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Antibiotics

Clarithromycin STADA® 500 mg


Pack size:

Box of 4 blisters x 7 film-coated tablets.

 

Composition:

Each film-coated tablet contains clarithromycin 500 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Clarithromycin are indicated in adults and children 12 years and older.

  • For treatment of infections caused by susceptible organisms. Indications include:
  • Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.
  • Upper respiratory tract infections for example, sinusitis and pharyngitis.
  • For initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens.
  • Skin and soft tissue infections of mild to moderate severity.
  • Acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of Helicobacter pylori in patients with duodenal ulcers.

Administered orally and may be given regardless to meals.

  • Patients with respiratory tract/skin and soft tissue infections.
    Adults and children older than 12 years: Usual dose is 250 mg twice daily although this may be increased to 500 mg twice daily in severe infections.
    The usual duration of treatment is 14 days. 
    Children younger than 12 years are not recommended.
  • Eradication of Helicobacter Pylori in patients with duodenal ulcers  (Adults and elderly).
    The usual duration of treatment is 14 days.
    Triple therapy: Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with amoxycillin 1000 mg twice daily.
  • Triple therapy: Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with metronidazole 400 mg twice daily.
    Triple therapy: Clarithromycin (500 mg) twice daily and omeprazole 20 mg twice daily should be given with amoxycillin 1000 mg twice daily or metronidazole 400 mg twice daily.
    Triple therapy: Clarithromycin (500 mg) twice daily should be given with amoxycillin 1000 mg twice daily and omeprazole 20 mg twice daily.
  • Renal impairment:
    In patients with renal impairment with creatinine clearance less than 30 ml/min, dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.

Or as prescribed by physicians.


 

  • Patients with known hypersensitivity to clarithromycin, erythromycin, or any other macrolide antibiotic or to any ingredient of the drug.
  • Concomitant use of clarithromycin with certain drugs, including terfenadine, astemizole, cisapride and pimozide is contraindicated because such use is likely to produce substantially increased plasma concentrations of the drugs and possibly cause serious and/or life-threatening cardiotoxicity.
  • Concomitant use with ergot alkaloids (ergotamine, dihydroergotamine) also is contraindicated because of potentially serious toxicity.
  • Clarithromycin should not be given to patient with history of QT prolongation or ventricular cardiac arrhythmia, including torsade de points.
  • Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to increased risk of myopathy, including rhabdomyolysis. Treatment with these agents should be discontinued during clarithromycin treatment.
  • Clarithromycin should not to be given to patients with hypokalemia (risk of prolongation of QT-time).
  • Clarithromycin should not be used in patients who suffer from severs hepatic failure. 

     

Common

  • Gastro-intestinal disturbances which have been seen particularly in young men, at a frequency of 5%.
  • Allergic reaction of different degrees, from urticaria to anaphylaxis and Stevens–Johnson syndrome.
  • Case of pseudomembraneous colitis have been report and they can vary in severity, from mild to life-threatening.
  • Hypersensitivity reactions as pruritus, urticarial, skin rash, irritation.

Less common

  • Symptoms indicative of cholestasis (upper abdominal pain, sometime severe), nausea, vomiting.
  • Abnormal liver function values, raised serum bilirubin with usually jaundice, rash fever and eosinophilia.
  • Reversible sensorineural deafness (high doses).

     

  • Prescribing clarithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
  • Clarithromycin is principally excreted via the liver and kidney. Clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.
  • Concomitant use of clarithromycin and ranitidine bismuth citrate is not recommended in patients with creatinine clearance less than 25 ml/minute, and should not be used in patients with a history of acute porphyria.
  • As with other anti-infective agents, use of clarithromycin may result in overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, appropriate therapy should be instituted.
  • Hepatic effects: Elevation in serum ALT (SGPT), AST (SGOT), γ-glutamyltransferase (γ-glutamyl transpeptidase, GGT, GGTP), alkaline phosphatase, LDH, and/or total bilirubin concentration has been reported infrequently (e.g., less than 1% of patients) in patients receiving clarithromycin alone or combined with omeprazole therapy. Hepatomegaly and hepatic dysfunction (including cholestasis, with or without jaundice) also have been report in patients receiving the drug. This hepatic dysfunction may be severe but usually is reversible. However, hepatic failure leading to death has been report rarely, generally in patients with serious underlying diseases and/or receiving concomitant drug therapy.
  • There are no adequate and well-controlled studies in pregnant women. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when clarithromycin is administered to a nursing woman.
  • There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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