Omeclara Tablet 625 mg (Amoxicillin Trihydrate and Clavulanic Acid Potassium (4:1))

Adult dose

Adults and children aged 12 years or older or weighing 40 kg or more should take amoxicillin/clavulanic acid potassium at a dose of 250 mg/125 mg orally three times a day every 8 hours. In cases of severe infection 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. - CrCl 30 mL/min and above: No dosage adjustment needed - Cr

Child dose

Children aged 12 years or older or weighing 40 kg or more should be administered the same dosage as adults. Dosing should be adjusted for younger children based on renal function.

This medication contains amoxicillin and clavulanic acid, which belong to the beta-lactam class of antibiotics and penicillin family. It should not be used in patients who have had hypersensitivity reactions to amoxicillin or other beta-lactam drugs, or if there has been a history of severe allergic reactions or skin symptoms. Caution is needed for patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, as there is a risk of developing a rash. In patients with liver dysfunction or a history of liver damage due to this medication or penicillin, it should be administered with caution and liver function should be closely monitored. In patients with moderate to severe renal impairment, dosing intervals should be adjusted due to potential increases in drug concentration and careful use is necessary. Patients with allergic tendencies or asthma who easily exhibit symptoms such as rashes and hives should also exercise caution. For patients who have difficulty with oral intake, the elderly, or those in poor general condition, monitoring is required as there can be an increased risk of vitamin K deficiency and bleeding. This medication can cause various gastrointestinal side effects such as diarrhea, abdominal pain, nausea, and vomiting; in severe cases, it can lead to pseudomembranous colitis or acute pancreatitis, so any symptoms should prompt immediate consultation with a doctor. Symptoms of liver dysfunction have also been reported, and if hepatic symptoms arise, the drug should be discontinued, and appropriate treatment administered. Severe skin reactions can occur, including itchiness, rashes, or in severe cases, Stevens-Johnson syndrome or toxic epidermal necrolysis, thus drug use should be stopped immediately if skin abnormalities arise. Blood-related abnormalities such as leukopenia, thrombocytopenia, and hemolytic anemia may occur rarely, so testing is necessary if abnormal symptoms develop. Central nervous system side effects may include anxiety, restlessness, confusion, and seizures, which can be more pronounced in patients with renal impairment. It may also affect the kidneys, leading to acute renal failure or interstitial nephritis, necessitating regular kidney function checks and discontinuation of the drug if abnormalities are detected. This medication may interact with other drugs, particularly probenecid, allopurinol, anticoagulants, and antibiotics, requiring caution when combined. During pregnancy, there is no established safety, so it is advisable to avoid use in the first three months of pregnancy; breastfeeding may result in drug transfer through breast milk and potential side effects in infants, necessitating discontinuation if symptoms occur. It is not recommended for children under 12 years of age or those weighing less than 40 kg, and elderly patients should use the medication cautiously with adjustments to dosage and intervals due to decreased physiological function and an increased risk of side effects. While taking this medication, it is important to routinely monitor liver and kidney functions, blood counts, and other parameters to detect and manage any abnormal signs early. In cases of overdose, gastrointestinal symptoms, renal failure, seizures, or allergic reactions may arise, so if suspected, immediate medical attention should be sought. Finally, this medication should be stored in a special container to prevent humidity, and it should be kept in a cool, dry place below 25 degrees Celsius to maintain its effectiveness.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reactions, high fever along with severe rash, blisters, peeling skin, mucosal pain in the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by coughing and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

• Diarrhea
• pseudomembranous colitis
• dyspepsia
• stomatitis
• gastritis
• glossitis
• black hairy tongue
• nausea
• vomiting
• loss of appetite

This medication is stored in a special container to prevent moisture. Additionally, it should be kept in a cool, dry place below 25 degrees Celsius for optimal effectiveness.

Appearance

White or nearly white oval film-coated tablet

Package unit

40 tablets (4 tablets/PTP×10)