Tobropt drops 0.3%, 5 ml

Locally.

With a mild course of an infectious process and an infectious process of moderate severity - 1-2 drops into the conjunctival sac every 4 hours. In a severe course of the infectious process - 2 drops into the conjunctival sac every 60 minutes, with a decrease in the frequency of instillations of the drug as inflammation decreases. The course of treatment depends on the etiology of the infection and can last from several days to several weeks. You can combine the use of eye drops and ointment.

To prevent contamination of the tip of the dropper bottle and solution, it is necessary to avoid contact with the eyelids, the periobital region or other surfaces. Close the bottle tightly after use. Keep the dropper bottle tightly closed. In the case of combined use with other drugs for topical use in ophthalmology, it is necessary to observe an interval of 5 minutes between instillations. In this case, eye ointments should be applied last. No dose adjustment is required when used in elderly patients. It is possible to use tobramycin in the form of eye drops in children aged 1 year and older in the same doses as in adults. The efficacy and safety of the drug in children under 1 year of age has not been established.The efficacy and safety of the drug in patients with renal and hepatic insufficiency has not been established.

With topical application of tobramycin, its low systemic exposure is noted. In the case of combined use with antibiotics for systemic use from the group of amine glycosides, it is necessary to control their concentration in the blood plasma to maintain the required systemic concentrations.

tobramycin

• children's age up to 1 year;

• lactation period (breastfeeding);

• hypersensitivity to the components of the drug.

pharmachologic effect

A broad-spectrum antibiotic from the aminoglycoside group. At low concentrations, it acts bacteriostatically (blocks the 30S ribosome subunit and disrupts protein synthesis), at higher concentrations it is bactericidal (disrupts protein synthesis and the permeability of the cytoplasmic membrane of a microbial cell, causing its death). Microorganisms sensitive to tobramycin: aerobic gram-positive microorganisms (Corynebacterium, Staphylococcus aureus (susceptible to methicillin); coagulase-negative species of staphylococci (susceptible to methicillin, including penicillin-resistant strains); gram-negative bacteria Escinella spp. spp .; Moraxella spp .; Morganella morganii; Pseudomonas aeruginosa). Tobramycin-resistant microorganisms:aerobic gram-positive microorganisms (some Staphylococcus species resistant to methicillin with a frequency of resistance up to 50% of all staphylococcal species in some European countries; Streptococcus pneumoniae and most strains of group D streptococci). Some gentamicin-resistant strains remain highly susceptible to tobramycin. The emergence of resistance to tobramycin is the result of modification and inactivation of antibiotics by enzymes present in the periplasmic space of bacteria. There are three different mechanisms by which aminoglycosides are inactivated: acetylation of amino groups, phosphorylation of hydroxyl groups, and adenylation of hydroxyl groups.Streptococcus pneumoniae and most strains of group D streptococci). Some gentamicin-resistant strains remain highly susceptible to tobramycin. The emergence of resistance to tobramycin is the result of modification and inactivation of antibiotics by enzymes present in the periplasmic space of bacteria. There are three different mechanisms by which aminoglycosides are inactivated: acetylation of amino groups, phosphorylation of hydroxyl groups, and adenylation of hydroxyl groups.Streptococcus pneumoniae and most strains of group D streptococci). Some gentamicin-resistant strains remain highly susceptible to tobramycin. The emergence of resistance to tobramycin is the result of modification and inactivation of antibiotics by enzymes present in the periplasmic space of bacteria. There are three different mechanisms by which aminoglycosides are inactivated: acetylation of amino groups, phosphorylation of hydroxyl groups, and adenylation of hydroxyl groups.There are three different mechanisms by which aminoglycosides are inactivated: acetylation of amino groups, phosphorylation of hydroxyl groups, and adenylation of hydroxyl groups.There are three different mechanisms by which aminoglycosides are inactivated: acetylation of amino groups, phosphorylation of hydroxyl groups, and adenylation of hydroxyl groups.Pharmacokinetics

When applied topically, systemic absorption is low. Tobramycin poorly penetrates the cornea, its concentration in aqueous humor after topical application of a 0.3% solution is not determined. Increasing the frequency of use may increase the concentration of tobramycin in aqueous humor.

Side effect

In clinical studies, conjunctival injection and eye discomfort were noted among the most common adverse reactions, which occurred in approximately 1.4% and 1.2% of patients, respectively. Information about adverse events was obtained in the course of clinical studies and post-registration experience with the use of the drug and was classified according to the following gradation of frequency of occurrence: very often (> 1/10), often (from> 1/100 to <1/10), infrequently (from> 1/1000 to <1/100), rare (> 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (the frequency of occurrence cannot be determined from the available data). In each group, adverse events are presented in descending order of severity. From the immune system: infrequently - hypersensitivity; frequency unknown - anaphylactic reaction.From the nervous system: infrequently - headache. From the side of the organ of vision: often - discomfort in the eye, conjunctival injection, allergic phenomena on the part of the organ of vision, itching of the eyelids; infrequently - keratitis, corneal erosion, blurred vision, blurred vision, erythema of the eyelids, eye discharge, conjunctival edema, eyelid edema, eye pain, dry eye syndrome, itching in the eye, lacrimation; frequency unknown - eye irritation. On the part of the skin and subcutaneous fat: infrequently - urticaria, dermatitis, madarosis, leukoderma, itching, dry skin; frequency unknown - skin rash, Stevens-Johnson syndrome, exudative erythema multiforme.corneal erosion, blurred vision, blurred vision, eyelid erythema, eye discharge, conjunctival edema, eyelid edema, eye pain, dry eye syndrome, itching in the eye, lacrimation; frequency unknown - eye irritation. On the part of the skin and subcutaneous fat: infrequently - urticaria, dermatitis, madarosis, leukoderma, itching, dry skin; frequency unknown - skin rash, Stevens-Johnson syndrome, exudative erythema multiforme.corneal erosion, blurred vision, blurred vision, eyelid erythema, eye discharge, conjunctival edema, eyelid edema, eye pain, dry eye syndrome, itching in the eye, lacrimation; frequency unknown - eye irritation. On the part of the skin and subcutaneous fat: infrequently - urticaria, dermatitis, madarosis, leukoderma, itching, dry skin; frequency unknown - skin rash, Stevens-Johnson syndrome, exudative erythema multiforme.erythema multiforme exudative.erythema multiforme exudative.

Application during pregnancy and lactation

Pregnancy

Data on topical ophthalmic use of tobramycin in pregnant women are lacking or limited. After intravenous administration to pregnant women, tobramycin crosses the placental barrier and enters the fetal bloodstream. The ototoxic effect of tobramycin is not expected if used during pregnancy. In animal studies, it has been shown that tobramycin has reproductive toxicity only at exposures that significantly exceed its maximum exposure in humans, from which it follows that these effects do not have significant clinical significance. No teratogenic effects of tobramycin were found in rats and rabbits. The use of the drug Tobropt during pregnancy is not recommended.

Breastfeeding period

It is not known whether tobramycin passes into human breast milk after topical ophthalmic use. Tobramycin passes into breast milk in humans after systemic use. The detection of tobramycin in breast milk or its ability to cause clinically significant effects in infants whose mothers used the drug are unlikely. However, the risk to the infant cannot be ruled out. A decision must be made to discontinue breastfeeding or to discontinue or suspend the use of the drug, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

Fertility

There have been no studies evaluating the effect of topical ophthalmic use of tobramycin on human fertility.

Application for violations of liver function

The efficacy and safety of the drug in patients with hepatic impairment has not been established.

Application for impaired renal function

The efficacy and safety of the drug in patients with renal insufficiency has not been established.

Application in children

Contraindicated in children under 1 year of age.

Use in elderly patients

No dose adjustment is required when used in elderly patients.

special instructions

Some patients may develop sensitivity to aminoglycosides when applied topically. Allergic reactions can be of varying severity and range from local effects to generalized reactions, including erythema, pruritus, urticaria, rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during the use of the drug, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides may occur. It should be borne in mind the possibility that patients who have developed hypersensitivity to tobramycin when applied topically may also be sensitive to other antibiotics from the group of aminoglycosides for local and / or systemic use. Serious adverse reactions including neurotoxicity, ototoxicity, and nephrotoxicity,may occur in patients receiving systemic tobramycin. Caution should be exercised when using tobramycin in the form of eye drops and antibiotics from the aminoglycoside group for systemic use. As with the use of other antibiotics, prolonged use of the drug Tobropt, eye drops, can lead to excessive growth of refractory microorganisms, incl. mushrooms. In case of superinfection, appropriate therapy should be prescribed. It is not recommended to wear contact lenses while treating an eye infection. Tobropt, eye drops, contains benzalkonium chloride, which can irritate the eye and discolor soft contact lenses. Avoid contact of the drug Tobropt with soft contact lenses. Patients using contact lensesmust be informed that before using the drug, the lenses should be removed and installed back no earlier than 15 minutes after the drug is instilled.

Influence on the ability to drive vehicles and use mechanisms

Temporary blurred vision or other visual impairments after using the drug may affect the ability to drive vehicles or mechanisms. If blurred vision occurs after the instillation of the drug, then before driving vehicles or machinery, the patient must wait until the clarity of vision is restored.

Overdose

Given the characteristics of this drug, toxic effects are not expected in case of overdose when applied topically or in case of involuntary swallowing of the contents of one vial. Symptoms: the clinical manifestations of an overdose when using tobramycin in the form of instillations (including punctate keratitis, erythema of the eyelids, lacrimation, conjunctival edema, itching of the eyelids) may be similar to the undesirable phenomena that were observed in a number of patients during treatment with the drug. Treatment: in case of local overdose, it is necessary to rinse the eyes with warm water; if accidentally swallowed, symptomatic therapy is performed.

Drug interactions

With topical ophthalmic use, no clinically significant interaction has been described. In the case of the simultaneous administration of tobramycin for topical use and antibiotics from the group of aminoglycosides for systemic use, it is possible to increase the side effects of a systemic nature. With the combined use of tobramycin in the form of eye drops and GCS for local use in ophthalmology, clinical symptoms of bacterial, fungal and viral diseases of the organ of vision can be masked, and hypersensitivity reactions can be suppressed.