Tobradex eye drops (3mg+1mg)/1ml 5ml №1

Name:
Tobradex. Release form Drops. MNNDexamethasone + tobramycin. FTH Glucocorticosteroid for topical use + aminoglycoside antibiotic.
Description:
White or almost white suspension. Composition Each ml of the drug contains: active substances: tobramycin – 3.0 mg; dexamethasone – 1.0 mg; excipients: benzalkonium chloride; disodium edetate; sodium chloride; sodium sulfate anhydrous; tyloxapol; hydroxyethylcellulose; sulfuric acid and/or sodium hydroxide (for pH adjustment); purified water. Pharmacotherapeutic groupMeans used in ophthalmology; a combination of corticosteroids and anti-infective agents. ATX code: S01CA01. Pharmacological properties Pharmacodynamics 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, it becomes necessary to use an antimicrobial agent at the same time. TOBRADEX is a combination of the powerful corticosteroid dexamethasone and the antibiotic tobramycin, which is active against a wide range of susceptible microorganisms. Although tobramycin and gentamicin are aminoglycoside antibiotics with a similar spectrum of activity, tobramycin is significantly more active against Pseudomonas aeruginosa than gentamicin. In vitro studies have shown that tobramycin is active against susceptible strains of the following microorganisms: – Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Proteus myxofaciens, Morganella morgani and most strains of Proteus vulgaris, Haemophylus influenzae and H. aeqyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species; – Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains; – some Streptococci (resistant strains may occur). In studies of the sensitivity of pathogens, it was found that in some cases, microorganisms resistant to gentamicin are sensitive to tobramycin. No significant population of bacteria resistant to tobramycin has yet been identified, but with long-term use of this antibiotic, the development of resistance is not excluded. Pediatric use Extensive clinical experience shows that the use of TOBRADEX eye drops in children is safe and effective, but only limited studies have been conducted. In a clinical study using TOBRADEX suspension in the treatment of bacterial conjunctivitis, 29 patients aged 1 to 17 years received 1 or 2 drops of TOBRADEX every 4-6 hours for 5-7 days. There were no differences in the safety profile between adult and pediatric patients in this study. Pharmacokinetics With topical application of the drug TOBRADEX eye drops suspension, systemic absorption of dexamethasone and tobramycin is small. 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 organisms sensitive to tobramycin, resistant to most others antibiotics, especially for infection 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 burns of the cornea, with penetration of foreign bodies (taking into account contraindications). Corticosteroid eye drops should only be given after an ophthalmic examination. Contraindications Hypersensitivity to the active substance or any of the excipients; herpetic keratitis (tree-like keratitis), vaccine disease, chickenpox and other viral diseases of the cornea and conjunctiva; mycobacterial infections of the eye, fungal diseases of the eye structures, or untreated parasitic eye infections. TOBRADEX should not be used after uncomplicated removal of a foreign body from the cornea, as well as in infections or damage to the surface layer of the corneal epithelium. Method of application and dosage Dosage 1-2 drops in the conjunctival sac every 4 hours. In the first 24-48 hours, the dose may be increased to 1-2 drops every 2 hours. In severe cases, instill 1-2 drops every hour until the infection is under control, and gradually reduce the frequency of instillations to 1-2 drops every 2 hours for 3 days, then 1-2 drops every 4 hours for 5-8 days and finally, if necessary, 1-2 drops every day for the next 5-8 days. Treatment should not be interrupted suddenly. If several eye medicines are used simultaneously for treatment, an interval of 5 minutes between their use should be observed. If an eye ointment is used for treatment, it should be applied last. Pediatric patients TOBRADEX eye drops suspension can be used in children aged 2 years 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. Method of application: For local use in ophthalmology. After opening the vial, before using the drug, remove the tear-off ring, which provides control of the first opening. Shake well before use. To prevent contamination of the suspension and dropper tip, care should be taken not to touch the eyelids, surrounding areas, or any other surface with the dropper tip. Keep bottle tightly closed after use. Compliance with the following recommendations will help when instilling the drug: WASH HANDS THOROUGHLY BEFORE INSERTING. TIP YOUR HEAD BACK. PULL LOWER EYELID DOWN AND LOOK UP. DROP 1-2 DROPS INTO THE SPACE BETWEEN THE EYELID AND THE EYEBALL. DO NOT TOUCH THE TIP OF THE BOTTLE TO YOUR EYELIDS, EYELASHES AND DO NOT TOUCH IT WITH YOUR HANDS. CLOSE YOUR EYE AND BLET IT WITH A DRY COTTON SWAB. WITHOUT OPENING YOUR EYES, LIGHTLY PRESS ITS INNER CORNER FOR 2 MINUTES. THIS WILL IMPROVE THE EFFICIENCY OF THE DROPS AND REDUCE THE RISK OF DEVELOPING SYSTEMIC ADVERSE REACTIONS. Special Warnings and Precautions The initial administration of the drug and re-appointment is possible only after examination of the patient using ophthalmic instruments, such as a slit lamp, and, if necessary, staining with fluorescein. 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 with therapeutic measures, then other therapy options should be used to reduce the risks. Some patients may develop hypersensitivity to topical aminoglycosides. The severity of hypersensitivity reactions can vary from local to general reactions such as erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid or bullous reactions. If signs of hypersensitivity appear during the use of this medicinal product, treatment should be discontinued. 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-pituitary-adrenal system, Cushing’s syndrome, growth retardation in children, especially when using the drug in high doses or with long-term treatment. Cushing’s syndrome and suppression of adrenal function associated with systemic absorption with ophthalmic use of dexamethasone may occur after intensive or long-term continuous therapy in patients with a predisposition, including children and patients treated with ritonavir. In these cases, treatment should not be stopped suddenly, but gradually, reducing the dose. Long-term use of corticosteroids can cause an increase in intraocular pressure and / or the development of glaucoma with damage to the optic nerve, 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 corticosteroid-induced increases in intraocular pressure. If these drugs are used for 10 days or more, intraocular pressure should be regularly monitored, although this may be difficult in the case of children and patients who are uncooperative. In patients with glaucoma, blood pressure should be monitored weekly. The use of corticosteroids can reduce resistance to bacterial, fungal, viral and parasitic infections and mask their clinical manifestations. TOBRADEX should be used in cases of acute purulent eye infection only when treatment with corticosteroids in combination with an anti-inflammatory agent is necessary. Long-term use may suppress immune responses and thus increase the risk of secondary eye infection. The possibility of a persistent fungal infection of the cornea after long-term use of corticosteroids should be taken into account. Patients using corticosteroids systemically or locally for other diseases may experience eye manifestations of herpes simplex. Use of corticosteroids for the treatment of herpes simplex, except in cases of epithelial keratitis caused by the herpes simplex virus, in which they are contraindicated, should be very cautious; periodic examination with a slit lamp is necessary. Cases of thinning and perforation of the cornea and sclera have been reported with the use of topical corticosteroids. 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 organisms. Cross-sensitivity to other aminoglycosides may develop. It is not recommended to wear contact lenses (hard or soft) during the treatment of an eye infection or inflammation. TOBRADEX should not be instilled into eyes containing contact lenses; lenses can be worn 15 minutes after using TOBRADEX. In addition, the preservative benzalkonium chloride, which is part of the drug, can cause eye irritation and discolour soft contact lenses. To reduce the systemic absorption of the drug after instillation, the following is recommended: close the eyelids for 2 minutes; press the inner corner of the eye for 2 minutes with your finger. 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 increased intraocular pressure 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 with steroids in pediatric patients is higher and an increase in IOP develops earlier. Interaction with other medicinal products Interaction has been observed with the systemic use of active ingredients. However, systemic absorption from the use of torbamycin and dexamethasone in ophthalmology is low and the likelihood of interaction is minimal. Plasma concentrations of dexamethasone may increase in patients taking ritonavir. Pregnancy, lactation Reproductive function Studies on the effect of tobramycin on reproductive function in humans or animals have not been conducted. There are limited clinical data evaluating the effects of dexamethasone on male and female reproductive function. Dexamethasone did not cause reproductive side effects in a study in human chorionic gonadotropin-sensitized rats. Pregnancy: Data on the topical ophthalmic use of tobramycin and dexamethasone in pregnant women are practically absent. Tobramycin crosses the placental barrier after intravenous administration to pregnant women. In utero ototoxicity caused by tobramycin is not expected. Prolonged or repeated use of corticosteroids during pregnancy has been associated with an increased risk of intrauterine growth retardation. Infants born to mothers who received significant doses of corticosteroids during pregnancy should be carefully examined for signs of hypoadrenalism. Animal studies have shown reproductive toxicity of tobramycin and dexamethasone when administered systemically and dexamethasone when administered topically. The use of TOBRADEX during pregnancy is not recommended. Breast-feeding Tobramycin is excreted into breast milk after systemic administration. There are no data on the excretion of dexamethasone in breast milk. It is not known whether tobramycin and dexamethasone are excreted in breast milk after topical ophthalmic use. It is unlikely that significant amounts of tobramycin and dexamethasone will be found in breast milk and cause clinical effects in the newborn after topical application of this drug. Since a risk to the nursing infant cannot be ruled out, a decision should be made to discontinue breastfeeding or discontinue/abstain from treatment, taking into account the benefit of breastfeeding for the baby and the benefit of treatment for the woman. Influence on the ability to drive a vehicle and work with mechanisms 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. If the patient’s visual clarity is temporarily reduced after using the drug, it is not recommended to drive a vehicle and engage in activities that require increased attention and reaction until it is restored. Adverse reactions 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. The following adverse reactions are classified by frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/10000 to <1/1000) and very rarely (<1/10000). In each group, adverse reactions are arranged in order of decreasing severity of manifestations. These adverse reactions were identified during clinical trials, as well as during post-marketing surveillance of the use of the drug TOBRADEX. System organ classification Adverse reactions Ophthalmic disorders Uncommon: increased intraocular pressure, eye pain, ocular itching, ocular discomfort, eye irritation. Rare: keratitis, ocular allergy, blurred vision, dry eyes, redness of the eyes. century, mydriasis, increased lacrimation. Digestive system disorders Rare: dysgeusia Frequency unknown: nausea, abdominal discomfort Immune system disorders Frequency unknown: anaphylactic reaction, hypersensitivity Nervous system disorders Frequency unknown: dizziness, headache Skin and subcutaneous tissue disorders Frequency unknown: polymorphic erythema, rash, swelling of the face, pruritus When used systemically, 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 lower than those used in systemic therapy, so it is unlikely that these systemic effects can develop with the use of TOBRADEX. Overdose When applied topically, overdose is unlikely. If an excessive amount of TOBRADEX gets into the eyes, rinse the eye(s) with warm water. In case of accidental ingestion, there is no danger of poisoning. Treatment for accidental ingestion should be symptomatic and supportive. Release form 5 ml in a DROPTAINER® dropper bottle made of low-density polyethylene. 1 bottle together with instructions for medical use in a cardboard box. Storage conditions At a temperature not exceeding 25 ° C, out of the reach of children. Do not freeze! Store upright. Shelf life 2 years. Do not use after the expiry date stated on the packaging. Use within 4 weeks after opening the vial. Conditions for dispensing from pharmacies By prescription. Buy Tobradex eye drops (3mg + 1mg) / 1ml 5ml No. 1 Price for Tobradex eye drops (3mg + 1mg) / 1ml 5ml No. 1 #1