Medication info
Aclan Tablet 375 mg

Aclan Tablet 375 mg

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
White or nearly white oval film-coated tablets
Packaging
80 tablets/box [(8 tablets/PTP*10)], 100 tablets/box [(10 tablets/PTP*10)]
Approval status
Active

MFDS item code 201306376 · Approved 2013.03.22 · Insurance code 653402750

Summary

Main use
Treatment of respiratory and genitourinary infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 years and above or weighing 40 kg or more should take 250 mg of Amoxicillin / 125 mg of Clavulanate orally every 8 hours (3 times daily). In cases of severe or respiratory infections, the dosage can be increased to 500 mg of Amoxicillin / 125 mg of Clavulanate. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment needed.
Child dose
Children aged 12 years and above or weighing 40 kg or more should take the same dosage as adults. In cases of renal impairment, the dosage should be reduced as per adult guidelines.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Treatment of respiratory and genitourinary infections (bronchitis, pneumonia, cystitis, etc.)

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

This medicine is effective against various bacterial infections. It is used to treat respiratory infections such as acute and chronic bronchitis, lobar and bronchopneumonia, empyema, lung abscess, tonsillitis, sinusitis, and otitis media. It is also effective for genitourinary infections such as cystitis, urethritis, and pyelonephritis, as well as pelvic infections and gonorrhea. It improves skin and soft tissue infections, boils and abscesses, and wound infections, and is used in the treatment of osteomyelitis and dental infections. Thus, it is widely used for bacterial infection diseases in various areas to alleviate symptoms and aid in healing.

How to take

Adult dose

Adults and children aged 12 years and above or weighing 40 kg or more should take 250 mg of Amoxicillin / 125 mg of Clavulanate orally every 8 hours (3 times daily). In cases of severe or respiratory infections, the dosage can be increased to 500 mg of Amoxicillin / 125 mg of Clavulanate. In cases of renal impairment, the dosage should be adjusted according to creatinine clearance. - Creatinine clearance above 30 mL/min: No dosage adjustment needed.

Child dose

Children aged 12 years and above or weighing 40 kg or more should take the same dosage as adults. In cases of renal impairment, the dosage should be reduced as per adult guidelines.

Precautions

This drug is a penicillin-class antibiotic and should not be administered to patients who have had hypersensitivity reactions to beta-lactam antibiotics. In particular, patients with a history of serious allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or shock should not use this medication. Additionally, it should be avoided in patients with infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients with liver dysfunction or a history of jaundice should exercise caution as symptoms may recur. Caution is also necessary for patients with reduced liver function or moderate to severe renal impairment, as the drug may remain in the body longer, increasing the risk of side effects. Patients with allergic predisposition, those who have difficulty with oral intake, the elderly, and those in poor general condition may show vitamin K deficiency and bleeding tendencies. In cases of gastrointestinal diseases with severe vomiting or diarrhea, careful usage is necessary as drug absorption might be inadequate. If symptoms like diarrhea, abdominal pain, or blood in stool appear while taking this medication, administration should be stopped immediately and a physician consulted. Allergic reactions such as abnormal liver tests, skin rash, itching, and difficulty breathing may occur, and if these symptoms appear, medical personnel should be informed immediately. It's important to perform regular checks on liver function, kidney function, and blood tests during prolonged use. Women who are pregnant or breastfeeding should use this medication cautiously after consulting with their physician, as it may affect the fetus or infant. This drug is not recommended for children, especially those under 12 years of age or weighing less than 40 kg. The elderly may experience adverse reactions more easily due to diminished physiological functions, so dosage and administration intervals should be adjusted with careful observation. This drug may interact with other medications, so it's critical to inform healthcare providers about any medications being taken, particularly anticoagulants, anti-inflammatory drugs, and other antibiotics. In cases of overdose, gastrointestinal symptoms, renal failure, seizures, and hypersensitivity shock may occur, necessitating immediate discontinuation of the drug and emergency treatment. This medication should be stored in a dry place below 25 degrees Celsius, and it's important to adhere to the prescribed duration and dosage as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe cutaneous adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe reactions

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
Show 23 more
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • loose stools
  • dry mouth
  • elevated AST
  • ALT
  • ALP
  • LDH
  • increased serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • polymorphous light eruption
  • angioedema
  • dermatitis
  • oral edema
  • reversible leukopenia
  • thrombocytopenia
  • hemolytic anemia
  • anemia
  • thrombocytopenic purpura

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

Storage

This medication is kept in a tightly sealed container to prevent moisture and air from entering. Store it in a cool location between 1 to 25 degrees Celsius. Avoid direct sunlight and do not place it in excessively hot or cold areas.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

80 tablets/box [(8 tablets/PTP*10)], 100 tablets/box [(10 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.