Amoclan Tablets 375 mg

Adult dose

For adults and children aged 12 and older or weighing more than 40 kg, orally administer 250 mg/125 mg of amoxicillin/clavulanic acid three times a day every 8 hours. In cases of severe or respiratory infections, the dose may be increased to 500 mg/125 mg. In the presence of renal impairment, dosage should be adjusted according to creatinine clearance. For creatinine clearance of 10–30 mL/min, administer 250 mg to 500 mg of amoxicillin every 12 hours; for clearance below 10 mL/min, administer 250 mg every 24 hours without exceeding the maximum dose.

Child dose

The same dosage applies to adults and children aged 12 years or older or weighing more than 40 kg. However, reduce the dose accordingly if renal impairment is present.

This medication contains a beta-lactam antibiotic and shares similar components with penicillin-based drugs. This medication should not be administered to patients with a hypersensitivity to its components or those who have had severe allergic reactions to beta-lactam drugs. Special caution is required for patients with infectious mononucleosis or lymphocytic leukemia since the risk of side effects like rashes is higher. Patients who have experienced liver dysfunction or jaundice from this drug or penicillin in the past should also avoid its use. Patients with impaired liver function or severe kidney impairment may have increased drug concentrations, so administration should be carried out cautiously. Allergy-prone patients or those with gastrointestinal symptoms such as vomiting or diarrhea may have reduced drug absorption, necessitating caution. While taking this medication, gastrointestinal symptoms like diarrhea, vomiting, and abdominal pain may occur, and in severe cases, serious intestinal diseases such as pseudomembranous colitis can develop. If symptoms worsen, it is crucial to stop the medication immediately and consult a physician. Liver dysfunction may occur infrequently, and liver function tests are necessary, especially for the elderly or long-term users. Skin rashes, itching, or in severe cases, serious skin reactions like Steven-Johnson Syndrome can occur; thus, administration should be stopped if any skin abnormalities appear. Blood-related abnormalities such as leukopenia, anemia, and thrombocytopenia may also arise, so any abnormal symptoms should be reported to a physician. Rarely, central nervous system symptoms, including dizziness, headache, and seizures, may occur, so caution is necessary. This medication is excreted through the kidneys, so patients with reduced kidney function require dosage adjustment and careful monitoring. During antibiotic use, it is advisable to administer the drug for only the necessary duration after sensitivity testing to avoid the development of resistant strains. Patients with an allergy to penicillin or a history of multiple allergies should be particularly cautious due to the potential for serious hypersensitivity reactions. Anaphylactic shock and other emergency situations may occur, so patients' conditions must be closely monitored after administration. If severe diarrhea occurs during or after antibiotic use, consider the possibility of pseudomembranous colitis and immediately discontinue the medication and consult healthcare personnel. Long-term administration may lead to overgrowth of resistant organisms; therefore, careful observation is advised if taken for more than 14 days. Pregnant women in early pregnancy or those who are pregnant should carefully weigh the risks and benefits before administration, and during breastfeeding, discontinuation is necessary if adverse effects in the infant occur. It is not recommended for children under 12 years, and elderly patients should use the drug cautiously while adjusting doses and intervals due to reduced physiological functions and a higher risk of side effects. This medication may affect certain test results, so inform healthcare personnel about use prior to examinations. In case of overdose, symptoms may include gastrointestinal symptoms, acute renal failure, seizures, and hypersensitivity reactions; immediate cessation and appropriate treatment are recommended. Store in a sealed container to prevent moisture and keep in a dry place at temperatures below 25 degrees Celsius. Interactions with other medications may occur, so consult healthcare personnel if taking other drugs.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rashes, blisters, skin peeling, painful mucous membranes in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough and fever, respiratory problems, jaundice (yellowing of skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden onset

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent moisture and kept in a dry place with low humidity. It is advisable to maintain storage temperatures below 25 degrees Celsius.

Appearance

Oval film-coated tablet, white or almost white

Package unit

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