Tobradex ointment or drops, which is better? What is the best analogue of Tobradex? Composition and effects

For the treatment of inflammatory and bacterial diseases eye ophthalmologists often recommend that patients use topically not pure antibiotics, but combined with hormonal or other anti-inflammatory substances. A popular drug of this type is Alcon Tobradex, available in drops and ointment form. How effective and safe is it?

Instructions for use of Tobradex

The product of the Belgian company Alcon-Couvreur is highly valued by ophthalmologists for fast action and pronounced effect: on initial stages The symptoms of the disease are relieved within 24 hours, and complete suppression of the activity of pathogenic microorganisms is carried out in 2-3 days. Infectious lesions With severe course may require 7-10 days for treatment, but only under the supervision of a specialist.

Composition and release form

Mostly for children and adults, doctors prescribe Tobradex eye drops - this is the most common form of this drug, which is a white or transparent suspension. It is sold in 5 ml dropper bottles. The composition looks like this:

Less popular among ophthalmologists is Tobradex ointment, which is available in small aluminum tubes with a volume of 3.5 g. In terms of the concentration of active substances, drops and ointment are identical to each other, and the number of auxiliary agents in the latter dosage form is less. The composition of the ointment looks like this:

Pharmacodynamics and pharmacokinetics

The key active ingredient of Tobradex is tobramycin, an antibiotic belonging to the group of aminoglycosides. When used topically for the treatment of ophthalmic diseases, it shows low systemic absorption and is more effective than neomycin. In low concentrations, tobramycin has a bacteriostatic effect (disturbs protein synthesis, inhibiting bacterial activity), and in high concentrations it has a bactericidal effect (impacts the function of cytoplasmic membranes). Tobramycin has a broad spectrum of action and is active against the following bacteria:

• escherichia coli.;
• proteus spp.;
• haemophilus influenzae;
• haemophilus aegypticus;
• klebsiella pneumonia;
• providencia spp.;
• enterobacter aerogene;
• moraxella lacunata;
• morganella morganii;
• acinetobacter calcoaceticus;
• neisseria spp. (including gonorrhoeae species).

Separately, doctors mention the effect of this antibiotic on staphylococci (especially those with resistance to penicillin and Staphylococcus aure s and epidermidis), and streptococci (beta-hemolytic strains of group A, streptococcus pheumonia), excluding representatives of group D. It also shows high effectiveness against Pseudomonas aeruginosa bacilli (pseudomonas aeruginosa), enterococci, especially in combination with penicillin series or cephalosporin. Dexamethasone is a glucocorticoid steroid that:

• suppresses inflammation at the stage of generation of pathological contents;
• has antiallergic and desensitizing effects;
• reduces the risk of developing an infectious process.

Indications for use

A combination of tobramycin and dexamethasone is used topically in ophthalmic practice to prevent infections after injury or surgical intervention on the eye area. Some doctors prescribe Tobradex for immunosuppressive treatment after corneal transplantation. The main indication for use is the treatment of diseases of the eyes and appendages caused by microorganisms sensitive to tobramycin:

• blepharitis;
• conjunctivitis;
• keratitis (if the epithelium is not damaged);
• iridocyclitis;
• viral keratitis, caused by herpes zoster.

Directions for use and dosage

Tobradex is introduced into the conjunctival sac, for which the lower eyelid is pulled back with clean hands. Contact lenses are removed before the procedure and put back on no earlier than after 15 minutes. The dosage of Tobradex for all ophthalmological diseases is the same, only the frequency of use changes. The duration of the therapeutic course is determined by the attending physician - according to official instructions, it does not exceed a week. A couple of nuances:

• Tobradex is discontinued by reducing the frequency of procedures;
• dosage forms can be combined - drops can be used during the day, and ointment can be used at night.

Eye drops

The suspension is injected into the conjunctival sac, after which pressure should be applied to the inner corner of the eye. The frequency of use is determined by the form of the disease and the severity of its manifestations. On the first day, doctors consider it advisable to instill Tobradex every 2 hours in the amount of 2 drops. If necessary, this schedule is extended for 48 hours. The basic regimen is 2 drops with an interval of 4-6 hours between procedures.

Ointment

General principle The application for all dosage forms of Tobradex is the same - the ointment is also injected into the conjunctival sac, but it should be measured literally along a ruler: a single dose is 1.25-1.5 cm. Before the procedure, you must wash your hands. After placing the ointment behind the lower eyelid, the eyes need to be opened and closed 2-3 times to distribute it. The interval between procedures is 6 hours, therefore maximum number procedures per day – 4.

special instructions

The tip of the dropper bottle does not touch the eye during instillation, and the suspension itself is shaken before use. After each use, the bottle and tube should be tightly closed. With long-term treatment with Tobradex after the procedure, a decrease in visual acuity may be observed, so it is advisable to refrain from driving.

During pregnancy

There have been no studies on the safety of using this drug in pregnant or breastfeeding women. Tobramycin has low systemic absorption when applied topically, but it accumulates in the fetal kidneys and can cause congenital bilateral deafness. The official instructions set out a relative contraindication and allow the use of Tobradex during pregnancy and lactation if the attending physician considers it necessary after assessing the potential benefits and harms of the drug.

For children

Drops and ointment are not used in children under one year old, and at the age of 2-12 years - only under the supervision of a doctor. Some sources report that Tobradex for children can be prescribed with constant monitoring of the child’s condition in the hospital, in the absence of alternatives. Clinical studies There have been no studies regarding the safety of this drug for children, so the issue should be addressed with a doctor.

Drug interactions

If complex therapy of ophthalmological diseases is planned, Tobradex is administered with other local medications at intervals of 15 minutes. and more. The exact duration and treatment regimen should be indicated by the doctor. Separately, you should take into account:

• the need for constant monitoring of blood tests during the use of Tobradex with systemic aminoglycosides;
• increased nephrotoxic, neurotoxic and ototoxic side effects when taking medications that contain them.

Side effects

With the external use of Tobradex, only local allergic reactions, among which the most obvious are itching, burning, a feeling of presence in the eye foreign body. Less common are redness or swelling of the conjunctiva and dry eyes. The official instructions for the drug Tobradex do not exclude:

• decreased visual acuity;
• pupil dilation;
• photophobia;
• promotion intraocular pressure;
• tearfulness;
• damage optic nerve;
• headache;
• dizziness;
• nausea;
• vomit;
• mucous discharge from the nose;
• spasms of the larynx;
• skin itching and rashes.

Overdose

• swelling of the eyelids;
• prolonged itching in the area where the drug is applied;
• rhinorrhea and lacrimation;
• hyperemia of the eye mucosa;
• increased arterial inflow of the conjunctiva;
• development of a secondary infection (mainly fungal, on the cornea).

If symptoms of overdose appear, Tobradex should be discontinued - some of the unpleasant moments will disappear on their own after a few hours. If necessary, carry out symptomatic treatment: rinse eyes with warm, clean water, select medications that relieve any adverse reactions that may occur. There is no local pharmaceutical antagonist for Tobradex.

Contraindications

Even if the systemic penetration of an antibiotic with a glucocorticosteroid is low, Tobradex is prohibited from being used against the background of intolerance to any of the components medicine, hypersensitivity or idiosyncrasy to them. If eye diseases are caused by viruses, especially herpes simplex, the causative agent of smallpox, Tobradex is also not used. Additionally, the list of contraindications according to the official instructions includes:

• Koch's bacillus infection - mycobacterial eye infection;
• carrying out conservative treatment against the background of removal of a foreign body of the cornea;
• purulent eye pathologies;
• tuberculous eye lesions;
• damage to the shell of the eyeballs by fungal microflora;
• thinning of the cornea (congenital/acquired) – treatment can only be carried out under the supervision of a doctor;
• glaucoma.

Terms of sale and storage

Tobradex is dispensed from pharmacies only after presenting a prescription from a doctor. Storage is carried out in a dark place with an air temperature of 8 to 27 degrees. The shelf life of sealed packages is 2 years, after opening both drops and ointment should be used within 4 weeks and then thrown away.

Analogs

The closest drug in the form of drops from the same manufacturer in terms of the principle of action (but not in composition) is Tobrex: it is based only on an antibiotic, therefore it has less anti-inflammatory activity. If you are looking for complete analogue Tobradex, which contains tobramycin and dexamethasone, consider:

• Tobrazon - identical dosages of active substances, but a lower price (up to 200 rubles), since the production is Indian.
• DexaTobropt is also a pure analogue, but from Romania, with increased sentence storage (3 years).

Tobradex price

Taking into account the short shelf life and small volume, doctors and patients classify this medicine as expensive: for 5 ml of drops you will have to pay from 400 to 600 rubles, depending on the pricing policy of a particular pharmacy. The ointment is cheaper - in the range of 300-350 rubles, but it is rarely found on sale. An approximate picture of Tobradex prices for Moscow pharmacies is as follows.

Active components eye drops are (dosage per 1 ml of drug):

• – 3 mg;
• – 1 mg.

The following are used as excipients that help the active substances achieve their full pharmaceutical effect:

• benzalkonium chloride;
• disodium edetate;
• sodium chloride;
• anhydrous sodium sulfate;
• tyloxapol ;
• hydroxyethylcellulose;
• sulfuric acid and/or sodium hydroxide to adjust pH;
• purified water up to 5 ml.

In its turn Tobradex eye ointment consists of (amount of active components per 1 g of drug):

• tobramycin – 3 mg;
• – 1 mg;
• anhydrous chlorobutanol ;
• mineral oil;
• white Vaseline.

Release form

The pharmaceutical drug is supplied to pharmacy kiosks in two main forms:

• Tobradex eye drops in dropper bottles designed for 5 ml of medicine with a special dispenser " Drop Tainer» (« Drop Tainer"). The liquid appears as a suspension of white or almost white. One bottle fits in a cardboard package.
• Homogeneous eye ointment Tobradex white or almost white in aluminum tubes, 3.5 g each. 1 tube is included in a cardboard box.

Pharmacological action

Tobradex eye drops– a combined pharmaceutical preparation that has antibacterial And anti-inflammatory effects , which are provided thanks to the main components of the drug. This complex of active substances can significantly reduce the risk infections and eliminate the main etiological factor pathology visual apparatus – harmful microorganisms brought to the surface of the eye.

Tobramycin is a substance that has the properties , which belongs to the group aminoglycosides and is produced by a colony of streptococci ( Streptococcus tenebrarius). A wide spectrum of bactericidal action covers such harmful microorganisms as:

• Staphylococcus , in particular Staphylococcus aureus and Staphylococcus epidermidis ( Staphylococcus aures And Staphylococcus epidermidis ), including strains that have developed resistance to (beta-lactamase , produced by such microflora does not affect the strength therapeutic effects antibiotic);
• Hemolytic species streptococci type A and microorganisms of this family that do not possess antigens of aggression towards blood cells, for example, the causative agent of typical lobar pneumonia (Streptococcus pneumonia);
• Pseudomonas aeruginosa (Pseudomonas aeruginosa );
• Escherichia coli ();
• Klebsiella pneumoniae(klebsiella pneumonia);
• Enterobacter aerogenes (anaerobic enterobacteria);
• Proteus mirabilis and Proteus vulgaris ( Proteus mirabilis And Proteus vulgaris );
• Morganella morganii (Morganella morganii);
• Haemophilus influenzae and Haemophilus aegypticus ( hemophilus influenzae and Koch-Wicks bacterium);
• Moraxella lacunata (Morax-Axenfeld stick);
• Acinetobacter calcoaceticus;
• Neisseria pneumonia ( neisseria pneumonia ).

Dexamethasone , another main component of Tobradex ointment, is a steroid of glucocorticoid origin, which has antiallergic , anti-inflammatory And desensitizing effect . Thanks to its chemical structure It also has an anti-exudative effect, suppressing inflammation in the phase of generation of pathological contents.

Pharmacodynamics and pharmacokinetics

Systemic absorption is low when the drug is applied topically.

Indications for use

• prevention of infections in postoperative care(for example, after deleting or foreign body);
• bacterial infection ocular apparatus;
• blepharitis – inflammation of the upper or lower eyelid;
• – inflammation of the conjunctiva of the eye;
• without damage to the epithelium – pathology of the cornea of ​​the eyeball;
• viral keratitis caused by a pathogen such as Herpes zoster;
• treatment and preventive therapy with traumatic eye injury.

Contraindications

• individual hereditary or acquired intolerance , hypersensitivity or idiosyncrasy to the constituent components of a pharmaceutical product;
• viral diseases of the visual apparatus (in particular keratitis , caused by ( Herpes simplex), or smallpox );
• mycobacterial eye infection (the causative agent of this disease is the well-known Koch's wand or Mycobacterium tuberculosa);
• conservative treatment after surgical removal of a corneal foreign body;
• fungal diseases membranes of the eyeball;
• purulent pathology of the eye ;
• age category of patients up to 1 year.

There are also a number pathological conditions when a pharmaceutical drug should be used with caution, only under the supervision of a qualified medical personnel, for example, during inpatient treatment in the ophthalmology department. These diseases include:

• hereditary or acquired thinning of the cornea .

Side effects

Typically, drug therapy occurs without obvious complications, since the main active components are well tolerated by the body, however, in some cases of conservative treatment with Tobradex, the following side effects may be observed:

• allergic reactions – itching , hyperemia or swelling of the eyelids and conjunctiva, swelling of the face, rash, ;
• promotion ;
• sensation of a foreign body in the eye;
• decreased visual acuity;
• photophobia ;
• long mydriasis (prolonged pupil dilation);
• subcapsular localized in the posterior part;
• slowing down reparative and regenerative mechanisms in open wounds;
• And ;
• bitter taste in the mouth;
• abundant rhinorrhea ;
• laryngospasm ;
• Patients with hereditary or acquired thinning of the sclera may develop it perforation (the risk increases significantly with a long course of treatment);
• secondary infection (the content of the glucocorticosteroid Dexamethasone in the drug in combination with the antibiotic component tobramycin leads to weakened immunity against fungal microflora , that is, invasions from this type of microorganisms can develop - typical symptom is the appearance of long-term non-healing ulcers on the cornea).

Tobradex, instructions for use (Method and dosage)

Instructions for eye drops Tobradex indicates that it is extremely easy to use a pharmaceutical drug for the conservative treatment of diseases of the visual apparatus. Apply 1-2 drops every 4-6 hours, placing the medicine directly into conjunctival sac . In the first 24-48 hours, the dosage can be increased to 1-2 drops with a time interval of only 2 hours for appropriate indications.

The drug is in the form of an ointment somewhat more difficult to apply. First of all, because of the unpleasant sensations foreign object on eyeball this pharmaceutical form is not so convenient to use. Like drops, eye ointment is applied to conjunctival sac . Before use, you should wash your hands thoroughly so that the antibiotic is not simply used to cleanse them of harmful microflora.

The head is tilted back, after which the lower eyelid is pulled back and about 1.5 cm of ointment is applied. Next, you need to open and close your eyes several times, so that the pharmaceutical drug is evenly distributed in the conjunctival sac. You need to make sure that the tip of the tube does not touch the skin, eyelashes or mucous membrane of the eye, as is the case with your hands, medicinal abilities active components will decrease if this rule is not followed. After using the ointment, close the tube tightly.

Duration conservative therapy determined by the attending physician; as a rule, a regimen of 3-4 applications per day is used. Between applications of the ointment, a time interval of at least 6 hours should be observed. If a dose is missed, it should be filled as soon as possible, but not less than 1 hour before the next one. You should not independently increase the amount of Tobradex ointment used, as this may cause an overdose or other undesirable consequences of treatment.

Overdose

In case of an overdose of Tobradex, the following symptoms may be observed:

• increased side effects;
• irritation and hyperemia mucous membrane of the eye;
• intense itching;
• copious lacrimation And rhinorrhea ;
• swelling of the eyelids;
• increased arterial inflow of the conjunctiva.

A specific pharmaceutical antagonist for the drug Tobradex on this moment does not exist, therefore in case of drug overdose it is used symptomatic treatment . So for cupping purposes this state eyes are washed generously warm water and prescribe drug therapy for the undesirable consequences of conservative treatment.

Interaction

When complex therapy together with other topical ophthalmic drugs, an interval between the use of drugs should be at least 5-15 minutes, depending on the individual appointments attending physician.

Before using Tobradex, you should remove contact lenses , so that they do not act as an additional barrier preventing the penetration of active substances. You can put on lenses again no earlier than 15 minutes after introducing the pharmaceutical drug into the conjunctival sac (these time intervals must be observed regardless of the form of the drug).

Tobradex drops can be prescribed against the background systemic treatment with aminoglycosides however, in this case it is strongly recommended to constantly monitor the big picture blood, since one of the components of the pharmaceutical drug is Tobramycin, which by its nature belongs to the group of aminoglycoside antibiotics.

During conservative therapy with Tobradex, you should avoid the use of drugs that have side effects such as ototoxic , nephrotoxic And neurotoxic , since potentiation is possible, resulting in increased adverse consequences treatment.

Terms of sale

The drug is not sold freely at pharmacy kiosks; it can only be purchased upon presentation of the appropriate prescription form certified by the attending physician.

Storage conditions

The drug should be stored out of the reach of young children, always in vertical position and at temperature conditions from 8 to 27 degrees Celsius.

Best before date

2 years for sealed carton packaging. After opening the bottle or tube – 4 weeks.

special instructions

Before each use of the drug, the container with the suspension should be shaken so that the components do not stagnate at the bottom under the influence of gravity. And after that, it is necessary to close the bottle tightly so that Tobradex does not erode.

You should not touch the tip of the dispenser to your eye, first of all, because this may cause discomfort. It is also not recommended to do this due to the reflex closure of the eyelids; this reduces the effectiveness of the active components of the drug, creating additional barriers to passage and increasing the duration of the therapeutic manipulation.

After using the drug Tobradex it is possible temporary blurred vision , therefore, you should not drive a car or other potentially dangerous mechanisms until your ability to see is fully restored. Exact period Renewal of visual abilities should be discussed with your doctor or qualified pharmacist.

Analogs

Level 4 ATX code matches:

Tobradex – combination drug , which to a certain extent is unique, since it simultaneously contains such components as strong antibiotic a group of aminoglycosides and a steroid of glucocorticoid origin, which is not found in every drug. Auxiliary components allow the use of Tobradex with a minimum number of side effects from the treatment of diseases of the visual apparatus and even in pediatric practice already after 1 year. That’s why analogues of drops are so few. Similar pharmacological action has the following range of drugs: , DexaTobropt , Betagenot , , Dexon .

Among these drugs, special mention should be made Tobrex . It is most often used as a competing drug in the conservative course of treatment of ophthalmic problems, because it contains the same aminoglycoside antibiotic ( tobramycin ) and is supplied to pharmacies in the form of eye drops. So what is better to use Tobrex or Tobradex and is it possible to independently replace their therapeutic effects with each other?

The answer to this question lies in the components pharmaceuticals. Tobradex, in addition tobramycin , contains such a biologically active substance as dexamethasone - a steroid glucocorticoid that has the widest spectrum therapeutic effects. Thanks to this highlight, Tobramycin acts as an antiallergic, desensitizing and anti-inflammatory agent. These properties allow us to confidently give priority in the treatment of eye diseases of infectious etiology to Tobradex.

Synonyms

Dexamethasone + Tobramycin.

For children

The drug is used in pediatric hospitals once the child reaches 1 year of age.

During pregnancy and lactation

The drug is not recommended for use during and during . When treating women childbearing age Before conservative treatment, pregnancy should initially be excluded.

• Instructions for use TOBRADEX
• Composition of the drug TOBRADEX
• Indications for the drug TOBRADEX
• Storage conditions for the drug TOBRADEX
• Shelf life of TOBRADEX

ATX Code: Preparations for the treatment of diseases of the sensory organs (S) > Preparations for the treatment of eye diseases (S01) > Anti-inflammatory drugs in combination with antimicrobials(S01C) > Corticosteroids in combination with antimicrobials (S01CA) > Dexamethasone in combination with antimicrobials (S01CA01)

Release form, composition and packaging

Excipients: benzalkonium chloride 0.01% (preservative), tyloxapol, disodium edetate, sodium chloride, hydroxyethylcellulose, sodium sulfate, sodium hydroxide or sulfuric acid (to maintain pH level), purified water.

5 ml - plastic dropper bottle Drop Tainer (1) with dispenser.

Description of the drug TOBRADEX eye drops created in 2013 on the basis of instructions posted on the official website of the Ministry of Health of the Republic of Kazakhstan. Update date: 12/19/2013

pharmachologic effect

Corticosteroids exert anti-inflammatory effects by inhibiting the adhesion of vascular endothelial cell molecules, cyclooxygenase I and II, and the release of cytokines. This action culminates in a decrease in the production of pro-inflammatory mediators and inhibition of adhesion of circulating leukocytes to the vascular endothelium, thus preventing adhesion to inflamed ocular tissues. Dexamethasone has significant anti-inflammatory activity with reduced mineralocorticoid activity compared to some other steroids and is the most potent anti-inflammatory agent.

Tobramycin is a broad-spectrum antibiotic from the group of aminoglycosides that are active against both gram-positive and gram-negative microorganisms. It has a primary effect on the bacterial cell by inhibiting the polypeptide compound and ribosome synthesis.

The drug Tobramycin ® eye drops is effective against the following pathogens:

Gram-positive microorganisms: Staphylococcus aureus (methicillin-sensitive or resistant), Staphylococcus epidermidis (methicillin-sensitive or resistant), other coagulase-negative Staphylococcus species, Streptococcus pneumonia (penicillin-sensitive or resistant), other Streptococcus species; gram-negative microorganisms:

• Acinetobacter species, Citrobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella species, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.

Pharmacokinetics

Systemic effect of dexamethasone after local application drug Tobradex eye drops low. The maximum plasma concentration lies in the range of 220-888 pg/ml (mean value 555±217 pg/ml) after topical application of the drug Tobradex ® eye drops in each eye 4 times a day for 2 days.

Dexamethasone is eliminated through a metabolic reaction. Approximately 60% of the dose is found in the urine as 6-β-hydroxydexamethasone. Unchanged dexamethasone was not detected in the urine. The plasma half-life is 3-4 hours. Dexamethasone is approximately 77-84% bound to serum albumin. The clearance range ranges from 0.111 to 0.225 l/hour/kg and the volume of distribution ranges from 0.576 to 1.15 l/kg. The oral bioavailability of dexamethasone is approximately 70%.

Systemic exposure to tobramycin is negligible with topical application of Tobradex ® eye drops. Tobramycin is excreted rapidly and extensively into the urine by glomerular filtration, mainly as unchanged drug. T1/2 from plasma is approximately 2 hours with a clearance of 0.04 l/hour/kg and a volume of distribution of 0.26 l/kg. Plasma protein binding to tobramycin is less than 10%. The oral bioavailability of tobramycin is low (< 1%).

Indications for use

Treatable with steroids inflammatory conditions eyes accompanied by bacterial infection of the ocular surface or risk of bacterial infection of the eye for which treatment with corticosteroids is indicated:

• inflammatory conditions of the palpebral and bulbar conjunctiva;
• inflammatory conditions of the cornea;
• inflammatory conditions of the anterior segment of the eye;
• chronic uveitis of the anterior segment of the eye;
• corneal damage chemicals, radiation or thermal burns, as well as as a result of penetration of foreign bodies;
• prevention and treatment of inflammation after cataract surgery.

Dosage regimen

For use in the eyes.

Shake well before use.

The standard dosage is 1-2 drops into the conjunctival sac of the affected eye every 4-6 hours. During the first 24 to 48 hours, the dose can be increased to 1-2 drops every 2 hours. As clinical signs improve, the frequency of use should be reduced until complete cessation . It is not recommended to stop treatment prematurely.

For acute infectious diseases instill 1-2 drops every hour until the condition stabilizes, then reduce the frequency to 1-2 drops every 3 hours over the next 3 days; then 1-2 drops every 4 hours for 5-8 days and finally 1-2 drops per day for the last 5-8 days if necessary.

After cataract surgery, the dose is 1 drop 4 times a day for 24 days starting from the day of surgery. Treatment can be started the day before surgery with 1 drop 4 times a day and continued after surgery, then 4 times a day for up to 23 days. If necessary, the frequency can be increased to 1 drop every 2 hours in the first two days of therapy.

After instillation, it is recommended to lightly cover the eyelids or press the nasolacrimal duct. This may reduce the systemic absorption of the drug administered through the ocular tissue and thus reduce systemic side effects.

Do not touch the tip of the pipette to your eyes or any other surface to avoid contaminating the contents of the bottle.

In the case of joint therapy with other local ophthalmic drugs, an interval between doses of about 10-15 minutes should be maintained.

in children over 8 years old

Side effects

Local

Infrequently: increased intraocular pressure, punctate keratitis, eye pain, eye itching, eyelid itching, eyelid erythema, conjunctival edema, eye discomfort, eye irritation.

Rarely: keratitis, hypersensitivity, blurred vision, dry eyes, sensation of a foreign body in the eye, eye hyperemia.

System

Infrequently: laryngospasm, rhinorrhea.

Rarely: impaired taste perception (unpleasant or bitter taste).

Frequency and severity of the following adverse reactions not determined due to insufficient data:

Local: glaucoma, cataracts, decreased visual acuity, eyelid edema, mydriasis, photophobia, increased tearing, blurred vision, eye hyperemia.

System: headache, dizziness, nausea, vomiting, discomfort in abdominal area, rash, facial swelling, itching, erythema.

Contraindications for use

• hypersensitivity to the active substances or to any of the excipients of the drug;
• acute epithelial keratitis of herpes simplex (dendritic keratitis);
• cowpox, chicken pox and a row viral diseases cornea and conjunctiva (with the exception of keratitis caused by herpes zoster);
• fungal diseases of eye structures;
• mycobacterial eye infections caused by, but not limited to, the following acid-fast bacilli: Mycobacterium tuberculosis, Mycobacterium leprae or Mycobacterium avium;
• acute purulent infection of the eye;
• children up to 8 years old.

Use during pregnancy and breastfeeding

There are no or very limited data regarding the topical ophthalmic use of tobramycin or dexamethasone during pregnancy. Aminoglycosides cross the placental barrier and therefore the risk to the fetus or newborn should be considered when using aminoglycosides during pregnancy. Tobradex ® eye drops are not recommended for use during pregnancy.

There are no data on the penetration of tobramycin or dexamethasone after topical ophthalmic use in breast milk. However, the risk for infant cannot be excluded.

Since the majority medicines excreted into breast milk, it is necessary to make an informed decision about interruption breastfeeding or stopping/abstaining from treatment with Tobradex ® eye drops, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.

Use in children

Use of the drug Tobradex ® eye drops for treatment acute inflammation eyes of bacterial origin within 7 days in children over 8 years old as effective and safe as for adult patients.

special instructions

For local ophthalmic use. Not for injection.

Prolonged use or increased frequency of use may lead to ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, decreased visual acuity, damage to the visual field, and subsequent formation of subcapsular cataracts. In susceptible patients, increased intraocular pressure may occur even after a single dose. In patients receiving long-term treatment with ophthalmic corticosteroids, intraocular pressure should be carefully monitored.

Long-term use of corticosteroids may reduce resistance to and detection of bacterial, viral, and fungal eye infections. Topical corticosteroids may mask Clinical signs infections, preventing detection of antibiotic ineffectiveness, or may suppress hypersensitivity reactions to active components drug. The possibility of fungal infections should be considered in patients with persistent corneal ulceration who have received or are receiving treatment with topical corticosteroids. If a fungal infection is confirmed, corticosteroid treatment should be discontinued and appropriate treatment initiated.

Sensitivity to topical aminoglycosides may cause eyelid itching, swelling and erythema of the conjunctiva in some patients. If hypersensitivity to the drug is observed, use should be discontinued.

The potential for cross-sensitivity with other aminoglycosides, especially kanamycin, gentamicin and neomycin, should be considered. In patients with hypersensitivity to topical tobramycin, there is a possibility hypersensitivity to other local and/or systemic aminoglycosides. The risk of sensitivity increases with repeated use. If hypersensitivity occurs while using Tobradex ® eye drops, treatment should be discontinued and another drug should be used for treatment.

The use of antibiotics such as tobramycin may lead to overgrowth of non-susceptible organisms, including fungi.

Topical use of steroids for diseases that cause thinning of the cornea or sclera, there is a risk of perforation.

Topical ophthalmic corticosteroids may slow the healing of corneal wounds.

When using local ophthalmic tobramycin in combination with systemic aminoglycoside antibiotics, their total plasma concentrations should be monitored.

If multiple courses of treatment are necessary or if clinically indicated, the patient should be assessed using slit-lamp biomicroscopy and, if necessary, fluorescein staining.

Corticosteroids are ineffective in the treatment of Sjögren's keratoconjunctivitis.

Contact lenses

Tobradex ® eye drops contain the preservative benzalkonium chloride, which may cause eye irritation or discolor soft contact lenses. Contact with soft contact lenses should be avoided. Before using Tobradex eye drops, you should remove contact lenses from your eyes and wait 15 minutes after using the drug before reinserting the lenses.

Impact on the ability to drive vehicles and operate machinery

As with other eye drops, temporary blurred vision or other visual disturbances may occur after instillation, which may impair your ability to operate a vehicle or operate other potentially dangerous machinery. In this case, you need to wait some time until your vision is restored.

Overdose

There were no cases of overdose.

Symptoms and clinically noticeable signs of overdose with Tobradex ® eye drops (punctate keratitis, erythema, increased lacrimation, itching and swelling of the eyelid) are similar to side effects observed in some patients.

Treatment: In case of local overdose of Tobradex ® eye drops, it is necessary to rinse the eyes with copious amounts of warm water.

Drug interactions

Specific studies drug interactions Tobradex ® eye drops have not been used.

Systemic absorption of tobramycin and dexamethasone is negligible and therefore the risk of interactions is minimal.

Combined and/or sequential use of an aminoglycoside (tobramycin) and another systemic, oral or local drug that have neurotoxic, ototoxic or nephrotoxic effects may lead to additive toxicity and should be avoided if possible.

Name:

Tobradex

Pharmacological
action:

Combination drug.
Tobramycin- a broad-spectrum antibiotic from the group of aminoglycosides.
It disrupts protein synthesis, structure and permeability of the cytoplasmic membrane of the microbial cell.
Active against gram-positive and gram-negative microorganisms: staphylococci (including Staphylococcus aureus, Staphylococcus epidermidis), including strains resistant to methicillin; streptococci, including some group A beta-hemolytic species, non-hemolytic species and some Streptococcus pneumoniae; Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter spp., Proteus mirabilis, Morganella morganii, Citrobacter spp., Haemophilus influenzae, Moraxella spp., Acinetobacter spp., Serratia marcescens.
Dexamethasone- synthetic fluorinated corticosteroids, does not have mineralocorticoid activity.
It has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, inhibiting the release of inflammatory mediators by zosinophils, the migration of mast cells and reducing capillary permeability and vasodilation.
The combination of GCS with an antibiotic (tobramycin) reduces the risk of an infectious process.

Pharmacokinetics
When Tobradex is applied topically, systemic absorption of dexamethasone is low.
Cmax of dexamethasone in blood plasma ranges from 220 to 888 pg/ml (about 555±217 pg/ml) after using 1 drop of Tobradex in each eye 4 times a day for 2 days.
About 77-84% of dexamethasone entering the systemic circulation is bound to plasma proteins. T1/2 averages 3-4 hours.
Excreted by metabolism, about 60% as 6-P-hydroxydexamethasone in urine.
When Tobradex is applied topically, systemic absorption of tobramycin is low.
The concentration of tobramycin in the blood plasma after using 1 drop of Tobradex in each eye 4 times a day for 2 days was below the detection threshold in 9 out of 12 patients.
The Cmax of tobramycin in blood plasma was 247 ng/ml, which is 8 times lower than the concentration threshold associated with nephrotoxicity.
It is excreted by the kidneys, mainly unchanged.

Indications for
application:

For the treatment of patients suffering inflammatory diseases eyes that are accompanied or not accompanied by superficial bacterial infection, including blepharitis, conjunctivitis and keratitis (without compromising the integrity of the epithelium);
- for the treatment and prevention of infectious and inflammatory eye diseases in patients who have had surgical interventions(eg cataract removal, foreign body removal);
- for eye injuries for the treatment and prevention of infectious and inflammatory diseases.

Mode of application:

Suspension (eye drops) Tobradex
The drug is intended for instillation into the conjunctival sac.
Before using the drug Tobradex, it is recommended to wash your hands thoroughly and shake the bottle with the drug until an equilibrium suspension is formed.
Required amount drops are introduced into the conjunctival sac, slightly throwing the head back and gently pulling the lower eyelid.
Immediately after instillation of the drops, you should close your eye and gently press your finger on the inner corner of the eye. When using drops, avoid contact of the dropper tip with the skin, eyelashes and mucous membrane of the eye.
After using the drops, carefully close the bottle with the lid.
The duration of use of the drug Tobradex and the dose of active substances is determined by the doctor. As a rule, 1-2 drops of Tobradex are prescribed into the affected eye every 4-6 hours.
If you miss the next dose of the drug, you should use the drops as soon as possible; if there is less than 1 hour left before the scheduled use of the next dose, the dose that was forgotten is skipped. It is not recommended to double the dose.

Tobradex eye ointment
The drug is intended for introduction into the conjunctival sac.
It is recommended to wash your hands thoroughly before using the ointment.
To apply the ointment, the head is tilted back slightly, the lower eyelid is pulled back and about 1.5 cm of ointment is applied.
After applying the ointment, it is recommended to open and close your eyes several times.
The tip of the tube should not be allowed to come into contact with the skin, eyelashes and mucous membrane of the eye.
After using the ointment, carefully close the tube with the cap.
The duration and schedule of use of Tobradex eye ointment is determined by the doctor. As a rule, the ointment is prescribed to be applied 3-4 times a day to the affected eye.
An interval of at least 6 hours should be observed between the use of the ointment.
If you miss another dose eye ointment apply as early as possible, but not less than 1 hour before the next dose.
If you remember the missed dose less than 1 hour before taking the next one, use only the planned dose. You should not double the dose of Tobradex.

Side effects:

Tobradex is generally well tolerated by patients.
Rare cases of the following undesirable effects have been reported when using Tobradex eye ointment and eye drops:
- local reactions : hyperemia, itching, burning and dryness of the eyes and eyelids, feeling of a foreign body in the eye, increased intraocular pressure, decreased visual acuity, keratitis, conjunctival edema, lacrimation. In isolated cases, the development of cataracts, glaucoma, mydriasis and photophobia was also noted;
- allergic reactions: facial swelling, itching, rash, erythema;
- other: nausea, vomiting, bitter taste in the mouth, dizziness, headache, rhinorrhea, laryngospasm.
In addition, patients with scleral thinning may develop perforation (the risk increases with prolonged use).
The development of a secondary infection (caused by microorganisms insensitive to the action of tobramycin) cannot be ruled out when using the drug Tobradex.

Contraindications:

Do not prescribe to patients with individual intolerance to tobramycin and dexamethasone;
- eye drops should not be prescribed to patients with hypersensitivity to benzalkonium chloride;
- do not use for the treatment of patients suffering from keratitis and other eye infections caused by the herpes virus, mycobacterium tuberculosis, fungi and other microorganisms insensitive to tobramycin;
- it is inappropriate to use the drug when removing a foreign body from the eye is not complicated;
- not used to treat children under 1 year of age.
Caution should be exercised, prescribing the drug Tobradex to patients with glaucoma, as well as thinning of the cornea.
Patients who operate potentially unsafe machinery and drive a car are advised to avoid these activities during therapy with Tobradex.

Interaction
other medicinal
by other means:

When using Tobradex drops or ointment simultaneously with other local ophthalmic agents, an interval of at least 15 minutes should be maintained between their use.
You should also remove contact lenses before using Tobradex; it is recommended to put on lenses no earlier than 15 minutes after introducing the drug into the conjunctival sac.
The combined use of Tobradex with topical and systemic drugs, which have ototoxic, nephrotoxic and neurotoxic effects, since mutual enhancement of these effects is possible.
Tobradex should not be used in combination with systemic aminoglycosides.

Storage conditions:

The drug Tobradex, regardless of the release form, should be stored for no more than 2 years after manufacture.
Eye drops and eye ointment should be stored in rooms with a temperature not exceeding 25 ° C.
It is forbidden to freeze the drug.
After the first opening of the tube or vial, Tobradex is valid for 30 days.

1 ml Tobradex eye drops contains:

- Excipients: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate anhydrous, tyloxapol, hydroxyethylcellulose, sodium hydroxide or sulfuric acid (to maintain pH level), purified water.

1 g ointment ophthalmic Tobradex contains:
- active ingredients: tobramycin - 3 mg, dexamethasone - 1 mg;
- excipients: anhydrous chlorobutanol, mineral oil, white petroleum jelly.

Latin name: Tobradex
ATX code: S01CA01
Active substance: Dexamethasone and tobramycin
Manufacturer: Alkon-Couvreur S.A., Belgium
Release from the pharmacy: On prescription
Storage conditions: t from 8 to 27 C
Best before date: 2 years

Tobradex is an ophthalmic drug for topical use, relieves inflammation, and is characterized by antibacterial properties.

Indications for use

A drug based on dexamethasone with tobramycin is used:

• In the postoperative period to prevent infection
• For signs of conjunctivitis and blepharitis
• In case of damage to epithelial tissues (keratitis).

Composition and release forms

Tobradex drops (1 ml) include tobramycin and dexamethasone in mass fractions 3 mg and 1 mg respectively. The drug also contains:

• Sulfuric acid
• Sodium hydroxide and chloride
• Disodium edetate
• Hydroxyethylcellulose
• Prepared water
• Sodium sulfate anhydrous
• Benzalkonium chloride
• Tiloxapol.

Tobradex ointment (1 g) contains the same amount of tobramycin and dexamethasone as in the drops. Additional substances are presented:

• Vaseline white
• Dehydrated chlorobutanol
• Mineral oil.

Eye drops are presented as a homogeneous suspension of a whitish tint; the drug is bottled in dropper bottles, the volume of which is 5 ml.

The ophthalmic ointment is almost white in color and has a uniform homogeneous structure of dense consistency. Packaged in tubes of 3.5 g.

Medicinal properties

A medicine with a combined composition, its mechanism of action is determined by the properties of each of its components.

Tobramycin is an antibacterial substance characterized by a wide spectrum of effects and belongs to the group of aminoglycosides. Under its influence, a disruption of the process of protein synthesis is observed, while the permeability of the cytoplasmic membrane of the pathogenic cell itself increases.

The activity of tobramycin is observed against gram-positive and gram-negative microorganisms, and in particular staphylococci; streptococci; strains resistant to methicillin; Pseudomonas aeruginosa and coli; Klebsiella pneumonia; enterobacter bacteria; proteas; Morgana bacteria; Citrobacter freundi; Haemophilus influenzae; Moraxella; Acinetobacter; serrations.

Dexamethasone is an artificially produced glucocorticosteroid (fluorinated) and does not exhibit mineralocorticoid activity. Relieves inflammation, exhibits antihistamine and desensitizing properties. With active suppression of the inflammatory process, suppression of the release of inflammatory mediators by eosinophil cells, as well as the migration of so-called mast cells, is recorded. Along with this, the permeability of the capillary walls decreases and vasodilation decreases.

The combination of an antibacterial substance with a glucocorticosteroid helps reduce the likelihood of infection.

In the case of topical use of the drug Tobradex, there is a slight penetration of its components into the general bloodstream.

The binding of dexamethasone to plasma proteins does not exceed 84%. The elimination period for this substance is usually no more than 4 hours. Approximately 60% of absorbed dexamethasone is excreted by the renal system in the form of 6-β-hydroxydexamethasone.

The highest concentration of tobramycin in the blood is approximately 8 r. below the level at which its nephrotoxicity manifests itself. Excretion from the body is carried out by the kidneys in its original form.

Tobradex: complete instructions for use

Price: from 340 to 550 rubles.

Tobradex drops and ointment are used in different ways; therapeutic therapy will depend on the severity of the pathological process.

Application of drops

The standard treatment regimen is to instill 1-2 drops. directly into the conjunctival sac after a period of 4-6 hours.

During the first two days of treatment, the frequency of use of the drug can be increased; the drug can be instilled no more often than every 2 hours. After the negative manifestations of the disease have decreased, you can switch to the standard dosage regimen.

In case of therapeutic therapy for acute infectious process it is recommended to adhere to next mode(single dose is 1-2 drops):

• To eliminate severe symptoms, instillation is carried out every hour
• Within 3 days - the time interval between instillation of the drug is 2 hours
• The next 5-8 days - drop the medicine every 4 hours.

If necessary, the doctor can extend treatment with this drug for 5-8 days.

To prevent complications after operations, Tobradex can be dripped 1 drop. four times a day. Treatment should begin on the day of the proposed operation and continue for 24 days. On doctor's recommendation for 2 days. after surgery, the single dose of the medicine can be increased 2 times (up to 2 drops), the frequency of use of drops is every 2 hours.

Immediately before using the drug, the bottle will need to be shaken.

To reduce the risk of systemic side symptoms After instilling Tobradex, you need to lightly press with your index finger on the inner corner of the eye for 2 minutes.

Application of ointment

For one application you will need to squeeze out a strip of ointment 1.5 cm long. The frequency of use of the drug is 3-4 r. throughout the day. As the severity of the disease symptoms decreases, the frequency of drug use is reduced.

Combined use

The drug in the form of a solution is best dripped during the day, eye ointment is used at night. The frequency of drug use is 3-4 rubles. during the day.

Use of Tobradex for the treatment of children

Tobradex eye drops and ointment can be used to treat ophthalmological diseases in children from 1 year of age. Before use, you must consult an ophthalmologist and read the instructions. Whether it is possible to administer drops to a child in a standard dosage and how long the treatment lasts should be checked with a doctor. Usually, children are given an individual treatment regimen. If within 7 days. The baby’s condition has not improved, you will need to consult an ophthalmologist.

Contraindications and precautions

You should not start treatment with this drug if:

• Excessive sensitivity to components
• Viral infection of the conjunctiva and cornea
• Development of mycobacterial infection
• Fungal infection of mucous membranes
• Injury to the cornea after removal of a foreign body from the eye.

Tobradex is not prescribed during pregnancy and during breastfeeding.

Before using the drug, you must remove contact lenses; further use is possible after 20 minutes. from the moment of instillation.

At long-term treatment(more than 2 weeks) you will need to monitor the condition of the cornea. When combining the drug with systemic aminoglycoside antibiotics, it will be necessary to monitor basic blood counts.

It is necessary to exclude contact of the dropper tip with mucous membranes in order to prevent contamination of the bottle and the drops themselves.

Cross-drug interactions

The drug can be used with other ophthalmic drugs; the interval between medications should be at least 5 minutes.

Side effects and overdose

Signs of hypersensitivity may appear, which is manifested by allergies (swelling of the eyelids, severe itching, redness of the conjunctiva).

The development of adverse symptoms is usually associated with the presence of a steroid substance:

• Deterioration of wound healing
• Development of subcapsular cataract
• Changes in intraocular pressure.

Secondary eye infection is observed after the use of drugs based on corticosteroids and antibiotics.

The spread of fungal flora is recorded during prolonged antibacterial treatment PM. The presence of poorly healing ulcers on the cornea is one of the signs of fungal invasion. The occurrence of secondary bacterial infection is possible with weakened immune defense.

Observed severe redness conjunctiva, the occurrence of erythema, keratitis, excessive lacrimation, swelling and severe itching of the eyelids.

Analogs

Today there are cheaper products based on tobramycin, including Tobrex.

Alcon-Couvreur, Belgium

Price from 195 to 215 rub.

Tobrex is a good medicine for inflammatory lesions eyes caused by the spread of bacterial flora. The main active ingredient of Tobrex is tobramycin. Available in the form of a solution for topical use.

Pros:

• Effectively treat stye
• Shelf life of drugs – up to 3 years
• Can be used for newborns.

Minuses:

• Long term use possible development fungal superinfection
• Should not be used concomitantly with tetracycline
• May provoke local allergic reactions.