instructions must be followed, and it should not be discontinued arbitrarily even if symptoms improve. After preparation, store in the refrigerator and use within 7 days, shaking well before use. In the event of overdose, gastrointestinal symptoms and renal function abnormalities may occur, so immediate medical attention should be sought. Lastly, this medication is used solely for treating bacterial infections and is ineffective against viral infections such as the common cold, which must be remembered.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanying cough + fever, jaundice (yellowing of skin or eyes), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Diarrhea
  • vomiting
  • contact dermatitis
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • appetite loss
  • abdominal pain
  • abdominal distension
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  • constipation
  • colonic pain
  • acid reflux
  • unusual stool
  • dry mouth
  • candidiasis
  • thrombocytopenia
  • anemia
  • thrombocytopenic purpura
  • eosinophilia
  • lymphopenia
  • reversible leukopenia
  • behavioral changes
  • drowsiness
  • insomnia
  • dizziness
  • headache
  • fatigue
  • dysgeusia
  • tooth discoloration
  • dermatitis
  • oral swelling
  • mucosal candidiasis
  • vaginal itching

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to store it in a cool, dry place below 25 degrees Celsius to maintain efficacy.

Appearance and packaging

Appearance

A syrup formulation in the form of a white or light yellow powder that is dissolved before use.

Package unit

50mL/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.