Medication info

Aclaneo Dry Syrup (Amoxicillin Hydrate - Clavulanate Potassium)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
알리코제약(주)
Appearance
A syrup preparation that dissolves in water, in white or light yellow powder form.
Packaging
50 milliliters/bottle
Approval status
Active

MFDS item code 201502815 · Notified 2015.05.11 · Insurance code 656003791

Summary

Main use
Treatment effect for recurrent (acute otitis media, acute sinusitis)
Who takes it
Adults · Children
Adult dose
There has been no experience using this medication in adults.
Child dose
For pediatric patients over 3 months: Based on the amoxicillin content (600 mg/5 mL), 90 mg/kg/day is divided into doses every 12 hours. For acute otitis media, the duration is 10 days; for acute sinusitis, the duration is 7 days.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Treatment effect for recurrent (acute otitis media, acute sinusitis)

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

This medication is effective against typical causative bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It acts not only on penicillin-sensitive strains but also on beta-lactamase producing strains. It is used to treat recurrent or persistent acute otitis media and recurrent acute sinusitis in pediatric patients. It is especially suitable for children under the age of 2 or those who have taken antibiotics for these conditions within the last 3 months. Therefore, it provides safe and effective treatment for pediatric patients with these conditions.

How to take

Adult dose

There has been no experience using this medication in adults.

Child dose

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

Precautions

This medication should not be administered to patients with hypersensitivity to beta-lactam antibiotics, including penicillins and cephalosporins. Particular caution is needed for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as there is a higher risk of rash. Patients who have experienced jaundice or liver dysfunction from this medication or penicillin should avoid its use due to the possibility of recurrence. Because it contains lactose, it should not be given to patients with genetic lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. In patients with impaired liver or kidney function, the concentration of the drug may increase, so careful administration is necessary, and dosing intervals may need to be adjusted. Those with allergies may be at risk for bronchial asthma, rash, urticaria, etc., and should be observed closely. Patients with gastrointestinal diseases accompanied by vomiting or diarrhea may have insufficient drug absorption, requiring careful monitoring. This medication is generally well tolerated, but side effects such as diarrhea, vomiting, rash, contact dermatitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, anorexia, abdominal pain, abdominal bloating, constipation, colonic pain, acid dyspepsia, black stools, dry mouth, elevations in AST, ALT, ALP, LDH, serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, etc. may occur. Severe allergic reactions, such as anaphylaxis or Stevens-Johnson syndrome, although rare, can occur, and should the symptoms arise, administration must be stopped immediately and a physician contacted. To prevent drug resistance while using antibiotics, it is important to perform susceptibility testing and administer the medication for the minimum duration necessary. Patients with a history of hypersensitivity should be observed closely for severe allergic reactions. If diarrhea occurs during antibiotic use, intestinal inflammation should be suspected, and if abdominal pain or blood in the stool is present, treatment should be stopped immediately and medical consultation is warranted. In cases of prolonged use, considerations should be made regarding the possibility of non-susceptible bacteria proliferation or super infection, and appropriate measures should be taken. Patients suspected of having liver dysfunction require regular liver function tests, especially during long-term use exceeding 14 days. As this medication is excreted through the kidneys, dosage adjustment is needed for patients with impaired kidney function. Administration should be avoided, especially during the first three months of pregnancy, and during lactation, if unusual symptoms appear in the infant such as diarrhea or hypersensitivity, administration should be stopped. Safety in infants under three months has not been established, and it is recommended not to use the medication in this age group. This medication may interact with other drugs, so caution should be taken when used in combination with anticoagulants, anti-inflammatory medications, oral contraceptives, etc. In cases of overdose, symptoms may include vomiting, diarrhea, convulsions, and renal failure, and immediate cessation of administration and appropriate measures should be taken is necessary. Before use, the medication should be well shaken to ensure uniformity, stored in refrigeration after preparation, and used within 7 days. Keep out of reach of children and store in a dry place below 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion of consciousness, vision abnormalities, paralysis.

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, dyspepsia, stomatitis, gastritis, glossitis, nausea, anorexia, abdominal pain, abdominal bloating, constipation, colonic pain, acid dyspepsia, black stools, dry mouth, elevations in AST, ALT, ALP, LDH, serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis.

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 exposure to air or moisture and kept in a cool, dry place below 25 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained for a long time.

Appearance and packaging

Appearance

A syrup preparation that dissolves in water, in white or light 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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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.