Amocitin Tablet 375 mg (Amoxicillin Trihydrate · Clavulanate Potassium)

Adult dose

For adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg per dose, taken orally three times a day every 8 hours. In the case of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per dose. In cases of renal impairment, dosage should be adjusted based on creatinine clearance. For creatinine clearance of 10 to 30 mL/min, the dose is 250 to 500 mg taken orally every 12 hours.

Child dose

Children over 12 years or weighing 40 kg or more shall follow the adult dosing regimen. Dosage should be adjusted similarly for children with renal impairment.

This medication should not be administered to patients who have had hypersensitivity reactions to beta-lactam drugs, as it is a penicillin-class antibiotic. Special caution is needed for those with a history of severe allergic reactions, such as anaphylaxis, Stevens-Johnson syndrome, or shock. It should be avoided in patients with infectious mononucleosis or lymphocytic leukemia due to an increased risk of rash. Patients who have experienced liver dysfunction or jaundice due to this medication or penicillin-related drugs in the past should not use it due to the risk of recurrence. Patients with liver disorders should use it with caution as liver function may deteriorate further, and patients with moderate to severe renal impairment should adjust the dosing interval due to the potential for increased drug concentration. Caution is also needed for patients with allergic constitutions or gastrointestinal symptoms such as vomiting and diarrhea, as they may affect the absorption and effectiveness of the drug. If any adverse reactions such as diarrhea, abdominal pain, rash, itching, or difficulty in breathing occur during use, immediate consultation with a healthcare professional is required. Particularly, if severe gastrointestinal symptoms such as pseudomembranous colitis appear, discontinuation of the drug should be done, and appropriate treatment must be received. Symptoms of liver dysfunction may occur during or after cessation of treatment, necessitating regular liver function tests during long-term use. Allergic reactions, including skin rash, angioedema, and anaphylactic shock, may rarely occur, so close monitoring of patient status is mandatory after administration. Blood tests may show symptoms such as leukopenia, thrombocytopenia, and anemia, requiring testing if any abnormal symptoms arise. Use during the first three months of pregnancy should be avoided, and pregnant or breastfeeding women should use it cautiously after consultation with a physician. It is not recommended for children, especially those under 12 years of age or weighing less than 40 kg. Elderly patients may experience more adverse reactions due to decreased renal and liver function, so dosing and administration intervals should be adjusted and monitored. This drug may interact with other medications, so it is essential to inform healthcare professionals about any drugs currently being taken, especially anticoagulants or other antibiotics, as caution is required when used together. In case of overdose, gastrointestinal symptoms, renal dysfunction, and allergic reactions may occur, requiring immediate medical attention. This medication should be stored in a sealed container to prevent moisture and kept in a dry place below 25 degrees Celsius. It is essential not to arbitrarily discontinue use or change the dosage.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome, shock, angioedema, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, difficulty or shortness of breath, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, hepatitis, cholestatic jaundice, sudden onset

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, acidity, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, blood in stool, itching, erythema multiforme, hematological adverse reactions (leukopenia, thrombocytopenia, anemia, etc.), vaginal itching or burning, increased secretions, restlessness, anxiety, behavioral changes, confusion, drowsiness

This medication should be stored in a sealed container to prevent moisture and kept in a dry place below 25 degrees Celsius. Be aware that efficacy may decrease in humid or high-temperature environments.

Appearance

White or almost white oval film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP × 10)]