Medication info

Clarithromycin Tablet 500 mg

Prescription medicationTabletExpired
Ingredient · strength
Clarithromycin›500mg / 1 tablet
Manufacturer / importer
Daewon Biotech Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Expired

MFDS item code 201906916 · Approved 2019.09.30

This product's status changed to Expired on 2024.09.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory and skin infections, mycobacterial infections, and eradication of Helicobacter pylori in duodenal ulcers
Who uses it
Adults · Children
Adult dosage
○ Adults: The usual dose of clarithromycin is 250mg (potency) twice daily. For severe infections, administer 500mg (potency) twice daily. The usual treatment period is 7~14 days. In patients with renal failure and creatinine clearance of 30mL/min or less, the dose should be reduced by half: 250mg (potency) once daily, or, for severe infections, 250mg (potency) twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it should be administered in combination with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer 500mg (potency) of this medicine three times daily in combination with omeprazole 40mg once daily for 14 days, followed by omeprazole 40mg once daily for 14 consecutive days. That is, administer clarithromycin 500mg (potency) three times daily for 14 days (days 1~14), and omeprazole 40mg once daily for 28 days (days 1~28).
Children's dosage
○ Children aged 12 years and older: Same as adults ○ For children under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
Daewon Biotech Co., Ltd.

Efficacy & effects

Treatment of respiratory and skin infections, mycobacterial infections, and eradication of Helicobacter pylori in duodenal ulcers

  • Bronchitis
  • pneumonia
  • pharyngitis
  • sinusitis
  • skin and soft tissue infections
  • mycobacterial infections
  • duodenal ulcer
View approved original text

This drug is effective for lower respiratory infections such as bronchitis and pneumonia, upper respiratory infections such as pharyngitis and sinusitis, and skin and soft tissue infections. It is also used for the treatment of mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare, and helps eliminate Helicobacter pylori bacteria in patients with duodenal ulcers. With its broad-spectrum antibacterial action against various bacteria, it is effective in treating multiple infectious diseases. Therefore, this medication is used to improve a variety of infectious diseases.

Dosage and Administration

Adult dosage

○ Adults: The usual dose of clarithromycin is 250mg (potency) twice daily. For severe infections, administer 500mg (potency) twice daily. The usual treatment period is 7~14 days. In patients with renal failure and creatinine clearance of 30mL/min or less, the dose should be reduced by half: 250mg (potency) once daily, or, for severe infections, 250mg (potency) twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it should be administered in combination with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer 500mg (potency) of this medicine three times daily in combination with omeprazole 40mg once daily for 14 days, followed by omeprazole 40mg once daily for 14 consecutive days. That is, administer clarithromycin 500mg (potency) three times daily for 14 days (days 1~14), and omeprazole 40mg once daily for 28 days (days 1~28).

Children's dosage

○ Children aged 12 years and older: Same as adults ○ For children under 12 years of age, use clarithromycin dry syrup.

Precautions

This drug should not be used in specific patients. Patients with allergies to any component of this drug or who have had hypersensitivity reactions to similar classes of antibiotics should not be administered this medication. Additionally, patients taking certain medications that affect heart rhythm, those with cardiac arrhythmias, severe liver disorders, or women who are pregnant or breastfeeding should not be treated with this drug. This drug may be affected by liver and kidney function; therefore, caution is required for patients with liver disorders or renal failure. Patients with heart disease, elderly patients, and those taking other antibiotics also require careful monitoring. This drug may cause various side effects including allergic reactions, gastrointestinal disturbances, skin rashes, liver function abnormalities, decreased kidney function, and central nervous system effects; thus, if any abnormal symptoms occur, immediate consultation with a physician is necessary. Furthermore, this drug may interact with various medications, so it is essential to inform healthcare professionals if you are taking other medications. It is generally recommended to avoid using this medication during pregnancy or breastfeeding; if unavoidable, breastfeeding should be discontinued. The use of this drug in children is limited based on age and condition, so it should be under the guidance of a professional. Elderly patients may require dose adjustments due to decreased kidney function. When using this drug, it is important to check the sensitivity of the infecting bacteria for therapeutic effectiveness and to administer it for only the necessary minimum duration. In the case of overdose, gastrointestinal disturbances or psychiatric symptoms may occur, so it is crucial to avoid overdose and seek treatment immediately if any abnormal symptoms appear.

Side effects

Shock, anaphylactic symptoms, shortness of breath, spasms, flushing, rash, itching, hives, skin flushing, angioedema, joint swelling, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, gas retention, diarrhea, oral mucosal erosion, upper abdominal pain, thirst, transient tooth discoloration, pancreatitis, increased amylase, dysgeusia, appetite loss, constipation, stool discoloration, pseudomembranous colitis, hemorrhagic colitis, fever, cough, abnormal chest X-ray, eosinophilia, eosinophilic pulmonary infiltrate, interstitial pneumonia, chronic bronchitis, exacerbation of acute maxillary sinusitis, thrombocytopenia, pancytopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, taste loss, smell loss, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucination, psychosis, derealization, spasms, tremors, numbness, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash with eosinophilia and systemic symptoms, jaundice, hepatocellular hepatitis, cholestatic hepatitis, increased liver enzymes, liver dysfunction, liver failure, fulminant hepatitis, elevated AST, elevated ALT, elevated γ-GTP, elevated LDH, elevated ALP, increased total bilirubin, elevated serum creatinine, elevated BUN, interstitial nephritis, phlebitis at the injection site, injection site pain, inflammation at the injection site, fever, myasthenia, chest pain, chills, fatigue, abnormal albumin-globulin ratio, elevated serum alkaline phosphatase, elevated serum lactate dehydrogenase, increased international normalized ratio, prolonged prothrombin time, abnormal urine color, decreased appetite, insomnia, anxiety, irritability, noise sensitivity, psychotic disorder, confusional state, derealization, depression, disorientation, hallucination, abnormal dreams, mania, dysgeusia, headache, loss of consciousness, movement disorder, non-vertiginous dizziness, drowsiness, tremor, spasms, taste loss, abnormal smell, smell loss, vertiginous dizziness, hearing impairment, hearing loss, cardiac arrest, atrial fibrillation, QT interval prolongation on ECG, extrasystole, palpitations, vasodilation, asthma, epistaxis, pulmonary embolism, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, belching, abdominal distension, tongue discoloration, tooth discoloration, abnormal liver function tests, bile duct obstruction, hepatitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated gamma-glutamyl transferase, hepatocellular jaundice, vesicular dermatitis, hyperhidrosis, papular rash, acne, Henoch-Schonlein purpura, myalgia, rhabdomyolysis, renal failure, nephritis

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

Storage

This drug is sensitive to light; therefore, it should be stored in a dark, airtight container that does not allow light penetration. Additionally, it is most suitable to store the drug at room temperature between 15 degrees and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle

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.