Medication info

Isilin Tablet 375 mg (Amoxicillin Trihydrate · Clavulanate Potassium)

Prescription medicationExpired
Ingredient · strength
Amoxicillin Hydrate›Strength being verifiedDilute Potassium Clavulanate›Strength being verified
Manufacturer / importer
삼익제약(주)
Appearance
White or almost white oval film-coated tablet
Packaging
8 tablets/PTP*10
Approval status
Expired

MFDS item code 201307120 · Approved 2013.04.30

This product's status changed to Expired on 2023.04.30. 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 and urinary tract infections
Who uses it
Adults · Children
Adult dosage
Adults and children over 12 years or weighing more than 40 kg: administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, three times daily every 8 hours. In cases of severe and respiratory infections, dosage may be increased to 500 mg/125 mg per dose. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. If creatinine clearance is between 10 and 30 mL/min: administer 250 mg to 500 mg of amoxicillin per dose every 12 hours.
Children's dosage
Administered in the same dosage as adults and children over 12 years old or weighing more than 40 kg; in children with renal impairment, dosage is adjusted similarly.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Treatment of bacterial infections such as respiratory and urinary tract infections

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

This medication is used for the treatment of acute and chronic bronchitis, pneumonia, cystitis, gonorrhea, skin and soft tissue infections, osteomyelitis, dental infections, etc., caused by various bacteria such as Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, and Neisseria gonorrhoeae. It is effective in broadly treating infections from the respiratory system to the urogenital system, skin, and dental infections. It can also be applied to various infectious diseases such as empyema, pelvic infections, and pyelonephritis. This drug is useful for treating infections in multiple areas as it can respond to complicated bacterial infections, improving patients' symptoms of infection and aiding recovery.

Dosage and Administration

Adult dosage

Adults and children over 12 years or weighing more than 40 kg: administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, three times daily every 8 hours. In cases of severe and respiratory infections, dosage may be increased to 500 mg/125 mg per dose. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. If creatinine clearance is between 10 and 30 mL/min: administer 250 mg to 500 mg of amoxicillin per dose every 12 hours.

Children's dosage

Administered in the same dosage as adults and children over 12 years old or weighing more than 40 kg; in children with renal impairment, dosage is adjusted similarly.

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with hypersensitivity to penicillin and cephalosporin drugs. Particularly in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, the risk of rash is higher. Patients with liver function problems should also be cautious as liver function impairment may recur upon taking this medication. Patients with poor liver function or moderately impaired kidney function may have an increased concentration of the drug, necessitating adjustment of the dosing interval or careful use. Patients with a history of allergies or who frequently experience asthma, skin rashes, or hives should also be cautious when using this medication. Patients with severe vomiting or diarrhea, those who have difficulty with oral intake, the elderly, and those in poor general health may show signs of vitamin K deficiency, requiring monitoring. This medication can cause various gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain, and in severe cases, serious colitis such as membranous colitis can occur, so if symptoms appear, use should be stopped immediately. Liver function abnormalities have been reported, particularly in elderly patients over 60 and men, so regular liver function tests during prolonged use are important. Severe skin reactions such as skin rashes and itching, and in severe cases, Stevens-Johnson syndrome can occur, requiring immediate cessation of the drug if such symptoms arise. Blood abnormalities such as leukopenia, thrombocytopenia, and anemia have been rarely reported and may require confirmation through blood tests. This medication may affect the central nervous system, leading to anxiety, drowsiness, and seizures; caution is advised, especially in patients with reduced kidney function or when taking high doses. Patients with severe renal impairment may experience acute renal failure or nephritis, necessitating regular testing. The use of antibiotics can reduce normal intestinal flora, leading to fungal infections or stomatitis, so consultation with a healthcare provider is advised if symptoms occur. This medication may also rarely cause bleeding tendency or symptoms of vitamin B deficiency due to vitamin K deficiency. It is advisable to avoid use during pregnancy, particularly in the first trimester, and during breastfeeding as it may affect the baby; usage should be discontinued if adverse reactions occur. It is not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients may experience adverse reactions more easily due to reduced bodily function, so dosage and administration intervals should be adjusted accordingly. While administering this medication, it may affect some clinical test results, so caution is advised during tests. In cases of overdose, gastrointestinal symptoms such as vomiting, diarrhea, and abdominal pain may occur, and rarely, central nervous system abnormalities or allergic reactions may present; in such cases, immediate medical attention is required. This medication should be stored in a dry place below 25 degrees Celsius, and to reduce the possibility of resistant bacteria during prolonged use, it is advisable to use it for the minimum necessary duration. Additionally, as there may be interactions with other medications, it is essential to consult with healthcare providers if any other medications are being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin adverse reactions, asthma attacks, respiratory issues with coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, thunderclap headache.

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal bloating
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  • constipation
  • colonic pain
  • acid reflux
  • loose stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • itching
  • erythema multiforme
  • dermatitis
  • serum sickness
  • drug reaction (DRESS)
  • angioedema
  • thrombocytopenic purpura
  • eosinophilia
  • leukopenia
  • agranulocytosis
  • lymphocytopenia
  • bone marrow suppression
  • prolonged bleeding time
  • and prothrombin time.

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

Storage

This medication should be kept in a sealed container to prevent moisture and stored in a cool, dry place below 25 degrees Celsius. Storing in this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

Package unit

8 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.