Medication info

Sinil Clarithromycin Tablet 500mg

Prescription medicationTabletExpired
Ingredient · strength
Clarithromycin›500mg / 1 tablet
Manufacturer / importer
Sinil Pharmaceutical Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Expired

MFDS item code 202004221 · Approved 2020.06.04

This product's status changed to Expired on 2025.06.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of infections (e.g., respiratory, skin, and mycobacterial infections); eradication of Helicobacter pylori
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 impairment and a creatinine clearance of 30mL/min or less, the dose should be reduced by half: 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 12 years of age and older: Same as the adult dose. ○ For children under 12 years of age, use clarithromycin dry syrup.

Ingredients

Manufacturer
Sinil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of infections (e.g., respiratory, skin, and mycobacterial infections); eradication of Helicobacter pylori

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

This medication is effective against various types of bacteria and is used to treat 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 particularly helpful in the treatment of infections caused by Mycobacterium avium and Mycobacterium intracellulare, and is used to eradicate Helicobacter pylori in patients with duodenal ulcers. It is a suitable drug for treating various bacterial infections and contributes to the improvement of patients' symptoms.

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 impairment and a creatinine clearance of 30mL/min or less, the dose should be reduced by half: 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 12 years of age and older: Same as the adult dose. ○ For children under 12 years of age, use clarithromycin dry syrup.

Precautions

This medication should not be administered to patients who are allergic to certain components. Patients who have had hypersensitivity reactions to macrolide antibiotics should also avoid this medication. Patients with a history of QT prolongation or cardiac arrhythmias should use caution as heart problems may worsen while taking this medication. This drug may not be administered to patients with severely impaired liver or kidney function, or dosage adjustment may be necessary. Pregnant or breastfeeding women are advised not to use this medication. This medication can cause serious side effects if taken with certain drugs, so it is essential to consult a physician or pharmacist if currently taking other medications. If any allergic reactions or serious side effects occur during administration, immediately discontinue use and seek medical assistance. Children or the elderly may have different physical responses, necessitating more careful observation when using this medication. Long-term or excessive use of this medication can lead to the development of resistant bacteria; thus, it should be taken only for the prescribed duration under a doctor's instructions. If gastrointestinal disturbances like diarrhea or abdominal pain worsen during use, consult a healthcare professional immediately. Patients with heart disease are advised to regularly check their heart condition through electrocardiogram tests while taking this medication. Due to possible interactions with other drugs that can alter blood drug concentrations, caution is needed when co-administering. This medication can cause dizziness or confusion when driving or operating machinery, so caution should be observed. In case of overdose, gastrointestinal disturbances or neurological abnormalities may arise, so the prescribed dosage should be strictly followed.

Side effects

Shock, anaphylactic symptoms, difficulty breathing, convulsions, redness, rash, itching, hives, skin redness, angioedema, joint swelling, drug rash, abdominal distension, nausea, vomiting, dyspepsia, abdominal pain, discomfort, gas retention, diarrhea, oral erosion, upper abdominal pain, thirst, transient tooth discoloration, pancreatitis, increased amylase, dysgeusia, poor appetite, constipation, stool discoloration, pseudomembranous colitis, hemorrhagic colitis, fever, cough, abnormal chest X-ray, eosinophilia, eosinophilic pulmonary infiltration, interstitial pneumonia, chronic bronchitis, acute maxillary sinusitis, thrombocytopenia, pancytopenia, hemolytic anemia, leukopenia, agranulocytosis, dizziness, depression, loss of taste, loss of smell, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucination, psychosis, depersonalization, tremor, paresthesia, behavioral changes, manic behavior, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic purpura, drug rash (DRESS), jaundice, hepatocellular hepatitis, cholestatic hepatitis, increased liver enzymes, liver dysfunction, liver failure, fulminant hepatitis, elevated AST, elevated ALT, increased γ-GTP, elevated LDH, increased ALP, elevated total bilirubin, increased 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, paresthesia, arthralgia, myalgia, olfactory disorder, auditory disorder, hypoglycemia, tinnitus, hearing impairment, purpuric rash, acute generalized exanthematous pustulosis, muscle cramping, musculoskeletal stiffness, myopathy, increased serum creatinine, elevated blood urea nitrogen, nephritis, venous thrombophlebitis at the injection site, pain at the injection site, inflammation at the injection site, fever, muscular weakness, chest pain, chills, fatigue, abnormal albumin-globulin ratio, elevated blood alkaline phosphatase, increased serum lactate dehydrogenase, increased INR, prolonged prothrombin time, urinary color abnormality

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

Storage

This medication should be stored in a closed container that blocks light, maintaining a storage temperature of room temperature between 15 to 30 degrees Celsius. Proper storage will help ensure the safe effectiveness of the drug.

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.