Medication info

Aiklan Syrup (Amoxicillin and Clavulanate Potassium)

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Amoxicillin Hydrate›21.6248g / 100gDilute Potassium Clavulanate›5.4062g / 100g
Manufacturer / importer
(주)보령바이오파마
Appearance
A whitish powder with a characteristic odor, this is a syrup to be dissolved and used.
Packaging
50 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 201803013 · Notified 2018.07.20

This product's status changed to Approval withdrawn on 2025.01.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of bacterial infections such as respiratory infections (bronchitis, pneumonia) and urinary tract infections (cystitis, pyelonephritis).
Who takes it
Adults · Children
Adult dose
For mild to moderate infections such as recurrent tonsillitis, upper respiratory infections, lower respiratory infections, urinary tract infections, and skin and soft tissue infections, take 20 mg/5 mg per kg of body weight divided into three doses daily. For severe infections such as otitis media, sinusitis, lower respiratory infections such as bronchopneumonia, and urinary tract infections, take 40 mg/10 mg per kg of body weight divided into three doses daily. To minimize potential gastrointestinal intolerance, it is advised to take the medication at the beginning of meals.
Child dose
There is insufficient clinical data on the use of the 4:1 syrup for infants under 2 months of age.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment of bacterial infections such as respiratory infections (bronchitis, pneumonia) and urinary tract infections (cystitis, pyelonephritis).

  • Acute bronchitis
  • chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
View approved original text

This medication is used to treat various infections caused by bacteria. It is effective not only for respiratory infections such as acute and chronic bronchitis and pneumonia but also for urinary tract infections such as cystitis, urethritis, and pyelonephritis. It is also used to treat sexually transmitted infections such as gonorrhea and pelvic inflammatory disease, as well as skin infections such as boils, abscesses, soft tissue infections, and wound infections. It can also be applied to osteomyelitis and dental infections, assisting in the treatment of a broad range of bacterial infections. Thus, it plays a crucial role in aiding the recovery of patients' health through the treatment of various bacterial infections.

How to take

Adult dose

For mild to moderate infections such as recurrent tonsillitis, upper respiratory infections, lower respiratory infections, urinary tract infections, and skin and soft tissue infections, take 20 mg/5 mg per kg of body weight divided into three doses daily. For severe infections such as otitis media, sinusitis, lower respiratory infections such as bronchopneumonia, and urinary tract infections, take 40 mg/10 mg per kg of body weight divided into three doses daily. To minimize potential gastrointestinal intolerance, it is advised to take the medication at the beginning of meals.

Child dose

There is insufficient clinical data on the use of the 4:1 syrup for infants under 2 months of age.

Precautions

This medication contains the artificial sweetener aspartame, so it should not be used in patients with phenylketonuria, a genetic disorder. Additionally, it should not be administered to patients with a history of hypersensitivity to this medication or beta-lactam antibiotics, patients with infectious mononucleosis or lymphocytic leukemia, patients with a history of liver dysfunction, and patients with genetic problems such as lactose intolerance. Patients with impaired liver function or moderate to severe renal impairment, allergic individuals, elderly patients, and those with gastrointestinal diseases should use this medication cautiously. Gastrointestinal symptoms such as diarrhea, vomiting, abdominal pain, etc. may occur, and rarely, symptoms such as pseudomembranous colitis, liver dysfunction, skin rashes, blood abnormalities, renal impairment, and central nervous system symptoms may occur, so immediate consultation with medical personnel is required if adverse symptoms appear. Long-term use of this medication may lead to the development of resistant bacteria, so it should only be used for the minimum necessary duration for treatment, and it is important to regularly check liver and renal functions. Patients who are allergic to penicillin class drugs or who have experienced severe hypersensitivity reactions in the past should be particularly cautious, and after administration, they should be closely monitored for the occurrence of serious allergic reactions such as anaphylactic shock. This medication may interact with other drugs, so patients taking anticoagulants, certain antibiotics, anti-inflammatory medications, and oral contraceptives should inform their healthcare provider and use it carefully. Women who are pregnant or may become pregnant should consult a physician before using this medication, especially during the first trimester of pregnancy, as it is advisable to avoid its use. Breastfeeding mothers should also be cautious as this medication may cause diarrhea or skin rashes in infants when taken. In pediatric patients, especially in newborns or premature infants under 2 months of age, safety has not been established, so caution is advised when using it. Elderly patients may experience more severe adverse reactions due to declining renal function, so dosage and intervals should be adjusted and administered cautiously. This medication should be refrigerated after preparation and used within 7 days, and it is important to shake well before administration. In cases of overdose, gastrointestinal symptoms or renal impairment and neurological abnormalities may occur, so administration should be stopped immediately and appropriate treatment sought. Finally, if unusual symptoms such as diarrhea, abdominal pain, or skin rashes occur while using this medication, immediate notification of medical personnel is necessary to receive appropriate care.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylactic shock, mucosal and skin syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), blistering exfoliative dermatitis, acute generalized exanthematous pustulosis, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, mucous membrane pain in the mouth/eyes, liver abnormalities (jaundice), sudden and severe headaches, seizures, consciousness.

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, decreased appetite, abdominal pain, bloating, constipation, colonic pain, acid reflux, soft stools, dry mouth, hepatitis, cholestatic jaundice, itching, erythema multiforme, skin rash, dermatitis, serum sickness symptoms (fever, rash, arthralgia, swelling, lymphadenopathy), blood abnormalities (leukopenia, thrombocytopenia, anemia, thrombocytosis, bone marrow suppression), mucosal.

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

Storage

This medication should be kept in a tightly sealed container to prevent moisture, and stored in a cool, dry place below 25 degrees Celsius to maintain its effectiveness. Care should be taken as the components of the medication may degrade in humid or high-temperature areas.

Appearance and packaging

Appearance

A whitish powder with a characteristic odor, this is a syrup to be dissolved and used.

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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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.