Medication info
Uniquea 625 mg Tablets

Uniquea 625 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
White or almost white oval film-coated tablet.
Packaging
40 tablets (4 tablets/PTP X 10)
Approval status
Active

MFDS item code 201902042 · Approved 2019.04.04

Summary

Main use
Treatment of bacterial infections including respiratory and urogenital infections.
Who takes it
Adults · Children
Adult dose
For adults and children aged 12 years or older or weighing 40 kg or more, the dosage is 250 mg/125 mg of amoxicillin/clavulanic acid potassium, taken orally three times a day at 8-hour intervals. In cases of severe or respiratory infections, the dosage can be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 10 to 30 mL/min: every 12 hours.
Child dose
For children under 12 years of age or those weighing less than 40 kg, the dosage should be reduced accordingly.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of bacterial infections including respiratory and urogenital infections.

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

This medicine is used to treat various bacterial infections. It is effective for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and lung abscesses, and is also used for upper respiratory infections such as tonsillitis, sinusitis, and otitis media. Additionally, it helps in the treatment of urinary tract infections such as cystitis, urethritis, and pyelonephritis. This drug is also used for treating pelvic infections and gonorrhea, and is effective for skin and soft tissue infections such as boils, abscesses, cellulitis, and wound infections. Rarely, it is used for treating osteomyelitis or dental infections, thereby improving overall bacterial infections.

How to take

Adult dose

For adults and children aged 12 years or older or weighing 40 kg or more, the dosage is 250 mg/125 mg of amoxicillin/clavulanic acid potassium, taken orally three times a day at 8-hour intervals. In cases of severe or respiratory infections, the dosage can be increased to 500 mg/125 mg per dose. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 10 to 30 mL/min: every 12 hours.

Child dose

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

Precautions

This medication should not be used in individuals with specific allergic reactions. For example, those who have experienced hypersensitivity symptoms with penicillin or beta-lactam drugs may be at risk when taking this medication. Additionally, individuals with viral infectious diseases such as infectious mononucleosis or lymphocytic leukemia may face a higher risk of side effects, such as rashes, when taking this medication. People with a history of liver dysfunction should exercise caution as taking this medication may worsen liver function. Patients with moderate to severe renal impairment may experience increased blood concentration of this medication, so dosing intervals should be adjusted and used with caution. Individuals with allergic dispositions or those exhibiting symptoms such as bronchial asthma, skin rashes, or hives should consult a physician before taking this medication. Those who have difficulty taking oral medications, elderly patients, or individuals in poor general health should be cautious of the risk of bleeding due to vitamin K deficiency. When experiencing gastrointestinal symptoms such as abdominal pain, diarrhea, or vomiting, absorption of the medication may be compromised, so the condition should be closely monitored. If symptoms such as diarrhea, abdominal pain, or bloody stools occur while taking this medication, it is important to stop taking it immediately and consult medical personnel, as these could indicate serious side effects like pseudomembranous colitis. Symptoms of liver dysfunction may also arise, so if there are elevated liver values or symptoms of jaundice, the physician should be informed immediately. Skin rashes, itching, and severe allergic reactions may occur rarely, so if such symptoms arise, the medication should be discontinued and medical advice should be followed. There have been rare reports of decreased white blood cell counts and anemia on blood tests, so regular blood testing may be necessary during long-term use. Symptoms affecting the central nervous system, such as dizziness, headache, and seizures, may occur rarely, so if any abnormal symptoms arise, seek advice from medical personnel immediately. There may be cases of rapid deterioration of kidney function, so regular testing is important for those with renal issues. This drug may affect the balance of intestinal bacteria, leading to symptoms such as candidiasis or stomatitis, so caution is advised. Long-term or high-dose administration poses a risk of bleeding due to vitamin K deficiency, so if such symptoms arise, bring it to the attention of medical staff immediately. Pregnant women or those who may become pregnant should avoid taking this medication during the first three months of pregnancy, and breastfeeding mothers should also be cautious as side effects may occur in the infant. This medication is not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly patients should be careful as declining body function increases the risk of side effects, and dosage and intervals should be adjusted accordingly. During the use of this medication, false positive results may occur in certain urine tests, so it's important to inform medical staff during testing. In the case of overdose, symptoms like vomiting, diarrhea, and abdominal pain may occur, and in severe cases, renal failure or seizures might develop, necessitating immediate visit to a medical facility. This medication should be stored in a tightly sealed container in a cool, dry place at or below 25 degrees Celsius. Stopping usage immediately and consulting with a doctor is advisable if any adverse reactions occur during treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe allergic reactions (including anaphylaxis), severe rashes with high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.), respiratory problems (bronchospasm, laryngeal edema, anaphylactic shock), jaundice (yellowing of skin or eyes), liver abnormalities (cholestatic jaundice).

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
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  • abdominal bloating
  • constipation
  • colonic pain
  • acid reflux
  • soft stools
  • dry mouth
  • candidiasis
  • antibiotic-associated colitis
  • severe colitis with bloody stools
  • itching
  • erythema multiforme
  • skin rash
  • serum sickness
  • arthralgia
  • lymphadenopathy
  • restlessness
  • anxiety
  • behavioral changes
  • confusion
  • drowsiness
  • insomnia
  • hyperactivity
  • dizziness
  • headache.

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, in a cool, dry place at or below 25 degrees Celsius. Storing it this way helps maintain the effectiveness of the medicine over time and prevents deterioration.

Appearance and packaging

Appearance

White or almost 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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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.