Omecal 625 mg (Amoxicillin Trihydrate · Clavulanate Potassium (4:1))

Adult dose

Adults and children 12 years or older or weighing more than 40 kg should take amoxicillin/clavulanate potassium at 250 mg/125 mg orally three times a day every 8 hours. In cases of severe or respiratory infections, the dosage can be increased to 500 mg/125 mg. For those with renal impairment, the dosage should be adjusted based on creatinine clearance. If creatinine clearance is 30 mL/min or higher, dose adjustment is not necessary.

Child dose

For children 12 years or older or weighing more than 40 kg, administer the same dosage as adults. For children with renal impairment, the dosage should be reduced accordingly.

This medication is a beta-lactam antibiotic and should not be administered to patients with an allergy to penicillin or cephalosporin drugs or those who have experienced hypersensitivity. Caution is required particularly for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as there is a risk of rash. Patients with liver function issues or a history of liver dysfunction or jaundice due to this medication or penicillin should avoid or use it with caution. Patients with impaired liver function should be careful as the drug may not be properly metabolized in the liver, potentially worsening their condition. Patients with moderate to severe renal impairment should adjust the dosing interval due to the increased risk of side effects as the drug stays in the body longer. Patients with allergic predispositions or family history, those unable to take orally, the elderly, and those in poor condition should be cautious of bleeding risks due to vitamin K deficiency. Patients with gastrointestinal disorders experiencing vomiting or diarrhea may not absorb the medication properly. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain, and in severe cases, serious enteritis such as pseudomembranous colitis can occur, requiring immediate cessation of the medication if symptoms arise. Liver function tests may show elevated levels of AST, ALT, etc., and in rare cases, hepatitis or jaundice can occur, so regular liver function testing is necessary for long-term use. Skin rash, itching, serious allergic reactions such as Stevens-Johnson syndrome or anaphylactic shock may occur rarely. Blood tests may reveal abnormalities in the blood system such as leukopenia, thrombocytopenia, or anemia, so any abnormal symptoms should prompt immediate consultation with healthcare professionals. Central nervous system abnormalities may lead to agitation, anxiety, dizziness, and rarely seizures, thus caution is especially needed for patients with impaired renal function or those receiving high doses. There may be a risk of deterioration in renal function or acute kidney failure, hence regular monitoring of kidney function is recommended. There may be a tendency towards bleeding due to vitamin K deficiency, so any bleeding symptoms should be reported immediately. Use should be avoided during pregnancy, especially in the first trimester, and pregnant or breastfeeding women should carefully consider the risks and benefits of administering this medication. This medication may interact with other drugs, particularly anticoagulants, probenecid, allopurinol, and antibiotics, requiring caution when used in combination. In cases of overdose, gastrointestinal symptoms, central nervous system symptoms, or allergic reactions may be present, necessitating immediate notification to healthcare professionals if symptoms occur.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin reactions, asthma attacks, respiratory abnormalities accompanied by coughing and fever, breathing problems, jaundice of the skin or eyes, extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, lightning headache, seizures, loss of consciousness.

Mild side effects

Diarrhea, indigestion, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, acute pancreatitis, candidiasis, colitis (including pseudomembranous colitis and hemorrhagic colitis), bloody stool, itching, erythema multiforme, dermatitis, oral edema, thrombocytosis, taste disorders, lethargy, anxiety, restlessness, drowsiness, insomnia, reversible hyperactivity, dizziness, and point.

This medication should be stored in a tightly sealed container to prevent moisture ingress and should be kept at a cool temperature between 1 and 25 degrees Celsius. Proper storage helps maintain the effectiveness of the medication and prevents deterioration.

Appearance

This medication is a white or almost white oval film-coated tablet.

Package unit

40 tablets (4 tablets/PTP packaging x 10)