Medication info

Newmok Craneo Syrup (Amoxicillin Hydrate · Clavulanate Potassium)

Prescription medicationSyrup경구Expired
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
안국뉴팜(주)
Appearance
A powder that is white to pale yellowish in color with a peculiar smell, used as a syrup that dissolves when taken.
Packaging
50 milliliters per bottle
Approval status
Expired

MFDS item code 201905679 · Notified 2019.08.12

This product's status changed to Expired on 2024.08.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Efficacy & effects

Effective in the treatment of 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 primarily used to treat recurrent or persistent acute otitis media and recurrent acute sinusitis in pediatric patients. It is especially suitable for children under 2 years of age or those who have received antibiotic treatment for acute otitis media or acute sinusitis within the last 3 months. This medication is effective against major pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Therefore, it helps improve infection symptoms in children with these conditions.

How to take

Adult dose

There is no experience with this medication in adults.

Child dose

For pediatric patients over 3 months: Based on amoxicillin content (600 mg/5 mL), administer 90 mg/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 contains the artificial sweetener aspartame, which is metabolized to phenylalanine in the body, so it should not be used by patients with the hereditary condition phenylketonuria. Additionally, the daily intake of aspartame included in this medication should be limited to below the WHO recommended amount and as minimal as possible. Patients who have shown hypersensitivity to this medication or other beta-lactam antibiotics, those with infectious mononucleosis or lymphocytic leukemia, or those who have had liver dysfunction due to this medication or penicillin should not be administered this medication. Since it contains lactose, patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also refrain from using this medication. Patients with impaired liver function or moderate to severe kidney impairment should use this medication with caution, as the blood concentration may increase, and administration intervals may need adjustment. Caution is also required for patients who are allergic, those who have difficulty with oral intake, the elderly, and those in poor general health. Generally, this medication has good tolerability, but side effects such as diarrhea, vomiting, rash, and contact dermatitis may occur, and in severe cases, administration should be discontinued. Gastrointestinal adverse reactions may include diarrhea, gastritis, vomiting, and abdominal pain, while liver function abnormalities are rarely reported, requiring regular liver function tests. Rarely, severe allergic or hypersensitivity reactions may occur; if symptoms such as rash or difficulty breathing appear, consult a healthcare professional immediately. Hematological adverse reactions such as leukopenia and thrombocytopenia have been reported, so caution is advised if abnormal symptoms appear. This medication may affect kidney function, so patients with kidney disease need regular monitoring. If diarrhea occurs during or after antibiotic use, there may be a risk of pseudomembranous colitis, requiring immediate discontinuation and medical attention. This medication may interact with other drugs; patients currently taking medication should inform their healthcare providers, especially when taking anticoagulants, anti-inflammatory drugs, or oral contraceptives. Pregnant women or those who could become pregnant are advised not to use this medication during the first three months of pregnancy, and caution is also needed during breastfeeding as side effects may occur in infants. The safety of this medication has not been established in infants under three months. Shake well before use and store refrigerated after preparation, using it within 7 days. Keep out of reach of children and store in a dry place below 25 degrees Celsius. In cases of overdose, symptoms such as gastrointestinal symptoms, electrolyte imbalance, rash, and drowsiness may occur, requiring immediate cessation and healthcare intervention. This medication should only be used to treat bacterial infections, as it has no effect on viral infections, making it essential to take as prescribed.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mouth/eyes mucosa, difficulty in breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headache, seizures, consciousness confusion, visual disturbances, paralysis.

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, dark tongue, nausea, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, candidiasis, antibiotic-induced colitis, itching, erythema multiforme, drug reaction (DRESS), serum sickness syndrome, hypersensitivity vasculitis, acute generalized exanthematous pustulosis, bronchospasm with respiratory distress.

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

Storage

This medication is sensitive to air and moisture, so it must be kept in a closed container. A suitable storage temperature is between 1 and 25 degrees Celsius in a cool, dry place to maintain the medication’s efficacy for a long time.

Appearance and packaging

Appearance

A powder that is white to pale yellowish in color with a peculiar smell, used as a syrup that dissolves when taken.

Package unit

50 milliliters per 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.