Medication info

Clarithromycin 500 mg Tablet

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Clarithromycin›500mg / 1 tablet
Manufacturer / importer
Korea Biochem Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
28 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201501120 · Approved 2015.03.04

This product's status changed to Approval withdrawn on 2025.02.18. 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 Helicobacter pylori infection
Who uses it
Adults · Children
Adult dosage
○ Adults: The usual dose of clarithromycin is 250mg (potency) per dose twice daily; for severe infections, administer 500mg (potency) per dose twice daily. The usual duration of treatment is 7~14 days. For patients with renal failure and a creatinine clearance of 30mL/min or less, the dose should be reduced by half: 250mg (potency) once daily, or, for severe infections, 250mg (potency) per dose twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) per dose twice daily. In this case, it must be administered in combination with other antimycobacterial agents, such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer this medicine 500mg (potency) 3 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) per dose 3 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 or older: Same as adults For children under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
Korea Biochem Co., Ltd.

Efficacy & effects

Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter pylori infection

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

This medication is used to treat various respiratory infections, ranging from lower respiratory infections such as bronchitis or pneumonia to upper respiratory infections such as pharyngitis and sinusitis. It also effectively improves infections of the skin and skin tissues, and is used for mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare. Furthermore, it helps eliminate Helicobacter pylori, which causes duodenal ulcers. With a broad spectrum of antibacterial activity against various bacterial infections, it is a good choice for symptom recovery. When used appropriately according to the patient's symptoms, it can effectively treat infections.

Dosage and Administration

Adult dosage

○ Adults: The usual dose of clarithromycin is 250mg (potency) per dose twice daily; for severe infections, administer 500mg (potency) per dose twice daily. The usual duration of treatment is 7~14 days. For patients with renal failure and a creatinine clearance of 30mL/min or less, the dose should be reduced by half: 250mg (potency) once daily, or, for severe infections, 250mg (potency) per dose twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) per dose twice daily. In this case, it must be administered in combination with other antimycobacterial agents, such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer this medicine 500mg (potency) 3 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) per dose 3 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 or older: Same as adults For children under 12 years of age, use clarithromycin dry syrup.

Precautions

It is crucial not to use this medication in certain patients. For example, patients who are allergic to any ingredient in this medication or have previously shown hypersensitivity to similar classes of antibiotics should not be administered this drug. Additionally, it may pose risks to patients with certain heart diseases or severely impaired liver and kidney functions. It is also safer for women who are pregnant or breastfeeding to avoid taking this medication. This drug has a high potential for drug interactions, so if you are already taking other medications, you must consult a doctor or pharmacist. Special caution is required when taking it with medications that may affect heart rhythm or those that are metabolized in the liver. During the use of this medication, allergic reactions or serious side effects may occur, so patients should notify medical personnel immediately if symptoms appear. Moreover, this drug can affect the balance of intestinal bacteria, and if symptoms such as diarrhea or abdominal pain persist, treatment should be discontinued, and consultation is advised. Elderly patients or those with impaired kidney or liver function may require dose adjustment and should follow a specialist's instructions. Lastly, this medication may have age-related usage restrictions for children, so pediatric patients must consult a specialist.

Side effects

Shock, anaphylactic symptoms, dyspnea, convulsions, flushing, rash, itching, urticaria, skin flushing, angioedema, joint swelling, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, flatulence, diarrhea, oral mucosal erosion, epigastric pain, thirst, dental discoloration, pancreatitis, increased amylase, taste disturbance, loss of appetite, constipation, change in stool color, pseudomembranous colitis, hemorrhagic colitis, fever, cough, dyspnea, abnormal chest X-ray, increased eosinophils, eosinophilic lung infiltrates, interstitial pneumonia, chronic bronchitis, acute maxillary sinusitis, increased eosinophils, thrombocytopenia, panhypopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, taste loss, anosmia, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization, convulsions, tremors, numbness, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash, jaundice, hepatocellular hepatitis, cholestatic hepatitis, increased liver enzyme levels, 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, renal failure, rhabdomyolysis, glossitis, stomatitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de pointes, malaise, headache, taste distortion, hearing loss, paresthesia, arthralgia, myalgia, olfactory dysfunction, tinnitus, auditory impairment, hypoglycemia, purpuric rash, acute generalized exanthematous pustulosis, muscle spasms, musculoskeletal rigidity, myopathy, vasodilation, bleeding, asthma, epistaxis, pulmonary embolism, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, belching, bloating, tongue discoloration, dental discoloration, vesicular dermatitis, hyperhidrosis, papular rash, acne, Henoch-Schonlein purpura, elevated serum alkaline phosphatase, elevated serum lactate dehydrogenase, increased international normalized ratio, prolonged prothrombin time, abnormal urine color, injection site phlebitis, injection site pain, injection site inflammation, fever, weakness, chest pain, chills, fatigue

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

Storage

This medication is sensitive to light, so it should be stored in a container that protects it from light. Also, it should be kept at room temperature between 15°C and 30°C, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

28 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.

Questions about this medicine

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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.