Medication info
Clarithromycin 500 mg Tablet

Clarithromycin 500 mg Tablet

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

MFDS item code 201507840 · Approved 2015.11.24 · Insurance code 669501640

Summary

Main use
Treatment of respiratory, skin, and mycobacterial infections; Helicobacter pylori eradication in duodenal ulcer
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 duration is 7~14 days. For patients with renal impairment 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 must be administered in combination with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. ○ Helicobacter pylori eradication in patients with duodenal ulcers: Administer 500mg (potency) of this medicine 3 times daily in combination with omeprazole 40mg once daily for 14 days, followed by omeprazole 40mg once daily for an additional 14 days. That is, administer clarithromycin 500mg (potency) per dose 3 times daily for 14 days (days 1~14), and administer omeprazole 40mg once daily for 28 days (days 1~28).
Children's dosage
Children 12 years of age and older: Same as adults For children under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
CTC Bio Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of various bacterial infections. It 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 for skin and soft tissue infections, particularly those caused by Mycobacterium avium and Mycobacterium intracellulare. It helps in the eradication of Helicobacter pylori in patients with duodenal ulcers. It effectively improves infections caused by a variety of bacteria.

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 duration is 7~14 days. For patients with renal impairment 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 must be administered in combination with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. ○ Helicobacter pylori eradication in patients with duodenal ulcers: Administer 500mg (potency) of this medicine 3 times daily in combination with omeprazole 40mg once daily for 14 days, followed by omeprazole 40mg once daily for an additional 14 days. That is, administer clarithromycin 500mg (potency) per dose 3 times daily for 14 days (days 1~14), and administer omeprazole 40mg once daily for 28 days (days 1~28).

Children's dosage

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

Precautions

This medication may not be suitable for certain patients. For example, individuals with allergies to the excipients of this medication or macrolide antibiotics should not be treated. Additionally, patients with heart disease or a history of prolonged QT interval, severe liver impairment, or significantly reduced kidney function may be at risk when taking this medication. It is advisable not to use this medication during pregnancy or while breastfeeding. This drug has various interactions with other medications, which may lead to serious side effects such as cardiac arrhythmias, liver function impairment, and kidney issues, so it is essential to inform your doctor or pharmacist about any current medications. During treatment, patients should carefully monitor for allergic reactions or serious side effects and discontinue use immediately if any unusual symptoms occur and consult a healthcare professional. Patients with heart disease, weak kidney or liver function, the elderly, and those taking other antibiotics should use this medication cautiously. This medication can cause various side effects including gastrointestinal disturbances, skin rashes, central nervous system symptoms, liver dysfunction, and kidney dysfunction, thus changes in symptoms should be closely monitored. Furthermore, prolonged or high-dose use may result in hearing impairment or tinnitus, so caution is necessary. To prevent the emergence of resistant bacteria, it is important to adhere strictly to the prescribed period and dosage and not to adjust or discontinue the treatment arbitrarily. Finally, this medication may cause symptoms such as dizziness or confusion, which can affect driving or operating machinery, so care should be taken if these symptoms occur.

Side effects

  • Shock
  • anaphylactic symptoms
  • difficulty breathing
  • convulsions
  • flushing
  • rash
  • itching
  • hives
  • skin flushing
  • angioedema
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  • joint swelling
  • drug eruption
  • abdominal distension
  • nausea
  • vomiting
  • dyspepsia
  • abdominal pain
  • discomfort
  • flatulence
  • diarrhea
  • oral mucosal erosion
  • upper abdominal pain
  • thirst
  • tooth discoloration
  • pancreatitis
  • increased amylase
  • taste disturbance
  • loss of appetite
  • constipation
  • discoloration of stool
  • pseudomembranous colitis
  • hemorrhagic colitis
  • fever
  • cough
  • increased eosinophils
  • eosinophilic pulmonary infiltrate
  • interstitial pneumonia
  • chronic bronchitis
  • acute sinusitis
  • increased eosinophils
  • 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 (DRESS)
  • 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 disorder
  • hearing loss
  • dysesthesia
  • arthralgia
  • myalgia
  • olfactory impairment
  • hearing impairment
  • cardiac arrest
  • atrial fibrillation
  • ECG QT prolongation
  • premature contractions
  • palpitations
  • vasodilation
  • vesicular dermatitis
  • papular rash
  • acne
  • Henoch-Schonlein purpura
  • acute generalized pustular dermatitis
  • muscle spasm
  • musculoskeletal rigidity
  • myopathy
  • elevated blood urea
  • nephritis
  • phlebitis at the injection site
  • pain at the injection site
  • inflammation at the injection site
  • fever
  • myasthenia
  • chest pain
  • chill
  • fatigue
  • abnormal albumin-globulin ratio
  • elevated serum alkaline phosphatase
  • elevated serum lactate dehydrogenase
  • increased INR
  • prolonged prothrombin time
  • abnormal urine color
  • gastrointestinal symptoms
  • 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 protects it from light. Additionally, it is important to maintain a temperature of 15 to 30 degrees Celsius during storage. Avoid storing in excessively hot or cold places for safe storage.

Appearance and packaging

Appearance

Yellow oblong film-coated tablets

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.

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.