Medication info
Clarithromycin Tablets 500mg (Clarithromycin)

Clarithromycin Tablets 500mg (Clarithromycin)

Prescription medicationTablet
Ingredient · strength
Clarithromycin›500mg / 1 tablet
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201603061 · Approved 2016.05.30 · Insurance code 669906850

Summary

Main use
Treatment of respiratory, skin, and mycobacterial infections; Helicobacter pylori eradication in duodenal ulcers
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 failure with 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 drug to these patients for more than 14 days. ○ Mycobacterial infections: Administer 500mg (potency) of this drug twice daily. In this case, it should be administered in combination with other antimycobacterial drugs such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer 500mg (potency) of this drug 3 times daily for 14 days in combination with omeprazole 40mg once daily, followed by omeprazole 40mg once daily for 14 consecutive days. That is, administer clarithromycin 500mg (potency) 3 times daily for 14 days (days 1~14), and administer 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, use clarithromycin dry syrup.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

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

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

This medication is effective against lower respiratory tract infections such as bronchitis and pneumonia, as well as upper respiratory tract infections such as pharyngitis and sinusitis. It is also used to treat skin and soft tissue infections. It helps in cases of mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare. Additionally, it is used to eradicate Helicobacter pylori in patients with duodenal ulcers. By treating various bacterial infections, it alleviates symptoms and contributes to health recovery.

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 failure with 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 drug to these patients for more than 14 days. ○ Mycobacterial infections: Administer 500mg (potency) of this drug twice daily. In this case, it should be administered in combination with other antimycobacterial drugs such as ethambutol, clofazimine, and rifampin. ○ Eradication of Helicobacter pylori in patients with duodenal ulcers: Administer 500mg (potency) of this drug 3 times daily for 14 days in combination with omeprazole 40mg once daily, followed by omeprazole 40mg once daily for 14 consecutive days. That is, administer clarithromycin 500mg (potency) 3 times daily for 14 days (days 1~14), and administer 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, use clarithromycin dry syrup.

Precautions

This medication should not be used in patients with hypersensitivity to specific components. It is particularly unsafe to administer to individuals with allergies to antibiotics in the same class. Concurrent use with medications that can affect the heart may pose risks, so patients taking such medications should avoid this drug. In patients with severely impaired liver or kidney function, use or dosage adjustment may be required. It is advisable for pregnant or breastfeeding women to avoid this medication. Rarely, this drug may cause severe allergic reactions or skin conditions; if unusual symptoms occur, use should be discontinued immediately. Gastrointestinal side effects may include nausea, vomiting, and diarrhea; if severe abdominal pain or frequent diarrhea occurs, medical consultation is necessary. As this medication can affect liver function, if jaundice or changes in urine color appear, its use should be halted. Central nervous system side effects reported include dizziness, anxiety, and hallucinations; if these symptoms appear, consultation with a physician is advised. This drug has numerous interactions with other medications, so patients currently taking other medications should inform their healthcare provider. Caution is necessary when using it alongside anticoagulants, certain heart medications, anticonvulsants, and immunosuppressants. Elderly patients or those with reduced kidney function require dosage adjustment and careful monitoring. To prevent resistant bacteria during antibiotic use, it should be administered only for the prescribed duration and not discontinued arbitrarily or used long-term. During the use of this medication, immediate reporting to healthcare providers is necessary for persistent diarrhea or other unusual symptoms. Caution is also advised when driving or operating machinery due to potential dizziness or confusion. Overdose may result in gastrointestinal disturbances or central nervous system issues, thus it is important to adhere to the prescribed dosage. When storing, avoid direct sunlight and keep at room temperature; refrigeration is not recommended.

Side effects

Shock, anaphylactic symptoms, respiratory distress, convulsions, redness, rash, itching, hives, skin erythema, angioedema, joint swelling, drug eruption, abdominal bloating, nausea, vomiting, indigestion, abdominal pain, discomfort, bloating, diarrhea, oral mucosal erosion, upper abdominal pain, convulsive form, dry mouth, transient tooth discoloration, pancreatitis, increased amylase, taste disturbance, loss of appetite, constipation, discoloration of stools, pseudomembranous colitis, hemorrhagic colitis, bloody stools, fever, cough, abnormal chest X-ray, eosinophilia, eosinophilic pulmonary infiltration, interstitial pneumonia, chronic bronchitis, 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, behavioral changes, manic behavior, 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, increased AST, increased ALT, increased γ-GTP, increased LDH, increased ALP, increased total bilirubin, loss of appetite, dark urine, pruritus, abdominal tenderness, elevated serum creatinine, increased BUN, interstitial nephritis, renal failure, rhabdomyolysis, acute renal failure, glossitis, stomatitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de pointes, fatigue, headache, taste distortion, hearing loss, paresthesia, arthralgia, myalgia, olfactory disturbance, tinnitus, hearing impairment, hypoglycemia, tinnitus, hearing impairment, vomiting, nausea, abdominal pain, purpuric rash, acute generalized eruptive pustulosis, leukopenia, neutropenia, thrombocytosis, agranulocytosis, thrombocytopenia, anaphylactic reaction, vascular edema, decreased appetite, insomnia, nervousness, noise sensitivity, psychotic disorder, confusion, non-vertiginous dizziness, drowsiness, tremor, movement disorder, loss of consciousness, vestibular dizziness, hearing impairment, hearing loss, cardiac arrest, atrial fibrillation, ectopic beats, palpitations, vasodilation, asthma, epistaxis, pulmonary embolism, esophagitis, gastroesophageal reflux disease, gastritis, rectal pain, belching, bloating, tongue discoloration, tooth discoloration, abnormal liver function tests, bile stasis, hepatitis, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyl transferase, liver failure, vesicular dermatitis, sweating, papular rash, acne, Henoch-Schonlein purpura, muscle spasms, musculoskeletal stiffness, myopathy, increased serum creatinine, increased serum urea, nephritis, injection site phlebitis, injection site pain, injection site inflammation, fever, weakness, chest pain, chills, fatigue, abnormal albumin-globulin ratio, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased international normalized ratio, prolonged prothrombin time, abnormal urine color

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 blocks light. Additionally, it is best stored in a cool place between 15 to 30 degrees Celsius. Storing it this way helps maintain its efficacy.

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.