Medication info

Ogumencaps 375 mg (Amoxicillin-Clavulanate Potassium (2:1))

Prescription medicationApproval withdrawn
Ingredient · strength
Amoxicillin Hydrate›Strength being verifiedDilute Potassium Clavulanate›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
It is a white or almost white oval film-coated tablet.
Packaging
100 tablets (10 tablets/PTPX10), 96 tablets (8 tablets/PTPX12), 80 tablets (8 tablets/PTPX10)
Approval status
Approval withdrawn

MFDS item code 201901489 · Approved 2019.03.11

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia), urinary (cystitis, urethritis) infections
Who uses it
Adults · Children
Adult dosage
Adults and children aged 12 or older or weighing more than 40 kg should receive amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg three times daily by mouth every 8 hours. In severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, dosing should be adjusted based on creatinine clearance. For a creatinine clearance of 10 to 30 mL/min, the dose should be 250 to 500 mg every 12 hours.
Children's dosage
Children under 12 or weighing less than 40 kg should be dosed similarly reduced.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia), urinary (cystitis, urethritis) infections

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

This medication is used to treat infections caused by various bacteria. It is effective against respiratory infections such as acute or chronic bronchitis and pneumonia, empyema, and lung abscess. It also helps with infections around the ears and nose such as tonsillitis, sinusitis, and otitis media. It is used for urinary tract infections such as cystitis, urethritis, and pyelonephritis, as well as for sexually transmitted infections like pelvic inflammatory disease and gonorrhea. It is also used to treat skin and soft tissue infections, furuncles or abscesses, wound infections, and osteomyelitis, an inflammation of the bones. It is effective for treating dental infections, thereby improving bacterial infections in various areas.

Dosage and Administration

Adult dosage

Adults and children aged 12 or older or weighing more than 40 kg should receive amoxicillin/clavulanate potassium at a dose of 250 mg/125 mg three times daily by mouth every 8 hours. In severe and respiratory infections, the dose may be increased to 500 mg/125 mg. In cases of renal impairment, dosing should be adjusted based on creatinine clearance. For a creatinine clearance of 10 to 30 mL/min, the dose should be 250 to 500 mg every 12 hours.

Children's dosage

Children under 12 or weighing less than 40 kg should be dosed similarly reduced.

Precautions

This medication is a beta-lactam antibiotic and should not be used in individuals allergic to penicillin or cephalosporin drugs or those who have experienced hypersensitivity reactions. Particularly, caution is advised for patients with infectious mononucleosis or lymphoblastic leukemia due to a higher risk of rashes. Patients who have had liver dysfunction should also use this drug cautiously, as it may worsen liver function. Patients with poor liver function or moderate to severe kidney impairment could experience elevated drug concentrations, necessitating adjusted dosing intervals. Individuals with allergic conditions or those prone to symptoms like bronchial asthma or hives should also be cautious when taking this medication. Patients who have difficulty taking oral medication, elderly individuals, or those in poor overall health may be at risk of bleeding due to vitamin K deficiency and should be monitored. In severe digestive disorders that cause vomiting or diarrhea, the drug's absorption may be reduced and its efficacy diminished. During treatment, gastrointestinal symptoms like diarrhea, abdominal pain, vomiting, and loss of appetite may occur, and in severe cases, serious conditions such as pseudomembranous colitis may develop, so if symptoms worsen, immediately discontinue use and consult a physician. Symptoms of abnormal liver function may also occur, particularly in men over 60 or elderly patients, so regular liver function tests are recommended. Severe skin reactions are rare but could include rashes, itching, Stevens-Johnson syndrome, or toxic epidermal necrolysis; if a rash appears, immediately discontinue and inform healthcare providers. Blood abnormalities such as leukopenia and thrombocytopenia have been reported, so consultation with a specialist is necessary if abnormal symptoms arise. CNS side effects such as anxiety, confusion, dizziness, or rare seizures could occur, so caution is advised for patients with renal impairment or those taking a high dose. Regular kidney function tests are needed as renal function may deteriorate, and if abnormalities are found, treatment should be stopped. This medication can alter intestinal flora, potentially leading to infections such as candidiasis or stomatitis, so consult with healthcare providers if symptoms develop. Prolonged use may increase the risk of bleeding due to vitamin K deficiency, so caution is warranted. During pregnancy, especially in the first trimester, avoid use; while breastfeeding, if symptoms such as diarrhea or allergic reactions occur in the infant, discontinuation is recommended. It is not recommended for children under 12 years or weighing less than 40 kg. Elderly patients may experience adverse reactions more readily due to diminished physiological functions and should use with caution, adjusting dose and interval as necessary. This medication may interact with other drugs, so patients should inform their healthcare providers of any other medications they are taking, particularly anticoagulants, anti-inflammatories, or oral contraceptives. In case of overdose, symptoms such as abdominal pain, diarrhea, vomiting, drowsiness, or seizures may appear, and immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, severe allergic reactions, with high fever and severe rashes, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with coughing and fever, yellowing of the skin or eyes (jaundice)

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, dark stools, nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, constipation, colonic pain, hyperacidity, melena, xerostomia, candidiasis, antibiotic-associated colitis, increased AST, ALT, ALP, LDH, serum bilirubin, hepatitis, itching, erythema multiforme, mucocutaneous syndrome, toxic epidermal necrolysis, vesicular eczema, acute generalized exanthematous pustulosis, eosinophilia

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

Storage

This medication should be stored in a tightly sealed container to prevent moisture. It is advisable to keep it in a cool, dry place below 25 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

It is a white or almost white oval film-coated tablet.

Package unit

100 tablets (10 tablets/PTPX10), 96 tablets (8 tablets/PTPX12), 80 tablets (8 tablets/PTPX10)

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.