Medication info

Aclan Neo Syrup (Amoxicillin and Potassium Clavulanate)

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

MFDS item code 201803014 · Notified 2018.07.20 · Insurance code 670501101

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 of this medication's use in adults. This medication is administered at the beginning of meals to minimize the potential for gastrointestinal disturbances. Administering this medication at the beginning of meals enhances the absorption of potassium clavulanate.
Child dose
For pediatric patients over 3 months: Based on amoxicillin content (600 mg/5 mL), take 90 mg/kg/day split into doses every 12 hours; treat acute otitis media for 10 days, and acute sinusitis for 7 days.

Ingredients

Manufacturer
(주)보령바이오파마

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 effective against various bacteria, including Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains). It is mainly used to treat recurrent or persistent acute otitis media and recurrent acute sinusitis in children. It is applicable for children who have a history of antibiotic treatment for acute otitis media or acute sinusitis within the past three months, are aged two years or younger, or attend daycare. Therefore, this medication can effectively treat infections in pediatric patients with these risk factors.

How to take

Adult dose

There is no experience of this medication's use in adults. This medication is administered at the beginning of meals to minimize the potential for gastrointestinal disturbances. Administering this medication at the beginning of meals enhances the absorption of potassium clavulanate.

Child dose

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

Precautions

This medication contains the artificial sweetener aspartame, which is broken down into phenylalanine in the body. Therefore, patients with the genetic disorder phenylketonuria should not take this medication. Additionally, the daily intake of aspartame contained in this medication should be adjusted to a minimal amount not exceeding the WHO recommended level, and care should be taken not to exceed 2.4g per day for a 60kg adult. Patients with allergies to any of the components of this medication or beta-lactam antibiotics should not take it, and those with viral infections such as infectious mononucleosis or lymphocytic leukemia should also avoid this medication. Patients with a history of liver dysfunction or jaundice may experience a worsening of symptoms if this medication is taken. Since it contains lactose, patients with genetic conditions such as lactose intolerance, galactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption should not take this medication. Patients with impaired liver or kidney function may accumulate this medication in their body; thus, dosage intervals should be adjusted or cautiously monitored. Individuals with allergic predispositions or those prone to bronchial asthma, skin rashes, or hives should exercise additional caution when taking this medication. Patients with gastrointestinal symptoms such as vomiting or diarrhea may not absorb the medication properly; therefore, caution is advised. Generally, this medication has good tolerability, but side effects such as diarrhea, vomiting, rashes, and contact dermatitis may occur. If severe diarrhea or vomiting occurs, it is advised to discontinue use and consult a physician. Gastrointestinal adverse reactions may include abdominal pain, dyspepsia, and gastritis, and rarely, severe symptoms such as pseudomembranous colitis may occur, thus requiring caution. There may also be abnormalities in liver function, particularly reported more frequently in elderly individuals or males, and liver function tests may be necessary. Severe allergic reactions or skin rashes, itching, or severe cases of skin reactions such as Stevens-Johnson syndrome may occur, so if any abnormal symptoms appear, the medication should be discontinued immediately. Hematological abnormalities such as leukopenia, thrombocytopenia, and anemia may occur rarely, hence blood tests are necessary in long-term use. Central nervous system abnormalities such as rare headaches, dizziness, or seizures may occur, and greater caution is needed for patients with decreased kidney function. This medication may interact with other drugs; therefore, particularly when used with anticoagulants, gout medications, or other antibiotics, it is essential to consult with a physician or pharmacist. Pregnant or breastfeeding women should use this medication only in special cases, as safety during pregnancy has not been established, especially during the first three months of pregnancy, it is advisable to avoid taking it. During breastfeeding, this medication may pass into breast milk, possibly causing diarrhea or skin rashes in infants; thus, caution is required. This medication should not be used in infants under three months due to the lack of confirmed safety and efficacy. While taking this medication, regular liver, kidney, and blood tests are important to monitor for abnormalities. This medication should be taken exactly as prescribed for the required duration and dosage; even if symptoms improve, it should not be discontinued arbitrarily. Before taking, shake the medication well, and after preparation, store it in a refrigerator and use it within seven days. In case of overdose, gastrointestinal symptoms, rashes, and seizures may occur, so use should be stopped immediately, and healthcare professionals consulted. Lastly, this medication should be used only for the treatment of bacterial infections and is not effective for viral infections such as colds, so unnecessary usage should be avoided.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, wheezing or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and very severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Diarrhea
  • vomiting
  • contact dermatitis
  • hyperacidity
  • abdominal pain
  • stomatitis
  • anorexia
  • rash
  • itching
  • headache
Show 25 more
  • dizziness
  • drowsiness
  • insomnia
  • dysgeusia
  • malaise
  • tooth discoloration
  • hematochezia
  • thrombocytopenia
  • leukopenia
  • anemia
  • mucosal candidiasis
  • vaginal itching
  • increased secretions
  • anxiety
  • restlessness
  • behavioral changes
  • confusion
  • hyperactivity
  • symptoms of vitamin deficiency
  • tendency to bleed
  • other minor skin reactions
  • dry mouth
  • constipation
  • colonic pain
  • nausea.

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. Additionally, it is recommended to keep it in a dry place between 1 and 25 degrees Celsius. Proper storage will help maintain the medication’s effectiveness over time.

Appearance and packaging

Appearance

A syrup preparation in powder form that is white to pale yellow with a distinctive smell to be 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.