Medication info
Okmactin Tablet 625 mg (Amoxicillin · Clavulanate Potassium (4:1))

Okmactin Tablet 625 mg (Amoxicillin · Clavulanate Potassium (4:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›500mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)알피바이오
Appearance
White or almost white oval film-coated tablet
Packaging
40 tablets (4 tablets/PTP*10)
Approval status
Active

MFDS item code 201600357 · Approved 2016.01.20 · Insurance code 661605060

Summary

Main use
Treatment of infections in the respiratory tract (bronchitis, pneumonia), and urogenital tract (cystitis, gonorrhea)
Who takes it
Adults · Children
Adult dose
Adults and children 12 years and older or weighing 40 kg or more: Administer orally as Amoxicillin/Clavulanate potassium 250 mg/125 mg, 3 times daily every 8 hours. In cases of severe or respiratory infections, the dose can be increased to 500 mg/125 mg once daily. For those with renal impairment, adjust the dosage based on creatinine clearance. - Creatinine clearance above 30 mL/min: Dosage adjustment is not necessary.
Child dose
For children under 12 years old or weighing less than 40 kg, reduce the adult dosage accordingly.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Treatment of infections in the respiratory tract (bronchitis, pneumonia), and urogenital tract (cystitis, gonorrhea)

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

This drug is effective against various bacterial infections and is used to treat respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It is also used for urinary tract infections such as cystitis, urethritis, and pyelonephritis, as well as reproductive infections such as pelvic inflammatory disease and gonorrhea. It heals skin infections such as boils, abscesses, soft tissue infections, and wound infections, and is also effective for osteomyelitis and dental infections. It acts against multiple strains, particularly resistant bacteria including beta-lactamase producing strains. It helps rapidly and effectively improve these various infections.

How to take

Adult dose

Adults and children 12 years and older or weighing 40 kg or more: Administer orally as Amoxicillin/Clavulanate potassium 250 mg/125 mg, 3 times daily every 8 hours. In cases of severe or respiratory infections, the dose can be increased to 500 mg/125 mg once daily. For those with renal impairment, adjust the dosage based on creatinine clearance. - Creatinine clearance above 30 mL/min: Dosage adjustment is not necessary.

Child dose

For children under 12 years old or weighing less than 40 kg, reduce the adult dosage accordingly.

Precautions

This drug is a beta-lactam antibiotic and should not be used in patients who have had hypersensitivity reactions to penicillin drugs. Patients with a history of anaphylaxis, severe skin reactions, or shock should avoid administration. It is advised not to use this drug in patients with infectious mononucleosis or lymphocytic leukemia due to the high risk of rash. Patients with liver function issues should be cautious as there is a risk of recurrence. In patients with liver dysfunction or moderate to severe renal impairment, drug concentrations may increase, and dose and interval adjustments may be necessary. Patients with allergies or conditions such as asthma and urticaria should use this drug cautiously. In patients with severe vomiting or diarrhea, the elderly, or those in poor nutritional status, care is needed due to the risk of bleeding from vitamin K deficiency. This drug may cause gastrointestinal adverse reactions such as diarrhea, abdominal pain, and vomiting, and in severe cases, may lead to pseudomembranous colitis or acute pancreatitis. Symptoms of liver dysfunction may also occur, particularly more commonly reported in elderly patients over 60 and males. Allergic reactions may manifest as skin rash, urticaria, angioedema, and anaphylactic shock, so immediate discontinuation of the drug is necessary if symptoms appear. Blood disorders such as leukopenia, thrombocytopenia, and hemolytic anemia have been reported, and neurogenic symptoms such as convulsions or confusion may rarely occur. Patients with renal impairment may experience acute renal failure or interstitial nephritis, so regular monitoring is necessary. Use of antibiotics can result in changes to the intestinal flora, leading to candidiasis or stomatitis. This drug may cause vitamin K deficiency, so patients with a tendency to bleed must be cautious. It should be avoided during the first three months of pregnancy, and pregnant or nursing women should use it cautiously based on a doctor's judgment. It is not recommended for children under 12 years old, and caution is necessary in the elderly due to a higher risk of adverse reactions associated with decreased bodily function. Since this drug interacts with other medications, patients taking other drugs must consult with a physician or pharmacist. In cases of overdose, gastrointestinal symptoms and central nervous system symptoms may occur, and immediate medical attention should be sought for appropriate treatment. Store this drug in a sealed container to avoid moisture, and it is important to maintain a cool temperature between 1 and 25 degrees Celsius. Avoid direct sunlight and do not store in extremely hot or cold places as this helps to maintain the drug's effectiveness over time.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, painful mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough + fever, jaundice, extreme lethargy, hepatic dysfunction (jaundice), sudden and severe symptoms.

Mild side effects

Diarrhea, dyspepsia, stomatitis, gastritis, glossitis, nausea, vomiting, loss of appetite, abdominal pain, bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, severe colitis with bloody stools, itching, erythema multiforme, rash, angioedema, serum sickness-like syndrome, hypersensitivity vasculitis, acute generalized exanthematous pustulosis, bronchospasm, laryngeal edema, blood abnormalities (reversible leukopenia)

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

Storage

This drug should be kept in a sealed container to prevent moisture, and it is important to maintain a cool temperature between 1 and 25 degrees Celsius while storing. Avoid direct sunlight and do not place it in extremely hot or cold locations to help preserve the drug's effectiveness.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

Package unit

40 tablets (4 tablets/PTP*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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.