Medication info
Oclan Tablet 625 mg (Amoxicillin and Clavulanate Potassium)

Oclan Tablet 625 mg (Amoxicillin and Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)오스코리아제약
Appearance
This medicine is a white or almost white oval film-coated tablet.
Packaging
40 Tablets (4 Tablets in PTP packaging x 10)
Approval status
Active

MFDS item code 201603899 · Approved 2016.06.24 · Insurance code 629701070

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing over 40 kg: Administer 250 mg/125 mg of amoxicillin/clavulanate potassium, orally, 3 times a day every 8 hours; in cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg. In cases of renal impairment, dosage should be adjusted based on creatinine clearance. - Creatinine clearance of 30 mL.
Child dose
For children under 12 years or weighing less than 40 kg, administer the same method as the adult dosage with appropriate adjustments.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

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

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

This medication is effective against various bacterial infections. It is used to treat respiratory infections such as acute and chronic bronchitis, lobar and bronchial pneumonia, tonsillitis, sinusitis, and otitis media. It is also effective for treating urinary infections such as cystitis, urethritis, and pyelonephritis. This drug can be applied to a variety of infectious diseases ranging from gonorrhea and pelvic infections to boils, abscesses, soft tissue infections, wound infections, osteomyelitis, and dental infections. It has therapeutic effects against various bacteria, including several resistant strains, and can be broadly utilized depending on the patient's infection status. Thus, this medication is used to treat a wide range of bacterial infections.

How to take

Adult dose

Adults and children over 12 years or weighing over 40 kg: Administer 250 mg/125 mg of amoxicillin/clavulanate potassium, orally, 3 times a day every 8 hours; in cases of severe and respiratory infections, the dosage can be increased to 500 mg/125 mg. In cases of renal impairment, dosage should be adjusted based on creatinine clearance. - Creatinine clearance of 30 mL.

Child dose

For children under 12 years or weighing less than 40 kg, administer the same method as the adult dosage with appropriate adjustments.

Precautions

This drug should not be administered to patients with allergies to beta-lactam antibiotics, including penicillins or cephalosporins. It is particularly unsafe for patients who have experienced anaphylaxis or severe skin reactions in the past. Patients with viral infections such as infectious mononucleosis or lymphocytic leukemia have a higher risk of rash when taking this drug and should be careful. Patients with liver dysfunction or a history of liver injury due to this drug or penicillin should be carefully reviewed before administration due to the risk of recurrence. For patients with moderate to severe kidney dysfunction, monitoring is needed as the drug's blood concentration may increase, necessitating dosage adjustments. Patients with allergic tendencies or symptoms like bronchial asthma and skin rashes should be mindful of potential side effects when using this medication. Caution is also needed when administering this drug to the elderly, patients in poor general condition, or those with gastrointestinal diseases accompanied by vomiting or diarrhea, as drug absorption may be unstable. Symptoms such as diarrhea, vomiting, abdominal pain may occur, and in severe cases, it could progress to serious colitis, such as pseudomembranous colitis, which requires immediate consultation with healthcare providers. Liver-related symptoms such as elevated liver enzymes or jaundice have also been reported, and long-term use requires liver function tests. Rarely, serious hypersensitivity reactions including skin rashes, hives, and anaphylactic shock can occur, so the use of the drug should be discontinued immediately if any skin abnormality appears. Blood tests may show leukopenia or thrombocytopenia, thus regular blood testing is recommended. Symptoms of central nervous system abnormalities, such as dizziness, headache, and seizures, may occur rarely; therefore, caution is necessary for patients with reduced kidney function or those receiving high doses. Use should be avoided in the first three months of pregnancy, and pregnant or lactating women should consult a physician before use, as there may be diarrhea or allergic reactions in infants during breastfeeding. This drug is recommended only for children over 12 years old or those weighing over 40 kg, and in the elderly, dose adjustments and monitoring are necessary due to the higher risk of side effects caused by diminished physical function. As interactions with other drugs may occur, it is essential to inform the physician or pharmacist about any medications currently being taken, especially when combined with anticoagulants, probenecid, or allopurinol. In the event of an overdose, symptoms such as vomiting, diarrhea, renal failure, and seizures may occur, requiring immediate medical attention. This drug should be stored in a dry place at temperatures below 25 degrees Celsius to maintain its effectiveness, whilst adhering to usage duration and dosage to prevent the occurrence of resistant strains and side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes accompanied by high fever, blisters, skin peeling, painful mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis.

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, anorexia, abdominal pain, abdominal bloating, constipation, colonic pain, acid reflux, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, severe colitis with bloody stools, itching, erythema multiforme, dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, vesicular exfoliative dermatitis, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms.

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

Storage

This drug should be stored in a tightly sealed container to avoid moisture, in a cool, dry place to maintain effectiveness. It is especially recommended to store it at temperatures below 25 degrees Celsius.

Appearance and packaging

Appearance

This medicine is a white or almost white oval film-coated tablet.

Package unit

40 Tablets (4 Tablets in PTP packaging 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.

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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.