APO-AZITHROMYCIN Z TABLET 250MG

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.

Active Ingredient / Synonyms

Azithromycine | Azithromycinum | Azitromicina | Azithromycin |

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.

Pharmacodynamics

Azithromycin, a semisynthetic antibiotic belonging to the macrolide subgroup of azalides, is used to treat STDs due to chlamydia and gonorrhea, community-acquired pneumonia, pelvic inflammatory disease, pediatric otitis media and pharyngitis, and Mycobacterium avium complex (MAC) in patients with advanced HIV disease. Similar in structure to erythromycin. azithromycin reaches higher intracellular concentrations than erythromycin, increasing its efficacy and duration of action.

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:

Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route of elimination.

Half-life

68 hours

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

References

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

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Approval Information

APO-AZITHROMYCIN Z TABLET 250MG was registered with Health Science Authority of Singapore by PHARMAFORTE SINGAPORE PTE LTD. It is marketed with the registration number of SIN15217P with effective from 2017-04-20.

This product contains 250mg of Azithromycin in the form of TABLET, FILM-COATED.

The medicine was manufactured by Apotex Research PTE LTD in INDIA

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

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: J01FA10

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