Medication info

Aclasneo Syrup (Amoxicillin-Clavulanate Potassium (14:1))

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
(주)아리제약
Appearance
A syrup preparation in the form of a powder that is white to pale yellowish with a peculiar smell, to be dissolved before use.
Packaging
50 mL / bottle
Approval status
Active

MFDS item code 201903852 · Notified 2019.06.13 · Insurance code 058200071

Summary

Main use
Effective for the treatment of recurrent acute otitis media and acute sinusitis in children.
Who takes it
Adults · Children
Adult dose
There is no experience with the use of this medication in adults.
Child dose
For children aged 3 months and older, the dosage is based on the amoxicillin content (600 mg / 5 mL), to be taken as 90 mg/kg/day divided into doses every 12 hours. For acute otitis media, administer for 10 days; for acute sinusitis, administer for 7 days.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Effective for the treatment of recurrent acute otitis media and acute sinusitis in children.

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

This medication is used to treat recurrent or persistent acute otitis media and acute sinusitis in children. It is especially effective in children who have had antibiotic treatment for these conditions within the past 3 months, are under 2 years of age, or attend daycare. It demonstrates treatment efficacy against major pathogens including Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing bacteria), and Moraxella catarrhalis. Due to these properties, it is used for the treatment of recurrent or persistent acute otitis media and acute sinusitis.

How to take

Adult dose

There is no experience with the use of this medication in adults.

Child dose

For children aged 3 months and older, the dosage is based on the amoxicillin content (600 mg / 5 mL), to be taken as 90 mg/kg/day divided into doses every 12 hours. For acute otitis media, administer for 10 days; for acute sinusitis, administer for 7 days.

Precautions

This medication contains the artificial sweetener aspartame and should not be taken by patients with the genetic disorder phenylketonuria. Care should be taken to not exceed the daily allowable amount of aspartame, which is up to 2.4 g for a 60 kg adult. Patients who have had an allergic reaction to the components of this medication or to beta-lactam antibiotics, patients with infectious mononucleosis or lymphocytic leukemia, and patients with a history of liver dysfunction or jaundice related to this medication or penicillin should not use this product. Also, patients with genetic disorders that prevent lactose digestion should not take this medication. Patients with impaired liver function or moderately to severely impaired renal function should use this medication with caution, as should those with a history of allergies, digestive diseases, elderly patients, and any patients in poor general health. While this medication generally has good tolerability, side effects such as diarrhea, vomiting, skin rash, and contact dermatitis can occur, and rare reports have been made of liver function abnormalities, hypersensitivity, blood disorders, and central nervous system symptoms in some patients. If significant side effects or unusual symptoms occur, discontinue use immediately and consult a doctor. This medication should only be used for bacterial infections and is ineffective for viral infections. Even if symptoms improve during treatment, it is essential to continue taking the medication as prescribed for the full duration. Discontinuing use can reduce treatment effectiveness and lead to resistant bacteria. This medication can interact with other drugs; therefore, patients taking anticoagulants or specific antibiotics, anti-inflammatory medications, etc., should inform their doctor or pharmacist without fail. Pregnant or breastfeeding women should consult their doctor before taking this medication, and it is particularly advised to avoid use during the first three months of pregnancy. Safety and effectiveness in infants under 3 months have not been established, and it should not be used in this age group. This medication must be shaken well before use and should be stored in the refrigerator after preparation, to be used within 7 days. In cases of overdose, gastrointestinal symptoms such as stomach pain, diarrhea, and vomiting, as well as electrolyte imbalances, and rarely renal dysfunction or seizures may occur, therefore, immediate medical attention should be sought if such symptoms arise. This medication should be kept out of the reach of children, protected from direct sunlight, and stored in a dry place at or below 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), pronounced malaise, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Contact dermatitis
  • diaper rash
  • diarrhea
  • vomiting
  • moniliasis
  • rash
  • indigestion
  • stomatitis
  • gastritis
  • glossitis
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  • black hairy tongue
  • nausea
  • loss of appetite
  • abdominal pain
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • candidiasis
  • itching
  • erythema multiforme
  • symptoms of rash
  • eosinophilia
  • serum sickness
  • thrombocytopenia
  • anemia
  • thrombocytopenic purpura
  • increased eosinophils
  • leukemia
  • increased platelets
  • bone marrow suppression
  • vaginitis

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. Additionally, it should be kept in a dry place at a stable temperature between 1 to 25 degrees Celsius for optimal effectiveness.

Appearance and packaging

Appearance

A syrup preparation in the form of a powder that is white to pale yellowish with a peculiar smell, to be 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.