Azidrop eye drops 15mg g N6
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Active ingredients
Azithromycin
Composition
1 g of azithromycin dihydrate 15 mg, which corresponds to the content of azithromycin 14.3 mg. Excipients: sodium metabisulfite - 0.4 mg, water d / and - up to 1 ml.
Pharmacological effect
Mechanism of resistance: Three mechanisms of resistance to macrolides for different types of bacteria are noted: due to modification of the target of action, modification of the antibiotic, or due to active release of the antibiotic from the microbial cell using transport systems (efflux). For bacteria, various efflux systems are described. An important efflux system for streptococci is encoded by the mef gene and leads to resistance limited to macrolides (M phenotype). Modification of the target of action, controlled by the erm-coded 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 for Streptococcus pneumoniae, &. 946.-Hemolytic streptococcus 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 isolated in vitro at low frequencies of approximately 10-7 CFU in the presence of azithromycin. Limit value: The following are the minimum inhibitory concentrations (MIC) for microorganisms for this indication. It should be noted that the MIC boundary values presented below and the spectrum of action refer to systemic use. Data MIC can not be used in the case of local drug treatment in the form of eye drops due to other concentrations and physico-chemical conditions that may affect the overall activity of the drug in the place of its action. Clinical data: Trachomatous conjunctivitis caused by Chlamydia trachomatis: A randomized, double-blind comparative study of 2 months of Azidrop with oral administration of a single dose of azithromycin for the treatment of active trachoma in 670 children aged 1-10 years was conducted. The main variable efficacy was clinical cure on day 60, i.e. the absence of active trachoma TF0 (according to a simplified classification of the severity of trachoma by WHO).On the 60th day, the frequency of clinical cure by Azidrop, which was applied 1 drop 2 times / day for 3 days, was not lower (96.3%) than when taking azithromycin orally (96.6%). The clinical efficacy of azidrop, administered 1 drop 2 times / day for 3 days, for the treatment and prevention of trachoma of the entire population (from birth) in Northern Cameroon (112,000 subjects) was evaluated in a multicenter, open, non-comparative phase IV study. The treatment was carried out in 3 periods lasting 1 year. The primary criterion of effectiveness was the prevalence of active trachoma, i.e. trachomatous follicular inflammation or marked trachomatous inflammation (TF + TI0 or TF + TI +). For analysis, a clinical assessment of trachoma was performed every year in 2400 children aged & # 8805 .1 and less than 10 years old, selected by random cluster sampling. The prevalence of active trachoma (TF + TI0 or TF + TI +) was observed in 31.1% of cases before the instillation of the drug Azidrop in "year 0" and decreased to 6.3% (1st year), 3.1% (2nd year) and 3.1% ( 3rd year). In general, the population was not observed serious adverse reactions to the study drug. Purulent bacterial conjunctivitis: A randomized, blind, comparative study of the drug Azidrop, used 1 drop 2 times / day for 3 days, with tobramycin (eye drops, 0.3%), applied 1 drop every 2 hours for 2 days, and then 4 times / day for 5 days for the treatment of purulent bacterial conjunctivitis in 1043 patients (ITT group), including 109 children under the age of 11 years, 5 of whom were newborns (from 0 to 27 days), 38 infants and toddlers (from 28 days to 23 months). According to the protocol, the population (n = 471) (group of PP) included 16 infants and toddlers and did not include newborns. Clinical research was conducted in different regions of Europe, North Africa and India. The main variable efficacy was a clinical cure on day 9 in the PP group and was defined as 0 points for bulbar conjunctival injection and for purulent discharge. On day 9, the frequency of clinical cure with Azidrop (87.8%) was not lower than with the use of tobramycin (89.4%). The microbiological efficacy of azithromycin was comparable to that of tobramycin. Pediatric population: The efficacy and safety of Azidrop in children and adolescents under the age of 18 were shown in a randomized study with researcher masking compared to tobramycin in 282 patients studied with a diagnosis of purulent bacterial conjunctivitis (including 148 patients in the 0 day – less than 24 month subgroup ).Patients received either azidrop (1 drop 2 times / day for 3 days), or tobramycin, eye drops, 0.3% (1 drop every 2 hours for 2 days, and then 4 times / day for 5 days). The main criterion of effectiveness was the clinical cure of the more affected eye on day 3 in patients with positive bacteriological analysis results on day 0. In patients using Azidrop, the clinical cure of the more affected eye on day 3 exceeded (47%) compared to with patients using tobramycin (28%). On the 7th day, 89% of patients receiving treatment with Azidrop were completely cured, while among patients receiving tobramycin, a full cure was observed in 78% of cases. There were no statistical differences between the groups treated with bacteriological resolution on day 7. Azidrop, used 1 drop 2 times / day for 3 days, was well tolerated in all age groups in a study of a large group of children. Adverse reactions noted in children were also found in adults. no new adverse reactions in children have been identified. Moreover, no age-related clinical problems were noted. The short duration of azithromycin therapy (1.5% eye drops), a small number of necessary instillations, and the ease of dropping the drops in children were taken into account by both children and parents.
Indications
Treatment of conjunctivitis caused by microorganisms sensitive to the drug: - purulent bacterial conjunctivitis in adults and children (from birth to 17 years of age). - trachomatous conjunctivitis caused by Chlamydia trachomatis in adults and children (from birth to 17 years).
Contraindications
- Hypersensitivity to azithromycin and other components of the drug - Hypersensitivity to other antibiotics of the macrolide group.
Use during pregnancy and lactation
Since the systemic exposure to azithromycin is negligible, the 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 system availability, the dose that enters the body of newborns 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 the fertility of men and women. The results of studies in humans are absent. Since the systemic effect of azithromycin on the body is insignificant, the effect of the drug on fertility is not expected.
Dosage and administration
Adults are buried in 1 drop in the conjunctival sac of the affected eye 2 times / day (morning and evening) for 3 days. If there is no positive trend within 3 days of using the drug, you should consult with your doctor and review the treatment regimen and diagnosis. Elderly patients dose adjustment is not required. In children, dose adjustment is not required.
Dosage and administration
Eye drops are instilled into the conjunctival sac of the affected eye. Patients should follow the following recommendations: - Wash hands thoroughly before instillation of the drug and after the procedure. - Do not touch the eye and eyelid with the tip of the dropper bottle. - after a single use, the bottle must be discarded along with the existing residue. Do not use the solution remaining in the vial for the next instillation.Side effects
Adverse reactions that were observed in clinical studies and post-registration studies From the immune system: infrequently (& # 8805. 1/1000, less than 1/100) - hypersensitivity. On the part of the organ of vision: very often (& # 8805. 1/10) - ocular discomfort (itching, burning, tingling) after instillation of the drug. often (& # 8805 .1 / 100, less than 1/10) - blurring of vision, feeling of "sticking of the eyelids", of a foreign body in the eye after instillation of the drug. infrequently (& # 8805 .1 / 1000, less than 1/100) - conjunctival hyperemia, lacrimation, eyelid erythema. Adverse reactions that have been observed in post-registration studies The inclusion of these adverse reactions is based on post-registration data. The frequency is determined on the basis of 3 / X, where X represents the total sample size, summarized across all relevant clinical studies, which at 3/879 gives the category “infrequently”. On the part of the immune system: infrequently (& # 8805 .1 / 1000, less than 1/100) - angioedema (angioedema). On the part of the organ of vision: infrequently (& # 8805 .1 / 1000, less than 1/100) - conjunctivitis, allergic conjunctivitis, keratitis, eyelid eczema, eyelid edema, ocular allergy.The profile of adverse reactions in children corresponds to the adult population, no side effects have been identified. The safety profile for the different pediatric groups was also identical.
special instructions
Adverse reactions that were observed in clinical studies and post-registration studies From the immune system: infrequently (& # 8805. 1/1000, less than 1/100) - hypersensitivity. On the part of the organ of vision: very often (& # 8805. 1/10) - ocular discomfort (itching, burning, tingling) after instillation of the drug. often (& # 8805 .1 / 100, less than 1/10) - blurring of vision, feeling of "sticking of the eyelids", of a foreign body in the eye after instillation of the drug. infrequently (& # 8805 .1 / 1000, less than 1/100) - conjunctival hyperemia, lacrimation, eyelid erythema. Adverse reactions that have been observed in post-registration studies The inclusion of these adverse reactions is based on post-registration data. The frequency is determined on the basis of 3 / X, where X represents the total sample size, summarized across all relevant clinical studies, which at 3/879 gives the category “infrequently”. On the part of the immune system: infrequently (& # 8805 .1 / 1000, less than 1/100) - angioedema (angioedema). On the part of the organ of vision: infrequently (& # 8805 .1 / 1000, less than 1/100) - conjunctivitis, allergic conjunctivitis, keratitis, eyelid eczema, eyelid edema, ocular allergy. The profile of adverse reactions in children corresponds to the adult population, no side effects have been identified. The safety profile for the different pediatric groups was also identical.