Moxicle Tablet 625 mg (Amoxicillin·Clavulanate Potassium)

Adult dose

Adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally 3 times a day every 8 hours; in cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg. In cases of renal impairment, the dosage should be adjusted based on creatinine clearance. Creatinine clearance of 10–30 mL/min: 250–500 mg per dose.

Child dose

The dosage is the same as for adults and children over 12 years or weighing 40 kg or more; however, in cases of renal impairment, it should be reduced in the same manner.

This medication is a beta-lactam antibiotic, and it should not be administered to patients with allergies to penicillins and cephalosporins. Particularly, there may be an increased risk of rash in patients with infectious mononucleosis or lymphocytic leukemia, so caution is needed. Patients who have previously experienced hepatic dysfunction or jaundice due to this medication or penicillin should avoid its use due to the risk of recurrence. Patients with impaired liver or kidney function may be affected by this medication; therefore, their condition should be carefully assessed before administration, and dosage adjustments may be necessary. In those with allergic predispositions, symptoms such as bronchial asthma or skin rashes may easily occur, requiring cautious use. Gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain may occur, and in severe cases, significant side effects such as pseudomembranous colitis may develop; immediate consultation with a physician is necessary if symptoms arise. Symptoms of abnormal liver function can occasionally occur, particularly in the elderly and males, so regular liver function tests are required during long-term use. Skin rashes, itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome may occur; if such symptoms appear, administration should be stopped immediately. Hematological reactions such as leukopenia or anemia have been rarely reported; thus, tests should be conducted if abnormal symptoms occur. CNS symptoms, such as anxiety, confusion, and seizures, may rarely appear, particularly in patients with impaired kidney function or those receiving high doses. Use of antibiotics may disrupt the normal intestinal bacterial balance, leading to outbreaks of candidiasis or stomatitis, which should be reported to a physician if symptoms arise. There may be a tendency for bleeding due to vitamin K deficiency, necessitating attention to bleeding symptoms, especially in the elderly or those at risk of vitamin deficiency. This medication can interact with other drugs, so if other medications are currently being taken, it is essential to inform the physician or pharmacist. Pregnant or breastfeeding women should consider the potential effects on the fetus or infant when using this medication, particularly avoiding it during the first three months of pregnancy. It is not recommended for children under 12 years or weighing less than 40 kg; in the elderly, the risk of side effects is higher due to decreased physical function, so use should be cautious with adjusted dosage and administration intervals. In case of overdose, gastrointestinal symptoms, kidney failure, and seizures may occur, necessitating immediate cessation of administration and appropriate treatment. This medication should be stored in a dry place at a temperature below 25 degrees Celsius; if any adverse reactions or suspicious symptoms occur while using it, immediate consultation with medical personnel is necessary.

Serious side effects

• Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reactions.
• Anaphylaxis, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis.
• Severe rashes with high fever, blisters, skin peeling, oral/ocular mucosal pain → severe skin adverse reactions.
• Shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever.

Mild side effects

• Diarrhea
• dyspepsia
• stomatitis
• gastritis
• glossitis
• nausea
• vomiting
• loss of appetite
• abdominal pain
• abdominal bloating

This medication must be kept in a sealed container that prevents moisture and air exposure, and it is important to maintain a cool temperature between 1 and 25 degrees Celsius during storage. Therefore, it should be kept away from direct sunlight and in locations that are not humid.

Appearance

White or nearly white oval film-coated tablets

Package unit

40 tablets (4 tablets/PTP)x10