Dexatobrom eye drops in a dropper bottle (1mg+3mg)/1ml 5ml №1

NameDexatobrom suspension (drop.eye) (1mg + 3mg) 1ml in vial-drop 5ml in pack No. 1 The main active ingredient Dexamethasone + tobramycin Form of release eye drops Dosage (1 mg + 3 mg) 1 ml Special instructions Like any eye drops, the drug can lead to a temporary decrease in visual acuity and affect the ability to drive a vehicle and work with mechanisms. Patients who temporarily lose their vision after the application are not recommended to drive a car or work with complex equipment immediately after instillation of the drug. Pharmacological actionMeans used in ophthalmology. Combinations of corticosteroids and anti-infective agents. ATC CODE: S01CA01 Pharmacodynamics Combined drug with antibacterial and anti-inflammatory action for topical use in ophthalmology, exhibits a pronounced anti-inflammatory effect. Corticosteroids suppress the inflammatory response to a variety of agents and may delay or delay the healing process. Since corticosteroids can suppress the body’s natural defenses against infection, there is a need for the simultaneous use of an antimicrobial agent. Tobramycin is a broad-spectrum antibiotic from the aminoglycoside group. Active against gram-positive and gram-negative microorganisms: Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis, including strains resistant to penicillin), some Streptococci (resistant strains may occur), Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, Proteus vulgaris, Haemophilus in?uenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, as well as some strains of Neisseria spp. Dexamethasone is a synthetic glucocorticosteroid (GCS). It has a pronounced anti-inflammatory, anti-allergic and desensitizing effect, as well as anti-shock and anti-toxic effects, and has immunosuppressive activity. Indications for use Adults and children aged 2 years and older with corticosteroid-sensitive inflammatory processes in ophthalmology, when corticosteroids are indicated and when there is a bacterial infection of the eyes or there is a risk of bacterial infection of the eyes due to the sensitivity of microorganisms resistant to most other antibiotics to bramycin , especially when infected with Pseudomonas aeruginosa. Corticosteroids in ophthalmology are indicated in inflammatory processes of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball, when the risk of using corticosteroids in certain infectious conjunctivitis is tolerated to reduce swelling and inflammation. Corticosteroids are also indicated for the treatment of chronic anterior uveitis, chemical, radiation or thermal corneal burns, foreign body penetration (taking into account contraindications). Corticosteroid eye drops should only be given after an ophthalmic examination. Dosage and administration The drug is intended for ophthalmic use only! Use in adolescents and adults, including the elderly The drug is instilled 1-2 drops into the conjunctival sac of the affected eye (or eyes) every 4-6 hours. During the first 24-48 hours, the dose can be increased to one or two drops every 2 h. The frequency of use of the drug should be gradually reduced with the improvement of the clinical picture. The duration of treatment is not more than 14 days. After instillation, it is recommended to close the eyes tightly and occlude the nasolacrimal canal. This reduces the risk of systemic side effects. Before instillation, wash your hands thoroughly, then shake the bottle well. To prevent contamination of the dropper tip and suspension, avoid touching the eyelids or other surfaces with the tip of the dropper bottle. Close the vial after use. When using the drug Dexatobrom in combination with other ophthalmic drops, a minimum interval of 15 minutes between instillations should be maintained. If the patient forgets to instill one dose, it should be instilled as soon as possible. Do not use a double dose to make up for a forgotten one. Pediatric patients Dexatobrom can be used in children 2 years of age and older at doses similar to adults. There are no data on the safety and efficacy of the drug in children under 2 years of age. Use during pregnancy and lactation There is no sufficient experience on the use of the drug during pregnancy, breastfeeding. The use of Dexatobrom in pregnant women is possible only on prescription, if the expected effect of therapy outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding. Precautions Dexatobrom is for topical use only (not for injection). The drug is not intended for injection into the subconjunctival or anterior chamber of the eye. Primary appointment re-appointment of the drug is possible only after examining the patient with the help of ophthalmic devices. Prolonged and/or uncontrolled use of ophthalmic corticosteroids increases the risk of ocular complications and may cause systemic side effects. If the condition caused by the inflammatory process does not improve in an appropriate time frame, other therapy options should be considered. Local application of corticosteroids may be accompanied by a decrease in urinary cortisol excretion, as well as a decrease in plasma cortisol concentration. The use of corticosteroids is associated with suppression of the hypothalamic-hylophyseal-adrenal system, Cushing’s syndrome, growth retardation in children, especially when using the drug in high doses or with long-term treatment. Long-term use of corticosteroids can cause increased intraocular pressure (IOP) and/or development of glaucoma with damage to the optic nerve, impaired visual acuity and visual field defects, and can also cause the formation of posterior subcapsular cataracts. Patients with a history of or family history of glaucoma are at greater risk of elevated IOP. If these drugs are used for 10 days or more, IOP should be monitored regularly. In patients with glaucoma, intraocular pressure should be monitored daily. The risk of increased IOP is higher in predisposed individuals, such as those with diabetes. Long-term use of corticosteroids may suppress immune responses and promote secondary eye infection, as well as mask the clinical signs of infection. It is necessary to take into account the possibility of developing a persistent fungal infection of the eyes after prolonged use of corticosteroids. When prescribing Dexatobrom simultaneously with antibiotics of the aminoglycoside group for systemic use, it is necessary to control the concentration of tobramycin in the blood serum (the risk of nephrotoxicity and ototoxicity of aminoglycosides increases). In the presence of diseases that lead to thinning of the cornea or sclera, topical steroids can cause perforation. With herpes simplex, the spread of the process can be observed. Therefore, treatment of herpes simplex (except in cases of epithelial herpetic keratitis, in which Dexatobrom is contraindicated), should be carried out with caution, conducting periodic examination with a slit lamp. With the development of allergic reactions, the use of the drug should be discontinued. Cross-sensitivity to other aminoglycosides may develop. Treatment should not be stopped prematurely, as abrupt withdrawal of antibiotics or corticosteroids may exacerbate the infection or inflammatory condition. As with other antibiotics, prolonged use of the drug may lead to overgrowth of non-susceptible microorganisms. This medicine contains benzalkonium chloride (a preservative), which can cause eye irritation and discolour soft contact lenses. It is recommended not to wear contact lenses during treatment. Patients who continue to wear lenses should remove the lenses 15 minutes before instillation and put them back on no earlier than 15 minutes after the procedure. Benzalkonium chloride has been reported to cause superficial punctate keratopathy or toxic ulcerative keratopathy. When using the drug Dexatobrom simultaneously with other eye drops or ointments, the interval between their applications should be at least 15 minutes. The bottle must be closed after each use. Shake the contents of the vial before use. When instilling, do not touch the tip of the pipette to the eye. Pediatric patients Frequent monitoring of intraocular pressure (IOP) is recommended. This is especially important for pediatric patients taking drugs containing dexamethasone, since the risk of an increase in IOP in children under 6 years of age due to steroid use is greater and the rate of pressure increase is higher than in adults. The choice of frequency and duration of such therapy should be carefully considered, and IOP should be monitored from the very beginning of treatment, given that the risk of an increase in IOP when taking steroids in pediatric patients is higher and an increase in IOP develops earlier. Interaction with other drugsDrug interaction of the drug Dexatobrom has not been established. In the case of use with other local ophthalmic preparations, the interval between their use should be at least 15 minutes. (See Precautions) If tobramycin is administered topically concomitantly with systemic aminoglycoside antibiotics, systemic side effects may increase, the overall blood picture should be monitored (increased risk of nephrotoxicity and ototoxicity of aminoglycosides). (See Precautions and Side Effects). Contraindications Herpetic keratitis caused by Herpes simplex (dendritic keratitis); viral diseases of the cornea and conjunctiva; chicken pox; mycobacterial eye infections; fungal eye diseases; hypersensitivity to any component of the drug; injury or ulceration of the cornea; glaucoma. With caution: children under 2 years of age ‚ pregnancy, lactation. IngredientsTobramycin 3 mg/ml, dexamethasone 1 mg/ml; excipients: benzalkonium chloride, tyloxopol, sodium edetate dihydrate, sodium chloride, hydroxyethylcellulose, anhydrous sodium sulfate, 1 M sodium hydroxide solution or 1 M sulfuric acid solution, purified water. Overdose Overdose with Dexatobrom is unlikely. At present, no cases of overdose of Dexatobrom have been reported. Symptoms: increased adverse reactions of the drug (irritation of the mucous membrane of the eye, itching, lacrimation, swelling of the eyelids, conjunctival hyperemia). Treatment: rinse eyes with plenty of warm water, symptomatic therapy. Side effects Adverse reactions can develop with the combined use of corticosteroids and antibiotics, and their appearance may be associated with both the corticosteroid and the antibacterial component. Adverse reactions are classified according to the frequency of their manifestation: very rarely (? 0.01%), rarely (? 0.01% < 0.1%), infrequently (? 0.1% < 1%). The following adverse reactions have been observed with topical application of dexamethasone in ophthalmology: Infections and invasions: rarely - eye infection (exacerbation or secondary). Endocrine system disorders: very rarely - suppression of adrenal function. Ophthalmic disorders: rarely - decreased visual acuity, glaucoma, visual field defects, development of subcapsular cataracts. General disorders and disorders at the injection site: rarely - a violation of the healing process. Research: infrequently - increased intraocular pressure. Damage, poisoning and procedural complications: rarely - damage to the optic nerve; very rarely - damage to the cornea. The following adverse reactions have been observed with topical application of tobramycin in ophthalmology: Infections and infestations: very rarely - eye infection (secondary). Immune system disorders: infrequently - hypersensitivity (local). Ophthalmic disorders: infrequently - eye irritation (burning and acute pain after instillation), ocular hyperemia, blurred vision; rarely - swelling of the eyelids, itching of the eyelids, pain in the eye (periorbital). Skin and subcutaneous tissue disorders: infrequently - erythema (periorbital). With systemic use, tobramycin can have a toxic effect on the kidneys, vestibular apparatus and auditory nerve, especially in patients taking high doses or receiving the drug for a long time. Doses recommended for use in ophthalmology are significantly less than those used in systemic therapy, so it is unlikely that these systemic effects can develop with Dexatobrom. Storage conditionsStore at a temperature of 15°-25°C in the original packaging. Keep out of the reach of children. Buy Dexatobrom eye drops in a dropper bottle (1mg + 3mg) / 1ml 5ml No. 1 in a dropper bottle (1mg+3mg)/1ml 5ml №1