Medication info

K-Silin Neo Syrup

Prescription medicationSyrup경구Expired
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
주식회사케이에스제약
Appearance
A syrup preparation in white to pale yellow powder form with a peculiar smell that dissolves before use.
Packaging
50 mL/bottle
Approval status
Expired

MFDS item code 202001154 · Notified 2020.02.19

This product's status changed to Expired on 2025.02.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Treatment effect for 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 primarily used for the treatment of recurrent or persistent acute otitis media and acute sinusitis in pediatric patients. It is especially effective for children under 2 years of age or those who have a history of antibiotic use for acute otitis media or sinusitis within the last 3 months, or who attend daycare centers. This drug is developed against major pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. The main target pathogens of the drug are penicillin-sensitive Streptococcus pneumoniae and beta-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis. Therefore, this drug effectively suppresses the pathogens causing acute otitis media and acute sinusitis, improving symptoms and aiding in rapid recovery. It is used safely and effectively to treat respiratory infections in children.

How to take

Adult dose

There is no experience using this drug in adults.

Child dose

For pediatric patients aged 3 months and older: Based on the amoxicillin content (600 mg/5 mL), administer 90 mg/kg/day divided into two doses every 12 hours, for 10 days in acute otitis media and 7 days in acute sinusitis.

Precautions

This drug contains the artificial sweetener aspartame, which metabolizes to phenylalanine in the body. Therefore, patients with the hereditary condition phenylketonuria should not take this drug. Patients with allergies to the ingredients of this drug or beta-lactam antibiotics should not use this drug. Particularly, patients with infectious mononucleosis or lymphocytic leukemia are at a higher risk for rash and should be cautious. Patients who have a history of liver dysfunction or jaundice due to this drug or penicillin should also avoid taking it. Since this drug contains lactose, patients with lactose intolerance or related hereditary diseases should not take it. Patients with impaired liver or kidney function should use this drug cautiously, as worsening liver function or increased blood concentration may occur, thus requiring adjustment of the dosing interval. Those with allergic predispositions, especially with a family history, should be cautious of allergic reactions when taking this drug. Patients who have difficulty swallowing orally, elderly individuals, or those in poor general condition may be at risk for vitamin K deficiency and should be cautious. Patients with gastrointestinal diseases may have insufficient absorption; therefore, consult with a physician before administration. This drug is generally safe, but side effects such as skin rash, diarrhea, vomiting, contact dermatitis, and others may occur. If diarrhea, abdominal pain, or blood in stools occur, immediately discontinue the drug and inform a physician. As there have been reports of liver function abnormalities, liver function tests may be necessary with long-term use. Severe allergic reactions or anaphylaxis may occur; therefore, patients should be closely monitored after administration. During antibiotic use, it is important to take only for the necessary duration to prevent the emergence of resistant bacteria and to note that it is not effective for viral infections. This drug may interact with other medications; therefore, if other medications are being taken, informing healthcare providers is essential. Women who are pregnant or breastfeeding should consult with a physician before taking this drug, and it is advisable to avoid administration, especially in early pregnancy. Safety has not been established for infants under 3 months, so use is not recommended. This drug should be shaken well before use and refrigerated after preparation, using it within 7 days. Keep out of the reach of children and store in a dry place away from direct sunlight and moisture at temperatures below 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanying cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, dyspepsia, stomatitis, gastritis, glossitis, nausea, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, hyperacidity, melena, xerostomia, candidiasis, antibiotic-associated colitis, hepatitis, cholestatic jaundice, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, systemic symptoms

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

Storage

This drug is sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is best stored in a cool, dry place between 1 and 25 degrees Celsius. This helps maintain the drug's effectiveness for a longer duration.

Appearance and packaging

Appearance

A syrup preparation in white to pale yellow powder form with a peculiar smell that dissolves 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

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.