Cramotin Tablet (Amoxicillin/Clavulanate Potassium (2:1))

Adult dose

Adults and children over 12 years or weighing more than 40 kg: Amoxicillin/Clavulanate Potassium at a dose of 250 mg/125 mg per intake, taken orally three times a day at 8-hour intervals. In cases of severe and respiratory infections, the dose can be increased to 500 mg/125 mg per intake. In cases of renal impairment, adjust the dosage according to the creatinine clearance. - Creatinine clearance 10～30 mL/min: administer 250～500 mg of amoxicillin intra-orally every 12 hours. 10 mL/min or less: administer 250 mg of amoxicillin intra-orally every 24 hours, ensuring not to exceed the set dosage.

Child dose

For children under 12 years of age or weighing less than 40 kg, the dose should be adjusted accordingly.

This medication should not be used in patients who are hypersensitive to beta-lactam antibiotics or have previously experienced severe allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock. Caution is needed in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia as they have a higher risk of rash. Patients with a history of liver dysfunction or jaundice should avoid or use this medication cautiously due to the risk of recurrence. Patients with liver impairments might experience worsened liver function, hence should use it carefully, while patients with moderate to severe renal impairment should adjust the dosing intervals as drug concentrations may elevate. Patients who are prone to allergic reactions or have symptoms such as bronchial asthma, rashes, and urticaria should use this drug with caution. Patients who have difficulty taking orally, those receiving non-oral nutrition, elderly patients, and those in poor general condition may show symptoms of vitamin K deficiency, thus observation is necessary. Patients with gastrointestinal diseases should take caution as vomiting or diarrhea may lead to inadequate drug absorption. This medication can cause various gastrointestinal adverse reactions such as diarrhea, gastroenteritis, and stomatitis, and especially acute pancreatitis or severe colitis may occur; hence, if abdominal pain or frequent diarrhea arises, the medication should be stopped immediately and medical attention sought. Liver function abnormalities may also appear, especially more frequently reported in elderly males, so liver function tests are needed during prolonged use. Rarely, skin rashes, urticaria, severe skin reactions, and anaphylactic shock may occur; if such symptoms arise, the medication should be stopped immediately and consultation with healthcare personnel is needed. Hematologic adverse reactions such as leukopenia, thrombocytopenia, and anemia are rarely reported, and caution is needed if unusual symptoms occur due to bleeding tendencies. Central nervous system adverse reactions such as anxiety, confusion, dizziness, and seizures may occur rarely, and caution is especially advised in patients with renal impairment or those receiving high doses. Renal function abnormalities may arise; hence regular renal examinations and monitoring of unusual symptoms are necessary. This medication may affect the gut microbiota, which could lead to fungal infections such as candidiasis; appropriate measures should be taken if symptoms arise. Vitamin K deficiency-related bleeding risks and symptoms of vitamin B complex deficiencies may rarely appear; hence caution is advised for long-term use. In pregnancy, it should especially be avoided during the first three months, and if necessary during pregnancy, should be determined cautiously based on a physician's judgment. During breastfeeding, the medication may transfer through breast milk, and infants may exhibit diarrhea or hypersensitivity; hence, if unusual symptoms occur, the medication should be discontinued. Not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients may exhibit more adverse reactions due to declining physiological function, so dosages and intervals should be closely monitored.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, skin and mucosal syndrome (Stevens-Johnson syndrome), shock, fever accompanied by severe rashes, blisters, skin peeling, pain in oral/ocular mucosa, dyspnea, asthma attacks, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, cholestatic jaundice, sudden and severe

Mild side effects

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

This medication should be stored in a tightly closed container to prevent moisture and kept in a dry place at or below 25 degrees Celsius. Storing it this way helps maintain the drug's efficacy over time and prevents deterioration or damage.

Appearance

White or almost white oval film-coated tablet

Package unit

100 tablets/PTP