Medication info

Ogmennneo Syrup (Amoxicillin and Clavulanate Potassium (14:1))

Prescription medicationApproval withdrawn
Ingredient · strength
Amoxicillin Hydrate›Strength being verifiedDilute Potassium Clavulanate›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
A syrup preparation that dissolves in water, appearing as a bright white powder with a distinctive odor.
Packaging
50mL/bottle
Approval status
Approval withdrawn

MFDS item code 201804494 · Notified 2018.11.12

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of recurrent acute otitis media and acute sinusitis (in children with risk factors)
Who uses it
Children
Children's dosage
For pediatric patients aged 3 months and older, the recommended dosage is based on amoxicillin content (600 mg/5 mL) at 90mg/kg/day, divided into doses every 12 hours. Administer for 10 days for acute otitis media, and for 7 days for acute sinusitis.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Treatment of recurrent acute otitis media and acute sinusitis (in children with risk factors)

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

This medication is primarily used for the treatment of recurrent or persistent acute otitis media and recurrent acute sinusitis in pediatric patients. It is particularly effective in children under two years of age who have been treated with antibiotics for these conditions within the past three months or who attend daycare. The drug acts on strains such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and is also effective against beta-lactamase producing strains. This efficacy helps improve inflammatory infections in children.

Dosage and Administration

Children's dosage

For pediatric patients aged 3 months and older, the recommended dosage is based on amoxicillin content (600 mg/5 mL) at 90mg/kg/day, divided into doses every 12 hours. Administer for 10 days for acute otitis media, and for 7 days for acute sinusitis.

Precautions

This medication contains the artificial sweetener aspartame, and should not be administered to patients with certain genetic disorders such as phenylketonuria. Additionally, it should be avoided in patients with a history of hypersensitivity to this medication or beta-lactam antibiotics, infectious mononucleosis, lymphocytic leukemia, liver dysfunction, and genetic issues such as lactose intolerance. Patients with liver or kidney problems should use this medication cautiously, and those with allergic tendencies or poor general health should also take care. This medication can cause gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain, and may rarely lead to liver dysfunction, severe skin reactions, blood abnormalities, or kidney issues. Serious gastrointestinal diseases such as pseudomembranous colitis may occur during antibiotic use, so if diarrhea or abdominal pain is severe, consult a doctor immediately. Additionally, as this medication is a penicillin-type antibiotic, patients with a history of allergy to penicillin or cephalosporins should inform their physician. Pregnant or breastfeeding women should use this medication cautiously only when necessary, especially avoiding it during the first three months of pregnancy. The safety of this medication has not been established in infants under three months of age, so it should not be used. It is important to adhere to the prescribed dosage and guidelines when taking medications, and to regularly monitor liver and kidney functions during treatment. Additionally, this medication may interact with other drugs, so inform your healthcare provider of any other medications you are taking. This medication should be stored in a closed container after preparation and used within 7 days; it should be shaken well before use. In case of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, and in severe cases, kidney dysfunction or seizures may arise, necessitating immediate medical assistance.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, breathlessness or difficulty breathing, asthma attack, cough with respiratory distress and fever, yellowing of the skin or eyes (jaundice), profound fatigue throughout the body, sudden and severe headache, lightning headache, seizure, confusion, 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 bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, increased serum bilirubin, hepatitis, elevated AST, ALT, ALP, LDH, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, rash

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a sealed container. Additionally, it should be kept in a dry place at a temperature between 1 and 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A syrup preparation that dissolves in water, appearing as a bright white powder with a distinctive odor.

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.