Medication info

Cramon Neo Syrup (Amoxicillin Hydrate - Clavulanate Potassium)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
코오롱제약(주)
Appearance
A white or light yellow powder that is dissolved before use as syrup
Packaging
50 milliliters
Approval status
Active

MFDS item code 201405422 · Notified 2014.11.20 · Insurance code 670303901

Summary

Main use
Treatment effect for recurrent acute otitis media and acute sinusitis
Who takes it
Children
Child dose
For pediatric patients over 3 months: Based on amoxicillin content (600 mg/5 mL), 90mg/kg/day is divided into doses every 12 hours. For acute otitis media, it is taken for 10 days; for acute sinusitis, it is taken for 7 days.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Treatment effect for recurrent acute otitis media and acute sinusitis

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

This medicine is used to treat recurrent or persistent acute otitis media and recurrent acute sinusitis in children. It is particularly suitable for children under the age of 2, those who have received antibiotic treatment for acute otitis media or sinusitis within the last three months, and children attending daycare. This medication is effective against major bacteria such as Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains). It helps improve symptoms of otitis media and sinusitis in children and aids in recovery of health.

How to take

Child dose

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

Precautions

This medicine contains a beta-lactam antibiotic and includes components from the penicillin group. It should not be administered to patients who have hypersensitivity to the ingredients or a history of allergy to beta-lactam antibiotics. Use in patients with specific viral infections, such as infectious mononucleosis or lymphocytic leukemia, may increase the risk of side effects like skin rashes. Patients with a history of liver dysfunction or jaundice should be cautious, as this medication may worsen their symptoms. This medication contains lactose, hence it should not be given to patients with lactose intolerance or galactose metabolism disorders. In patients with liver impairments or severe renal impairments, careful use is required, and dosing intervals should be adjusted as the drug concentration may increase. Patients with allergic constitutions or who easily exhibit hypersensitivity reactions, like asthma or urticaria, should be careful when using this medication. Patients who have difficulty swallowing, are elderly, or have poor general health may exhibit symptoms of vitamin K deficiency; caution should be exercised. Patients with gastrointestinal diseases may have reduced absorption of this medication, so their condition should be checked before administration. This medicine is generally well tolerated, but side effects such as diarrhea, vomiting, skin rashes, and contact dermatitis may occur. In severe cases, symptoms like pseudomembranous colitis, hepatitis, severe skin reactions, blood abnormalities, and renal function impairment may arise; if any unusual symptoms occur, the medication should be stopped immediately and a physician consulted. Since this is a penicillin-class antibiotic, severe allergic reactions, like anaphylactic shock, may rarely occur; patients should be closely monitored after administration. Prolonged use may carry a risk of resistant strains developing, so it is important to administer only for the minimum necessary duration after sensitivity testing. It is advisable to avoid this medication during pregnancy, particularly in the first three months, and caution should be observed during breastfeeding, as a small amount may be excreted into breast milk, leading to side effects in infants. Safety and efficacy have not been established in infants under three months of age; thus, it should not be administered. This medicine may interact with other medications; care should be taken when coadministering with anticoagulants, probenecid, allopurinol, etc. In the case of overdose, gastrointestinal symptoms, renal damage, and seizures may be observed; immediate discontinuation and appropriate treatment are necessary. This medication should be stored in a refrigerated condition after preparation and used within seven days, keeping out of reach of children. Before use, the medication should be shaken well to ensure uniformity.

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 fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthmatic attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, loss of appetite, abdominal pain, abdominal distention, constipation, colonic pain, acidity, loose stools, dry mouth, elevated AST, ALT, ALP, LDH, increased serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesiculobullous dermatitis, acute generalized exanthematous pustulosis, fever

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. Furthermore, it should be kept in a cool, dry place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A white or light yellow powder that is dissolved before use as syrup

Package unit

50 milliliters

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.