Medication info

Amocrane Syrup (Amoxicillin – Clavulanate Potassium 14:1)

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›54.545g / 100gDilute Potassium Clavulanate›7.8g / 100g
Manufacturer / importer
건일제약(주)
Appearance
A syrup in white or pale yellow powder form, to be dissolved before use.
Packaging
50mL/bottle
Approval status
Active

MFDS item code 201900779 · Notified 2019.01.31 · Insurance code 646802891

Summary

Main use
Effectiveness for recurrent acute otitis media and acute sinusitis treatment
Who takes it
Adults · Children
Adult dose
There is no experience with this medication in adults. To minimize the possibility of gastrointestinal disturbances, it should be taken at the beginning of meals. Taking it at the beginning of meals increases the absorption of clavulanate potassium.
Child dose
For children over 3 months, the Amoxicillin dosage is based on the amount of Amoxicillin (600 mg/5 mL) at 90 mg/kg/day divided into 12-hour intervals. For acute otitis media, the treatment duration is 10 days, and for acute sinusitis, it is 7 days.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Effectiveness for recurrent acute otitis media and acute sinusitis treatment

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

This medicine is 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 the age of two or those attending daycare, who have received antibiotics within the last three months. It is also effective against bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. It is helpful in the treatment of infections in pediatric patients with these conditions.

How to take

Adult dose

There is no experience with this medication in adults. To minimize the possibility of gastrointestinal disturbances, it should be taken at the beginning of meals. Taking it at the beginning of meals increases the absorption of clavulanate potassium.

Child dose

For children over 3 months, the Amoxicillin dosage is based on the amount of Amoxicillin (600 mg/5 mL) at 90 mg/kg/day divided into 12-hour intervals. For acute otitis media, the treatment duration is 10 days, and for acute sinusitis, it is 7 days.

Precautions

This medication is a penicillin-class antibiotic and should not be given to patients with hypersensitivity to beta-lactam drugs or those who have experienced severe allergic reactions in the past. Caution is necessary for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as the risk of side effects such as rashes is elevated. Patients with a history of liver dysfunction or jaundice should use this medication carefully, as symptoms may recur upon taking it. Patients with lactose intolerance or genetic lactose metabolism disorders should not take this medication due to the lactose it contains. Patients with impaired liver function or severe renal impairment may have increased drug concentration, so the dosage interval should be adjusted or used cautiously. Patients with allergic predispositions, bronchial asthma, or those who easily develop symptoms such as rashes or hives should take this medication with caution. Patients who have difficulties in oral intake, poor nutritional status, or elderly individuals should be careful, as vitamin K deficiency symptoms may occur. Patients experiencing gastrointestinal symptoms such as vomiting or diarrhea should be cautious as drug absorption may be inadequate. This medication generally has few side effects, but diarrhea, vomiting, skin rashes, and contact dermatitis may occur. Liver dysfunction, acute pancreatitis, and rarely, serious skin reactions or blood abnormalities have also been reported; if symptoms appear, consult a doctor immediately. Exceeding the prescribed dose may lead to gastrointestinal symptoms, kidney issues, or seizures, so it is important to adhere to the specified dosage. During antibiotic use, serious intestinal diseases like pseudomembranous colitis may occur; thus, if diarrhea or abdominal pain worsen, cease use immediately and seek medical attention. Pregnant women in early stages or during pregnancy should carefully consider the risks and benefits of using this medication; breastfeeding women should be cautious as side effects may appear in infants. The safety and efficacy of this medication have not been established in infants under three months, and its use is not recommended in this population. Some clinical test results may be affected during medication use; therefore, inform the testing personnel that this medication is being taken. Interactions with other medications may occur, so especially patients taking anticoagulants, anti-inflammatory drugs, or oral contraceptives should consult a physician or pharmacist before use. This medication should only be used for infection treatment and is not effective against viral infections; therefore, unnecessary use should be avoided. Before consumption, shake the medication well, store it in the refrigerator after preparation, and use it within 7 days. It is important to keep this medication out of children's reach and to avoid exposure to direct sunlight and high temperatures during storage.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucous membranes (severe skin abnormal reaction), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy (liver abnormalities), sudden and severe headache.

Mild side effects

Contact dermatitis (diaper rash), diarrhea, vomiting, moniliasis, rash, pseudomembranous colitis, indigestion, stomatitis, gastritis, glossitis, black hairy tongue, nausea, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, acid reflux, loose stools, dry mouth, candidiasis, antibiotic-associated colitis, itching, erythema multiforme, serum sickness-like syndrome, hypersensitivity vasculitis, acute generalized exanthematous pustulosis, respiratory distress with bronchospasm.

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

Storage

This medication can be sensitive to air and moisture; it should be stored in a tightly closed container. Additionally, it should be kept in a cool, dry place below 25 degrees to maintain its effectiveness.

Appearance and packaging

Appearance

A syrup in white or pale yellow powder form, to be dissolved before use.

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.