Medication info

Clarin Neo Syrup [Amoxicillin·Clavulanate Potassium (14:1)]

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

MFDS item code 201501082 · Notified 2015.03.02 · Insurance code 645702741

Summary

Main use
Effectiveness in treating recurrent acute otitis media and sinusitis
Who takes it
Adults · Children
Adult dose
There is no experience using this medication in adults.
Child dose
For pediatric patients over 3 months: based on the amoxicillin content (600 mg/5 mL), administer 90mg/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
삼아제약(주)

Efficacy & effects

Effectiveness in treating recurrent acute otitis media and sinusitis

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

This medicine is effective against several pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is specifically used for treatment of recurrent or persistent acute otitis media and recurrent acute sinusitis in children. However, the targeted patients are limited to children under 2 years old who have a history of antibiotic use for acute otitis media or sinusitis within the last 3 months, or children attending daycare. Therefore, this medicine helps in the treatment of acute infections in these at-risk children.

How to take

Adult dose

There is no experience using this medication in adults.

Child dose

For pediatric patients over 3 months: based on the amoxicillin content (600 mg/5 mL), administer 90mg/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 is a beta-lactam antibiotic and contains components that belong to the penicillin class. This medication should not be administered to patients who have previously exhibited allergic reactions to its components or to beta-lactam drugs. Caution is particularly necessary for patients with viral diseases such as infectious mononucleosis or lymphoblastic leukemia, as they may have a higher risk of skin rash. It is safer not to use this medication in patients who have had liver dysfunction, or those with genetic issues such as lactose intolerance or galactose intolerance. For patients with impaired liver function or moderate to severe kidney dysfunction, the concentration of this medication in the body may increase, requiring dosage and administration interval adjustments. Patients with allergic predispositions, those receiving parenteral nutrition, elderly individuals, and patients in poor general health should be administered with caution, as there is a risk of vitamin K deficiency. This medication is generally safe, but minor side effects such as diarrhea, vomiting, rash, and contact dermatitis may occur. Gastrointestinal symptoms may include diarrhea, vomiting, and abdominal pain; if severe abdominal pain or persistent diarrhea occurs, treatment should be discontinued immediately and medical consultation should be sought. Reports of liver function abnormal symptoms are also rare, and may occur more frequently in the elderly or males, necessitating caution during prolonged use. Rarely, serious allergic reactions or skin reactions may occur; if symptoms such as hives, rashes, or difficulty breathing appear, administration should be immediately ceased and healthcare professional consulted. Hematologic-related side effects including leukopenia, thrombocytopenia have been reported, indicating a potential bleeding tendency which may require blood tests and monitoring. This medication may interact with certain drugs, so it is essential to inform healthcare providers if other medications are being taken. Administration should be avoided during the first three months of pregnancy, and caution should be exercised during breastfeeding as side effects may occur in infants. It is advisable not to administer this medication to infants under three months of age, as safety and efficacy have not been established. Patients should adhere strictly to the prescribed duration and dosage while taking this medication, and should not discontinue use prematurely even if symptoms have improved. The medication should be well shaken before use and stored in a refrigerator after preparation while using it within 7 days. In the case of overdose, gastrointestinal symptoms or renal dysfunction may occur; if symptoms appear, contact healthcare providers immediately for appropriate management. This medication should only be used for the treatment of bacterial infections and is not effective against viral infections, thus should not be used for the common cold or similar conditions. If unusual symptoms occur during use, administration should be stopped immediately and follow the physician's instructions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, oral/eye mucosal pain, difficulty in breathing or shortness of breath, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, dyspepsia, stomatitis, gastritis, glossitis, black tongue, anorexia, abdominal pain, abdominal distension, constipation, colic, gastric acid increase, loose stools, dry mouth, hepatitis, elevated AST, ALT, ALP, LDH, serum bilirubin, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, serum sickness, hypersensitivity

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it must be kept in a cool, dry place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A syrup preparation that dissolves in use, in white or pale yellow powder form

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

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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.