Medication info

Clarithromycin Tablets 250 mg (Clarithromycin)

Prescription medicationApproval withdrawn
Ingredient · strength
Clarithromycin›Strength being verified
Manufacturer / importer
Daehwa Pharmaceutical Co., Ltd.
Appearance
Yellow oval film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201702281 · Approved 2017.05.04

This product's status changed to Approval withdrawn on 2023.06.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter infection
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 duration of treatment 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) per dose twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) of this medicine per dose twice daily. In this case, it should 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 for 14 days, in combination with omeprazole 40mg once daily, 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 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 of age: Use clarithromycin dry syrup.

Ingredients

Manufacturer
Daehwa Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter infection

  • 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 lower respiratory infections, such as bronchitis and pneumonia, as well as upper respiratory infections, such as pharyngitis and sinusitis. It is also effective for skin and soft tissue infections. It is utilized for the treatment of mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare. It assists in eradication of Helicobacter pylori in patients with duodenal ulcers. This medication is widely applied to various types of bacterial infections and contributes to improving patients' health.

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 duration of treatment 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) per dose twice daily. Do not administer for more than 14 days to these patients. ○ Mycobacterial infections: Administer 500mg (potency) of this medicine per dose twice daily. In this case, it should 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 for 14 days, in combination with omeprazole 40mg once daily, 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 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 of age: Use clarithromycin dry syrup.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to any of the components of this drug or who have allergies to similar classes of antibiotics should not be administered this medication. Moreover, it is also safe not to use this drug in patients with certain heart conditions, severely impaired liver or kidney function, and women who are pregnant or breastfeeding. This medication should be administered with caution in patients with slightly impaired liver or kidney function, heart disease, or the elderly. Furthermore, there may be interactions when used with other antibiotics or specific medications, so caution is required. During the course of taking this medication, severe allergic reactions, skin rashes, gastrointestinal disturbances, liver dysfunction, kidney dysfunction, and neurological abnormalities may rarely occur. Therefore, if symptoms such as difficulty breathing, severe rashes, abdominal pain, or jaundice occur, immediate consultation with a physician is necessary. This medication may disturb the balance of intestinal bacteria and can lead to serious intestinal disorders such as diarrhea or pseudomembranous colitis, so treatment should be discontinued and healthcare personnel informed if persistent diarrhea occurs. Additionally, this medication may interact with various other drugs; therefore, if other medications are being taken, it is essential to inform a physician or pharmacist, and regular tests such as blood tests or electrocardiograms may be required. Pregnant or breastfeeding women should not take this medication, and children, the elderly, or patients with impaired kidney or liver function may need dosage adjustments. In the event of an overdose, gastrointestinal disturbances or psychiatric symptoms may arise, so it is vital to adhere strictly to the prescribed dosage, and if abnormal symptoms occur, immediate medical assistance should be sought. Finally, caution is required when driving or operating machinery during the course of this medication as dizziness or confusion may occur.

Side effects

Shock, anaphylactic symptoms, dyspnea, convulsions, erythema, rash, pruritus, urticaria, skin erythema, angioedema, arthralgia, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, flatulence, diarrhea, oral erosion, upper abdominal pain, dry mouth, transient tooth discoloration, pancreatitis, increased amylase, taste alteration, decreased appetite, constipation, discoloration of stools, pseudomembranous colitis, hemorrhagic colitis, fever, cough, abnormal chest X-ray, eosinophilia, eosinophilic lung infiltration, interstitial pneumonia, chronic bronchitis, acute maxillary sinusitis, leukopenia, thrombocytopenia, pancytopenia, hemolytic anemia, agranulocytosis, dizziness, depression, loss of taste, loss of smell, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization, convulsions, tremors, paresthesia, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash with eosinophilia and systemic symptoms, jaundice, hepatocellular hepatitis, cholestatic hepatitis, elevated 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, renal failure, rhabdomyolysis, stomatitis, cheilitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de Pointes, malaise, headache, taste dysfunction, hearing loss, paresthesia, arthralgia, myalgia, olfactory impairment, hypoglycemia, tinnitus, hearing impairment, purpuric rash, acute generalized pustular rash, muscle cramps, musculoskeletal stiffness, myopathy, elevated blood urea nitrogen, nephritis, venous thrombophlebitis at the injection site, pain at the injection site, inflammation at the injection site, 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, urinary discoloration

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 tightly closed container that blocks light. It is best to maintain a storage temperature between 15 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow oval film-coated tablets

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.

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.