Augmentis 500 mg Tablets (Amoxicillin·Clavulanate Potassium (7:1))

Adult dose

For adults with severe infections and respiratory infections, administer 2 tablets, orally, twice a day every 12 hours. Patients with renal impairment may have their dosage reduced based on the degree of kidney function. In the case of severe renal failure (glomerular filtration rate below 30 mL/min), this medication should not be administered.

This medication should not be used in patients with allergies to penicillin and beta-lactam drugs. In particular, it is contraindicated in patients who have had serious hypersensitive reactions, such as anaphylaxis or Stevens-Johnson syndrome. Exercise caution in patients with viral diseases such as infectious mononucleosis or lymphocytic leukemia due to increased risk of rash. Patients with a history of jaundice or liver dysfunction associated with this medication or penicillin should avoid re-use due to the risk of recurrence. Dose adjustment and administration interval adjustment may be necessary for patients with compromised liver function or severe renal impairment, as drug concentrations may increase. Persons with allergic constitution or those who frequently experience bronchial asthma, urticaria, and related symptoms should use this medication cautiously. Care is required for patients who have difficulty swallowing, those with poor nutritional status, or the elderly as vitamin K deficiency symptoms may occur. Gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting may occur, and especially severe intestinal diseases such as membrane colitis can occur, so immediate cessation of the medication should be done if symptoms are severe. Liver function abnormalities may occur, requiring regular liver function tests, and symptoms such as hepatitis or cholestatic jaundice may appear. Skin rashes, itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can occur, so medication should be discontinued immediately if a rash develops. There may be rare adverse hematological effects such as leukopenia and thrombocytopenia, making regular blood tests necessary. Central nervous system symptoms such as agitation, anxiety, confusion, drowsiness, and seizures have been reported rarely, especially in patients with diminished renal function or when administered at high doses. Renal functional abnormalities or acute renal failure symptoms may occur, requiring regular renal function tests. This drug can affect the intestinal microbiota, leading to the chance of stomatitis or candidiasis, and caution should be exercised regarding the bleeding tendency due to vitamin K deficiency. For pregnant women, safety has not been fully established, so use should be avoided during early pregnancy. During lactation, observation is required as the baby may experience diarrhea or hypersensitivity reactions. Not recommended for children under 12 years of age or weighing less than 40 kg. Elderly patients may experience an increased risk of adverse reactions due to decreased physical function, so dosing and administration intervals should be adjusted with caution. There are many drug interactions, so patients taking anticoagulants, anti-inflammatory drugs, oral contraceptives, immune suppressants, etc. should consult their physician. In cases of overdose, symptoms such as vomiting, diarrhea, rash, drowsiness, and seizures may occur, requiring immediate cessation of administration and appropriate treatment. This medication should be stored in a dry place below 25 degrees Celsius, and during long-term usage, monitoring for resistant bacteria and regular liver, kidney, and blood function tests is crucial.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, severe allergic reactions, serious skin adverse reactions, anaphylaxis, severe rashes with fever, blistering, skin peeling, pain in mouth/eyes, respiratory issues, jaundice, profound lethargy, liver abnormalities, sudden and severe headache, thunderclap headache, seizures, loss of consciousness.

Mild side effects

Diarrhea, membranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, hyperacidity, loose stools, dry mouth, elevated AST, ALT, ALP, LDH, increased serum bilirubin, hepatitis, cholestatic jaundice, itching, erythema multiforme, vesicular dermatitis, acute generalized exanthematous pustulosis, angioedema, serum sickness, hypersensitivity vasculitis, bronchospasm.

This medication may be vulnerable to air and moisture, so it should be stored in a tightly sealed container. Additionally, keeping it in a cool, dry place at or below 25 degrees Celsius is crucial to maintain its efficacy.

Appearance

White or almost white rectangular film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)