Medication info
Samsung Clarithromycin Tablet 500 mg

Samsung Clarithromycin Tablet 500 mg

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

MFDS item code 201901976 · Approved 2019.04.02 · Insurance code 642307590

Summary

Main use
Treatment of respiratory and skin infections, mycobacterial infections, and Helicobacter pylori infection
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 impairment and a creatinine clearance of 30mL/min or less, the dose should be reduced by half. That is, administer 250mg (potency) once daily, or, for severe infections, 250mg (potency) twice daily. Do not administer this medicine to these patients for more than 14 days. ○ 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. ○ Eradication of Helicobacter pylori 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 14 consecutive days. That is, administer clarithromycin 500mg (potency) 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 For children under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
Samsung Pharm., Co., Ltd.

Efficacy & effects

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

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

This medication works effectively against various bacteria. It 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 for skin and soft tissue infections. It helps in the treatment of mycobacterial infections caused by Mycobacterium avium and intracellularis. Additionally, it is used to eradicate Helicobacter pylori in patients with duodenal ulcers, making it useful for the treatment of various infectious diseases.

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 impairment and a creatinine clearance of 30mL/min or less, the dose should be reduced by half. That is, administer 250mg (potency) once daily, or, for severe infections, 250mg (potency) twice daily. Do not administer this medicine to these patients for more than 14 days. ○ 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. ○ Eradication of Helicobacter pylori 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 14 consecutive days. That is, administer clarithromycin 500mg (potency) 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 For children under 12 years of age, use clarithromycin dry syrup.

Precautions

This medication should not be used in patients with allergic reactions to specific ingredients. It is also safer not to administer it to patients taking certain antibiotics or medications, patients with severely impaired liver or kidney function, and women who are pregnant or breastfeeding. Caution is required for patients with heart conditions or prolonged QT interval when administering this medication. This medication can cause various side effects; therefore, if symptoms like difficulty breathing, rash, severe abdominal pain, or cardiac irregularities occur during use, immediately inform medical personnel. Abnormal liver function, decreased kidney function, and symptoms of blood abnormalities may also occur, so regular testing may be necessary. As this medication interacts with various drugs, it is essential to consult healthcare professionals if other medications are being taken. Particularly, caution is needed when used in combination with certain cardiac medications, anticoagulants, antidiabetics, steroids, antifungals, and antiviral drugs. It is recommended that pregnant or breastfeeding women do not take this medication, and if it is unavoidable, it should be done according to a specialist's instructions. Children or the elderly may require dosage adjustments or special monitoring due to physical differences. In case of overdose, gastrointestinal disturbances or central nervous system abnormalities may appear, and immediate medical attention should be sought. While taking this medication, it is crucial to adhere to the prescribed duration and dosage as directed by the doctor, and to consult immediately if adverse reactions occur.

Side effects

Shock, anaphylactic symptoms, dyspnea, convulsions, flushing, rash, pruritus, urticaria, skin flushing, angioedema, joint swelling, drug rash, abdominal bloating, nausea, vomiting, dyspepsia, abdominal pain, discomfort, flatulence, diarrhea, oral mucosal erosion, abdominal pain in the upper part, thirst, transient tooth discoloration, pancreatitis, increased amylase, taste disturbance, loss of appetite, constipation, stool discoloration, pseudomembranous colitis, hemorrhagic colitis, fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, eosinophilic lung 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, disorientation, impaired orientation, 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 enzymes, hepatic dysfunction, liver failure, fulminant hepatitis, AST elevation, ALT elevation, γ-GTP elevation, LDH elevation, ALP elevation, total bilirubin increase, loss of appetite, jaundice, dark urine, itching, abdominal tenderness, increased serum creatinine, elevated BUN, interstitial nephritis, renal failure, rhabdomyolysis, myalgia, weakness, increased CPK, elevated serum myoglobin, increased urinary myoglobin, glossitis, stomatitis, oral candidiasis, QT prolongation, ventricular tachycardia, Torsades de pointes, malaise, headache, taste disorder, hearing loss, paresthesia, arthralgia, myalgia, olfactory disorder, tinnitus, hearing impairment, hypoglycemia, tinnitus, hearing loss, vomiting, nausea, abdominal pain, purpuric rash, acute pancreatitis, increased amylase, AST and ALT elevation, leukopenia, thrombocytopenia, ALT elevation, AST elevation, γ-GTP elevation, ALP elevation, LDH elevation, increased serum alkaline phosphatase, elevated serum lactate dehydrogenase, abnormal albumin-globulin ratio, increased international normalized ratio, prolonged prothrombin time, abnormal urine color, venous thrombophlebitis at the injection site, injection site pain, injection site inflammation, fever, weakness, chest pain, chills, fatigue

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

Storage

This medication is sensitive to light and should be stored in a tightly closed container protected from light. It is also advisable to keep it in a cool room, ideally at temperatures between 15 to 30 degrees Celsius.

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.