Amoclen Tablet 375mg (Amoxicillin-Clavulanate Potassium (2:1))

Adult dose

Adults and children aged 12 or older or weighing over 40 kg should take 250 mg/125 mg of amoxicillin/clavulanate potassium orally three times a day at 8-hour intervals. In cases of severe and respiratory infections, the dosage may be increased to 500 mg/125 mg in one dose. For those with renal impairment, dosage should be adjusted based on creatinine clearance. For creatinine clearance of 10-30 mL/min, 250-500 mg should be taken every 12 hours.

Child dose

Adults and children aged 12 or older or weighing over 40 kg will follow the same dosage regimen. In case of renal impairment, adjust in the same manner.

This medication is a penicillin-class antibiotic and should not be administered to patients with a history of allergy to specific components or beta-lactam antibiotics. Patients with infectious mononucleosis or lymphocytic leukemia are at higher risk for rash and should be cautious. Patients with a history of liver function issues should also be careful, as reoccurrence of liver damage may occur when taking this medication. Patients with decreased liver function should use cautiously, as the drug may burden the liver. Patients with moderate to severe kidney function impairment may need dosage adjustments due to potentially increased drug concentration. Patients with allergic tendencies or conditions such as bronchial asthma or urticaria should be cautious for potential side effects. Patients who have difficulty swallowing or elderly patients, and those in poor systemic condition, may be at risk of bleeding due to vitamin K deficiency and require observation. Patients with gastrointestinal disorders experiencing vomiting or diarrhea may have impaired absorption of the drug. This medication may cause gastrointestinal side effects such as diarrhea, vomiting, and abdominal pain; in severe cases, serious colitis like pseudomembranous colitis may occur. Symptoms of liver function abnormalities have also been reported, occurring more frequently in the elderly or males, thus regular liver function tests should be scheduled. Rarely, severe allergic reactions such as skin rash, anaphylaxis, and angioedema may occur, and drug administration must be stopped immediately upon manifestation of symptoms. Blood-related issues such as leukopenia or thrombocytopenia have been reported, so tests should be performed if any abnormal symptoms occur. CNS symptoms such as anxiety, confusion, and seizures may occasionally arise, especially in patients with renal impairment or when administered at high doses. Renal damage may worsen, thus regular kidney function tests should be conducted and usage should be stopped if abnormalities are noted. Antibiotic use may lead to the development of candidiasis due to opportunistic infections, necessitating treatment for oral or vaginal symptoms if they arise. Rare symptoms of bleeding tendency due to vitamin K deficiency or vitamin B complex deficiency may manifest, thus caution should be exercised. To prevent the emergence of resistant bacteria, it is advisable to perform susceptibility tests and administer for the minimum necessary duration. Those with a history of severe allergic reactions to penicillin-based drugs may experience extremely serious reactions upon taking this medication and should be closely monitored. Anaphylactic shock may rarely occur, so patients must be stabilized and prepared for emergency intervention following administration. Antibiotic-related pseudomembranous colitis may occur, and should diarrhea or abdominal pain worsen, administration must cease immediately, and medical attention must be sought. Prolonged use may allow non-susceptible bacteria to proliferate; thus, careful observation is warranted for durations exceeding 14 days. Caution should be exercised if signs of liver function abnormalities develop, and treatment duration should not exceed 14 days. As renal excretion is the main route, patients with reduced kidney function will require dosage adjustments. If infectious mononucleosis is suspected, this medication should be avoided. Should symptoms such as urticaria, skin rash, or serum sickness appear, drug administration must be stopped immediately and according to a doctor's guidance. For long-term administration, regular tests assessing kidney, liver, and hematopoietic functions are advisable. It is essential to check beforehand for any hypersensitivity history to penicillin or cephalosporin drugs. In high-dose administration, sufficient hydration should be maintained to prevent renal impairment. Due to limited experience in pediatric use, it is recommended only for children over 12 years old or weighing more than 40 kg. It should be avoided during the first three months of pregnancy and used cautiously during pregnancy, while nursing mothers should be aware of potential side effects appearing in infants. Interactions may occur with specific medications during the course of this drug, and any concurrent medications should be disclosed to a physician or pharmacist. In cases of overdose, gastrointestinal symptoms and neurological symptoms may appear; immediate contact with a healthcare provider is necessary for appropriate management.

Serious side effects

• Urticaria
• severe swelling
• chest tightness
• difficulty breathing
• sweating
• pallor
• severe allergic reactions
• severe rashes with high fever
• blisters
• skin peeling

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent moisture and kept in a dry place below 25 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevents deterioration.

Appearance

White or almost white oval film-coated tablets

Package unit

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