Medication info
Amoxicillin/Clavulanate Potassium Tablet 625 mg

Amoxicillin/Clavulanate Potassium Tablet 625 mg

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
This medication is a white or nearly white oval film-coated tablet.
Packaging
40 tablets (4 tablets / PTP X 10)
Approval status
Active

MFDS item code 201401381 · Approved 2014.03.26 · Insurance code 669905960

Summary

Main use
Treatment of respiratory and urogenital infections (such as bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years and older or weighing 40 kg and above should take amoxicillin/clavulanate potassium as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours. In cases of severe respiratory infections, the dose may be increased to 500 mg/125 mg per single intake. For patients with renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed
Child dose
For children under 12 years of age or those weighing less than 40 kg, the dosage should be adjusted similarly.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Treatment of respiratory and urogenital infections (such as bronchitis, pneumonia, cystitis, etc.)

  • Acute bronchitis
  • chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
View approved original text

This medication acts effectively against various bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, and Escherichia coli to treat respiratory infections including acute and chronic bronchitis, pneumonia, empyema, tonsillitis, sinusitis, and otitis media. It is also used for the treatment of urinary tract infections like cystitis, urethritis, and pyelonephritis as well as sexually transmitted infections like gonorrhea and pelvic infections. It is highly effective against various infectious diseases including skin and soft tissue infections, osteomyelitis, and dental infections, helping to improve patient symptoms. This medication is particularly effective against beta-lactamase producing strains, making it significant in treating resistant bacteria. It is an important therapeutic agent that can be used appropriately based on the site and symptoms of the patient’s infection.

How to take

Adult dose

Adults and children aged 12 years and older or weighing 40 kg and above should take amoxicillin/clavulanate potassium as a single dose of 250 mg/125 mg, administered orally three times a day every 8 hours. In cases of severe respiratory infections, the dose may be increased to 500 mg/125 mg per single intake. For patients with renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 30 mL/min or more: No dosage adjustment needed

Child dose

For children under 12 years of age or those weighing less than 40 kg, the dosage should be adjusted similarly.

Precautions

This medication is a penicillin-class antibiotic and should not be used in certain patients. Patients who have had allergic reactions to this medication or to beta-lactam antibiotics may experience severe allergic symptoms if given this medication and should not take it. Patients with viral infections like infectious mononucleosis or lymphocytic leukemia are at higher risk of skin rash when taking this medication, requiring caution. Patients with a history of liver dysfunction or jaundice due to this medication or penicillin-class drugs in the past should not take it as it may recur. Patients with impaired liver function may experience further deterioration in liver function when taking this medication and should use it with caution. Patients with moderate or severe renal impairment may experience increased risk of side effects since the medication may remain in the body longer, requiring careful monitoring and adjustment of dosing intervals. Patients with allergic tendencies or family histories, those difficult to take orally, elderly patients, or those in poor health should be cautious as they may experience side effects such as vitamin K deficiency. Patients with gastrointestinal diseases who experience significant vomiting or diarrhea may not absorb the medication effectively, necessitating caution. Taking this medication may lead to various gastrointestinal symptoms such as diarrhea, abdominal pain, vomiting, and indigestion, and rarely may result in severe colitis. Symptoms of liver dysfunction may also occur, especially in elderly and male patients, and if symptoms develop, they should consult a physician immediately. Skin rashes, itching, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome can occur; if these symptoms develop, treatment should be stopped and medical advice sought. Hematological abnormalities such as leukopenia, anemia, or thrombocytopenia have been rarely reported, and regular blood tests may be required. CNS-related symptoms like dizziness, headache, and seizures may appear rarely, particularly in patients with poor renal function or when taking higher doses, requiring close monitoring. There is a risk of renal impairment or acute kidney failure, hence regular renal function tests are necessary, and any unusual symptoms should be reported immediately to a physician. Antibiotic usage may lead to oral candidiasis or other fungal infections; if symptoms appear, appropriate treatment should be administered. Bleeding tendencies due to vitamin K deficiency or vitamin B complex deficiency symptoms may occur, albeit rarely, requiring caution. Long-term use of this medication may lead to the development of resistant bacteria; thus it should be taken for the minimum necessary period as directed by a physician. It is advisable to avoid use during the first trimester of pregnancy and women who are pregnant or breastfeeding should consult a physician before use to assess potential impacts on the baby. Not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly patients are at higher risk of side effects due to decreased bodily functions, so careful adjustment of dosage and administration intervals is necessary. This medication may interact with other drugs, so patients taking anticoagulants or certain antibiotics, anti-inflammatory drugs, etc., should inform their physician or pharmacist and exercise caution. In case of overdose, symptoms may include vomiting, diarrhea, abdominal pain, drowsiness, and seizures; treatment should be immediately ceased, and necessary medical care obtained. Store in a closed container to protect from moisture and air. The suitable storage temperature is a cool place between 1 and 25 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a long time.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweat, pallor, high fever, severe rash, blisters, shedding skin, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes, extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, markedly decreased urine output

Mild side effects

Diarrhea, pseudomembranous colitis, indigestion, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, gastric acid increase, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, bloody stools, itching, erythema multiforme, mucocutaneous syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia, angioedema, serum sickness syndrome, hypersensitivity

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from moisture and air. A cool place between 1 and 25 degrees Celsius is suitable for storage. This way of storage helps to maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

This medication is a white or nearly white oval film-coated tablet.

Package unit

40 tablets (4 tablets / PTP X 10)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.