AZYTER is indicated for the local healing treatment, antibacterial of conjunctivitis due to germs, sensitive (see sections 4.4 and 4.4)
· Pulmonary bacterial conjunctivitis in children (from birth to 17 years) and adults

Trachomatous conjunctivitis due to Chlamydia, trachomatis, in children (from birth to 17 years of age), and adults (see Warnings and Precautions for Use in Newborns)

Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage

Adults

Instill 1 drop into the cul-de-sac, conjunctival 2 times a day, morning and evening, for 3 days.
It is not necessary to prolong the treatment beyond 3 days.

Respect of the dosage is important, for the success of the treatment.

Elderly subjects

No dose adjustment is necessary.
Population, pediatric




No dosage adjustment is necessary (see sections 4.4 and 4.4) and
Mode of administration

Ophthalmic pathway.

It should be recommended to the patient

· Wash your hands thoroughly before and after instilling

· Avoid touching the eye or eyelids with the mouthpiece of the single-dose container

· To discard the single-dose container after use, and not to retain it for future use.

Oily solution clear, colorless, slightly yellowish

Class: Pharmacotherapeutic: antibiotics, ATC code; S01AA26

Mode of action

Azithromycin is a second-generation macrolide, belonging to the class Azalides.

This antibiotic inhibits the synthesis of bacterial proteins by binding to the 50 S subunit of the ribosome and preventing peptide translocation.
Mechanisms of resistance

It is generally reported that the resistance of various bacterial species to macrolides is associated with three mechanisms: target modification, inactivation of the antibiotic, or impairment of antibiotic transport (efflux). Have been described in bacteria. In streptococci, a large efflux system, controlled by the mef genes, results in limited resistance to macrolides (phenotype M). The modification of the target by gene-controlled methylases, erm (MLS B phenotype) can lead to cross-resistance against several classes of antibiotics (see below). Br>

Cross-resistance is total between erythromycin, azithromycin, other macrolides and lincosamides and streptogramines B for Streptococcus pneumoniae, streptococci, beta-hemolytic group A, Enterrococcus, spp. And Staphylococcus aureus, including S. aureus, resistant to methicillin (MRSA).

Mutants constituting strains having an inducible resist with either erm (A) or erm (C) can be selected in vitro at low frequencies ~ 10 -7 ufc in the presence of azithromycin.

Critical Concentrations

The list of micro-organisms listed below has been taken into account: indications (see section Therapeutic indications)

The critical concentrations and in vitro spectrum of activity shown below are applicable to systemic use. These concentrations are not directly transportable to topical ocular use due to in situ concentrations and local physicochemical conditions which may alter the general activity of the antibiotic at the application site. Br>

According to EUCAST (European Committee on Antimicrobial Susceptibility Testing), the following critical concentrations have been defined for azithromycin

Haemophilus influenzae: sensitive ≤ 0.12 mg / l and resistant> 4 mg / l

· Moraxella catarrhalis: sensitive ≤ 0.5 mg / l and resistant> 0.5 mg / l

· Neisseria gonorrhoeae: sensitive ≤ 0.25 mg / l and resistant> 0.5 mg / l

· Staphylococcus spp. *: Sensitive ≤ 1.0 mg / l and resistant> 2.0 mg / l

Streptococcus pneumoniae: sensitive ≤ 0.25, mg / l and resistant> 0.5 mg / l

Streptococcus A, B, C, G: sensitive ≤ 0.25 mg / l and resistant> 0.5 mg / l

* Spp. Includes all species of the genus

For the other listed species, EUCAST indicates that the sensitivities obtained for erythromycin can be used for azithromycin

The prevalence of acquired resistance may vary according to geography and time for some species. It is therefore useful to have information on the prevalence of local resistance, especially for the treatment of severe infections. If necessary, it is desirable to obtain specialized advice, especially when the interest of the drug in some infections may be implicated because of the prevalence level of local resistance

Table: Spectrum of antibacterial activity of azithromycin for bacterial species corresponding to

Species usually, sensitive

Gram aerobics, negative

Moraxella (Branhamella) catarrhalis

Neisseria, gonorrhoae 1

Haemophilus; influenzae $

Haemophilus, parainfluenzae $

Other

Chlamydia trachomatis *

Inconsistently sensitive species

(Resistance acquired ≥ 10%)

Gram-positive aerobes

Staphylococcus aureus (methicillin-resistant and methicillin-sensitive)

Staphylococcus coagulase negative (methicillin-resistant and methicillin-sensitive)

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci viridans

Streptococcus agalactiae

Streptococcus group G

Species naturally resistant

Gram-positive aerobes

Corynebacterium spp.

Enterococcus faecium

Gram aerobics, negative

Pseudomonas aeruginosa

Acinetobacter

Enterobacteriaceae

* Clinical efficacy demonstrated for isolated susceptible strains in approved indications

$ Species, naturally intermediate

1. Conjunctivitis due to Neisseria gonorrhoeae requires systemic treatment (see section 4.4).


Trachomatous conjunctivitis due to Chlamydia, trachomatis

AZYTER was evaluated in a two-month randomized double-blind study comparing AZYTER to a single dose of azithromycin administered orally to 670 children (1 to 10 years of age) with trachoma. The primary efficacy endpoint was clinical cure at day 60, ie TF0 (TF '= trachomatous-follicular inflammation) (according to the WHO simplified scale). At day 60, the clinical cure rate with AZYTER instilled twice daily for 3 days (96.3%) was not less than that of oral azithromycin (96.6%). >

The clinical efficacy of AZYTER (instilled twice a day, for 3 days) as a mass, curative and prophylactic treatment of trachoma, of an entire population (from birth) was evaluated in A multicenter, open, single arm study conducted in a region of northern Cameroon (112,000 patients). Three annual processing periods have been completed. The main criterion of effectiveness was the prevalence of trachoma, active, ie follicular inflammatory trachoma, or intense inflammatory trachoma (TF + TIO or TF + TI +). The clinical evaluation of trachoma was carried out annually on a sample of 2,400 children aged ≥ 1 year and at