Azidrop®
Laborator Uniter
740 Items
2019-09-19
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Clinical Pharmacology
Azithromycin is a broad-spectrum antibacterial agent, belonging to the class of azalides, inhibits protein synthesis, binds to the 50S-subunit of ribosomes, slows the growth and reproduction of bacteria, has a bactericidal effect in high concentrations. It acts on extracellular and intracellular pathogens. Active against gram-positive microorganisms: Streptococcus spp. (groups C, F and G, except those resistant to erythromycin), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans group, Staphylococcus epidermidis, Staphylococcus aureus; Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Prevotella bivia, Clostridium perfringens, Peptostreptococcus spp; as well as Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium avium complex, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Inactive against Gram-positive bacteria resistant to erythromycin.
Pharmacokinetics
Provided the drug is used twice a day, a sufficient therapeutic concentration of azithromycin in the tear fluid is provided. The half-life of the tear fluid is about 12 hours. The concentration of azithromycin in the blood plasma after instillation of Azidrop eye drops at the recommended dose is less than the detection threshold (less than 0.0002 mcg / ml).
Indications
Treatment of conjunctivitis caused by pathogens sensitive to the drug, incl. Chlamydia trachomatis, in adults and children from 1 year.
Composition
1 g of eye drops contains:
active ingredient: azithromycin dihydrate 15 mg, which corresponds to the content of azithromycin 14.3 mg,
excipients: medium chain triglycerides up to 1 g.
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Dosage and Administration
Locally.
Adults and teenagers (from 12 to 17 years old), children (from 2 to 11 years old)
Instill one drop in the conjunctival sac of the affected eye twice a day (morning and evening) for three days.
If there is no positive trend within 3 days of use of the drug, you should consult with your doctor and review the treatment.
Children (from 1 year to 2 years)
When treating trachomatous conjunctivitis, dose adjustment is not required.
There is not enough experience in the treatment of purulent bacterial conjunctivitis using Azidrop eye drops in children under 2 years of age.
Children up to a year
There is not enough experience in treating trachomatous conjunctivitis and purulent bacterial conjunctivitis using Azidrop eye drops in children under one year of age.
In the elderly
Elderly patients dosage adjustment is not required.
Patients should follow the following guidelines:
- hands should be thoroughly washed before instillation of drops and after the procedure;
- do not touch the eye and eyelid with the tip of the dropper bottle;
- after a single use, the tube-dropper must be discarded along with the remaining residue. Do not use the remaining solution in a tube-dropper for the next instillation.
Adverse reactions
Side effects, noted during the study of the drug Azidrop, eye drops, are systematized in accordance with the classification of the World Health Organization (WHO) by frequency of occurrence: very often (more than 1/10); often (more than 1/100, less than 1/10); infrequently (more than 1/1000, less than 1/100), rarely (more than 1/10000, less than 1/1000) and very rarely (less than 1/10000).
Immune system disorders: very rarely - hypersensitivity, angioedema (angioedema).
Eye disorders: very often - eye discomfort (itching, burning, tingling) after instillation of the drug; often - blurred vision, a feeling of sticking of the eyelids, foreign body in the eye; infrequently - lacrimation; very rarely - eczema, erythema, eyelid edema, eye allergies, conjunctival hyperemia, allergic conjunctivitis, conjunctivitis, keratitis.
Contraindications
Individual hypersensitivity to azithromycin and other macrolide antibiotics, as well as components of the drug Azidrop; age less than 1 year.
Drug interactions
Studies of the interaction of the drug Azidrop with all specific drugs have not been conducted.
Due to the absence of detectable concentrations of azithromycin in the blood plasma when Azidrop is instilled in the eye drops (see Pharmacokinetics section), no interaction with any of those drugs that interact with azithromycin after oral administration is expected.
Pregnancy and Lactation
Since systemic exposure to azithromycin is insignificant, the harmful effects of the drug during pregnancy are not expected.
It is possible to use the drug Azidrop, eye drops, for treating pregnant women as prescribed by the attending physician, if the expected therapeutic effect for the mother exceeds the risk of the development of possible side effects in the fetus.
There is limited evidence that azithromycin is excreted in breast milk, but given the low doses and low system availability, the effect on the body of the newborn is extremely small. Thus, treatment with the use of the drug Azidrop during breastfeeding is permissible.
Special instructions
Eye drops should not be injected or swallowed.
Eye drops can not be administered as peri-and intraocular injections.
In case of an allergic reaction to the drug, treatment should be discontinued.
In case of concomitant treatment with other ophthalmologic drugs, Azidrop should be instilled last, 15 minutes after the installation of another drug.
According to existing international guidelines for the treatment of diseases of the eye and urogenital tract, which can be very likely to be transmitted to the newborn, conjunctivitis of non-traumatic origin caused by Chlamydia trachomatis and conjunctivitis caused by Neisseria gonorrhoeae require systemic treatment.
With the exception of the treatment of trachomatous conjunctivitis, Azidrop eye drops are not recommended for use in children younger than two years old, since there is not enough clinical information about therapy in this age group.
This type of treatment is not intended to be used as a preventive measure for bacterial conjunctivitis in newborns.
The patient should be informed that it is not necessary to continue to bury eye drops after completion of therapy on the third day, even if residual signs of bacterial conjunctivitis are still present. Patients suffering from bacterial conjunctivitis should not wear contact lenses.
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, such a risk does not exist, since the systemic exposure of the active substance is extremely small.
Influence on ability to drive motor transport and control mechanisms
Patients who, after applying eye drops, have a transient blurred vision, do not recommend driving or working with mechanisms to restore vision.
Overdosage
Information on overdose cases is not available.
In a single-use package, azithromycin is contained in an amount sufficient to treat both eyes, but not sufficient to cause adverse reactions after accidental intravenous administration or oral ingestion of the solution.
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