Medication info

Amoktasim Neo Dry Syrup

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

MFDS item code 201405452 · Notified 2014.11.24 · Insurance code 642905281

Summary

Main use
Treatment effect for recurrent acute otitis media and acute sinusitis.
Who takes it
Children
Child dose
For pediatric patients over 3 months, the dosing is based on the amoxicillin content (600 mg/5 mL) at 90 mg/kg/day divided into doses every 12 hours. For acute otitis media, treat for 10 days; for acute sinusitis, treat for 7 days.

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Treatment effect for 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 pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is mainly used in children for the treatment of recurrent or persistent acute otitis media and recurrent acute sinusitis. It is applicable in children under 2 years of age or those attending daycare who have had antibiotic treatment within the last 3 months. This medication is used to relieve symptoms caused by otitis media and sinusitis and to aid in recovery.

How to take

Child dose

For pediatric patients over 3 months, the dosing is based on the amoxicillin content (600 mg/5 mL) at 90 mg/kg/day divided into doses every 12 hours. For acute otitis media, treat for 10 days; for acute sinusitis, treat for 7 days.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with a history of hypersensitivity to penicillin or cephalosporin antibiotics. Special attention is needed for patients with viral infections such as infectious mononucleosis or lymphoid leukemia, as the risk of rash is high. Patients with a history of liver dysfunction or jaundice due to this medication or penicillin should not use it due to the risk of recurrence. This medication contains lactose and should not be given to patients with lactose intolerance or certain genetic metabolic disorders. In patients with impaired liver or kidney function, the drug concentration may increase, so it should be administered cautiously, and the dosing interval may need to be adjusted. Patients with an allergic constitution or those who frequently experience bronchial asthma, skin rashes, or urticaria should use this medication with caution. Patients having difficulty with oral intake or those in poor general condition, and those experiencing vomiting or diarrhea should be cautious, as absorption of the medication may be insufficient. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, abdominal pain, and rarely serious issues like pseudomembranous colitis or acute pancreatitis. Liver function abnormalities have also been reported, especially in the elderly or when administered long-term, liver function tests may be necessary. Severe skin reactions such as rashes, itching, and in severe cases, Stevens-Johnson syndrome due to hypersensitivity may occur, so if symptoms present, administration should be stopped immediately. Blood abnormalities such as leukopenia, thrombocytopenia, or hemolytic anemia may rarely occur, so periodic blood tests may be necessary. Central nervous system abnormalities have been rarely reported, including headache, dizziness, and seizures, with a higher risk of seizures in patients with poor kidney function. If severe diarrhea, abdominal pain, or fever occurs during medication use, consult a doctor immediately and consider the possibility of complications such as pseudomembranous colitis. This medication may interact with other medications, so patients taking anticoagulants, antibiotics, and anti-inflammatory drugs should inform their doctor and use caution. The use of this medication is limited in women in early pregnancy or during pregnancy, and caution is necessary during breastfeeding as it may cause side effects in the infant. The safety of this medication is not established for pediatric patients, especially infants under 3 months, and it should not be used in them. This medication is not effective against viral infections and should only be used for bacterial infections, and even if symptoms improve, it should be taken consistently for the prescribed duration. Before taking the medication, shake it well, and after preparation, store it refrigerated and use it within 7 days. In the case of overdose, gastrointestinal symptoms or kidney abnormalities may appear, and immediate cessation of administration and appropriate treatment are required. When using this medication, keep it out of reach of children, and it is advisable to store it in a cool, dry place below 25 degrees Celsius, away from direct sunlight and moisture.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • abdominal bloating
  • constipation
  • colonic discomfort
  • hyperacidity
  • dark stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • contact dermatitis
  • moniliasis
  • rash
  • itching
  • erythema multiforme
  • thrombocytopenia
  • anemia
  • thrombocytopenic purpura
  • eosinophilia
  • leukemia
  • agranulocytosis
  • lymphopenia
  • bone marrow suppression
  • mucosal candidiasis.

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

Storage

This medication may be affected by air or moisture, so it should be stored in a tightly closed container. Additionally, it should be kept in a cool and dry place at a temperature below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A syrup that is 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

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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.