AIM 500
(AZITHROMYCIN 500mg TABLETS)

Antibiotic Class: Macrolide

AIM 500 is an antibiotic, which belongs to a group of medicines called azalides. The azalides are a sub-class of a group of antibiotics called macrolides. AIM 500 is a bacteriostatic drugs which works by killing or stopping the growth of bacteria causing your infection.

AIM 500 contains the active ingredient azithromycin. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most strains of the following microorganisms.

Antimicrobial Spectrum:

Aerobic gram-positive microorganisms

• Staphylococcus aureus
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Streptococcus pyogenes

Aerobic gram-negative microorganisms

• Haemophilus ducreyi
• Haemophilus influenzae
• Moraxella catarrhalis
• Neisseria gonorrhoeae

“Other” microorganisms

• Chlamydia pneumoniae
• Chlamydia trachomatis
• Mycoplasma pneumoniae

Aerobic gram-positive microorganisms

• Streptococci (Groups C, F, G)
• Viridans group streptococci

Aerobic gram-negative microorganisms

• Bordetella pertussis
• Anaerobic microorganisms
• Peptostreptococcus species
• Prevotella bivia

INDICATIONS AND USAGE

AIM 500 (azithromycin) is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Adults :

Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. AIM 500 is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to AIM 500, susceptibility tests should be performed when patients are treated with AIM 500. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.

Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.

Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

AIM 500, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with AIM 500 may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AIM 500 (azithromycin) and other antibacterial drugs, AIM 500 (azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Pregnancy :

Category B: No evidence of risk in humans but studies inadequate.

Nursing Mothers :

It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

Dosage :

The usual adult dose of azithromycin is 500 mg as a single dose daily for 3 days. For uncomplicated genital infections due to Chlamydia trachomatis, 1 g of azithromycin is given as a single dose. A single dose of 2 g has been given for uncomplicated gonorrhoea.

Availability:

500mg tablets.