Medication info
Cloaran Tablet 375 mg [Amoxicillin Hydrate. Clavulanate Potassium (2:1)]

Cloaran 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
(주)동구바이오제약
Appearance
Oval film-coated tablets that are white or almost white
Packaging
100 tablets/PPT [(10 tablets x 10)]
Approval status
Active

MFDS item code 200201112 · Notified 2002.01.04 · Insurance code 657303330

Summary

Main use
Treatment of respiratory and urinary tract infections (such as bronchitis, pneumonia) and soft tissue infections
Who takes it
Adults · Children
Adult dose
For adults and children over 12 years of age or weighing 40 kg or more, administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, 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 dose. For patients with renal impairment, adjust the dose based on creatinine clearance. - Creatinine clearance of 10-30 mL/min: Administer 250-500 mg of amoxicillin per dose every 12 hours.
Child dose
For children under 12 years of age or weighing less than 40 kg, administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, orally 3 times a day every 8 hours. In cases of renal impairment, use the same dosing as for adults.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment of respiratory and urinary tract infections (such as bronchitis, pneumonia) and soft tissue infections

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

This medication is used to treat various bacterial infections. It improves respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, and lung abscess. It is effective for upper respiratory infections including tonsillitis, sinusitis, and otitis media. It treats urogenital infections such as cystitis, urethritis, and pyelonephritis. It is also used for genital infections, including pelvic inflammatory disease and gonorrhea, as well as abscesses, furuncles, soft tissue infections, wound infections, and osteomyelitis. It is effective for dental infections as well. Overall, it is widely used for the treatment of infections caused by various bacteria.

How to take

Adult dose

For adults and children over 12 years of age or weighing 40 kg or more, administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, 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 dose. For patients with renal impairment, adjust the dose based on creatinine clearance. - Creatinine clearance of 10-30 mL/min: Administer 250-500 mg of amoxicillin per dose every 12 hours.

Child dose

For children under 12 years of age or weighing less than 40 kg, administer 250 mg/125 mg of amoxicillin/clavulanate potassium per dose, orally 3 times a day every 8 hours. In cases of renal impairment, use the same dosing as for adults.

Precautions

This medication is a beta-lactam antibiotic and should not be used in patients with allergies to penicillins or cephalosporins. Particularly, individuals who have experienced severe allergic reactions or skin conditions in the past should avoid this medication. Patients with infectious mononucleosis or lymphocytic leukemia are at a higher risk for skin rashes and should use this medication with caution. Patients with impaired liver function should use it carefully as liver function may worsen. Patients with moderate to severe renal impairment should adjust the dosing intervals, as the drug can accumulate in the body and cause side effects. Patients with allergic tendencies or bronchial asthma should also use this medication with caution. Elderly individuals or those in poor overall health may be at risk of bleeding due to vitamin K deficiency, and caution is necessary. Patients with gastrointestinal diseases who experience significant vomiting or diarrhea may have reduced drug absorption, so caution is advised. Symptoms such as diarrhea, vomiting, and abdominal pain may occur upon taking this medication, and in rare cases, severe colitis may develop, requiring careful monitoring of symptoms. Abnormal liver function may arise, especially in the elderly and males, necessitating regular liver function tests with long-term use. Skin rashes, itching, and severe skin reactions such as Stevens-Johnson syndrome may occur and should prompt immediate discontinuation of the medication. Rare reports of blood-related reactions such as leukopenia, anemia, and thrombocytopenia have been noted, and tests may be required if abnormal symptoms occur. Central nervous system reactions such as anxiety, confusion, and seizures may occur rarely, particularly in patients with poor renal function or with high doses. Patients with renal impairment are at risk of acute renal failure, requiring regular testing. This medication may affect the normal intestinal microbiota, leading to phenomena like candidiasis. Symptoms of vitamin K deficiency bleeding or vitamin B-group deficiency may rarely occur, so symptom monitoring is essential. Extended use of this medication may lead to drug-resistant bacteria; therefore, it is important to take it for the minimum necessary duration. Serious allergic reactions, such as anaphylaxis, can very rarely occur, so patients should be closely monitored after administration. If severe diarrhea or abdominal cramps occur during or after antibiotic use, the medication should be discontinued immediately, and a physician should be consulted. This medication may interact with other drugs, so patients should inform their healthcare provider of any other medications they are taking. It should be avoided during the early stages of pregnancy, and pregnant or breastfeeding women should consult a physician before using this medication. It is not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly individuals may experience adverse reactions more easily due to reduced bodily functions, so dosage and administration intervals should be adjusted, with careful monitoring. In case of overdose, symptoms such as vomiting, diarrhea, drowsiness, and rashes may occur; if suspected, immediate notification of healthcare providers and appropriate treatment are necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, mucocutaneous syndrome (Stevens-Johnson syndrome), shock, fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden severe headache, lightning headache, seizures,

Mild side effects

  • Diarrhea
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • loss of appetite
  • abdominal pain
  • abdominal distension
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  • constipation
  • colonic pain
  • gastric acidity
  • loose stools
  • dry mouth
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • elevated serum bilirubin
  • increased AST
  • ALT
  • ALP
  • LDH
  • hepatitis
  • itching
  • erythema multiforme
  • thrombocytopenic purpura
  • mucosal candidiasis
  • vaginal itching
  • increased secretion
  • restlessness
  • anxiety
  • behavioral changes

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 and should be kept in a dry place below 25 degrees Celsius. Storing this way helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

Oval film-coated tablets that are white or almost white

Package unit

100 tablets/PPT [(10 tablets 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.