Medication info

Myungmoon Amoclavan Neo Syrup (Amoxicillin-Clavulanate Potassium 14:1)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
명문제약(주)
Appearance
A syrup preparation that is white or slightly yellow powder to be dissolved for use.
Packaging
50 milliliters/bottle
Approval status
Active

MFDS item code 202001109 · Notified 2020.02.18 · Insurance code 649807541

Summary

Main use
Treatment effect for recurrent (acute otitis media, 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 of age: Based on the content of amoxicillin (600 mg/5 mL), administer 90 mg/kg/day divided every 12 hours; for acute otitis media for 10 days and for acute sinusitis for 7 days.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Treatment effect for recurrent (acute otitis media, acute sinusitis)

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

This medication is used to treat recurrent or persistent acute otitis media and acute sinusitis in pediatric patients. It is particularly effective for children under the age of 2 who have had antibiotic treatment for acute otitis media or acute sinusitis within the last 3 months, or for children attending daycare. It is also effective against major bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. These properties help in the treatment of otitis media and sinusitis in children.

How to take

Adult dose

There is no experience with this medication in adults.

Child dose

For pediatric patients over 3 months of age: Based on the content of amoxicillin (600 mg/5 mL), administer 90 mg/kg/day divided every 12 hours; for acute otitis media for 10 days and for acute sinusitis for 7 days.

Precautions

This medication should not be administered to patients with a history of allergy or hypersensitivity to penicillin or cephalosporin antibiotics. Caution is necessary for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as the risk of rash may increase. Patients with liver dysfunction or a history of jaundice should avoid this medication, as symptoms may recur upon taking it. This medication contains lactose, so individuals with genetic problems such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use it. Patients with impaired liver or renal function may require careful dosage adjustment and monitoring of administration intervals, as drug concentrations may increase. Patients with allergic tendencies, bronchial asthma, skin rashes, or hives should be administered this medication with caution. Patients who have difficulty swallowing orally, such as elderly individuals with poor nutritional status, should be cautious as symptoms of vitamin K deficiency may appear. Patients with gastrointestinal diseases may experience unstable drug absorption, so their conditions should be closely monitored. This drug generally has good tolerance, but side effects such as diarrhea, vomiting, skin rashes, and contact dermatitis may occur. Serious intestinal disorders such as pseudomembranous colitis may occur, so if severe diarrhea or abdominal pain develops, the medication should be discontinued immediately and a physician consulted. Liver function abnormalities may develop, so regular liver function tests are recommended for prolonged treatment. Rarely, serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur; therefore, the medication should be discontinued immediately if any skin abnormalities arise. Blood-related adverse reactions such as leukopenia and thrombocytopenia have been reported, and periodic blood examinations may be required. Central nervous system issues such as anxiety, confusion, and seizures may rarely occur, necessitating close observation for any neurological symptoms. Kidney function abnormalities may arise, so regular renal function tests should be conducted, and discontinuation should be considered if any abnormalities are found. Like other antibiotics, this medication can disrupt the balance of intestinal flora, leading to the risk of fungal infections or candidiasis. There may be a tendency for bleeding associated with vitamin K deficiency; thus, any bleeding symptoms should be reported immediately. Use should be avoided during the first trimester of pregnancy, and during pregnancy it should be administered only if the benefits outweigh the risks, as judged by the physician. Breastfeeding women should discontinue use if the baby exhibits diarrhea or skin rashes, as the medication can be transmitted to breast milk in small amounts. Use in infants under 3 months is not recommended as safety and efficacy have not been established. Any allergic symptoms such as diarrhea, rashes, or difficulty breathing occurring during medication should be reported to medical personnel immediately. The prescribed duration and dosage should be strictly adhered to, as arbitrary discontinuation or skipping doses may reduce therapeutic effects and increase the risk of resistant bacteria. This medication may interact with other drugs, so any other medications being taken should be reported to medical personnel. Shake the medication well before use to ensure uniform mixture, and store in the refrigerator after preparation, consuming it within 7 days. Overdosage may lead to gastrointestinal symptoms, kidney damage, and seizures, so contact medical personnel immediately for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory anomalies accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, and others.

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rashes, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic discomfort, gastric acid increase, soft stools, dry mouth, elevated AST, ALT, ALP, LDH, elevated serum bilirubin, hepatitis, cholestatic jaundice, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, and others.

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

Storage

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

Appearance and packaging

Appearance

A syrup preparation that is white or slightly yellow powder to be dissolved for use.

Package unit

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

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.