Medication info
Amosicle Tablet 375 mg (Amoxicillin-Potassium Clavulanate (2:1))

Amosicle Tablet 375 mg (Amoxicillin-Potassium Clavulanate (2:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White or nearly white oval film-coated tablet
Packaging
80 tablets (8 tablets/PTP × 10), 100 tablets (10 tablets/PTP × 10)
Approval status
Active

MFDS item code 201303029 · Approved 2013.01.31 · Insurance code 657202440

Summary

Main use
Treatment of bacterial infections (respiratory, urinary) and relief of inflammation
Who takes it
Adults · Children
Adult dose
For adults and children 12 years and older or weighing 40 kg or more, the dosage is 250 mg/125 mg of amoxicillin/potassium clavulanate, taken orally three times a day at 8-hour intervals. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: every 12 hours
Child dose
For children under 12 years or weighing less than 40 kg, the dosage is adjusted to be administered similarly to adults.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of bacterial infections (respiratory, urinary) and relief of inflammation

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

This medication is effective against various bacterial infections such as Staphylococcus aureus, coagulase-negative staphylococci, and Streptococcus pneumoniae. It is used to treat respiratory infections like acute and chronic bronchitis, pneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also effective against urinary tract infections such as cystitis, urethritis, and pyelonephritis, and is used in the treatment of pelvic infections and sexually transmitted diseases like gonorrhea. It can be utilized for abscesses,furuncles, cellulitis, wound infections, osteomyelitis, and dental infections. It is widely applicable to various infections, helping to improve symptoms in patients.

How to take

Adult dose

For adults and children 12 years and older or weighing 40 kg or more, the dosage is 250 mg/125 mg of amoxicillin/potassium clavulanate, taken orally three times a day at 8-hour intervals. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance 10 to 30 mL/min: every 12 hours

Child dose

For children under 12 years or weighing less than 40 kg, the dosage is adjusted to be administered similarly to adults.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with a history of hypersensitivity to penicillins or cephalosporins. Particularly, patients with infectious mononucleosis or lymphocytic leukemia are at higher risk of rash and should be monitored closely. Patients with impaired liver function may experience a recurrence of symptoms if this medication is used, thus it should be avoided. Patients with liver dysfunction should use caution as the drug may exacerbate liver function. Patients with moderate to severe renal impairment may require dosage adjustments due to the medication remaining in the body longer and causing side effects. Patients with allergies or a family history of allergies should be cautious due to the risk of hypersensitivity. Patients who have difficulty swallowing or the elderly, as well as those in poor general health, may be at risk of bleeding due to vitamin K deficiency and should be monitored. Patients with gastrointestinal diseases accompanied by vomiting or diarrhea may not absorb the medication well. Gastrointestinal side effects may include diarrhea, abdominal pain, and vomiting, and in severe cases, pseudomembranous colitis may occur; therefore, medication should be stopped immediately if symptoms arise. Liver function abnormalities may develop, especially in the elderly or males, necessitating liver function tests. Serious skin reactions or anaphylactic shock may rarely occur, so any signs of rash, itching, or difficulty breathing should be reported to healthcare professionals immediately. Hematological side effects such as leukopenia and anemia are rarely reported, hence regular blood tests are recommended. Central nervous system side effects such as anxiety, drowsiness, and seizures may occur rarely, and extra caution is needed for patients with renal impairment. During medication use, serious diarrhea symptoms such as pseudomembranous colitis may appear, so if diarrhea or abdominal pain is severe, consulting healthcare professionals immediately is advised. This medication can interact with other drugs, so patients taking anticoagulants, anti-inflammatory drugs, or oral contraceptives should discuss with their physician. It is advisable for women in early pregnancy to avoid using this medication, and caution should be exercised during breastfeeding due to potential side effects in the baby. It is not recommended for children under 12 years or those weighing under 40 kg. Elderly individuals have a higher risk of side effects due to decreased bodily functions, so dosage and administration intervals should be adjusted with monitoring. Overdosing may lead to gastrointestinal symptoms or renal dysfunction, so if symptoms occur, medication should be stopped immediately, and appropriate treatment should be sought. This medication should be stored in a dry place at temperatures below 25 degrees Celsius and according to the exact usage and dosage as prescribed by a physician.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blistering, peeling skin, painful mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal bloating
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  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • bloody stools
  • vomiting
  • pseudomembranous colitis
  • elevated AST
  • ALT
  • ALP
  • LDH
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucous membrane syndrome
  • toxic epidermal necrolysis
  • vesicular exfoliative dermatitis
  • acute

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 moisture and air from entering, preferably in a cool place at a temperature between 1 and 25 degrees Celsius. This will help maintain the efficacy of the medication.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablet

Package unit

80 tablets (8 tablets/PTP × 10), 100 tablets (10 tablets/PTP × 10)

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.