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AZITHROMYCIN FILM COATED TABLET 500MG

Product Information

Registration Status: Active

SIN14142P

AZITHROMYCIN FILM COATED TABLET 500MG is approved to be sold in Singapore with effective from 2012-04-30. It is marketed by ZIWELL MEDICAL (S) PTE LTD, with the registration number of SIN14142P.

This product contains Azithromycin 500mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Laboratorios Lesvi in SPAIN.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Azithromycin is a semi-synthetic macrolide antibiotic of the azalide class. Like other macrolide antibiotics, azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of the bacterial 70S ribosome. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the process of translation. Its effects may be bacteriostatic or bactericidal depending of the organism and the drug concentration. Its long half life, which enables once daily dosing and shorter administration durations, is a property distinct from other macrolides.

Indication

For the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions: H. influenzae, M. catarrhalis, S. pneumoniae, C. pneumoniae, M. pneumoniae, S. pyogenes, S. aureus, S. agal

Mechanism of Action

Azithromycin binds to the 50S subunit of the 70S bacterial ribosomes, and therefore inhibits RNA-dependent protein synthesis in bacterial cells.

Pharmacokinetics

Absorption
Bioavailability is 37% following oral administration. Absorption is not affected by food. Azithromycin is extensively distributed in tissues with tissue concentrations reaching up to 50 times greater than plasma concentrations. Drug becomes concentrated within macrophages and polymorphonucleocytes giving it good activity against Chlamydia trachomatis.
Distribution
* 31.1 L/kg
Metabolism
Hepatic. In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed.
Elimination

Clearance

* apparent plasma cl=630 mL/min [following single 500 mg oral and i.v. doses]

Toxicity

Potentially serious side effects of angioedema and cholestatic jaundice were reported

Active Ingredient/Synonyms

Azithromycine | Azithromycinum | Azitromicina | Azithromycin |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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