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1. Name Of The Medicinal Product


2. Qualitative And Quantitative Composition

Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin.

One single-dose container of 250 mg solution contains 3.75 milligrams of azithromycine dihydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution in single-dose container.

Clear, colourless to slightly yellow, oily liquid.

4. Clinical Particulars 4.1 Therapeutic Indications

Local antibacterial treatment of conjunctivitis caused by susceptible strains:

- Purulent bacterial conjunctivitis,

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration


Adults, Adolescents (12 to 17 years), children (2 to 11 years):

Instil one drop in the conjunctival fornix twice a day, morning and evening, during three days.

It is unnecessary to prolong treatment beyond three days.

Adherence to the dosing regimen is important for the success of treatment.

Children (1 to 2 years)

For trachomatous conjunctivitis, no dose adjustment is necessary.

For purulent bacterial conjunctivitis, there is no sufficient experience with Azyter in children younger than 2 years of age (see section 5.1).

Children (less than1 year)

There is no sufficient experience with Azyter in children younger than 1 year of age for trachomatous conjunctivitis as well as for purulent bacterial conjunctivitis (see section 5.1).

Elderly patients:

No dose adjustment is necessary.

Method of administration

Ocular use.

The patient should be advised to:

- thoroughly wash hands before and after the instillation,

- avoid touching the eye or eyelids with the dropper tip of the single-dose container,

- discard the single-dose container after use, and not keep it for subsequent use.

4.3 Contraindications

Hypersensitivity to azithromycin, to any other macrolide or to the excipient.

4.4 Special Warnings And Precautions For Use

The eye drops solution should not be injected nor be swallowed.

The eye drops solution should not be used for peri- or intra-ocular injection.

In the event of an allergic reaction, the treatment should be discontinued.

Based on the international consensus on diseases involving the eye and genital tractus and susceptible to be transmitted to new-borns, non-trachomatous conjunctivitis caused by Chlamydia trachomatis and conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment.

Except for the treatment of trachomatous conjunctivitis, Azyter is not recommended in infants under 2 years of age due to the lack of sufficient clinical data in this class of age.

This treatment is not intended to be used as prophylaxic treatment of bacterial conjunctivitis in newborn infants.

The patient should be informed that it is not necessary to continue to instil the eye drops solution after the end of treatment on the third day, even if residual signs of bacterial conjunctivitis remain.

Symptomatic relief occurs generally within 3 days. If there are no signs of improvement after 3 days, diagnosis should be reconsidered.

Contact lenses should not be worn by patients with bacterial conjunctivitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interaction study has been performed with Azyter.

In view of the absence of detectable concentrations of azithromycin in the plasma during the administration of Azyter by ocular instillation (see section 5.2), none of the interactions with other medicinal products described for orally administered azithromycin is expected with use of the eye drops solution.

In the event of concomitant treatment with another eye drops solution, an interval of 15 minutes should be respected between instillation of the two solutions. Azyter should be instilled last.

4.6 Pregnancy And Lactation


There are no adequate and well controlled studies in pregnant women. Animal reproduction studies show passage across the placenta. No teratogenic effects were observed in rat reproduction studies (see further section 5.3). Since animal studies are not always predictive of human response, Azyter should be used with caution during pregnancy.


Limited data indicate that azithromycin is excreted in breast milk, but, considering the low dose and the low systemic availability, the doses taken by the new-born are negligible. Consequently, breast feeding is possible during the treatment.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

Vision may be transiently blurred after instillation. In this case, the patient should be advised to avoid driving or using machines until normal vision has been re-established.

4.8 Undesirable Effects

During clinical trials and according to post-marketing safety data on Azyter eye drops solution, the following treatment-related signs and symptoms were reported:

Eye disorders


Very common (


Ocular discomfort (pruritus, burning, stinging) upon instillation.


Common (


Blurred vision, sticky eye sensation, foreign body sensation upon instillation.


Uncommon (


Lachrymation increased upon instillation.

Immune system disorders


Very rare (< 10,000)



4.9 Overdose

The total amount of azithromycin in a single-dose container, containing a sufficient quantity for treating both eyes, is too small to induce adverse effects after inadvertent intravenous or oral administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antibiotics, ATC code: S01AA26

Mode of action

Azithromycin is a second-generation macrolide antibiotic belonging to the azalide group.

It inhibits the synthesis of bacterial proteins by binding to the 50S ribosomal subunit and preventing peptide translocation.

Mechanism of resistance

Generally, the resistance of different bacterial species to macrolides has been reported to occur by three mechanisms associated with target site alteration, antibiotic modification, or altered antibiotic transport (efflux). Various efflux pump systems have been described in bacteria. An important efflux system in streptococci is conferred by the mef genes and results in a macrolide-restricted resistance (M phenotype). Target modification is controlled by erm encoded methylases (MLSB phenotype) and results in cross-resistance to several classes of antibiotics (see below).

A complete cross-resistance exists among erythromycin, azithromycin, other macrolides and lincosamides and streptogramin B for Streptococcus pneumoniae, beta-haemolytic streptococci of group A, Enterococcus spp. and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA).

Constitutive mutants in inducibly resistant strains with erm(A) or erm(C) can be selected in vitro at low frequencies ~10-7 cfu in the presence of azithromycin.


The list of micro-organisms presented hereafter has been targeted to the indications (see section 4.1.).

Note that the breakpoints and in-vitro activity spectrum presented hereafter are those applicable to systemic use. These breakpoints may not be applicable to topical ocular application of the drug product due to the local concentrations that are reached and the local physicochemical conditions that may influence the overall activity of the agent at the site of application.

According to the EUCAST (European Committee on Antimicrobial Susceptibility Testing) the following breakpoints have been defined for azithromycin:

- Haemophilus influenzae : S

- Moraxella catarrhalis: S

- Neisseria gonorrhoeae: S

- Staphylococcus aureus: S

- Streptococcus pneumoniae: S

- Streptococcus A, B, C, G: S

For other species, EUCAST allows that erythromycin can be used to determine the susceptibility of the listed bacteria to azithromycin.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence is such that the utility of the agent in at least some types of infections is questionable.

Table: Antibacterial spectrum of azithromycin for bacterial species relevant to the indications

Commonly susceptible species

Aerobic Gram-negative

Moraxella (Branhamella) catarrhalis

Neisseria gonorrhoeae1

Haemophilus influenzae$

Haemophilus parainfluenzae$

Other micro-organisms

Chlamydia trachomatis*

Species for which acquired resistance may be a problem

Aerobic Gram-positive

Staphylococcus aureus Methi-S

Staphylococcus aureus Methi-R

Staphylococcus capitis

Staphylococcus coagulase negative Methi-S

Staphylococcus coagulase negative Methi-R

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus hyicus

Staphylococcus intermedius

Staphylococcus warnerii

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci viridans

Streptococcus agalactiae

Streptococcus group G

Inherently resistant organisms

Aerobic Gram positive

Corynebacterium spp.

Enterococcus faecium

Aerobic Gram-negative

Pseudomonas aeruginosa


* Clinical effectiveness is demonstrated by sensitive isolated organisms for approved indications.

$ The correlation between H. influenzae macrolide MICs and clinical outcome is weak. Therefore, breakpoints for macrolides and related antibiotics were set to categorise wild type H. influenzae as intermediate.

Natural intermediate susceptibility

1 Conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment (see section 4.4).

Information from clinical trials

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Azyter was evaluated in a two-month, randomised, double-masked study comparing Azyter with a single oral dose of azithromycin for the treatment of trachoma in 670 children (1-10 years). The primary efficacy variable was the clinical cure at Day 60, i.e. a grade TF0 (simplified WHO grading scale). At Day 60, clinical cure rate of Azyter instilled twice daily for 3 days (96.3%) was non-inferior to that of oral azithromycin (96.6%).

- Purulent bacterial conjunctivitis.

Azyter was evaluated in a randomised, investigator-masked study comparing Azyter, instilled twice daily for 3 days, with tobramycin 0.3% eye drops, instilled every two hours for 2 days then four times daily for 5 days, for the treatment of purulent bacterial conjunctivitis in 1043 patients (ITT set), including 109 children up to the age of 11 years from whom 5 were newborn infants (0 to 27 days) and 38 infants and toddlers (28 days to 23 months of age). In the Per Protocol set (n=471), there were no newborns and only 16 infants and toddlers. The clinical study was performed in different areas in Europe, North Africa, and India. The primary efficacy variable was the clinical cure at Day 9 in the PP set, defined as a score of 0 for both the bulbar conjunctival injection and the purulent discharge. At Day 9, clinical cure rate of Azyter (87.8%) was non-inferior to that of tobramycin (89.4%). Microbiological resolution rate of Azyter was comparable to that of tobramycin.

5.2 Pharmacokinetic Properties

Azithromycin was not detected in the blood of patients with bacterial conjunctivitis after instillation of Azyter at the recommended dose (detection limit: 0.0002 µg/mL of plasma).

5.3 Preclinical Safety Data

In animals, azithromycin caused reversible phospholipidosis. This effect was seen after oral exposures which were about 300 times in excess of the maximum human exposure after ocular administration indicating little relevance to clinical use.

Electrophysiological investigations have shown that azithromycin prolongs the QT interval.

Carcinogenic potential

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenic potential

There was no evidence of a potential for genetic and chromosome mutations in in vivo and in vitro test models.

Reproductive toxicity

No teratogenic effects were observed in embryotoxicity studies in rats after oral administration of azithromycin. In rats, azithromycin dosages of 100 and 200 mg/kg body weight/day led to mild retardations in fetal ossification and in maternal weight gain. In peri- and postnatal studies in rats, mild retardations following treatment with 50 mg/kg/day azithromycin and above were observed. These effects were seen after oral administration at exposures which were about 1000 times in excess of the maximum human exposures after ocular administration. Because of the high safety margin, these findings do not point to a relevant risk for human reproduction.

Ocular toxicity

Ocular administration of Azyter eye drops to animals twice or three times a day during 28 days did not demonstrate any local or systemic toxic effect.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Triglycerides, medium-chain.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Shelf-life of product in its commercial packaging: 18 months

After opening of the single-dose container, the eye drops, solution should be used immediately.

Discard the opened single-dose container immediately after first use.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the single-dose containers in the sachet in order to protect them from light.

6.5 Nature And Contents Of Container

Single-dose low-density polyethylene container, each containing 0.25 g, enclosed in a sachet.

Pack-size: box of six single-dose containers.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder


12, rue Louis Bl?riot



8. Marketing Authorisation Number(S)

PL 20162/0012

9. Date Of First Authorisation/Renewal Of The Authorisation


10. Date Of Revision Of The Text






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