Medication info

Amoclan Neo Syrup (Amoxicillin-Potassium Clavulanate (14:1)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
건일바이오팜주식회사
Appearance
A powder that is white to light yellow in color with a distinct odor; it is used as a syrup that dissolves when mixed.
Packaging
50 milliliters/bottle
Approval status
Active

MFDS item code 201903380 · Notified 2019.05.24 · Insurance code 073000891

Summary

Main use
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 drug in adults. To minimize the possibility of gastrointestinal disturbances, this drug should be administered at the beginning of meals. The absorption of potassium clavulanate increases when given at the beginning of meals.
Child dose
Pediatric patients over 3 months: The recommended dosage of this drug is 90 mg/kg/day based on the amoxicillin content (600 mg/5 mL), taken in divided doses every 12 hours. For acute otitis media, it is administered for 10 days; for acute sinusitis, it is administered for 7 days.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

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 drug is effective against various bacteria including Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis. It is mainly used in young patients under 2 years of age with recurrent or persistent acute otitis media and acute sinusitis who have a history of antibiotic treatment for acute otitis media or acute sinusitis within the past 3 months. Therefore, this drug can effectively improve these infectious diseases.

How to take

Adult dose

There is no experience with the use of this drug in adults. To minimize the possibility of gastrointestinal disturbances, this drug should be administered at the beginning of meals. The absorption of potassium clavulanate increases when given at the beginning of meals.

Child dose

Pediatric patients over 3 months: The recommended dosage of this drug is 90 mg/kg/day based on the amoxicillin content (600 mg/5 mL), taken in divided doses every 12 hours. For acute otitis media, it is administered for 10 days; for acute sinusitis, it is administered for 7 days.

Precautions

This medication contains the artificial sweetener aspartame, which should not be used in patients with phenylketonuria, a genetic disorder. Patients with allergies to the components of this drug or to beta-lactam antibiotics, those with viral infections such as infectious mononucleosis or lymphocytic leukemia, and patients with a history of hepatic dysfunction due to this drug or penicillin should not use it. Additionally, this drug should not be administered to patients with genetic issues that prevent them from digesting lactose. Patients with liver dysfunction or severe renal impairment should use this drug with caution, and those with allergic tendencies or gastrointestinal diseases accompanied by vomiting and diarrhea also need attention. While taking this medication, side effects such as diarrhea, vomiting, rash, dermatitis may occur, and in severe cases, medication should be discontinued. Especially in cases of gastrointestinal disturbances, taking the drug with food may reduce symptoms, and because hepatic dysfunction may appear, regular checks are necessary during prolonged use. Allergic reactions such as itching, severe skin rashes, and difficulty breathing may occur, so if abnormal symptoms arise, consult a doctor immediately. This drug may interact with other medications, so patients taking anticoagulants, certain antibiotics, or anti-inflammatory drugs should be cautious. Women who are pregnant or breastfeeding must consult a doctor before taking this medication, and it is especially advised to avoid it during the first trimester of pregnancy. This drug has not been proven safe for infants under 3 months, and should not be used for this age group. In case of overdose, gastrointestinal symptoms, renal dysfunction, and neurological abnormalities may occur, and immediate medical attention should be sought. This medication should be shaken well before use, and after preparation, it must be stored in the refrigerator and used within 7 days. When storing, it is safe to keep it out of reach of children in a dry place below 25 degrees Celsius. Antibiotics should only be used for the treatment of bacterial infections and are ineffective against viral infections, so it is essential to adhere to the prescribed duration and dosage.

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, peeling skin, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), generalized lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems.

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, indigestion, stomatitis, gastritis, glossitis, dark tongue, nausea, decreased appetite, abdominal pain, abdominal distension, constipation, colonic pain, acidity, black stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, bloody stools, itching, erythema multiforme, serum sickness symptoms (fever, rash, arthralgia, swelling, lymphadenopathy), eosinophilia, thrombocytopenia, anemia, thrombocytopathy.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also advisable to keep it in a cool, dry place between 1 degree and 25 degrees Celsius.

Appearance and packaging

Appearance

A powder that is white to light yellow in color with a distinct odor; it is used as a syrup that dissolves when mixed.

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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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.