Eye Drops Tobradex Purpose and Application. Tobradex (eye drops) - description and instructions for children

  • The date: 05.03.2020

If the cornea of \u200b\u200bthe eye is inflated, eye drops or ointment of Tobradex are prescribed doctors. The drug is distinguished by a combined effect. It is recommended as a preventive measure against secondary infections that may develop after the operation.

Pharmacological action and group

The international non-payable name (MNN) of Tobradex is known as dexamethasone + Tobramycin; These active active ingredients are contained in its composition. This medicine preparation is prescribed to cure the bacterial inflammation of the cornea. The effect of using this tool is based on the properties of its main substances.

Tobramycin has antimicrobial effects, which makes it possible to more effectively deal with gram-negative and gram-positive bacteria, and dexamethasone can have an anti-inflammatory, antiallergic and antihistamine effect.

Tobradex is not able to provoke the slowdown in the cornea, for this reason, is used in the postoperative period.

The high efficiency of this pharmaceutical preparation with antibacterial effect is proven, when combating the following bacteria:

  • Staphylococci;
  • Sinnaya, intestinal and sticks of the PFFEF;
  • Klebsiellee pneumonia;
  • Optional and anaerobic sticky-shaped spore-forming bacteria;
  • Morgan bacterium;
  • Koch wand, etc.

This antibiotic group of aminoglycosides is characterized by a low system of systemic suction in the treatment process.

Release form and composition

Medical preparation Tobradex is produced in two forms: in the form of eye drops and ointments. The first are produced in the form of a white liquid resembling a suspension, in 5 ml bottles. At the end, they are equipped with a special nozzle. The eye ointment is produced in aluminum tubes of 3.5 gr.

Regardless of the form of release, the drug contains the active active ingredients mentioned above, and some auxiliary components: sodium chloride, benzalconium chloride, etc.

Indications for use

The medicine is prescribed to patients as the therapeutic and preventive measure of the following inflammatory diseases of the front departments of the eye:

  1. Keratitis;
  2. Swelling conjunctiva;
  3. Cataract;
  4. Prevention of infections in the postoperative period;
  5. Inflammation of the edges of the age;
  6. Injured injuries.

Instructions for use

Before using Tobradex, you need to thoroughly wash your hands with detergent. The bottle shakes several times to give the homogeneity of the suspension. The head is a bit thrust back. The lower eyelid is slightly dedicated down and drove a couple of droplets of the medical preparation in the conjunctival. The eye after that is closed and a little pressed with your finger on its inner corner.

In case of passing the next dose of the medical drug, you should not double the following you can take a medicine for the previously planned period, observing the gap between two instillations at least one hour.

If the ointment is used, it is applied to the lower eyelid mucosa, pulling it down. After the procedure is performed, it is necessary to slowly blink slowly.

It is impossible in the process of applying the composition to concern the tube of skin, mucous eye and eyelashes. After the tobradex ointment is applied, it is necessary to thoroughly twist the cap. If the next dose is to skip, then you need to adhere to the same recommendation, as in the case of drops, which is described above.

Side effects and contraindications

At the moment, experts identified the following side effects from the use of the means:

  • Spazm larynx;
  • The occurrence of an allergic reaction, which manifested itself with a rash, the edema of the conjunctive bag and the age, itching;
  • Gorky taste in the mouth;
  • Intraocular pressure increased;
  • Headaches;
  • Dry conjunctiva;
  • Often felt dizziness;
  • The acuity of sight falls sharply after injection of eye drops;
  • Inflammation of the cornea of \u200b\u200bthe eye is developing;
  • Acute eye pain as a reaction to light;
  • Pupils are greatly expanded.

When the sclera of the patient acquired either inherited pathology, symptoms of perforation can be manifested on it, especially if the therapy with the use of Tobradex will continue more marked in the period instructions.

As a result of the weakening of immunity and the influence of the active substances contained in the composition of the eye drops, the development of secondary infection is possible.

  • Intolerance to substances that are in the medical process;
  • Viral eye diseases (keratitis, which manifested himself after lesion by smallpox or herpes);
  • Mycobacterial ophthalmologic infectious diseases;
  • Conducting conservative therapy after operating intervention in extracting a foreign body from the cornea;
  • Fungal ophthalmic diseases;
  • Inflammatory purulent diseases.

Tobradex must be used with special caution and only under the control of the doctor in the case of glaucoma and the thinning of the cornea of \u200b\u200bthe eye, which was served by hereditary pathology or acquired.

Interaction with other drugs

The Medical Medicine Tobradex can be combined with other eye drops and means, for example, Venarar and Ozomistin, but before driving or accept any other drug, you need to withstand the interval between the use of drugs at least five minutes.

It should not be in parallel with the Tobradex to use glucocorticosteroid eye ointments, since such interaction of medicines will increase the possibility of developing side effects and the risk of probable overdose. Also concerns co-use with alcohol.

Use in children

Tobradex is allowed to apply for the treatment of children aged at least 12 years. The medicine is contraindicated with newborns and kids up to 1 year.

The duration of the course of treatment with eye drops and ointment Tobradex can not be more than one week.

Use during pregnancy

Tobradex do not recommend taking women who are under pregnancy. The experience of using the means during the baby tooling is limited, for this reason, it is possible to proceed with therapy only in case of extreme need, when the benefit for the future mother is significantly more than possible risk for the baby.

With caution you need to apply a tool to women who feed the baby with breasts. When there is no need to finish lactation.

Storage conditions and shelf life

The bottle after was opened and first used, it should be stored no more than one month. The same applies to ointment. If the Packaging of the Tobradex for the treatment of the eye is sealed, then it can be kept at home for two years from the moment of production.

In both situations, the drug is required in room conditions in a place where children cannot get it.

Analogs

Similar cheap substitutes from Russia, the following medical drugs can be called:

  • Tobrax;
  • Sofradex;
  • Timony.

Before replacing the appointed funds presented above preparations, the patient must be consulted by the doctor.

Price and Reviews

The cost of Tobradeks in pharmacies in the territory of the Russian Federation is mainly in the limit of 280-340 rubles. At the same time, sometimes it can be purchased at a reduced price, approximately 270-280 rubles.

As for the opinions of patients who had to drove and smear the therapeutic measure, they note the effectiveness of the drug in the course of treatment and subsequent disease prophylaxis. However, it is mentioned everywhere that the drug was appointed by the attending physician ophthalmologist. We recommend contacting the recipes to the services of qualified specialists, and not engage in self-medication.

With inflammatory processes in the eye caused by various factors, it is important to find a suitable and effective tool for treatment. In the head of the eye drops, respect for consumers and doctors won Dradex drops that meet the modern requirements of medicine.

Composition and form of release

The drug is a transparent or slightly white solution. The main active ingredients of the drug are the powerful antibiotic tobramycin and the healing component of dexamethasone. To enhance the impact, the drops also include:

  • benzalconium chloride;
  • sodium hydroxide;
  • sulfuric acid required to align the pH level;
  • purified from extra impurities water.

Available drops in cardboard packs. Inside there is a bottle with a dispenser. Volume - 5 ml.

Pharmacological impact

Due to the antibiotic of a wide range of action, a complete suppression of the reproduction of pathogenic bacteria occurs, including in running cases. With the simultaneous effect of dexamethasone, there is a violation of the metabolism of allergens and bacteria. As a result of the ingress of substances in the upper part of the eye there is a rapid removal of swelling, burning and painful sensations.

Indications for use

The main indications for the use of Tobradex serve:

  • to prevent inflammatory processes in the presence of injuries and in the postoperative recovery period;
  • for the treatment of cuts caused by wearing contact lenses;
  • for the treatment of conjunctivitis;
  • with inflammatory processes without expressed damage to the epithelium;
  • for the treatment of barley, blufaritis, keratitis.

Sometimes the use of drops are allowed to eliminate the fatigue of eyes and allergic reactions due to the presence of dexamethasone.

Method of application and dosage

Regardless of the diagnosis, the drops are buried in a conjunctival bag closer to the inner corner of the affected eye.

In severe or special cases, smaller or large dosages can be assigned. Therefore, when using Tobradex, consultation of an ophthalmologist is required. If for some reason one dose of the drug was passed, it should be accepted immediately. At the same time, in no case cannot receive a double dose so as not to cause side effects.

Side effects

The main side effects include:

  • strongest itching and eye swelling;
  • inflammation of conjunctiva;
  • preventing the healing of available wounds;
  • suppression of the protective function of the body;
  • increased;
  • subcapsular cataract in the rear of the eye;
  • the development of fungal infection.

Contraindications to use

Among the contraindications to the use of Tobradex have:

  • diseases of cornea and conjunctivations provoked by viral bacteria;
  • chickenpox;
  • eye fungus;
  • individual intolerance to the drug and its components;
  • manifestation of an allergic reaction after use;
  • removing a foreign body from the cornea.

During pregnancy and breastfeeding

Due to the lack of accurate studies and the availability of data on the behavior of the body of a pregnant woman, it is not recommended to apply Tobradex in any of the trimesters of pregnancy.

The use of droplets in the II or III trimester is allowed if the treatment does not hurt the health of the fetus. During breastfeeding period, the child should be transferred to artificial feeding to avoid hitting the antibiotic in the blood.

Video - How to drip drops in a conjunctival eye bag

Special guidelines when using

When taking a medicinal product worth knowing:

  • with the simultaneous treatment of Tobramycin and antibiotics of the Aminoglycoside group, it is necessary to monitor the periphery of the blood;
  • also, with this method of treatment, there is a manifestation of strong side effects;
  • with complex treatment with other eyebraps it is necessary to use drugs with a break of 5-10 minutes for better assimilation and action;
  • when applied, the dispenser dispenser with the eye is not allowed to avoid further distribution and enhancement of the inflammatory process;
  • to protect the dispenser from entering it dust and dirt, the bottle closes after each use;
  • before use, you should definitely shake the drops to obtain a homogeneous solution.

Despite the proven efficacy of the drug, it is necessary to consult a doctor before applying. With properly designated therapy, it will be possible to avoid complications and quickly identify the main cause of the disease.

Eye drops Tobradex - an effective preparation that has simultaneously anti-inflammatory and antimicrobial effects. A medication is used to relocate inflammatory processes of organs of vision, as well as in order to prevent eye infection after operations. In the article, we will consider in detail the features of this drug, find out the composition of the Tobradex, instructions for use, is it possible to use the drug for the treatment of children.

Description of eye drops of Tobradex when prescribed and how to apply

Dropradex drops are very popular in ophthalmology - and all due to the directional influence of its active ingredients: glucocorticosteroid and antibiotic - dexamethasone and thoramicin. The combined composition provides Tobradeks at once anti-inflammatory and antibacterial effect: it is due to this particular nature of the drops that are so effective.

The drug is used to eliminate inflammatory processes of organs of vision, is able to cope with bacterial infections. The medicine can cope with such types of pathogenic bacteria as:

  • staphylococci (including golden);
  • streptococci;
  • shangna wand, intestinal, etc.

Useful information on the topic! When it is necessary to use droplets: testimony, contraindications, dosage selection.

The tool has the following types of therapeutic effects:

  • antihistamine;
  • antibacterial;
  • anti-inflammatory.

It should be noted that the drug does not have a negative impact on the rehabilitation processes of the cornea, so it is widely used after operations in the eyes. The tool is intended for use in the therapy of ophthalmic diseases generated by bacterial infections, including:

As already mentioned above, the drug is excellent for the restoration period after operations: in this case, Tobradex protects the eyes from the development of inflammatory processes, infection.

Interesting on the topic! : To whom and in what cases are prescribed, the main contraindications, the calculation of the correct dosage, analogues.

Features of the composition of the drug

The powerful combination effect is explained by the presence of two active components as part of the drug:


In addition to these basic ingredients, there are auxiliary standard components as part of the funds:

  • sodium derivatives;
  • boric acid;
  • thiloxapol;
  • non-relation chloride;
  • water.

A medication is produced in plastic sterile vials with a capacity of 5 ml, equipped with droppers. Externally, the tool is transparent absolutely, the colors and any smell does not have. It can be purchased at the pharmacy freely, the recipe is not needed.

Instructions for use for adults and children

Droprandex drops are introduced in a standard way - with the deserted lower eyelid into the conjunctival bag. It is extremely recommended before the drug to bury, wash my hands with soap, as well as shake the bottle slightly, to warm it in your hands.

When Introduction, a little thorns back the head - thus the medicine will more reliably fall on the destination, and will not turn back. After the introduction, close the eyelid and press the inner angle of the eye to the finger.

Follow the rules of hygiene and be careful: do not touch the glass pipette any surface around. In addition, immediately after the instillation, you carefully close the bottle. These measures will prevent the eye contact with the infection drops.

The course of treatment and dosage is appointed by a doctor. Usually, the Tobradex is administered every 5-6 hours of 1-2 drops into each eye. If you for any reason, miss the next instillation time, use a double dose is then forbidden: Install the tool in usually dosage, but as early as possible.

If until the next scheduled injection, it remains less than an hour, then wait for this time, and log in to normal mode.

An ordinary course of treatment with this drug lasts, as well as using almost all antibiotics, 5-7 days. If, after the designated period, the symptoms of bacterial infection and inflammation are preserved, it is necessary to consult a doctor, since the positive impact of the tool should be noticeably earlier.

As a result of the use of droplets, immediately after the introduction may observe a temporary vision. Therefore, it is not recommended immediately after applying the means to get driving behind the wheel, it is necessary to wait 20-30 minutes until the vision comes to normal.

On the video - a rule of drunking eyes:

In pediatrics, the means is used to achieve a child of one year, no newborns are used to treat newborns. As for pregnancy, a pregnancy must be excluded during the treatment of a thradex. The lactation period also refers to the forbidden for the use of the drug.

If simultaneously with the introduction of Tobradex, you are forced to apply other drops, leave the interval between the injections of the drugs at least 15 minutes.

Contact lenses before administration of the medication must be removed, since the solution can have a negative impact on the quality of the lenses, lead to superval. Turning the lenses back recommended 20 minutes after installation.

It is not recommended to use Tobradex drops simultaneously with the treatment of the following drugs:

  • neurotoxic;
  • overtoon;
  • nephrotoxic.

The ban is explained by the enhancement of the effects of drugs while simultaneously use.

Stored Tobradex standard: in a dark place at a temperature not higher than +25 degrees. If the bubble is opened, it is necessary to use its contents for the next month.

Contraindications

The preparation of Tobradex cannot be used in the following cases:

The means is not prescribed if it is necessary to remove the foreign bodies from the eye. Caution is used to treat patients with a thinned cornea or glaucoma.

It is impossible to use the drug under herpetic infection in the aggravation stage, that is, with visible manifestations. Windmill in children is also contraindications to use this medicine. It is forbidden to use drop data for any diseases that entail purulent emissions from the eyes.

Adverse reactions

Sometimes the use of the drug leads to unpleasant side reactions of the organism, most often these are the following manifestations:

Rarely, such side effects can be observed as:

If any negative manifestations occur, immediately stop using this drug. If the consequences were serious, it is necessary to refer to the doctor for the examination and appointment of symptomatic treatment.

It should be noted that the overdose of the drug leads to an increase in side effects and more likely their appearance in principle. If you accidentally entered more than you need, the amount of solution, rinse your eyes with clean water, if necessary, call the doctor.

Price of the eye for the eye, analogues

The cost of this drug today ranges from 330 to 460 rubles: such a price variation is due to various approach of pharmacy networks to pricing, as well as the degree of regions' remoteness.

Among the analogues of Tobradeks, the following drugs deserve special attention:

We highlight among all the analogues such a drug as. This tool has both Tobramycin, and is a direct "competitor" of Tobradex. However, we note that the drug considered by us differs a much broader spectrum of impact, rather than a purely antibacterial tobrax. Analogues on the acting substance can be attributed and, however, any change of the drug must be discussed with the doctor.

Composition

Active substances: tobramycin, dexamethasone; 1 ml of suspension contains Tobramycin 3 mg and dexamethasone 1 mg

Auxiliary substances: Benzalconium chloride, sodium Edestat, sodium chloride, sodium diesel sulfate, thyloxapol, hydroxyethylcellulose, sulfuric acid and / or sodium hydroxide, purified water.

Dosage form

Eye drops.

The main physico-chemical properties: suspension of white or almost white.

Pharmacological group

Anti-inflammatory and antimicrobial means in combination. Corticosteroids and antimicrobial means in combination.

Pharmacological properties

Pharmacological.

dexametanone

The effectiveness of corticosteroids for the treatment of anti-inflammatory states is well known. Corticosteroids achieve their anti-inflammatory effect by suppressing the adhesion of molecules in the endothelial cells of vessels, cyclooxygenase I or II, and the selection of cytokines. As a result, the formation of inflammatory mediators is reduced and the adhesion of circulating leukocytes to the vascular endothelium is oppressed, which prevents their penetration into inflamed fabrics of the eye. Dexamethasone has a pronounced anti-inflammatory effect with reduced mineralocorticoid activity compared to some other steroids and is one of the most potent anti-inflammatory funds.

tobramycin

Tobramycin is a highly active high-speed bactericidal antibiotic group of aminoglycosides, which counteracts both gram-positive and gram-negative microorganisms. Its mechanism of action is associated with the oppression of a complex of polypeptides and synthesis in ribosomes of bacterial cells.

In general, the effect of Tobramycin is described in vitro by determining the minimum depressing concentration (IPC), which determines the activity of the antibiotic for each type of bacteria. Since the MPK Tobramycin is very low against most eye pathogenic organisms, it is considered an antibiotic of a wide range of action. Critical values \u200b\u200bof the IPC were identified, which determine the sensitivity or resistance of bacterial culture to a specific antibiotic. The existing critical value of the IPC for Tobramycin relative to certain types of bacteria takes into account the sensitivity of the species, as well as the maximum concentration and pharmacokinetic values \u200b\u200bof the dependence time / concentration, measured in serum after oral administration. The definition of these critical values \u200b\u200bis separated by microorganisms on sensitive and resistant, used to determine the clinical efficacy of antibiotics that were used systemically. However, with local use of the antibiotic in high concentrations directly to the infection, the definition of critical values \u200b\u200bis not used. Most microorganisms that could be classified as resistant by defining critical values \u200b\u200bin systemic use are actually well reacting to local treatment. In order to prevent the ability to suspend the development of such microorganisms that cause infection.

During clinical studies, a solution of Tobramycin, which was used locally, showed effectiveness against many existing strains of pathogenic for the eyes of organisms in patients who participated in research. It is believed that some of these pathogenic organisms are resistant, based on the definition of critical values \u200b\u200bin systemic use. During clinical studies, it was shown that Tobramycin is effective for the treatment of surface infections of the eye caused by the pathogenic microorganisms below.

Gram-positive bacteria:

Staphylococcus aureus (Methicillin sensitive or resistant *)

Staphylococcus Epidermidis (sensitive to meticillin or resistant *)

Other coagulazo-negative types of Staphylococcus

Streptococcus Pneumoniae (Penicillin sensitive or resistant *)

Other types of Streptococcus

* Penotype of beta-lactam resistance (i.e., meticillin; penicillin) is not associated with the phenotype of the resistance of aminoglycosides and both non-virulence and phenotypes of pathogenic organisms. It was revealed that many staphylococci resistant to meticillin are resistant to Tobramycin (and other aminoglycosidic antibiotics). However, these persistent staphylococcal cultures (as defined by critical values \u200b\u200bof the IPC) usually react well to Torumcin treatment used by local.

Gram-negative bacteria:

Acinetobacter SPP.

Citrobacter SPP.

Enterobacter SPP.

Escherichia Coli.

Haemophilus influenzae.

Klebsiella Pneumoniae.

Morganella Morganii.

Proteus Mirabilis

Pseudomonas Aeruginosa.

Serratia Marcescens.

The study of the sensitivity of bacteria was demonstrated that in some cases, microorganisms, resistant to gentamicin, remain sensitive to drawing. In a significant part of microflora, the resistance to Tobramycin has not yet developed; However, bacterial resistance can develop with prolonged use.

The occurrence of cross-sensitivity to other aminoglycosid antibiotics is possible. In the event of increased sensitivity, when applying the drug, it should be discontinued and to carry out appropriate treatment.

Pharmacokinetics.

dexametanone

The system exposure to dexamethasone after the local ophthalmologic application of eye drops of Tobradex ® is low. The levels of peak concentrations in the blood plasma range from 220 to 888 pg / ml (an average of 555 ± 217 pg / ml) after instilcing one drop of Tobradex ® in each eye 4 times a day in sequence within two days.

Dexamethasone is excreted from the body by metabolism. Approximately 60% of the dose is distinguished with urine in the form of 6-β-hydroxidexamethane. Unchanging dexamethasone in the urine was not detected. Plasma semi-alone period is relatively short - 3-4 hours.

Dexamethasone approximately 77-84% is associated with albumin serum. The clearance ranges from 0.111 to 0.225 l / h / kg and the distribution range ranges from 0.576 to 1.15 l / kg. Bioavailability during oral administration is about 70%.

tobramycin

Systemic effects of tobramycin after the local ophthalmologic use of eye drops of Tobradex ® low. The levels of the concentration of Tobramycin in the blood plasma were not quantified by quantitatively definition in 9 of 12 patients used the eye drops of Tobradex ® one drop in each eye 4 times a day in series for two days. The largest measured level was 0.25 μg / ml, which is 8 times lower than the concentration of 2 μg / ml, which is known below the risk boundary of the occurrence of nephrotoxicity.

Tobramycin is quickly and actively excreted with urine by glomerular filtration, mainly unchanged. The half-life of plasma is approximately 2:00 with a clearance of 0.04 l / h / kg and a distribution volume of 0.26 l / kg. The binding of blood plasma protein with Tobramycin is slightly less than 10%. Bioavailability with oral administration is low (<1%).

Preclinical Safety Data

Safety data

Data on system toxicity of active substances well studied. The systemic effect of Tobramycin with toxic doses, far exceeding the dose when local use in the eye, can be associated with nephrotoxicity and isotoxicity. The system exposure to dexamethasone may be associated with effects related to the GKS of the imbalance. Studies of the toxicity of repeated doses of eye drops Tobradex ® in rabbits found systemic effects associated with corticosteroids, but even in doses that significantly exceeding a dose for a person, this manifestation has a minor clinical relevance. When using Tobradex ® in recommended doses, the emergence of these effects is unlikely.

mutagness

In vitro and in vivo studies of each of the actors of mutagenic action did not find.

teratogenicity

Tobramycin penetrates the placenta in the blood flow of the fetus and the oily water. Studies on animals with systemic use of pregnant animals of large doses of triamcin during organogenesis discovered renal toxicity and outotoxicity of the fetus. Other studies conducted on rats and rabbits using Tobramycin in doses of more than 100 mg / kg / day with parenteral administration (\u003e 400 times the maximum clinical dose), did not reveal any cases of disruption of fertility or harmful effect on the fetus.

It was found that during research on animal corticosteroids should teratogenic influence. The use of 0.1% dexamethasone to the eyes of pregnant rabbits led to an increase in cases of disruption of the development of the fetus and the delay of intrauterine development. The delay in the development of the fetus and an increase in deaths were observed in rats with long-term dexamethazone therapy.

Tobradex ® should be used during pregnancy only if the potential benefit from the use of the drug will exceed the potential risk to the fetus.

No studies were conducted to assess the carcinogenic action of Tobradex ®.

Indications

Eye inflammation in patients sensitive to steroids, under which the use of corticosteroids is shown and there is a surface bacterial infection or the risk of developing a bacterial infection of the eye. These inflammatory processes may occur after surgery or may be caused by infection, in the eye of a foreign body or eye injury.

Contraindications

  • Increased sensitivity to active substances or any component of the drug.
  • Keratitis caused by the Herpes Simplex virus.
  • Cow of Phase, chickenpox and other viral corneal infections and conjunctiva.
  • Fungal diseases of the structures of the eye.
  • Mycobacterial eye infections.

Interaction with other medicines and other types of interactions

The simultaneous purpose of steroids for local use and the NSAIDs for local applications can increase the risk of complications in the healing of Rounds of the cornea.

Concomitant and / or consistent use of antibiotics of the aminoglycoside group (such as Tobramycin) and other systemic oral or drugs for local applications, which have a toxic (harmful) effect on the nervous system, hearing or kidney organs can lead to additive toxicity, so if It is possible to avoid such an application.

If more than one ophthalmic agent is used, the interval between their application should be at least 5 minutes. Eye ointments should be applied last.

Features of application

Only for ophthalmologic application.

After opening the bottle, remove the protective ring intended to control the opening.

Some patients have increased sensitivity to aminoglycosides applied locally. In the event of an increased sensitivity response, the use of the drug should be discontinued.

The occurrence of cross-increased sensitivity to other aminoglycosides is possible. It should be considered the likelihood that patients with increased sensitivity to Tobramycin under local application can also be sensitive to other aminoglycosides, which are prescribed locally or systemically.

Serious adverse reactions have been reported, including neurotoxicity, dysotoxicity and nephrotoxicity, in patients who received systemic therapy of aminoglyigosides. With simultaneous use with systemic aminoglycosides, you should be careful.

Long-term treatment with corticosteroids for local ophthalmologic use can lead to eye hypertension and / or glaucoma with damage to the optic nerve, deterioration of visual acuity and field of view, as well as the formation of subcapsular cataracts of the rear eye chamber. In patients with which therapy with corticosteroids applied into the eyes continued, it is necessary to regularly and repeatedly monitor intraocular pressure. This is especially important for children, since the risk of increased intraocular pressure caused by corticosteroids may be more in children and appear earlier than adults.

The risk of increased intraocular pressure caused by corticosteroids and / or the risk of cataracts caused by the use of corticosteroids increases in predisposed patients (for example, in diabetic patients).

GCS can reduce resistance to bacterial, fungal or viral infections and prevent identifying such infections and mask clinical signs of infection.

In case of persistent, the cornea ulcers should take into account the possibility of fungal infection. In the event of fungal infection, the treatment with corticosteroids should be discontinued.

Long-term use of antibiotics, such as Tobramycin, can cause excessive growth of insensitive microorganisms, including mushrooms. If superinfection occurs, it is necessary to start the appropriate therapy.

Corticosteroids for ophthalmologic use can slow down the healing of the cornea wounds. It is also known that the NSAIDs for local applications slow down or delay healing wounds. The simultaneous purpose of the NSAIDs for local use and steroids for local applications may increase the risk of complications during wound healing (see section "Interaction with other drugs and other types of interactions").

If there are diseases leading to the thinning of the cornea or sclera, the local use of steroids can lead perforation.

Tobradex ®, eye drops containing benzalconium chloride, which can cause eye irritation and, as you know, bleach soft contact lenses. Contact with soft contact lenses should be avoided. In the event that the patient is allowed to wear contact lenses, it should be warned that it is necessary to remove contact lenses before using eye drops of Tobradex ® and wait at least 15 minutes before putting the contact lenses again.

Application during pregnancy or breastfeeding.

reproductive function

Studies in order to assess the impact on fertility in a person with the local application of Tobradex ®, eye drops, were not conducted.

pregnancy

Data on the use of tobramycin or dexamethasone pregnant women are absent or their number is limited. Research on animal reproductive toxicity after systemic appointment of corticosteroids and tobramycin. The use of Tobradex ® drug during pregnancy is not recommended.

lactation

It is not known, Tobramycin and dexamethasone in breast milk under local ophthalmologic application. Corticosteroids and tobramycin fall into breast milk after systemic use. It is impossible to exclude risk for a child who is breastfeeding.

Since many drugs fall into breast milk, it should be given to the possibility of temporary cessation of breastfeeding at the time of use of Tobradex ®.

The ability to influence the reaction rate when managing motor vehicles or other mechanisms.

Tobradex ®, Eye drops, does not have an insignificant effect on the ability to control vehicles or other mechanisms. Temporary viewing of vision or other violations of vision can affect the ability to manage vehicles or other mechanisms. If the vision of vision occurs during the instillation, the patient needs to wait until the vision before driving vehicles or other mechanisms.

Method of application and dose

For ophthalmologic application.

Application of adults, including elderly patients, children aged 12 to 18 years

1 or 2 drops to bury in the conjunctival bag (ki) every 4-6 hours. During the first 24-48 hours, the dose can be increased to 1 or 2 drops every 2:00. The frequency of use of the drug should be gradually reduced by improving clinical signs. You should be attentive and not stop therapy prematurely.

In case of severe diseases, he bore 1 or 2 drops every hour until the inflammation becomes controlled, and gradually reduce the frequency of use up to 1 or 2 drops every 2:00 for 3 days after that, to bury 1-2 drops every 4:00 during 5-8 days and at the end - 1-2 drops every day for 5-8 last days, if necessary.

After the operation to remove the cataract, the dose is 1 drop 4 times a day, starting from the day the operation and continuing within 24 days. Treatment can be started the day before the operation of 1 drop 4 times a day, continuing to bury 1 drop after the operation, and then 4 times a day for 23 days. If necessary, the frequency of use of the drug can be increased to 1 drops every 2:00 during the first two days of therapy.

It is recommended to click on the portion of the nasty holes and carefully close the eyelids after the instillation. This reduces the system absorption of the drug introduced into the eye, which reduces the likelihood of systemic side effects.

application of children

The data obtained confirm the safety and efficacy of the drug in children aged 1 year, which was used for 7 days to treat surface inflammation of bacterial origin.

It is possible to use children who need to carry out surgery to remove cataracts.

With violation of the liver and kidney function

Tobradex ® did not investigated for this category of patients. However, due to the low system absorption of Tobramycin and dexamethasone, after the local application of the drug, there is no need for a dose adjustment.

mode of application

Before use, the bottle should be good to shake.

To prevent contamination of the tipper tip and the contents of the bottle, care must be taken and do not touch for centuries and other surfaces with the tip of the bottle of the dropper.

Store bottle in a vertical position.

The data obtained confirm the safety and efficiency of the drug in children aged 1 year.

Safety and efficiency of use in children under the age of 1 year are not established.

Overdose

Considering the characteristics of this drug intended for local application, no toxic effect is expected to be not expected to be available both when applied in ophthalmology in the recommended doses and when accidentally swallowing the contents of the bottle. Clinical signs and symptoms of overdose by the drug (point keratitis, erythema, increased tearing, swelling and itching age) may be similar side effects that were observed in some patients.

In case of overdose by the preparation of Tobradex ®, under the local application, wash the excess the preparation from the eye (eye) with warm water.

Adverse reactions

When carrying out clinical studies, the most frequent side reactions were pain in the eyes, increased intraocular pressure, eye irritation and itching eyes, which occurred in less than 1% of patients.

When conducting clinical studies of the eye drops of Tobradex ®, a message was obtained about the following adverse reactions, which were estimated at the following frequency: very often (≥ 1/10); Often (≥ 1/100 -<1/10); редкие (≥ 1/1000 - <1/100); единичные (≥ 10 000 - <1/1 000) единичные (<1/10 000). В рамках каждой группы побочные эффекты представлены в порядке убывания их степени тяжести.

Table 1

According to postmarketing research, the following adverse reactions were discovered.

Based on the submitted data, it is impossible to calculate the frequency of their occurrence.

table 2

Description of some adverse reactions

Long-term use of corticosteroids is local to the eye can lead to an increase in intraocular pressure, followed by damage to the visual nerve, deterioration of visual acuity and impaired field of view, as well as to form the rear subcapsular cataracts and slowdown in wound healing (see the section "Features of application").

Since the drug contains GCS, then in the presence of diseases leading to the thinning of the cornea or sclera, the risk of perforation is increasing especially after long-term use (see section "Features of application").

The development of secondary infections after the use of combinations containing corticosteroids and antimicrobial substances is possible. Fungal infections of the cornea are particularly actively developing with prolonged use of steroids. (See section "Features of application").

In patients who conducted systemic therapy with Tobramycin, there were serious adverse reactions, including neurotoxicity, output toxicity and nephrotoxicity (see "Features of application").

Some adverse reactions, such as corneal abrasion, impairment of vision, edema of conjunctiva, violations by the eyelids, separation from the eyes, itching the century, urticaria, dermatitis, Madaryos, leukoderma, dry skin was observed during Torumcin's therapy.

Packaging

5 ml of the drug is placed in the Drop-Tainer® drop-dropper from low density polyethylene with a polypropylene cover. 1 bottle in a cardboard box of packing cardboard.

Combined drug with antimicrobial, anti-inflammatory effect. It has an antibiotic tobramycin and dexamethasone.

Ingredients: dexamethasone 1 mg, Tobramycin 3 mg, sodium chloride, thyloxapol, Dinatari Edetate, hydroxyethylcellulose, purified water, sodium hydroxide, sodium, anhydrous sodium, benzalconium chloride. Available in plastic bottle-drops 5 ml.

pharmachologic effect

Tobramycin - affects the cell of the microorganism by disrupting the polypeptide compounds and the formation of ribosomes.

Dexamethasone - inhibits adhesion of endothelium cells, cyclooxygenase I, II, cytokines. Reduces the emission of mediators responsible for inflammation.

Indications for use

  1. Infectness of eye appendages ().
  2. The infection of the vascular shell of the eye (wipe).
  3. (Maibolit).
  4. Infectious inflammation of the cornea, without damage to the epithelial layer (keratitis).
  5. Temar bag infection (chronic).
  6. Infections of the front departments of the eye caused by foreign bodies.
  7. Prevention of bacterial infections before and after operations in the eyes (cataract removal).
  8. Inflammatory states of palpebral, bulbar conjunctiva.
  9. Damage to chemical, thermal agents of the eyes.

Is it possible to give children?

The drug can be taken to children over 8 years old Not more than seven days. Dexamethasone, being glucocorticosteroid, after long-term use reduces immunity. With an increase in the therapeutic dose of Tobramycin, it may be difficult to bring their kidneys. As a result, toxic substances accumulate.

To prevent system side effects, after instillation, the means must not strongly press the finger at the inner edge of the eye, where the tear bag is projected. Thus, the medicine is absorbed in the tissues of the eye without going into the bloodstream. Do not use the medicine more prescribed in the dose instruction.

During pregnancy, prescribed only in severe cases, due to the ability of Tobramycin passes through the placenta barrier. The drug has toxic influence on the ears and kidney of the fetus. Dexamethasone violates the development of the fetus. The decision on the feasibility of appointment takes the attending physician, comparing the risk of side effects to the severity of the disease in a pregnant woman. Nursing mothers for the time of receiving drops must be stopped feeding.

Instructions for use

  • Children up to 8 years old drug is prohibited.
  • Application of the drug no longer than 7 days for children over 8 years old is efficient and safe. (1-2 drops after 4-6 hours).
  • Children over 12 and adult 1-2 drops every 4-6 hours. For the first time, 2 days of treatment may be 1-2 drops every 2 hours.
  • With severe infections of gravity 1-2 drops every 60 minutes, to improvements. Then 3 days 2 drops after 2 hours. Then 5-8 days 1-2 drops after 4 hours.
  • After operations in front of 1 drop 4 times. Duration no more than 24 days.

Side effects

  • Increased pressure in the eye (glaucoma).
  • Point keratitis.
  • Eye pain, burning.
  • Itching century, itchy eyes.
  • Redness of the eyelids.
  • Eye swelling.
  • Hypersensitivity (allergic reactions).
  • Violation of vision.
  • Redness conjunctiva.
  • The narrowing of the lumen of the larynx (laryngospasm).
  • Rinorea.

Rarely: not healing wounds in the eye, secondary infections, due to the reduction of immunity and activation of human conditionally pathogenic microflora.

Contraindications:

  • Allergy.
  • The lesion caused by herpes virus (tree keratitis).
  • Viral eye diseases.
  • Fungal diseases (myoses).
  • Tuberculous eye damage.
  • Eye infections with pus.
  • Up to 8 years in children.

Analogs

According to effects and compositions similar: Floxal, Stylavit, Azelastine, Ey Pi-Vi, Dilaterol, Tobramycin-Gobby, Brumancine, Tobropt, Nezzem, Bramitob, Tobrop, Tabrcin-ADS.

Price of the drug: 300-400 rubles.

  1. Recently he treated his son Cabinutivitis Tobradex. After 3 days passed. The drug fully justifies its price.
  2. My daughter got a barley. I first tried to cure folk medicine. Greed potatoes and applied, but did not help. After I took it to an ophthalmologist who registered Tobradex. He helped her daughter well.
  3. We also treated the eyebound. Already on the second day there was a good result. Tobradex can not take more than 7 days.
  4. The doctor first prescribed sulfacyil, but he did not help. Then the doctor prescribed her Tobradex, saying that he was stronger. The drug really helped quickly.
  5. The daughter has blushed eyes. At first I thought she was getting out of him. But he began to hurt and we went to the clinic, where the doctor appointed Tobradex. The medicine helps very well.