Omekra Tablet 375 mg (Amoxicillin Trihydrate · Clavulanate Potassium (2:1))

Adult dose

Adults and children aged 12 years or over or weighing more than 40 kg are administered 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times daily every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per administration. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - For creatinine clearance greater than 30 mL/min: no dosage adjustment is necessary.

Child dose

For children under 12 years or weighing less than 40 kg, doses should be adjusted from the adult regimen.

This medication is a penicillin-type antibiotic and should not be administered to patients with a history of specific allergic reactions. Patients with previous hypersensitivity reactions to beta-lactam antibiotics or those with infectious mononucleosis or lymphocytic leukemia are at increased risk of rash and should be cautious. Patients with a history of liver dysfunction or jaundice may also experience recurrence of symptoms when using this medication. Patients with impaired liver or kidney function may have increased drug concentration, thus requiring adjustments to the dosing interval. Caution is advised for patients with allergic predispositions or poor nutritional states, the elderly, and those with gastrointestinal disorders accompanied by vomiting or diarrhea. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, abdominal pain, and, rarely, serious symptoms like pseudomembranous colitis or acute pancreatitis can occur. Symptoms suggesting liver dysfunction have also been reported, so especially the elderly or those on long-term therapy should have liver function tests. Serious skin reactions, including rash, itching, and severe cases like Stevens-Johnson syndrome, may occur, necessitating immediate medical attention upon symptom onset. Changes such as leukopenia, anemia, and thrombocytopenia may appear on blood tests, so regular blood tests are recommended. Central nervous system-related symptoms such as anxiety, dizziness, and seizures have been reported, although infrequently, and caution is necessary for patients with kidney impairment. Patients with reduced kidney function may present acute renal failure or hematuria, thus requiring periodic monitoring. This medication may disrupt the intestinal bacterial balance, potentially leading to fungal infections such as candidiasis. The risk of bleeding tendencies due to vitamin K deficiency may occur, so caution regarding bleeding symptoms is essential. If this medication is taken for an extended period, regular tests for kidney, liver, and hematopoietic function are necessary. Especially in cases with a history of hypersensitivity to penicillin or other beta-lactam antibiotics, consultation with a physician before use is mandatory. Use during the first three months of pregnancy is to be avoided, and pregnant or nursing women should carefully evaluate the benefits and risks of using this medication. If nursing mothers take this medication, monitoring for diarrhea or skin rashes in infants is necessary. It is not recommended for children under 12 years or weighing less than 40 kg due to limited usage experience. The elderly may experience a greater likelihood of adverse reactions due to decreased physiological function, thus requiring careful adjustment of dosage and dosing intervals. This medication may interact with other drugs, particularly anticoagulants or specific antibiotics, so strict adherence to a physician's directions is required when used in combination. In case of overdose, gastrointestinal symptoms and central nervous system anomalies may occur, necessitating immediate treatment, including possible hemodialysis if required. This medication should be stored in a cool, dry place below 25 degrees Celsius, and it is important to take it exactly as prescribed by a physician.

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, severe allergic reactions, high fever with severe rashes, blistering, peeling skin, pain in oral/ocular mucosa, severe dermatological adverse reactions, asthma attacks, accompanying cough and fever with respiratory abnormalities, dyspnea or difficulty breathing, yellowing of the skin or eyes (jaundice), and systemic reactions.

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, bloating, constipation, colonic pain, hyperacidity, loose stool, dry mouth, candidiasis, antibiotic-associated colitis, itching, erythema multiforme, dermatitis, hematologic adverse reactions (leukopenia, thrombocytopenia, hemolytic anemia, etc.), vaginal itching, increased secretions, restlessness, anxiety, behavioral changes, drowsiness, insomnia, hyperactivity.

This medication should be stored in a tightly sealed container to prevent moisture, in a cool, dry place below 25 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance

White or nearly white oval film-coated tablet

Package unit

80 tablets (8 tablets/PTP × 10)