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Composition:


active ingredients: dexamethasone sodium phosphate, gentamicin sulfate;


1 ml of the solution contains 1 mg of dexamethasone sodium phosphate and 5 mg of gentamicin sulfate (which is equivalent to 3 mg of gentamicin);


excipients: benzalkonium chloride, potassium dihydrogen phosphate, potassium hydrophosphate, sodium chloride, water for injection.


Dosage form. Eye drops.


Basic physical and chemical properties: transparent colorless solution.


Pharmacotherapeutic group. Products used in ophthalmology. Corticosteroids in combination with antimicrobials.


ATX code S01C A01.


Pharmacological properties.


Pharmacodynamics.


Gentamicin is a bactericidal antibiotic of the aminoglycoside group, which is a mixture of components of gentamicin C1, C2 and C1a, similar in chemical structure. The mechanism of bactericidal action of gentamicin is based on the disruption of protein biosynthesis in bacterial ribosomes due to interaction with mRNA and subsequent inhibition of translation.


Sensitivity to gentamicin has generally been confirmed for the following microorganisms:


- aerobic gram-positive microorganisms: Bacillus spp., Corynebacterium spp. Staphylococcus aureus (methicillin-sensitive strains);


- aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter lwoffii, Haemophilus influenzae, Haemophilus parainfluenzae, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.


At the same time, if infected with certain microorganisms, treatment may not be effective due to the development of resistance. These microorganisms include:


- aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis, Enterococcus spp., Streptococcus spp.;


- aerobic gram-negative microorganisms: Stenotrophomonas maltophilia.


Gentamicin resistance is most often mediated by enzymatic inactivation of the aminoglycoside molecule, which makes it impossible for the antibiotic to bind to ribosomes. There is widespread cross-resistance of gentamicin with other aminoglycoside antibiotics. The prevalence of acquired gentamicin resistance can vary significantly depending on the location and time.


Dexamethasone is a monofluorocorticosteroid with pronounced anti-allergic, anti-inflammatory and membrane-stabilizing properties, which also affects the metabolism of carbohydrates, proteins and lipids. Dexamethasone does not have the activity inherent in mineralcorticosteroids.


Corticosteroids, such as dexamethasone, work by activating the transcription of sensitive genes. The anti-inflammatory, immunosuppressive, and antiproliferative effects of corticosteroids are partly due to a decrease in the formation, release, and activity of inflammatory mediators and inhibition of specific functions and migration of cells involved in the inflammatory process. In addition, it is possible that corticosteroids inhibit the activity of sensitized T lymphocytes and macrophages on target cells.


Pharmacokinetics.


After topical application, depending on the frequency of application, bactericidal concentrations of gentamicin are achieved in the conjunctiva and cornea. After frequent use on the inflamed eye, therapeutically active concentrations are also achieved in watery moisture. With ophthalmic use, systemic absorption phenomena are not expected to develop, which could lead to the achievement of serum gentamicin levels above the detection limit.


Dexamethasone sodium phosphate almost does not penetrate the intact epithelium, but its absorption is significantly increased with inflammation or damage to the mucous membranes of the eye.


Dexamethasone binds to plasma albumin in a dose-dependent manner. The biological half-life of dexamethasone is more than 36 hours, so it can be considered a very long-acting corticosteroid. Due to this mode of action, continuous daily systemic use of dexamethasone can cause accumulation and overdose phenomena.


The mean (serum) Half-Life of dexamethasone in adults is approximately 250 minutes (± 80 minutes). Dexamethasone is partially metabolized and is mainly excreted by the kidneys as a free alcohol derivative of dexamethasone. Dexamethasone metabolites are also mainly excreted by the kidneys in the form of glucuronates or sulfates.


Clinical characteristics.


Indications.


Inflammation of the anterior segment of the eye with concomitant infectious diseases caused by bacterial strains sensitive to gentamicin, or with the risk of developing bacterial infections; allergic inflammation of the anterior segment of the eye, accompanied by bacterial superinfection.

Contraindications.


Hypersensitivity to active substances or to any excipients of the drug; epithelial herpetic keratitis and other viral diseases of the eye; wounds and ulcerative lesions of the cornea; closed - and open-angle glaucoma; ocular tuberculosis; fungal or exclusively bacterial infections of the eye.

Interactions with other drugs and other types of interactions.


Special Studies of drug interactions of the drug have not been conducted.


Clinically significant drug interactions of gentamicin are not known.


CYP3A4 inhibitors, including ritonavir and cobicistat, may reduce the clearance of dexamethasone, which leads to an increased effect and the development of adrenocortical suppression/Cushing's syndrome. Such combinations should be avoided if the benefits of treatment do not exceed the increased risk of systemic side effects inherent in corticosteroids. If such a combination is used, the patient should be under medical supervision to detect the systemic effects of corticosteroids.


Concomitant use of dexamethasone ophthalmic drugs with atropine and other anticholinergic agents may lead to an additional increase in intraocular pressure.


When Dexa-gentamicin is co-administered with other topical ophthalmic medications, a 15-minute interval between applications should be maintained.


Application features.


Before instilling Dex-gentamicin eye drops, remove contact lenses and re-insert them no earlier than 15 minutes after applying the drug.


It is not allowed to use soft contact lenses during treatment with the drug, since the drug contains benzalkonium chloride, which can cause eye irritation and discoloration of soft contact lenses.


Since long-term corticosteroid treatment can cause a reversible increase in intraocular pressure (glaucoma) or irreversible cataract formation, when using the drug for more than 10 consecutive days, the patient's intraocular pressure and eye condition should be regularly checked.


If hypersensitivity reactions develop during the use of the drug, treatment should be discontinued immediately.


In the case of diseases that cause thinning of the cornea, the use of the drug can lead to its perforation.


When using the drug, the risk of developing fungal or viral (keratitis caused by herpes simplex) eye diseases may increase.


Cases of visual disturbances may occur during the use of systemic or topical corticosteroid medications. If a patient experiences symptoms such as blurred vision or other visual impairments, they should consult an ophthalmologist to determine possible causes, including cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSH), which occurred after the use of systemic or topical corticosteroid medications.


Cushing's syndrome and/or adrenocortical suppression caused by systemic absorption of dexamethasone ophthalmic drugs may occur after intensive or long-term continuous therapy in patients with a tendency to such disorders, including children and patients taking CYP3A4 inhibitors (including ritonavir and cobicistat). In such patients, treatment should be gradually discontinued.


Use during pregnancy or lactation.


Pregnancy


Data on the use of dexamethasone and gentamicin sulfate in pregnant women are limited. For this reason, Dex-gentamicin eye drops should not be used in the first trimester of pregnancy, and during the subsequent period of pregnancy, the drug can only be used after a thorough assessment of the benefits and risks of such use.


Breast-feeding


When applied topically, dexamethasone can be systemically absorbed and enter breast milk during breast-feeding. So far, the harmful effects of the drug on infants who are breastfed have not been reported.


Ability to influence the reaction rate when driving vehicles or working with other mechanisms.

Immediately after using the drug, short-term blurred vision is possible, so before you start driving vehicles or working with other mechanisms, you should wait a few minutes.


Dosage and administration.


The drug is instilled into the conjunctival sac of the affected eye 1 drop 4-6 times a day.


Usually, the duration of treatment should not exceed 2 weeks. Depending on the clinical picture, the effectiveness of treatment should be periodically monitored in order to determine the feasibility of prolonging or changing therapy.


When instilling eye drops, avoid any contact of the dropper tip with the eye or skin.


Children.


There is no experience of using DeX-gentamicin eye drops for the treatment of children.


Overdose.


No overdose cases have been reported. With proper use of Dex-gentamicin eye drops, overdose or intoxication is not expected.

Adverse reactions.


From the immune system: local hypersensitivity reactions, such as temporary slight burning and tingling in the eye, irritation, foreign body sensation in the eye, conjunctival hyperemia, as well as contact allergic reactions accompanied by itching, swelling or eczema of the eyelids.


From the side of the visual organ: temporary blurred vision, increased eye pressure (glaucoma), irreversible cataracts, temporary accommodation disorders, uveitis, corneal perforation in existing keratitis, ptosis, mydriasis, delayed wound healing.


Infections and infestations: herpetic keratitis caused by herpes simplex, fungal infections of the eye, for example, caused by Candida albicans, masking or exacerbation of concomitant bacterial infections of the cornea.


From the endocrine system: Cushing's syndrome, adrenocortical suppression (see the section "application features").


In some patients with significant corneal damage, cases of corneal calcification associated with the use of phosphate-containing eye drops have been reported in very rare cases.


Expiration date. 3 years old.


Do not use after the expiration date indicated on the package.


Apply no more than 6 weeks after the first opening of the bottle.


Storage conditions.


Store in the original packaging at a temperature not exceeding 25 °C.


Keep out of reach of children.

Tags: Dex-Gentamicin® [Gentamicin, Dexamethasone]