Medication info
Clarithromycin 500 mg

Clarithromycin 500 mg

Prescription medicationTablet
Ingredient · strength
Clarithromycin›500mg / 1 tablet
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
Yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201900850 · Approved 2019.02.11

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) per dose, twice daily; for severe infections, administer 500mg (potency) per dose, twice daily. The usual treatment duration is 7~14 days. For patients with renal failure whose creatinine clearance is 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 to these patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine per dose, twice daily. In this case, it should be administered concomitantly with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. Helicobacter pylori eradication in patients with duodenal ulcers: Administer this medicine 500mg (potency) 3 times daily 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
Pediatric patients aged 12 years and older: Same as adults For pediatric patients under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
Cosmax Pharma 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 medication is used to treat lower respiratory infections such as bronchitis and pneumonia, as well as upper respiratory infections like pharyngitis and sinusitis. It is also effective in treating skin and soft tissue infections and infections by Mycobacterium avium and Mycobacterium intracellulare. This drug helps eradicate Helicobacter pylori, the causative agent of duodenal ulcers. It is effective against a variety of bacteria and can be used for the improvement of various infectious diseases. It can be prescribed appropriately based on the patient's infection site and causative organism, ensuring safe treatment. This medication is used for improving infection.

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 treatment duration is 7~14 days. For patients with renal failure whose creatinine clearance is 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 to these patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine per dose, twice daily. In this case, it should be administered concomitantly with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. Helicobacter pylori eradication in patients with duodenal ulcers: Administer this medicine 500mg (potency) 3 times daily 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

Pediatric patients aged 12 years and older: Same as adults For pediatric patients under 12 years of age, use clarithromycin dry syrup.

Precautions

This medication should not be used in patients with allergies to certain ingredients. Patients who have experienced hypersensitivity to clarithromycin or similar class antibiotics should not be given this drug. Patients with certain heart conditions, especially those with arrhythmias, should be cautious as this medication may exacerbate heart problems. Patients with severely impaired liver or kidney function should use this medication cautiously as it can affect metabolism and excretion. Pregnant or breastfeeding women should avoid taking this medication. This drug may interact with many other medications, so it is essential to inform healthcare professionals if you are taking other drugs. If allergic symptoms, severe skin rash, or respiratory distress occur while taking this medication, stop use immediately and consult a healthcare professional. Long-term or high-dose use may result in auditory disturbances or tinnitus; report such symptoms. This medication may cause gastrointestinal disturbances, diarrhea, vomiting etc.; if symptoms are severe, it is advisable to inform healthcare professionals. Elderly patients or those with weakened immune systems are at a higher risk of side effects with this medication and should be more cautious. Dizziness or confusion may occur while driving or operating machinery during medication; caution is necessary. Overdosing may cause gastrointestinal disturbances or central nervous system symptoms, so the prescribed dosage must be strictly followed.

Side effects

Shock, anaphylactic symptoms, difficulty breathing, seizures, flushing, rash, itching, hives, skin flushing, angioedema, joint swelling, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, malaise, flatulence, diarrhea, oral mucosal erosion, upper abdominal pain, thirst, transient tooth discoloration, pancreatitis, increased amylase, taste disturbance, loss of appetite, constipation, discoloration of feces, pseudomembranous colitis, hemorrhagic colitis, fever, cough, abnormal chest X-ray, eosinophilia, eosinophilic pulmonary infiltrates, interstitial pneumonia, chronic bronchitis, acute maxillary sinusitis, thrombocytopenia, pancytopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, loss of taste, loss of smell, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychiatric disorders, depersonalization, trembling, numbness, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash (DRESS), 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, increased 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 dysfunction, hypoglycemia, soft tissue infection, candidiasis, gastroenteritis, infection, vaginal infection, pseudomembranous colitis, impetigo, superficial soft tissue infection, erythema nodosum, leukopenia, neutropenia, thrombocytosis, eosinophilia, agranulocytosis, thrombocytopenia, anaphylactic reaction, hypersensitivity anaphylactic reaction, angioedema, loss of appetite, decreased appetite, hypoglycemia, insomnia, anxiety, nervous irritability, noise sensitivity, psychotic disorder, confused state, depersonalization, depression, disorientation, hallucinations, abnormal dreams, mania, taste disturbance, headache, loss of consciousness, dyskinesia, non-vestibular dizziness, drowsiness, tremors, seizures, loss of taste, abnormal olfaction, loss of smell, vestibular dizziness, hearing impairment, tinnitus, hearing loss, cardiac arrest, atrial fibrillation, QT prolongation on ECG, extrasystole, palpitations, vasodilation, asthma, nasal bleeding, pulmonary embolism, diarrhea, vomiting, dyspepsia, nausea, abdominal pain, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, stomatitis, glossitis, abdominal distension, constipation, thirst, belching, bloating, acute pancreatitis, tongue discoloration, tooth discoloration, abnormal liver function tests, cholestasis, hepatitis, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated gamma-glutamyltransferase, liver failure, hepatocellular jaundice, rash, hyperhidrosis, vesicular dermatitis, itching, hives, papular rash, acne, Henoch-Schonlein purpura, acute generalized exanthematous pustulosis, muscle spasms, musculoskeletal rigidity, myalgia, rhabdomyolysis, myopathy, increased blood creatinine, increased blood urea, renal failure, nephritis, injection site phlebitis, injection site pain, injection site inflammation, fatigue, fever, weakness, chest pain, chills, fatigue, abnormal albumin-globulin ratio, elevated serum alkaline phosphatase, elevated serum lactate dehydrogenase, increased international normalized ratio, prolonged prothrombin time, urine discoloration, changes in mental status, obsessive behavior, hypokalemia, hypoxemia

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 does not allow light to enter. It is advisable to maintain a storage temperature between 15 and 30 degrees Celsius to preserve the medication’s effectiveness.

Appearance and packaging

Appearance

Yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 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.