Medication info

Omecle Neo Syrup (Amoxicillin Hydrate - Potassium Clavulanate)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
A syrup preparation in the form of a white to light yellow powder with a distinctive odor that is dissolved before use.
Packaging
50 mL/bottle
Approval status
Active

MFDS item code 201500217 · Notified 2015.01.15 · Insurance code 671704451

Summary

Main use
Treatment effect for recurrent acute otitis media and acute sinusitis
Who takes it
Adults · Children
Adult dose
The experience of using this medicine in adults is lacking. To minimize the possibility of gastrointestinal disturbance, this medicine is administered at the beginning of meals. When administered at the beginning of meals, the absorption of potassium clavulanate is increased.
Child dose
Children over 3 months: The dosage is based on amoxicillin content (600 mg/5 mL) at 90 mg/kg/day divided into doses every 12 hours, with 10 days for acute otitis media and 7 days for acute sinusitis.

Ingredients

Manufacturer
주식회사제뉴원사이언스

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 mainly used for the treatment of recurrent or persistent acute otitis media and recurrent acute sinusitis in pediatric patients. It is particularly suitable for children under 2 years old or those attending daycare who have a history of antibiotic use for acute otitis media or acute sinusitis within the past 3 months. It is effective against common pathogens such as Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains). By treating infections caused by these strains, it helps to improve symptoms and facilitate recovery in children.

How to take

Adult dose

The experience of using this medicine in adults is lacking. To minimize the possibility of gastrointestinal disturbance, this medicine is administered at the beginning of meals. When administered at the beginning of meals, the absorption of potassium clavulanate is increased.

Child dose

Children over 3 months: The dosage is based on amoxicillin content (600 mg/5 mL) at 90 mg/kg/day divided into doses every 12 hours, with 10 days for acute otitis media and 7 days for acute sinusitis.

Precautions

This medicine contains the artificial sweetener aspartame, so patients with phenylketonuria should not take this medicine. The intake of aspartame should be minimized to not exceed the recommended amount by WHO, and in the case of a 60 kg adult, it should not exceed 2.4g per day. Patients with hypersensitivity to any ingredients of this medicine or beta-lactam antibiotics should not take this medicine, and particularly, patients with infectious mononucleosis or lymphocytic leukemia should avoid it due to the risk of skin rash. Patients who have experienced liver dysfunction or jaundice in the past due to this medicine or penicillin should not be administered as there is a risk of recurrence. This medicine contains lactose, so it should not be administered to patients with lactose intolerance, galactose intolerance, or glucose-galactose malabsorption. Patients with impaired liver function should use this medicine with caution, and for those with moderate to severe renal impairment, the dosing interval should be extended. Patients with a history of allergies or those with easily appearing symptoms such as bronchial asthma, skin rashes, or urticaria should use this medicine with caution. Patients who have difficulty with oral intake, elderly patients, or those in poor condition should be careful as vitamin K deficiency symptoms may occur. Patients with digestive diseases accompanied by vomiting or diarrhea should be cautious as the medication may not be properly absorbed. Generally, this medicine has good tolerability, but side effects such as contact dermatitis, diarrhea, vomiting, rashes, etc. may occur, and in severe cases, administration should be stopped. Gastrointestinal side effects may include diarrhea, gastritis, vomiting, abdominal pain, with a higher incidence in infants under 2 years old. Liver function abnormalities may rarely occur and are more frequent in the elderly or males, so regular monitoring of liver function is recommended. Allergic reactions may feature itching, skin rashes, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome, so immediate consultation with medical personnel is necessary if symptoms arise. Hematologic abnormalities such as leukopenia, thrombocytopenia, and hemolytic anemia have been rarely reported; any abnormal symptoms should be confirmed. Neurological abnormalities may include anxiety, confusion, seizures, and more caution is needed in patients with reduced renal function. Renal adverse reactions of acute renal failure or nephritis may occur, necessitating regular renal function tests. This medicine may affect the intestinal flora, potentially leading to fungal infections like candidiasis. Long-term use may lead to vitamin K deficiency symptoms, so caution is advised for patients with bleeding tendencies. As an antibiotic, this medicine is ineffective against viral infections, and even if symptoms improve during treatment, it is essential to continue taking it for the prescribed duration. The solution must be shaken well before use, stored in the refrigerator after preparation, and used within 7 days. Pregnant women or those who may become pregnant should particularly avoid taking this medicine during the first trimester, and caution should be exercised while breastfeeding, as it may cause adverse effects in infants. This medicine should not be used in pediatric patients, especially infants under 3 months, as safety and efficacy have not been established. There may be interactions with other medications, so patients should inform their healthcare provider if they are taking any other medications, particularly with anticoagulants or certain antibiotics. In cases of overdose, gastrointestinal symptoms, renal damage, and seizures may occur, requiring immediate medical attention. This medicine should be kept out of reach of children and stored in a dry place below 25 degrees Celsius. Patients should follow the doctor's instructions accurately and consult medical personnel immediately if any abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine changes

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, anorexia, abdominal pain, abdominal distention, constipation, colonic pain, hyperacidity, loose stools, dry mouth, candidiasis, cholestatic jaundice, hepatitis, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, serum sickness, overdose

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

Storage

This medicine is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool, dry place between 1 to 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A syrup preparation in the form of a white to light yellow powder with a distinctive odor that is dissolved before use.

Package unit

50 mL/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.

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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.