Medication info

Clamoxen Neo Syrup (Amoxicillin-Potassium Clavulanate (14:1))

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Amoxicillin Hydrate›54.55g / 100gDilute Potassium Clavulanate›3.9g / 100g
Manufacturer / importer
엔비케이제약(주)
Appearance
A syrup that dissolves in water with a peculiar odor, in the form of a white to pale yellow powder
Packaging
50 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 201906647 · Notified 2019.09.23

This product's status changed to Approval withdrawn on 2023.10.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in treating recurrent acute otitis media and acute sinusitis in children
Who takes it
Children
Child dose
For pediatric patients over 3 months: Based on the amoxicillin content (600 mg/5 mL), take 90 mg/kg/day divided into two doses every 12 hours. For acute otitis media, treat for 10 days; for acute sinusitis, treat for 7 days.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Effectiveness in treating 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 for the treatment of recurrent or persistent acute otitis media and acute sinusitis in pediatric patients. It is particularly effective in children under 2 years of age who have received antibiotics for these conditions within the last 3 months, as well as those attending daycare. This medication effectively treats several harmful bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Therefore, it helps improve the symptoms of acute otitis media and acute sinusitis in pediatric patients with these conditions.

How to take

Child dose

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

Precautions

This medication contains the artificial sweetener aspartame, which breaks down into phenylalanine in the body. Hence, it should not be used in patients with the genetic disorder phenylketonuria. The daily intake of aspartame in this medication should be managed to not exceed the recommended daily amount by WHO, and for a 60 kg adult, it should not exceed a maximum of 2.4 g per day. Caution should be exercised when administering this medication to patients with known allergies to its components or beta-lactam antibiotics, those with infectious mononucleosis or lymphocytic leukemia, those with a history of liver dysfunction or jaundice, and those with lactose intolerance or other genetic issues. Patients with impaired liver function or severe renal disease should use this medication cautiously, and those with allergic tendencies, older adults, or those in poor general condition may be at risk for vitamin K deficiency and should be monitored closely. This medication may cause gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain, and in rare cases, liver disease such as hepatitis or cholestatic jaundice may occur. Symptoms of liver dysfunction may arise during or after treatment, so careful observation is necessary. Furthermore, severe allergic reactions such as rash, urticaria, Stevens-Johnson syndrome, or others may appear, and any unusual symptoms should prompt immediate discontinuation and consultation with a physician. Blood abnormalities may also occur infrequently, and neurological symptoms such as dizziness, headaches, and seizures have been reported, so caution should be taken if these symptoms appear. This medication can affect kidney function; hence, patients with renal impairment should undergo regular testing, and in cases of overdose, gastrointestinal symptoms such as vomiting, diarrhea, and abdominal pain may accompany the risk of kidney damage, necessitating proper hydration and management. This medication may interact with other drugs, so patients taking anticoagulants, certain antibiotics, anti-inflammatory drugs, etc., should definitely inform their doctor. Women who are pregnant or nursing should weigh the risks and benefits when using this medication, especially avoiding use during the first trimester of pregnancy. This medicine should not be used in infants under 3 months as safety and efficacy have not been established. Lastly, this medication is ineffective for viral infections and should only be used for treating bacterial infections, and it must be taken exactly as prescribed regarding the duration and dosage. The medication should be shaken well before use and stored in the refrigerator after preparation and used within 7 days.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blistering, skin peeling, pain in oral/ocular mucosa, wheezing or difficulty breathing, asthma attack, respiratory distress with cough and fever, jaundice or yellowing of skin/eyes, a feeling of extreme fatigue throughout the body, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

Contact dermatitis, diarrhea, vomiting, moniliasis, rash, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, hyperacidity, melena, dry mouth, elevated liver enzymes (AST, ALT, ALP, LDH, serum bilirubin), hepatitis, cholestatic jaundice, itching, erythema multiforme, serum sickness symptoms, hypersensitivity vasculitis, acute generalized exanthematous pustulosis

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 tightly closed container. Additionally, it must be kept in a cool and dry place between 1 to 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A syrup that dissolves in water with a peculiar odor, in the form of a white to pale yellow powder

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

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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.