Medication info
Omen Tablet 375 mg (Amoxicillin Hydrate · Clavulanate Potassium) (2:1)

Omen Tablet 375 mg (Amoxicillin Hydrate · Clavulanate Potassium) (2:1)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
White or nearly white oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3), 100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 200203015 · Notified 2002.06.27 · Insurance code 649501820

Summary

Main use
Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years and older or weighing 40 kg or more, administer Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per administration. In cases of renal impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance 10 - 30 mL/min: Administer 250 - ...
Child dose
For adults, and children aged 12 years and older or weighing 40 kg or more, administer Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. For children with renal impairment...

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Treatment of infections in the respiratory system (bronchitis, pneumonia) and urinary system (cystitis, urethritis)

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

This medication is used for the treatment of various infections caused by different bacteria. It is effective against acute and chronic bronchitis, lobar or bronchial pneumonia, empyema, lung abscess, tonsillitis, sinusitis, otitis media, and others. It is also utilized for urinary tract infections such as cystitis, urethritis, pyelonephritis as well as for pelvic infections and gonorrhea. Additionally, it is employed for skin infections such as boils and abscesses, soft tissue infections, wound infections, and osteomyelitis. Finally, it is also beneficial in treating dental infections, thus being widely used for various infection treatments.

How to take

Adult dose

For adults and children aged 12 years and older or weighing 40 kg or more, administer Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. In cases of severe and respiratory infections, the dose may be increased to 500 mg/125 mg per administration. In cases of renal impairment, the dose should be adjusted according to creatinine clearance. - Creatinine clearance 10 - 30 mL/min: Administer 250 - ...

Child dose

For adults, and children aged 12 years and older or weighing 40 kg or more, administer Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. For children with renal impairment...

Precautions

This medication is a beta-lactam antibiotic and should not be administered to patients with a history of hypersensitivity to penicillins or cefems. Caution should be exercised in patients with viral diseases such as infectious mononucleosis or lymphocytic leukemia, as the risk of rash may be increased. Patients with liver dysfunction or a history of jaundice may have a recurrence of symptoms if this drug is used. Caution should be taken when administering to patients with liver disease or severe kidney impairment, as drug concentration may increase, requiring careful adjustment of dosing and administration frequency. Patients with allergies or symptoms such as bronchial asthma, rash, or hives are at risk of side effects and should be monitored closely. Patients experiencing severe vomiting or diarrhea, patients receiving non-oral nutrition, and elderly patients may be at risk for bleeding tendencies such as vitamin K deficiency, requiring caution. This medication can cause gastrointestinal side effects such as diarrhea, abdominal pain, nausea, and vomiting, and in severe cases, can lead to serious colitis like pseudomembranous colitis. Rarely, symptoms of liver dysfunction may manifest, particularly more commonly reported in males over 60 years old. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; therefore, administration should be halted immediately if any unusual symptoms present. Blood-related side effects such as leukopenia, thrombocytopenia, and anemia have been reported rarely, necessitating regular blood tests. Central nervous system adverse reactions may include restlessness, anxiety, drowsiness, and rarely seizures; patients with impaired kidney function may have an increased risk of seizures. Rarely, renal-related abnormalities such as acute renal failure or interstitial nephritis may appear, requiring regular monitoring of kidney function. This medication may affect gut flora, leading to dysbiosis such as candidiasis or stomatitis. A risk of bleeding tendencies may arise due to vitamin K deficiency, so consultation with healthcare personnel is necessary if bleeding symptoms are noted. It is advisable to avoid administration during the initial three months of pregnancy, and caution is required during breastfeeding, as side effects such as diarrhea or skin rashes may occur in the infant. It is not recommended for children under 12 years or those weighing less than 40 kg. Elderly patients may be at a higher risk for side effects due to decreased physiological functions, thus requiring careful dose adjustment and administration spacing. This medication may interact with other drugs, so it is crucial to inform healthcare personnel, especially if anticoagulants, other antibiotics, or anti-inflammatory drugs are being taken. In case of overdose, symptoms may include vomiting, diarrhea, kidney failure, and seizures, necessitating immediate medical attention. When storing, keep in a dry, sealed container at or below 25 degrees Celsius to maintain the efficacy of the drug. If any unusual symptoms or discomfort occur while using, consult a doctor or pharmacist immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/eye mucous membranes, severe dermatological reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and very severe reactions

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • indigestion
  • stomatitis
  • gastritis
  • glossitis
  • black hairy tongue
  • nausea
  • vomiting
  • loss of appetite
Show 22 more
  • abdominal pain
  • abdominal distension
  • constipation
  • colon pain
  • acid reflux
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • increased serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • thrombocytopenia
  • anemia
  • decreased platelet count

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

Storage

This medication should be stored in a sealed container to prevent moisture, in a cool, dry place at or below 25 degrees Celsius. This will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 100 tablets (10 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.