Medication info

Moxicle Neo Syrup 14:1 (Amoxicillin·Clavulanate Potassium)

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
(주)대웅제약
Appearance
A syrup formulation that dissolves when used, appearing as a white to pale yellowish powder with a distinctive smell.
Packaging
50mL x 1 bottle
Approval status
Approval withdrawn

MFDS item code 201502478 · Notified 2015.04.27

This product's status changed to Approval withdrawn on 2025.03.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effective for the treatment of recurrent acute otitis media and acute sinusitis in children.
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 dosage (600 mg/5 mL), 90mg/kg/day divided into 12-hour intervals, administered for 10 days for acute otitis media, or for 7 days for acute sinusitis.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Effective for the treatment of recurrent acute otitis media and acute sinusitis in children.

  • 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 suitable for children who have previously taken antibiotics for acute otitis media or acute sinusitis within the last 3 months, or are under 2 years of age, or are attending daycare. This medication effectively treats bacterial infections such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Therefore, it is very useful for treating recurrent acute 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: Based on amoxicillin dosage (600 mg/5 mL), 90mg/kg/day divided into 12-hour intervals, administered for 10 days for acute otitis media, or for 7 days for acute sinusitis.

Precautions

This medication contains the artificial sweetener aspartame, and should not be used in patients with phenylketonuria, a genetic disorder. The intake of aspartame must be limited to less than 40mg/kg per day, with a maximum of 2.4g per day for adults. Patients with hypersensitivity to any ingredient of this medication or beta-lactam antibiotics should not be administered this medication. Patients with infectious mononucleosis or lymphoblastic leukemia should avoid use due to the risk of rash. Patients who have previously experienced jaundice or liver dysfunction from this medication or penicillin should also avoid use. Since this medication contains lactose, patients with lactose intolerance or related genetic disorders should refrain from taking this medication. Patients with compromised liver function should use caution as their liver function may further deteriorate with this medication. Patients with moderate to severe renal impairment may experience increased plasma drug concentrations and dosage intervals should be adjusted. Patients with allergic tendencies or a history of bronchial asthma, rashes, or urticaria should use with caution. Patients who have difficulty taking orally, elderly patients, and those with poor general condition are at risk of symptoms of vitamin K deficiency and should be closely monitored. Patients with gastrointestinal diseases that include vomiting or diarrhea may experience inadequate drug absorption. This medication is generally considered safe, but side effects such as diarrhea, vomiting, skin rashes, contact dermatitis may occur. If symptoms are severe, consult a physician. Rare but serious side effects may occur, such as liver dysfunction, hypersensitivity reactions, blood disorders, renal issues, or central nervous system abnormalities. If any adverse symptoms appear, discontinue use immediately and inform healthcare professionals. During antibiotic treatment, it is important to perform susceptibility testing to prevent the emergence of resistant bacteria and to administer the medication only for the necessary duration. Patients with a history of hypersensitivity to penicillin-class drugs may experience severe allergic reactions, so it is essential to confirm their medical history before administration. This medication is not effective against viral infections and should only be used for bacterial infections. Even if symptoms improve, it should be taken consistently for the prescribed duration. Shake well before use and refrigerate after preparation. Use within 7 days. The safety of this medication in pregnant women or during early pregnancy has not been established, so it should be used with caution only if necessary, and during lactation, attention should be paid since side effects may affect the baby. It is advisable to avoid use in children under 3 months of age as safety has not been confirmed. There may be interactions with other medications, so it is essential to inform the physician or pharmacist of any currently taken medications. In case of overdose, gastrointestinal symptoms, kidney problems, or seizures may occur, and immediate medical attention should be sought. Keep out of reach of children and store in a dry place at or below 25 degrees Celsius; avoid transferring to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headaches, lightning-like headaches, seizures, confusion, vision changes, paralysis, markedly reduced urine output

Mild side effects

Diarrhea, vomiting, contact dermatitis, rash, itching, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, rarely observed anxiety, restlessness, behavioral changes, confusion, drowsiness, insomnia, dizziness, headache, malaise, taste disturbances, mucosal candidiasis, vaginal itching, increased secretions, stomatitis, candidiasis, tooth discoloration, symptoms of vitamin K deficiency, symptoms of vitamin B group deficiency, bleeding

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, ideally in a dry place between 1 to 25 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A syrup formulation that dissolves when used, appearing as a white to pale yellowish powder with a distinctive smell.

Package unit

50mL x 1 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.