Azidrop eye drops 15mg / g, 0.25 No. 6

Treatment of conjunctivitis caused by microorganisms sensitive to the drug:

• purulent bacterial conjunctivitis in adults and children (from birth to 17 years);

• trachomatous conjunctivitis caused by Chlamydia trachomatis in adults and children (from birth to 17 years).

Consideration should be given to the recommendations of official guidelines for the proper use of antibacterial agents.

Adults are instilled 1 drop into the conjunctival sac of the affected eye 2 times / day (morning and evening) for 3 days.

If there is no positive dynamics within 3 days of using the drug, you should consult your doctor and revise the treatment regimen and diagnosis.

Elderly patients do not need dose adjustment.

Dose adjustment is not required for children.

Mode of application

Eye drops are instilled into the conjunctival sac of the affected eye.

Patients should follow these guidelines:

• wash your hands thoroughly before instilling the drug and after the procedure;

• do not touch the eye and eyelid with the tip of the dropper bottle;

• after single use, the bottle must be discarded along with the remaining residue. Do not use the solution remaining in the vial for the next instillation.

Eye drops in the form of a clear oily liquid from colorless to light yellow.

1 g

azithromycin dihydrate 15 mg,

which corresponds to the content of azithromycin 14.3 mg

Excipients: medium-chain triglycerides - up to 1 g.

• Hypersensitivity to azithromycin and other components of the drug;

• hypersensitivity to other antibiotics of the macrolide group.

pharmachologic effect

Mechanism of action

Azithromycin is an antibiotic of the second generation macrolide-azalide group. Inhibits bacterial protein synthesis by binding to the 50S-subunit of ribosomes and preventing peptide translocation.

Mechanism of resistance

Three mechanisms of resistance for different types of bacteria to macrolides are noted: due to modification of the target of action, modification of the antibiotic, or due to the active release of the antibiotic from the microbial cell using transport systems (efflux). Various efflux systems have been described for bacteria. An important efflux system for streptococci is encoded by the mef gene and results in macrolide-confined resistance (M-phenotype). Modification of the target of action, controlling the erm encoded methylase (MLSB phenotype), leads to cross-resistance to different classes of antibiotics.

Cases of cross-resistance to erythromycin, azithromycin, other macrolides and lincosamide and streptogramin B have been described for Streptococcus pneumoniae, group A ?-hemolytic streptococci, Enterococcus spp. and Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA). Constitutive mutants in inducibly resistant strains with erm (A) or erm (C) can be isolated in vitro at low frequencies of about 10-7 CFU in the presence of azithromycin.

Pharmacokinetics

After instillation of eye drops Azidrop in the treatment of bacterial conjunctivitis in the recommended dose, azithromycin is not detected in the blood of patients (detection limit: 0.0002 ?g / ml).

Pharmacokinetic studies have only been performed in adults.

Side effect

Adverse reactions that were observed during clinical trials and according to post-registration data on the safety of the drug Azidrop

From the immune system: infrequently, hypersensitivity.

From the side of the organ of vision: very often - eye discomfort (itching, burning, tingling) after instillation of the drug; often - blurred vision, a feeling of 'sticking eyelids', a foreign body in the eye after instillation of the drug; infrequently - conjunctival hyperemia, lacrimation, erythema of the eyelids.

Adverse reactions that were not observed during clinical trials

The inclusion of these adverse reactions is based on post-registration data. The frequency is determined on the basis of 3 / X, where X is the total sample size summed over all relevant clinical trials, which at 3/879 gives the category 'infrequent'.

From the immune system: infrequently - angioedema (Quincke's edema).

From the side of the organ of vision: infrequently - conjunctivitis, allergic conjunctivitis, keratitis, eczema of the eyelids, edema of the eyelids, allergic reactions from the eyes.

The profile of adverse reactions in children corresponds to the adult population, no side effects have been identified. The safety profile for different pediatric groups was also identical.

Application during pregnancy and lactation

Since the systemic exposure of azithromycin is insignificant, a negative effect of the drug during pregnancy is not expected. The use of the drug Azidrop, eye drops, in pregnant women is possible.

There is limited evidence that azithromycin is excreted in breast milk, but given the low doses and low systemic availability, the dose that enters the neonate is extremely small. Thus, the use of the drug Azidrop during breastfeeding is permissible.

Data from animal studies have not confirmed the effect of azithromycin on fertility in men and women. There are no human studies. Since the systemic effect of azithromycin on the body is insignificant, the effect of the drug on fertility is not expected.

Application in children

Dose adjustment is not required for children.

Use in elderly patients

Elderly patients do not need dose adjustment.

special instructions

Eye drops should not be injected or swallowed.

Eye drops should not be administered as peri- and intraocular injections.

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

The patient should be informed that eye drops should not be instilled after completion of the 3-day course of therapy, even if residual signs of bacterial conjunctivitis persist.

Symptom relief usually occurs within 3 days. If there are no signs of improvement after 3 days, the diagnosis should be revised.

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

Against the background of systemic use of azithromycin, cases of fulminant hepatitis have been reported, which can potentially lead to life-threatening liver failure. When using the drug in ophthalmology, there is no such risk, since the systemic effect of the active substance is extremely small.

Use in pediatrics

Comparative studies of the efficacy and safety of the drug in trachomatous conjunctivitis in children under 1 year of age have not been conducted. However, taking into account the experience of clinical use in children of this age group with trachomatous conjunctivitis and taking into account the experience of therapy with Azidrop in newborn children with purulent bacterial conjunctivitis, safety concerns and differences in the pathological process, which make it possible to exclude the use of Azidrop eye drops in children under the age of 1 year for this indication for use, absent.

According to existing international recommendations for the treatment of diseases of the eyes and genitourinary tract, which can with a high degree of probability be transmitted to newborns, conjunctivitis of non-trachomatous origin caused by Chlamydia trachomatis and conjunctivitis caused by Neisseria gonorrhoeae requires systemic therapy.

In newborns and children under 3 months of age, systemic infections (such as pneumonia and bacteremia) caused by Chlamydia trachomatis can be associated with conjunctivitis. If such conditions are suspected, systemic therapy is necessary.

The drug is not intended for the prevention of bacterial conjunctivitis in newborns.

Influence on the ability to drive vehicles and use mechanisms

The effect on the ability to drive vehicles and mechanisms has not been studied.

Transient blurred vision may occur after eye drops are applied. In this case, the management is not recommended to drive vehicles or work with mechanisms until vision is restored.

Overdose

In a single-use package, azithromycin is contained in an amount sufficient to treat both eyes, but not sufficient to cause adverse reactions if the solution is administered accidentally or taken orally.

Drug interactions

Special studies of the drug interaction of the drug Azidrop have not been conducted.

Due to the absence of detectable concentrations of azithromycin in the blood plasma when instilling Azidrop eye drops, interaction with any of the drugs that interacted with azithromycin when taken orally is not expected.

In the case of concomitant treatment with other ophthalmic drugs, Azidrop should be instilled last, 15 minutes after the instillation of another drug.