Medication info
Clarithromycin Tablets 500 mg

Clarithromycin Tablets 500 mg

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

MFDS item code 201603563 · Approved 2016.06.17

Summary

Main use
Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter pylori infection associated with duodenal ulcers
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 duration of treatment is 7~14 days. In 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) twice daily. Do not administer to these patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it should be administered concomitantly with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. Eradication of Helicobacter pylori in patients with duodenal ulcers: For 14 days, administer 500mg (potency) of this medicine 3 times daily with omeprazole 40mg once daily, 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 and older: Same as adults Children under 12 years: Use clarithromycin dry syrup.

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter pylori infection associated with duodenal ulcers

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

This medication is effective for the treatment of various bacterial infections. It is primarily used for lower respiratory tract infections such as bronchitis and pneumonia, and upper respiratory tract infections such as pharyngitis and sinusitis. It is also highly effective for skin and soft tissue infections. It is utilized for the treatment of infections caused by Mycobacterium avium and intracellular bacteria, and helps eradicate Helicobacter pylori in patients with duodenal ulcers. It is used to improve various bacterial infections.

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 duration of treatment is 7~14 days. In 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) twice daily. Do not administer to these patients for more than 14 days. Mycobacterial infections: Administer 500mg (potency) of this medicine twice daily. In this case, it should be administered concomitantly with other antimycobacterial agents such as ethambutol, clofazimine, and rifampin. Eradication of Helicobacter pylori in patients with duodenal ulcers: For 14 days, administer 500mg (potency) of this medicine 3 times daily with omeprazole 40mg once daily, 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 and older: Same as adults Children under 12 years: Use clarithromycin dry syrup.

Precautions

This medicine should not be used in certain patients. For example, patients who are allergic to the components of this medication or have had hypersensitivity reactions to specific antibiotics should avoid its use. Additionally, it is safe for patients taking medications that may affect heart rhythm, patients with severely impaired liver or kidney function, pregnant or breastfeeding women to avoid this medication. Special caution should be taken with patients who have impaired liver or kidney function, those with heart disease, elderly patients, and patients who are taking other antibiotics. When taking this medication, an allergic reaction may occur, so if symptoms such as skin rash or difficulty breathing appear, usage should be stopped immediately and consult with a healthcare professional. Gastrointestinal side effects may include nausea, vomiting, diarrhea, and abdominal pain; if severe diarrhea or abdominal pain occurs persistently, the medication should be stopped and medical attention should be sought. Serious side effects such as pneumonia, liver dysfunction, or renal impairment can occur rarely; thus, any abnormal symptoms should be reported to a healthcare professional immediately. This medication has many interactions with other drugs, increasing the risk of side effects depending on concurrently taken medications; therefore, all medications being taken should be disclosed to a healthcare professional. Particularly, caution is needed when used with heart disease medications, certain antifungals, anticoagulants, blood sugar lowering agents, and immunosuppressants. Pregnant or breastfeeding women are advised to avoid this medication, and if it is necessary to take it, they should consult a specialist. Children and the elderly have different physical functions, so careful consideration should be taken regarding dosage adjustments or whether to administer this medication. Long-term or excessive use of this medication may cause tinnitus, hearing loss, or severe allergic reactions, so prescribed dosages must be strictly followed. Dizziness or confusion may occur during driving or operating machinery while taking this medication, thus caution is required. In case of overdose, appropriate treatment such as gastric lavage may be necessary, and this medication cannot be removed by dialysis. Finally, this medication should be stored away from direct sunlight at room temperature, and refrigeration is not recommended.

Side effects

  • Shock
  • anaphylactic symptoms
  • shortness of breath
  • convulsions
  • flushing
  • rash
  • itching
  • hives
  • erythema
  • angioedema
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  • joint swelling
  • drug rash
  • abdominal distension
  • nausea
  • vomiting
  • dyspepsia
  • abdominal pain
  • malaise
  • flatulence
  • diarrhea
  • oral mucosal erosion
  • upper abdominal pain
  • thirst
  • tooth discoloration
  • pancreatitis
  • increased amylase
  • taste disturbance
  • loss of appetite
  • constipation
  • discoloration of stools
  • pseudomembranous colitis
  • hemorrhagic colitis
  • fever
  • cough
  • eosinophilia
  • eosinophilic pulmonary infiltrates
  • 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
  • convulsion
  • tremors
  • numbness
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • allergic purpura
  • drug rash
  • 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
  • elevated serum creatinine
  • elevated BUN
  • interstitial nephritis
  • kidney failure
  • rhabdomyolysis
  • stomatitis
  • oral mucositis
  • oral candidiasis
  • QT interval prolongation
  • ventricular tachycardia
  • Torsades de pointes
  • malaise
  • headache
  • taste alteration
  • hearing loss
  • paresthesia
  • arthralgia
  • myalgia
  • olfactory disturbance
  • tinnitus
  • auditory impairment
  • hypoglycemia
  • purpuric rash
  • acute generalized pustular dermatosis
  • muscle cramps
  • musculoskeletal stiffness
  • myopathy
  • elevated blood creatinine
  • elevated blood urea
  • nephritis
  • phlebitis at injection site
  • injection site pain
  • inflammation at injection site
  • fever
  • asthenia
  • 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
  • diaphoresis
  • papular rash
  • acne
  • Henoch-Schonlein purpura

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

Storage

This medication is sensitive to light; therefore, it should be stored in a container that protects it from light, in a cool place between 15 and 30 degrees Celsius. Proper storage will maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Yellow, oblong film-coated tablet

Package unit

30 tablets, 100 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.

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.