Medication info

Clarithromycin Tablet 500 mg

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

MFDS item code 201508008 · Approved 2015.11.30

This product's status changed to Expired on 2025.11.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections (respiratory, skin, and mycobacterial) and eradication of Helicobacter pylori in duodenal ulcer
Who uses it
Adults · Children
Adult dosage
Adults: The usual dose is 250mg (potency) of clarithromycin twice daily. For severe infections, administer 500mg (potency) twice daily. The usual treatment duration is 7~14 days. In patients with renal impairment 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) twice daily. Do not administer this medicine to such patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it must be administered concomitantly 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 for 14 days together with omeprazole 40mg once daily, 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, use clarithromycin dry syrup.

Ingredients

Manufacturer
Seoul Pharma Co., Ltd.

Efficacy & effects

Treatment of infections (respiratory, skin, and mycobacterial) and eradication of Helicobacter pylori in duodenal ulcer

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

This medication is used to treat various bacterial infections. The main targets for treatment are lower respiratory tract infections such as bronchitis and pneumonia, and it is also effective against upper respiratory tract infections such as pharyngitis and sinusitis. It is used for skin and soft tissue infections as well. It is particularly helpful in treating mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare. Additionally, it is used to eradicate Helicobacter pylori in patients with duodenal ulcers. Overall, this drug improves a variety of bacterial infections.

Dosage and Administration

Adult dosage

Adults: The usual dose is 250mg (potency) of clarithromycin twice daily. For severe infections, administer 500mg (potency) twice daily. The usual treatment duration is 7~14 days. In patients with renal impairment 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) twice daily. Do not administer this medicine to such patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it must be administered concomitantly 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 for 14 days together with omeprazole 40mg once daily, 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, use clarithromycin dry syrup.

Precautions

This medication should not be used in certain patients. For example, patients who have allergies to the additives or active ingredients of this medication, those with severe liver or kidney disease, and women who are pregnant or lactating should not take this drug. Additionally, patients with heart rhythm abnormalities or those taking certain other medications should avoid this drug. Since this medication is primarily excreted through the liver and kidneys, it should be administered cautiously to patients with liver disabilities or kidney failure. Elderly patients, those with heart disease, and patients taking other antibiotics also require careful observation. During treatment, various side effects such as allergic reactions, gastrointestinal disturbances, liver function abnormalities, kidney function decline, skin rashes, and nervous system anomalies can occur, so careful monitoring is necessary. If serious allergic reactions or skin diseases occur, discontinue administration immediately and seek appropriate treatment. This drug can interact with several other medications, so if you are taking any other drugs, it is essential to inform healthcare professionals. Pregnant or nursing women should not take this medication unless absolutely necessary and should follow the guidance of a healthcare expert. Some formulations are only suitable for children, and the safety for children under 12 years has not been sufficiently confirmed. Elderly patients may require dose adjustments due to declining kidney function. Overdosage may lead to gastrointestinal disturbances or central nervous system abnormalities, and medical treatment should be sought immediately. This drug should not be refrigerated during storage; it should be kept at room temperature away from direct sunlight. Lastly, caution is advised during driving or operating machinery as dizziness or confusion may occur while taking this medication.

Side effects

Shock, anaphylactic symptoms, respiratory distress, convulsions, flushing, rash, itching, hives, mild skin erythema, angioedema, joint swelling, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, gas retention, diarrhea, oral mucosal erosion, epigastric pain, thirst, transient tooth discoloration, pancreatitis, increased amylase, taste disturbances, loss of appetite, constipation, change in stool color, membrane colitis, hemorrhagic colitis, fever, cough, abnormal chest X-ray findings, eosinophilia, eosinophilic lung infiltration, interstitial pneumonia, chronic bronchitis, acute exacerbation of acute maxillary sinusitis, eosinophilia, thrombocytopenia, pancytopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, loss of taste, loss of smell, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization, convulsions, tremors, numbness, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash accompanied by eosinophilia and systemic symptoms, 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, increased BUN, interstitial nephritis, renal failure, rhabdomyolysis, glossitis, stomatitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de pointes, fatigue, headache, taste distortion, hearing loss, paresthesia, arthralgia, myalgia, olfactory disorder, hypoglycemia, tinnitus, auditory impairment, purpuric rash, acute generalized pustular psoriasis, muscle spasms, musculoskeletal rigidity, myopathy, elevated blood creatinine, elevated blood urea, renal failure, nephritis, phlebitis at injection site, injection site pain, injection site inflammation, fever, weakness, chest pain, chills, fatigue, abnormal albumin-globulin ratio, elevated serum alkaline phosphatase, elevated serum lactate dehydrogenase, increased INR, prolonged prothrombin time, abnormal urine color, asthma, epistaxis, pulmonary embolism, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, belching, bloating, tongue discoloration, tooth discoloration

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

Storage

This medication is sensitive to light, so it must be stored in a special container that does not allow light in. Additionally, it is best to store the drug at room temperature between 15 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be well maintained.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets 200 tablets

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.