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Composition:


active ingredients: ciprofloxacin hydrochloride, dexamethasone;


1 ml contains ciprofloxacin hydrochloride in terms of ciprofloxacin 3.0 mg, dexamethasone-1.0 mg;


excipients: disodium edetate, benzalkonium chloride, mannitol (E 421), hydroxypropyl-beta-cyclodextrin, hydrochloric acid, water for injection.


Dosage form. Eye/ear drops.


basic physical and chemical properties: transparent colorless or pale yellow liquid.


Pharmacotherapeutic group.


Combined medications containing corticosteroids and antimicrobials. Dexamethasone and antimicrobials. ATX code S03C A01.


Pharmacological properties.


Pharmacodynamics.


Ciprofloxacin. Active ingredient-ciprofloxacin hydrochloride belongs to the class of quinolones. The bactericidal effect of quinolones, which mainly affects the synthesis of bacterial DNA, is aimed at inhibiting DNA gyrase.


Ciprofloxacin is highly active in vitro against most gram-negative microorganisms, including Pseudomonas aeruginosa. It is also effective against aerobic gram-positive microorganisms such as staphylococci and streptococci.


Ciprofloxacin is active against:


aerobic gram-positive microorganisms: Staphylococcus aureus (including strains sensitive or resistant to methicillin), Staphylococcus epidermidis, Staphylococcus spp., other coagulase-negative Staphylococcus spp species., including S. haemolyticus and S. hominis, Corynebacterium spp., Streptococcus rpeimopiae, Streptococcus of the Viridans group;


aerobic gram-negative microorganisms: Acinetobacter spp., Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella spp. (including M. catarrhalis).


Ciprofloxacin is active against pathogenic microorganisms isolated from patients with acute otitis media of the middle ear using tympanostomy tubes.


Due to the specific mode of action, there is no cross-resistance between ciprofloxacin and other antibacterial agents with different chemical structures, such as beta-lactam antibiotics, aminoglycosides, tetracyclines, macrolides and peptides, as well as sulfonamides derived from trimethoprim and nitrofuran. Thus, microorganisms that are resistant to these drugs may be sensitive to ciprofloxacin.


Dexamethasone. The general mechanism of anti-inflammatory action of corticosteroids is the inhibition of vascular adhesive molecules of endothelial cells, cyclooxygenase I or II and the release of cytokines. As a result, the formation of inflammatory mediators decreases and the adhesion of white blood cells to the vascular endothelium is inhibited, thus preventing their penetration into inflamed eye tissues.


Pharmacokinetics.


Ciprofloxacin. After topical application to the eye (s), Ciprofloxacin is well absorbed. Systemic absorption of ciprofloxacin after instillation into the eye is low.


Ciprofloxacin is rapidly distributed in body tissues, with tissue levels usually higher than plasma levels. The volume of distribution in a stable state is 1.7–2.71 l/kg. Binding to serum protein is 16-43 %. The serum Half-Life of Ciprofloxacin is 3-5 hours. 15-50% of the dose is excreted unchanged in the urine, 10-15% — in the form of metabolites within 24 hours. Approximately 20-40% of the dose is excreted unchanged in the faeces and in the form of metabolites within 5 days.


Dexamethasone. After instillation in the eye, the drug penetrates well into the corneal epithelium and conjunctival cells. After instillation into the conjunctival cavity, therapeutic concentrations in the watery moisture of the eye are achieved. The maximum level of dexamethasone in the intraocular fluid was approximately 30 ng/mL, reached within 2 hours. Then there was a decrease in concentration with a Half-Life of 3 hours. Dexamethasone is eliminated from the body by metabolism. Approximately 60% of the dose is excreted in the urine as 6-β-hydrohidexamethasone. Unchanged dexamethasone was not detected in the urine. The plasma half – life is relatively short-3-4 hours. Dexamethasone binds approximately 77-84% to serum albumin. Ground clearance ranges from 0.111 to 0.225 L/H/kg, volume of distribution ranges from 0.576 to 1.15 l/kg.


Clinical characteristics.


Indications.


Acute otitis media of the outer ear, as well as acute otitis media of the middle ear with drainage through the tympanostomy tube, are caused by strains of bacteria sensitive to ciprofloxacin.


Inflammatory eye diseases in patients with corticosteroid use and superficial bacterial infection caused by strains of bacteria sensitive to ciprofloxacin.


Contraindications.


- Hypersensitivity to dexamethasone, ciprofloxacin, other fluoroquinolones or to any other components of the drug;


- viral keratitis;


- herpetic infection (tree keratitis, Herpes simplex);


- purulent infections of the mucous membrane of the eye and eyelids;


- tuberculosis of the eyes and ears;


- smallpox, chickenpox and other viral lesions of the conjunctiva and cornea;


- vaccinations;


- viral ear lesions;


- fungal eye lesions;


- acute untreated bacterial infections;


- mycobacterial infections of the eye.


Interactions with other drugs and other types of interactions.


Since the drug is applied topically, interaction with drugs used systemically is unlikely.


However the interaction of ciprofloxacin with such systemic drugs cannot be excluded:


 Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics).


- Formation of a chelate complex: with the simultaneous use of ciprofloxacin (orally) and drugs containing multivalent cations and mineral additives (for example, calcium, magnesium, aluminum, iron), phosphate-binding polymers (for example, sevelamer or Lanthanum Carbonate), sucralfates or antacids, as well as drugs with a large buffer capacity (such as didanosine tablets) containing magnesium, aluminum or calcium, the absorption of ciprofloxacin decreases. In this regard, ciprofloxacin should be taken either 1-2 hours before or at least 4 hours after taking these medications. This restriction does not apply to antacids belonging to the class of H2 receptor blockers.


- Food and dairy products: calcium in food products has little effect on absorption. However, you should avoid taking ciprofloxacin and dairy or mineral-fortified foods (such as milk, yogurt, orange juice with a high calcium content) at the same time, as the absorption of ciprofloxacin may decrease.


- Probenecid: probenecid affects the renal secretion of ciprofloxacin. Concomitant use of probenecid and ciprofloxacin leads to an increase in the concentration of ciprofloxacin in the blood serum.


- Omeprazole: concomitant use of ciprofloxacin and drugs containing omeprazole leads to a slight decrease in the Cmax and AUC of ciprofloxacin.


- Theophylline: when used concomitantly with the drug, the concentration of theophylline in the blood serum may increase and the Half-Life may lengthen, which, in turn, increases the risk of side effects of theophylline. In isolated cases, such adverse reactions can be life-threatening or fatal. Therefore, when ciprofloxacin and theophylline are used simultaneously, the concentration of theophylline in the blood serum should be monitored and, if necessary, its dose should be reduced.


- Caffeine, other xanthine derivatives: like all quinolones, ciprofloxacin has the ability to reduce the metabolic rate of caffeine, which in turn causes an increase in caffeine clearance and prolongs the half-life. After concomitant administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifillin), increased serum concentrations of these xanthine derivatives have been reported.


- preparations containing polyvalent cations (magnesium, aluminum): magnesium - and aluminum-containing antacids, bismuth subsalicylate, sucralfate, products containing calcium, iron or zinc significantly reduce their absorption and their level in blood serum and urine decreases accordingly;


- pirenzepine: delays but does not reduce the absorption of ciprofloxacin;


- phenytoin: usually does not interact with ciprofloxacin, but there are isolated reports of a decrease in its level in patients treated with ciprofloxacin;


- sulfonylurea: may sometimes cause hypoglycemia when used concomitantly;


- methotrexate: concomitant use may reduce the rate of renal excretion of methotrexate, which increases the risk of increased toxicity;


- nonsteroidal anti-inflammatory drugs: the combined use of high doses of nonsteroidal anti-inflammatory drugs (except acetylsalicylic acid) with quinolones can provoke seizures.


- Tizanidine. The drug should not be used simultaneously with ciprofloxacin (see the section "contraindications"). In a clinical study involving healthy volunteers with simultaneous use of ciprofloxacin and Tizanidine, an increase in the concentration of Tizanidine in blood plasma was revealed (an increase in Cmax by 7 times, range – 4-21 times; an increase in AUC – by 10 times, range – 6-24 times). Antihypertensive and sedative adverse reactions are associated with an increase in the concentration of Tizanidine in the blood serum.

Cyclosporine: A transient increase in serum creatinine was determined with the simultaneous use of ciprofloxacin and drugs containing cyclosporine. Therefore, frequent (2 times a week) monitoring of serum creatinine concentrations in these patients is necessary.


- Vitamin K antagonists: concomitant use of ciprofloxacin and vitamin K antagonists may increase their anticoagulant effect. The degree of risk may vary depending on the main type of infection, age, and general condition of the patient, so it is difficult to accurately assess the effect of ciprofloxacin on increasing the value of the international normalized ratio (INR). Frequent INR monitoring should be performed during and immediately after concomitant use of ciprofloxacin and vitamin K antagonists (for example, warfarin, acenocoumarol, fenprocumone, fluindione).


- Duloxetine: in clinical studies, it has been shown that concomitant use of Duloxetine with strong CYP450 1A2 inhibitors, such as fluvoxamine, can lead to an increase in the AUC and Cmax of Duloxetine. Despite the lack of clinical data on possible interactions with ciprofloxacin, similar effects can be expected with the simultaneous use of these drugs.


- Ropinirole: in clinical studies, it was found that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isoenzyme, leads to an increase in the Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole side effects and appropriate dose adjustment are recommended during and immediately after concomitant use with ciprofloxacin.


- Lidocaine: concomitant use of ciprofloxacin, a moderate inhibitor of cytochrome P450 1A2 isoenzymes, and lidocaine-containing drugs has been shown to reduce intravenous lidocaine clearance by 22% in healthy individuals. Despite the normal tolerability of lidocaine treatment, interaction with ciprofloxacin is possible, which is associated with adverse reactions with the simultaneous use of these drugs.


- Clozapine. After concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. It is recommended to carry out clinical monitoring and appropriate dose adjustment of clozapine during and immediately after concomitant use with ciprofloxacin.


- Sildenafil. The Cmax and AUC of sildenafil increased approximately 2-fold in healthy volunteers after concomitant oral administration of 50 mg of sildenafil and 500 mg of ciprofloxacin. Therefore, caution should be exercised when concomitant administration of ciprofloxacin with sildenafil and the risk/benefit ratio should be taken into account.


- H2 receptor antagonists: do not affect the kinetics of ciprofloxacin.


- Metoclopramide: do not interact when used together.


Also, the interaction of dexamethasone with such drugs of systemic action cannot be excluded:


- aminoglutetiamide: as an enzyme-inducing agent, it enhances the metabolism and clearance of steroids in the liver, thereby enhancing their effect;


- amphotericin B and other potassium-removing drugs: combined use may cause hypokalemia, heart congestion, and heart failure;


- macrolide antibiotics: cause a significant decrease in corticosteroid clearance.


- Anticholinesterase drugs: concomitant use of anticholinesterase agents and corticosteroids may cause severe weakness in patients with myasthenia gravis. If possible, anticholinesterase medications should be discontinued at least 24 hours before starting corticosteroid therapy.


- anticoagulants: concomitant use of corticosteroids with warfarin may reduce the activity of warfarin, so it is necessary to monitor the anticoagulant effect;


- Hypoglycemic drugs: since corticosteroids can increase the concentration of glucose in the blood, it may be necessary to adjust the dose of antidiabetic agents.


- Cholestyramine: may increase corticosteroid clearance;


- cyclosporine: mutual enhancement of the effect of drugs can cause seizures;


- digitalis glycosides: combined use may cause increased arrhythmia and seizures;


- ephedrine: when combined with corticosteroids, it is possible to increase the metabolism of the latter, which leads to a decrease in the concentration of blood levels and, accordingly, the level of corticosteroid activity;


- estrogens( including oral contraceptives): combined use reduces the level of hepatic metabolism of corticosteroids, and thus increases their effect;


- inducers and inhibitors and substrate of liver enzymes: barbiturates, phenytoin, carbamazepine, rifampicin and other substances that enhance the action of liver enzymes, reduce the level of corticosteroids in the body;


ketoconazole, macrolides (erythromycin) enhance the effect of corticosteroids;


dexamethasone weakens the activity of cytochrome CYP3A4, so the combined use of drugs metabolized with this cytochrome (indinavir, erythromycin) reduces the concentration of these drugs in the blood serum; CYP3A4 inhibitors (including ritonavir and cobicistat) can reduce the clearance of dexamethasone and/or increase the effect of adrenal suppression/ Cushing's syndrome. Such combinations should be avoided unless the benefits outweigh the risk of increased systemic side effects of corticosteroids – in this case, careful monitoring of the systemic effects of corticosteroids should be carried out.


nonsteroidal anti-inflammatory drugs: combined use increases the risk of gastroenterological complications, hypoprothrombinemia; glucocorticoids may increase the need for salicylates as the plasma clearance of salicylate increases. Concomitant administration of topical steroids and topical nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of complications in corneal wound healing.


- Ketoconazole: ketoconazole is known to reduce the metabolism of certain corticosteroids by up to 60%, which leads to an increased risk of corticosteroid effects. In addition, ketoconazole may inhibit the synthesis of adrenal corticosteroids and may cause adrenal insufficiency during corticosteroid withdrawal.


- Phenytoin: post-marketing studies show fluctuations in phenytoin levels when used concomitantly with dexamethasone, which reduces the effectiveness of seizure control.

Application features.


In acute purulent eye lesions, corticosteroids can mask or aggravate infectious processes.


Application features associated with ciprofloxacin.


Hypersensitivity to the drug.


Since a certain part of the drug can enter the systemic circulation when using the drug, severe hypersensitivity reactions (anaphylactic reactions) are likely to develop in patients who used quinolones, and in some patients after the first dose.


Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial swelling, dyspnoea, urticaria, and pruritus. Severe anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen therapy, intravenous infusions, intravenous administration of antihistamines, corticosteroids, amines that constrict blood vessels, artificial ventilation according to clinical indications.


Photosensitivity.


There is a known photosensitizing and phototoxic effect from moderate to severe degree during the use of drugs of the Quinoline class in the form of severe sunburn in patients exposed to direct sunlight. Since when using the drug, a certain part of it can enter the systemic circulation and cause similar manifestations, excessive exposure to solar radiation should be avoided. In case of phototoxicity, the drug should be discontinued.


Superinfection.


Prolonged use of ciprofloxacin, like any other antibacterial drugs, can lead to the development of superinfection. When using it, the risk of getting the drug into the nasopharynx should be taken into account, which may contribute to the occurrence and spread of bacterial resistance.


When instilling in the ear, medical monitoring should be carried out to allow timely implementation of other therapeutic measures.


When using other eye medications at the same time, it is necessary to maintain at least a 5-minute break between applications. After instillation, careful eyelid closure or nasolacrimal occlusion is recommended in order to reduce the systemic absorption of drugs injected into the eye, which reduces the risk of systemic side effects.


Alcohol.


Simultaneous use of the drug with alcohol leads to increased manifestations of adverse reactions.


Ciprofloxacin should be discontinued at the first sign of a skin rash or any other signs of a hypersensitivity reaction.


Musculoskeletal system.


In general, ciprofloxacin should not be used in patients with a history of tendon diseases/ disorders associated with the use of quinolones. Inflammation and tendon rupture are possible with systemic therapy with fluoroquinolones, including ciprofloxacin, especially in elderly patients, as well as in patients who are co-treated with corticosteroids. If any signs of tendinitis occur (such as painful swelling, inflammation), treatment with eye/ear drops should be discontinued.


Ciprofloxacin should be used with caution in patients with myasthenia gravis, due to possible exacerbation of the symptoms of this disease (see the section "adverse reactions").


The central nervous system.


Ciprofloxacin, like other quinolones, is known to cause seizures or lower the threshold of convulsive readiness. Cases of epileptic status have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders who may be prone to seizures. If seizures occur, ciprofloxacin should be discontinued (see Section "adverse reactions"). Even after the first use of ciprofloxacin, psychotic reactions may occur. In rare cases, depression or psychosis can progress to suicidal thoughts and actions, such as suicide or attempting it. In these cases, ciprofloxacin should be discontinued.


Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances, or muscle weakness, alone or in combination) have been reported in patients treated with ciprofloxacin. Ciprofloxacin should be discontinued in patients with symptoms of neuropathy, in particular pain, burning, tingling, numbness and/or weakness, in order to prevent the development of irreversible conditions (see the section "adverse reactions").


Heart disorders.


Fluoroquinolones, including ciprofloxacin, should be used with caution in patients with known risk factors for prolongation of the QT interval, in particular:


* in hereditary syndrome, prolongation of the QT interval;


* in the case of concomitant use of drugs that may prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, neuroleptics);


* with an uncorrected electrolyte imbalance (for example, hypokalemia, hypomagnesemia);


* in the presence of heart diseases (for example, heart failure, myocardial infarction, bradycardia).


Elderly patients and women may be more sensitive to medications that prolong QTc. Therefore, fluoroquinolones, including ciprofloxacin, should be used with caution in these groups of patients (see the sections "dosage and administration", "interactions with other drugs and other types of interactions", "adverse reactions", "overdose").


Hypoglycemia.


As with other quinolones, hypoglycemia was most common among diabetic patients, mainly in elderly patients. Careful monitoring of blood glucose levels in all diabetic patients is recommended (see the section "adverse reactions").

Gastrointestinal tract.


The occurrence of severe and persistent diarrhea during or after treatment (even a few weeks after treatment) may indicate the development of antibiotic-associated colitis (life-threatening with a possible fatal outcome) and require urgent treatment (see the section "adverse reactions"). In such cases, the use of ciprofloxacin should be discontinued and appropriate therapy should be initiated. Medications that suppress peristalsis are contraindicated in this clinical situation.


Kidneys and urinary system.


Crystalluria associated with ciprofloxacin has been reported (See section "adverse reactions"). Patients taking ciprofloxacin should receive sufficient fluids. Excessive alkalinity of the urine should be avoided.


Impaired renal function.


Since Ciprofloxacin is mainly excreted unchanged by the kidneys, in patients with impaired renal function, it is necessary to adjust the dose according to the section "dosage and administration" in order to avoid an increase in the frequency of adverse reactions caused by the accumulation of ciprofloxacin.


Hepatobiliary system.


Cases of liver necrosis and life-threatening liver failure have been reported with ciprofloxacin (see Section "adverse reactions"). If any signs and symptoms of liver disease appear (such as anorexia, jaundice, dark urine, itching, or tightness of the anterior abdominal wall), treatment should be discontinued.


Glucose-6-phosphate dehydrogenase deficiency.


Hemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in such patients unless the potential benefit outweighs the potential risk. In this case, the possible occurrence of hemolysis should be monitored.


Resistance.


During or after ciprofloxacin treatment, resistant bacteria may be isolated, with or without clinically defined superinfection. There may be some risk of isolation of ciprofloxacin-resistant bacteria during long-term courses of treatment and in the treatment of nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.


Cytochrome P450.


Ciprofloxacin inhibits CYP1A2 and therefore can cause an increase in the serum concentration of simultaneously used substances that are also metabolized by this enzyme (for example, theophylline, clozapine, Olanzapine, ropinirole, Tizanidine, Duloxetine). Therefore, patients who use these substances simultaneously with ciprofloxacin should be carefully monitored for possible clinical signs of overdose. It may also be necessary to determine serum concentrations (for example, theophylline) (see the section "interactions with other drugs and other types of interactions").


Influence on the results of laboratory tests.


Ciprofloxacin in vitro can affect the results of Mycobacterium tuberculosis culture by inhibiting the growth of Mycobacterium culture, which can lead to false-negative results of the culture analysis in patients taking ciprofloxacin.


Application features associated with dexamethasone.


- To prevent possible systemic adsorption after instillation of the drug, hold the tear ducts with your finger for 2-3 minutes.


- Long-term treatment with corticosteroids for topical ophthalmic use can lead to ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, deterioration of visual acuity, as well as to the formation of subcapsular cataracts of the posterior chamber of the eye. If corticosteroids are used in the eye for a long time, 10 days or more, intraocular pressure should be monitored regularly and frequently (primarily in patients who have already experienced an increase in intraocular pressure due to taking steroids, in patients with high intraocular pressure even before taking steroids, and in patients with glaucoma). This is especially important for children, as the risk of ocular hypertension caused by corticosteroids is higher in children. The risk of increased intraocular pressure caused by corticosteroids and/or the risk of cataract formation due to corticosteroid use increases in predisposed patients (for example, in patients with diabetes mellitus).


- The use of topical corticosteroids should not last longer than a week, except in cases of careful monitoring and measurement of intraocular pressure.


- Given the possibility of systemic absorption of dexamethasone, Cushing's syndrome and/or adrenal suppression may occur, especially after prolonged continuous use of dexamethasone eye drops in predisposed patients, including children and patients using CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be gradually discontinued.


- Corticosteroids can reduce resistance to bacterial, viral or fungal infection and mask the clinical signs of infection, preventing the detection of ineffective antibiotics. Fungal infections of the cornea are especially active with prolonged use of steroids. If corneal ulcers persist, the presence of fungal infection should be excluded in patients treated or treated with corticosteroids. Treatment should be discontinued if a fungal infection occurs.


- Corticosteroids applied topically to the eye can slow the healing of corneal wounds. Concomitant use of topical NSAIDs and corticosteroids may contribute to the development of healing problems. (see the section "interactions with other drugs and other types of interactions").


- It is known that in the presence of diseases that lead to thinning of the cornea or sclera, topical use of corticosteroids can cause perforations.


- Visual disturbances may occur due to systemic and topical use of corticosteroids. If blurred vision or other visual disturbances occur, an ophthalmologist should be consulted to determine possible causes, which may include cataracts, glaucoma, or other rare diseases such as central serous chorioretinopathy that has been reported after systemic corticosteroid use.


- The drug should be used with extreme caution and only in combination with antiviral therapy in the treatment of stromal keratitis or uveitis caused by herpes simplex. Patients with systemic or topical corticosteroid therapy used to treat other diseases developed ocular herpes simplex. The use of corticosteroids in the treatment of herpes simplex, with the exception of epithelial keratitis caused by herpes simplex, in which corticosteroids are contraindicated, requires special caution; periodic biomicroscopy using a slit lamp is necessary.


- In addition, the drug contains benzalkonium chloride as a preservative — this can cause irritation, discoloration of soft contact lenses.


- Benzalkonium chloride can cause eye irritation, especially with symptoms of dry eyes or diseases of the cornea (the transparent anterior layer of the eye).


- Treatment should not be stopped prematurely, as sudden discontinuation of topical treatment with large doses of steroids can cause re-inflammation of the eye.


- In acute purulent eye diseases, corticosteroids can mask infections or spread an existing infection. If treatment lasts more than 10 days, intraocular pressure should be monitored.


- During long-term treatment with dexamethasone, the corneal condition should be checked with a fluorescent test and intraocular pressure should be monitored. In case of a positive fluorescence test or increased intraocular pressure, treatment should be discontinued.


- Cases of corneal calcification requiring corneal transplants to restore vision have been reported in patients treated with phosphate-containing ophthalmic medications. At the first signs of corneal calcification, it is necessary to stop using the drug and further treatment of the patient should be carried out with products that do not contain phosphates.


In patients with hypersensitivity, intraocular pressure may increase even after the use of conventional doses. Do not exceed the recommended duration of treatment, except in cases where the expected therapeutic effect prevails over the risk; intraocular pressure should be constantly monitored.


Corticosteroids should not be used after uncomplicated removal of a foreign body from the eye or in the presence of an infection or injury limited to the corneal surface epithelium.


Patients with kidney or liver disease.


The use of the drug in ophthalmology/Otorhinolaryngology in patients with impaired liver and kidney function has not been studied, but since dexamethasone has low systemic absorption, there is no need to adjust the dose when using eye/ear drops.


To prevent contamination of the edge of the dropper and the drug, you must be careful not to touch the eyelids, adjacent areas or other surfaces with the edge of the dropper bottle.


Children.


Due to the lack of safety data, the drug should not be used in children.


Use during pregnancy or lactation.


Do not prescribe during pregnancy or lactation.


It is not known whether ciprofloxacin and dexamethasone pass into breast milk when applied topically, so if necessary, breast-feeding should be discontinued.

Dosage and administration.


The drug should be used as instillations in adult patients.


In ophthalmology: 1-2 drops in the conjunctival sac of one or both eyes every 6 hours. After 1-2 days of use, if necessary, the dose can be increased to 1-2 drops every 2 hours. After achieving a therapeutic effect, the dose and frequency of use should be reduced. The course of treatment is usually 7 days.


In Otorhinolaryngology: 4 drops in the affected ear twice a day. The Daily Dose is 8 drops in one ear canal, which is 8 mg of dexamethasone and 24 mg of ciprofloxacin, respectively. The course of treatment is usually 7 days.


The external ear canal should be thoroughly cleaned. To prevent vestibular stimulation, it is recommended to administer a solution at room temperature or body temperature.


The patient should be in a supine position on the opposite side relative to the affected ear. It is advisable to stay in this position for 5-10 minutes. Also, after local cleaning, a moistened swab of gauze or hygroscopic cotton wool can be inserted into the ear canal for 1-2 days, but it must be wetted to saturate the drug 2 times a day.


Children.


Due to the lack of safety data, the drug should not be used in children.


Overdose.


Symptoms. Increased symptoms of side effects (keratitis, erythema, edema of the eyelids, tearing).


Treatment. The drug should be discontinued. Symptomatic therapy: when using the drug in the eye (s) – rinse with plenty of warm water; when using the drug in the ear, the patient should turn his head to one side and wait until the excess drug flows out of the ear.


Adverse reactions.


Since this drug is two-component, side effects characteristic of both active substances may occur.


Adverse reactions caused by ciprofloxacin.


Infections and infestations: barley, rhinitis, exacerbation of infectious diseases of the cornea, reactivation or exacerbation of herpes simplex infection, oral moniliosis, candidiasis, fungal superinfections.


From the hematopoietic system and the lymphatic system. Eosinophilia, leukopenia, anemia,


neutropenia, leukocytosis, thrombocytopenia, thrombocytemia, hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), bone marrow suppression (life-threatening).


From the immune system: hypersensitivity, allergic reactions, allergic/ angioedema, anaphylactic reactions, anaphylactic shock (life-threatening) (see the section "application features"), reactions similar to serum sickness. 


Metabolic and nutritional disorders: decreased appetite, hyperglycemia, hypoglycemia (see the section "application features").


Mental disorders: psychomotor excitability/ anxiety, confusion and disorientation, anxiety, pathological dreams, depression (with possible suicidal thoughts / thoughts or attempts/ to commit suicide) (see Section "application features"), hallucinations, psychotic reactions (with possible suicidal ideas/thoughts or attempts/ to commit suicide) (see Section "application features").


From the nervous system: dysgeusia, headache, tearfulness, dizziness, paresthesia (tingling) and dysesthesia, hypesthesia, tremor, convulsions (including epileptic status, see the section "features of use"), dizziness, sleep disorders, migraines, coordination disorders, gait disorders, olfactory disorders, intracranial hypertension and pseudotubules of the brain, peripheral neuropathy and polyneuropathy (see the section "features of use").


From the side of the visual organs: temporary burning sensation in the eye, deposits on the cornea, discomfort in the eye, hyperemia of the eye, keratopathy, corneal infiltrates, corneal staining, photophobia, decreased visual acuity, edema of the eyelids, blurred vision, eye pain, dry eye, swelling of the eyes, itching of the eye, foreign body sensation in the eye, increased lacrimation, discharge from the eye, formation of scales at the edges of the eyelids, peeling of the eyelids, conjunctival edema, erythema of the eyelids, toxic effect on the eye, point keratitis, keratitis, conjunctivitis, corneal dysfunction, corneal epithelial defect, diplopia, hypesthesia of the eye, asthenopia, eye irritation, eye inflammation, conjunctival hyperemia, color perception disorders.


Hearing disorders: ear pain, ear congestion, otorrhea, itchy ear, ringing in the ears, blockage of the tympanostomy tube, decreased hearing acuity, hearing loss/ hearing impairment.


From the heart: tachycardia, ventricular arrhythmia and pirouette tachycardia (torsades de pointes) (determined mainly in patients with risk factors for prolongation of the QT interval), prolongation of the QT interval (see the sections "application features", "overdose").


Vascular disorders: vasodilation, hypotension, syncopal state, vasculitis.


Respiratory disorders, thoracic and mediastinal disorders: sinus hypersecretion, dyspnoea (including asthmatic conditions).


From the digestive tract: nausea, diarrhea, abdominal pain, in isolated cases antibiotic-associated colitis (very rarely – with a possible fatal outcome) (see the section "features of use"), pain in the stomach and along the intestines, dyspepsia, flatulence (flatulence), pancreatitis. 


From the hepatobiliary system: increased levels of transaminases and bilirubin, impaired liver function, cholestatic jaundice, hepatitis, liver necrosis (which in rare cases progresses to life-threatening liver failure) (see the section "application features").

Tags: Dexamethasone, Ciprofloxacin