Medication info

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

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
동성제약(주)
Appearance
A white or pale yellow powder that is dissolved in water to be used as syrup
Packaging
Bottle - 50 milliliters/bottle
Approval status
Active

MFDS item code 201900951 · Notified 2019.02.15 · Insurance code 643203081

Summary

Main use
Treatment effectiveness for recurrent acute otitis media and acute sinusitis
Who takes it
Adults · Children
Adult dose
There is no experience of using this medication in adults.
Child dose
For pediatric patients over three months old, the dosage is based on amoxicillin content (600 mg/5 mL) at 90 mg/kg/day, divided every 12 hours, for 10 days for acute otitis media and 7 days for acute sinusitis.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Treatment effectiveness for recurrent acute otitis media and acute sinusitis

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

This medication is effective against various bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is particularly used in pediatric patients for the treatment of recurrent or persistent acute otitis media and acute sinusitis. However, this medication is suitable for children under two years old and those who have had antibiotic treatment within the last three months. It is safe and effective for treating infections in children with these conditions. Therefore, this medication helps improve recurrent otitis media and sinusitis in children.

How to take

Adult dose

There is no experience of using this medication in adults.

Child dose

For pediatric patients over three months old, the dosage is based on amoxicillin content (600 mg/5 mL) at 90 mg/kg/day, divided every 12 hours, for 10 days for acute otitis media and 7 days for acute sinusitis.

Precautions

This medication should not be administered to patients allergic to penicillin or cephalosporin classes or who have experienced hypersensitivity. In particular, caution is required for patients with viral infections such as infectious mononucleosis or lymphoblastic leukemia, as there may be a higher risk of rash. Additionally, patients who have had hepatic dysfunction or jaundice due to this medication or penicillin should avoid its use due to the risk of recurrence. This medication contains lactose and should not be administered to patients with hereditary lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Patients with impaired liver or kidney function should use this medication cautiously, and especially if kidney function is moderately impaired or worse, dosing intervals should be increased. Patients prone to allergies or who easily develop bronchial asthma, rash, or hives also need to be cautious. Elderly patients or those in poor general condition may show signs of vitamin K deficiency, so this medication should be administered carefully. If there are gastrointestinal diseases or severe vomiting or diarrhea, drug absorption may not be sufficient. This medication is generally well tolerated, but side effects like diarrhea, vomiting, rash, or contact dermatitis may occur, and if symptoms are severe, consult a physician. Symptoms of liver dysfunction can appear during or after stopping treatment, so report any unusual symptoms immediately. Serious allergic reactions or anaphylaxis may rarely occur, so closely monitor the patient's condition after administration. If diarrhea occurs during antibiotic use, consider the possibility of pseudomembranous colitis and consult medical personnel immediately. Prolonged use can increase the risk of resistant bacteria and fungal infections; therefore, caution is necessary if used for more than 14 days. Avoid use during the first three months of pregnancy, and if pregnant or breastfeeding, consult a physician before carefully using this medication. It is not used in infants less than three months old due to lack of proven safety and efficacy. This medication can interact with other drugs, so inform your physician of any medications you are taking, especially if combined with anticoagulants or specific antibiotics. In cases of overdose, gastrointestinal symptoms and renal dysfunction may occur, so immediate medical treatment is required. Shake well before administration, and after dispensing, store in the refrigerator and use within seven days. Keep out of reach of children, and store in a dry place at or below 25 degrees Celsius.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (skin or eyes turning yellow), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, changes in urine output

Mild side effects

Contact dermatitis, diaper rash, diarrhea, vomiting, moniliasis, rash, indigestion, stomatitis, gastritis, glossitis, nausea, loss of appetite, abdominal pain, bloating, constipation, colonic pain, acid reflux, dark stools, dry mouth, candidiasis, antibiotic-associated colitis, itching, erythema multiforme, serum sickness-like syndrome, hypersensitivity vasculitis, acute generalized exanthematous pustulosis, bronchospasm associated with dyspnea, laryngeal edema, reversible leukopenia

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

Storage

This medication may be sensitive to air or moisture, so it is important to keep it in a sealed container. Additionally, to maintain the efficacy of the medication, store it in a cool, dry place at or below 25 degrees Celsius.

Appearance and packaging

Appearance

A white or pale yellow powder that is dissolved in water to be used as syrup

Package unit

Bottle - 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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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.