Tobradex after opening. Tobradex eye drops - what is eye medicine prescribed for


Tobradex- a combined preparation containing corticosteroid and antimicrobial components. The drug has a pronounced anti-inflammatory and bactericidal action. Tobradex contains two active ingredients - dexamethasone and tobramycin.
Tobramycin is a broad-spectrum antibiotic. Tobramycin is active against strains of most microorganisms that cause infectious diseases eye.
Dexamethasone - corticosteroid medicinal substance, which has an anti-inflammatory effect.

Indications for use

Tobradex is intended for the treatment of patients suffering from inflammatory diseases of the eye, which are accompanied or not accompanied by a superficial bacterial infection, including blepharitis, conjunctivitis and keratitis (without compromising the integrity of the epithelium). Tobradex can also be used for the treatment and prevention of infectious and inflammatory eye diseases in patients who have undergone surgery (for example, cataract removal, removal foreign body). Tobradex can be prescribed 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 conjunctival sac. Before using Tobradex, it is recommended to wash your hands thoroughly and shake the vial with the drug until an equilibrium suspension is formed. The required number of drops is introduced into the conjunctival sac, slightly throwing the head back and gently pulling the lower eyelid. Immediately after the instillation of the drops, close your eye and gently press your finger on the inner corner of the eye. When applying drops, avoid contact of the dropper tip with skin, eyelashes and mucous membrane of the eye. After applying the drops, carefully close the bottle with a lid. The duration of the 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 in the affected eye every 4-6 hours. In case of missing the next dose of the drug, drops should be applied as early as possible, if less than 1 hour is left before the planned use of the next dose, the dose that was forgotten is skipped. Doubling the dose is not recommended.
Eye ointment Tobradex :
The drug is intended for introduction into the conjunctival sac. Wash your hands thoroughly before applying the ointment. To apply the ointment, the head is tilted back somewhat, 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. Do not allow the tip of the tube to come into contact with the skin, eyelashes and mucous membranes of the eye. After applying the ointment, carefully close the tube with a cap. The duration and scheme of application of Tobradex ophthalmic ointment is determined by the doctor.
As a rule, the application of the ointment is prescribed 3-4 times a day in the affected eye. An interval of at least 6 hours between application of the ointment should be observed. If the next dose is missed, the eye ointment is used as early as possible, but not less than 1 hour before the next dose. If the missed dose is remembered less than 1 hour before the next dose, only the planned dose is used. Do not double the dose of Tobradex.

Side effects

Tobradex well tolerated by patients. Reported rare cases the development of such undesirable effects when using eye ointment and eye drops Tobradex:
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: swelling of the face, pruritus, rash, erythema.
Others: nausea, vomiting, bitter taste in the mouth, dizziness, headache, rhinorrhea, laryngospasm. In addition, patients with thinning of the sclera may develop perforation (the risk increases with prolonged use). It is impossible to exclude the development of a secondary infection (caused by microorganisms insensitive to the action of tobramycin) when using the drug Tobradex.

Contraindications

:
Tobradex contraindicated in patients with individual intolerance to tobramycin and dexamethasone. Eye drops should not be administered to patients with hypersensitivity to benzalkonium chloride; 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; with uncomplicated removal of a foreign body from the eye; for the treatment of children under the age of 1 year.
Caution should be observed when prescribing 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 the period of therapy with Tobradex.

Pregnancy

:
It is contraindicated to use the drug Tobradex during lactation and pregnancy. Before prescribing the drug to women of childbearing age, pregnancy should be excluded.

Interaction with other drugs

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

Overdose

:
Data on drug overdose Tobradex no. When using high doses, it is possible to increase the severity of undesirable effects. When using high doses of eye drops or eye ointment Tobradex, rinse the eye with plenty of clean running water and consult a doctor.

Release form

Eye ointment 3.5 g in aluminum tubes, 1 tube is enclosed in a cardboard box.
Suspension (eye drops) of 5 ml in dropper bottles made of polymeric materials, 1 bottle is enclosed in a cardboard box.

Storage conditions

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

Compound

:
1g eye ointment Tobradex contains:
Dexamethasone - 1mg;
Tobramycin - 3 mg;
Additional ingredients.

1ml suspensions (eye drops) Tobradex contains:
Dexamethasone - 1mg;
Tobramycin - 3 mg;
Additional ingredients including benzalkonium chloride.

Instructions for use:

Tobradex - combined local drug with anti-inflammatory and antibacterial action, used in ophthalmology.

Release form and composition

Dosage forms of Tobradex release:

  • eye drops: suspension from almost white to white (5 ml each in plastic Drop Tainer bottles, in a carton box 1 dropper bottle);
  • eye ointment: homogeneous, almost white or white (in aluminum tubes of 3.5 g, in a cardboard box 1 tube).

Active ingredients in 1 ml drops and 1000 mg ointment:

  • tobramycin - 3 mg;
  • dexamethasone - 1 mg.

Auxiliary components:

  • drops (1 ml): hydroxyethylcellulose (gietellose) - 2.5 mg; benzalkonium chloride - 0.1 mg (as a solution); edetate disodium - 0.1 mg; sodium chloride - 3 mg; tyloxapol - 0.5 mg; anhydrous sodium sulfate - 12 mg; sulfuric acid and / or sodium hydroxide - to bring the pH; purified water - up to 1 ml;
  • ointment: liquid paraffin (mineral oil), chlorobutanol (anhydrous chlorobutanol), white petrolatum.

Indications for use

  • inflammatory diseases of the eyes and their appendages, which are caused by pathogens sensitive to the active substances of Tobradex, including keratoconjunctivitis, blepharitis, conjunctivitis, keratitis, blepharoconjunctivitis, iridocyclitis (treatment);
  • inflammation in the postoperative period after cataract extraction (treatment and prevention).

Contraindications

  • fungal / purulent eye diseases;
  • mycobacterial eye infections;
  • viral eye diseases, including keratitis caused by Herpes simplex, chickenpox;
  • conditions after removal of a foreign body of the cornea;
  • lactation period;
  • age up to 12 years (drops) or 18 years (ointment);
  • individual intolerance to the components of the drug.

Tobradex is prescribed to pregnant women only in cases where the expected benefit is higher than the possible harm (due to the lack of necessary clinical data to evaluate its effectiveness / safety).

Method of application and dosage

Tobradex is applied topically (in the conjunctival sac).

Eye drops

In the first 2 days of therapy, the frequency of use can be increased (every 2 hours), then gradually, as the severity of the inflammatory process decreases, the frequency is reduced to the standard.

In the treatment of an acute severe infectious process, the following dosing regimen is indicated (single dose - 1-2 drops):

  • until the severity of the condition decreases: every 60 minutes;
  • for 3 days: every 2 hours;
  • for 5-8 days: every 4 hours.

If necessary, the course can be continued for another 5-8 days.

WITH preventive purpose in the postoperative period, Tobradex is prescribed 1 drop 4 times a day. Therapy begins on the day of surgery, the duration of the course is 24 days. The total duration of the course does not change if the drug is started 1 day before the operation. If necessary, during the first 2 days after surgery, a single dose can be increased to 2 drops, the frequency of use - every 2 hours.

Shake the bottle with drops before use.

To reduce the likelihood of developing systemic adverse reactions (by reducing the systemic absorption of the drug), after instillation of Tobradex, it is recommended to lightly press a finger at the inner corner of the eye on the area of ​​​​the projection of the lacrimal sacs for 1-2 minutes for 1-2 minutes.

Eye ointment

A single dose of ointment is a strip 1.5 cm long, the frequency of application is 3-4 times a day. As the severity of the process decreases, the frequency of application is reduced.

Combined application

Scheme of the combined use of Tobradex:

  • drops: throughout the day;
  • ointment: in the evening before going to bed.

The total frequency of use of the drug is 3-4 times a day.

Side effects

Possible violations (> 10% - very often; > 1% and< 10% – часто; >0.1% and< 1% – нечасто; >0.01% and< 0,1% – редко; < 0,01% – очень редко; с неизвестной частотой – в случаях невозможности определить частоту появления по имеющимся сведениям):

  • local reactions: often - a feeling of discomfort in the eyes, pain and irritation of the eyes; rarely - increased intraocular pressure, allergic reactions and hypersensitivity, keratitis (including punctate), eyelid erythema, itching, conjunctival hyperemia, blurred vision, foreign body sensation in the eye, conjunctival/eyelid edema, dry eye syndrome, increased lacrimation; with an unknown frequency - a decrease in visual acuity, the development of cataracts and glaucoma, photophobia, mydriasis;
  • systemic reactions: rarely - laryngospasm, dysgeusia, headache, rhinorrhea.

With a long course (longer than 24 days) or an increase in the frequency of Tobradex instillations, the following may be observed adverse reactions: posterior subcapsular cataract, an increase in intraocular pressure with the possible subsequent occurrence of steroid glaucoma, a slowdown in the healing process of wounds (in diseases that cause thinning of the cornea, its perforation is possible).

As a result of the local immunosuppressive action of glucocorticosteroids, secondary bacterial infection may develop. In most cases fungal infections corneas occur with prolonged use of glucocorticosteroids. Evidence of the development of a fungal infection is the appearance of non-healing ulcers on the cornea after prolonged treatment with glucocorticosteroids. At purulent diseases eyes in an acute course, glucocorticosteroids can enhance / mask the existing infectious process.

special instructions

The eye drops contain benzalkonium chloride, which can be absorbed by contact lenses. In this regard, before using the drug, it is recommended to remove contact lenses. You can install them again 20 minutes after using the drug.

If therapy is carried out for more than 14 days, monitoring of the condition of the cornea is required.

At combined application with systemic aminoglycoside antibacterial drugs you need to control the overall picture of the blood.

To avoid contamination, do not touch the tip of the dropper bottle containing the drops and the tube containing the ointment to any surface. The bottle and tube must be closed after each use.

In cases of decreased visual acuity after the use of Tobradex, you should not drive vehicles until it is fully restored.

drug interaction

At combination therapy with other local ophthalmic drugs, the interval between their use should be at least 5 minutes.

Analogues

Analogues of Tobradex are: DexTobropt, Tobrazon.

Terms and conditions of storage

Store at 8-27°C. Keep away from children. The dropper bottle containing the drops should be stored upright.

Shelf life - 2 years.

Drops after opening the package can be used for 1 month.

Tobradex - combined medicinal product anti-inflammatory and antibacterial action for local use in ophthalmic practice.

Release form and composition

Tobradex is available in the following forms:

  • eye drops: white or almost white suspension (5 ml each in Droptainer polyethylene dropper bottles, one bottle in a cardboard box);
  • eye ointment: white or almost white homogeneous mass (3.5 g each in aluminum tubes with a plastic screw cap, one tube in a cardboard box).

Composition of 1 ml drops:

  • auxiliary components: disodium edetate, anhydrous sodium sulfate, benzalkonium chloride, hydroxyethylcellulose, sodium chloride, tyloxapol, purified water, sodium hydroxide and / or sulfuric acid to bring to the required pH level.

Composition of 1 g of ointment:

  • active ingredients: dexamethasone - 1 mg; tobramycin - 3 mg;
  • auxiliary components: liquid paraffin, chlorobutanol, white petrolatum.

Indications for use

Tobradex is used for the following inflammatory diseases of the eye and its appendages, the causative agents of which are microorganisms sensitive to the drug:

  • conjunctivitis;
  • iridocyclitis;
  • blepharitis;
  • keratitis (without damage to the epithelium);
  • blepharoconjunctivitis;
  • keratoconjunctivitis.

The drug is also used for the prevention and treatment of inflammatory processes after surgical removal cataracts.

Contraindications

  • purulent eye diseases;
  • viral eye diseases (including chickenpox and keratitis caused by Herpes simplex);
  • fungal diseases of the eyes;
  • mycobacterial eye infections;
  • children's age up to 12 years (for Tobradex in the form of drops);
  • children's and adolescence up to 18 years (for Tobradex in the form of an ointment);
  • condition immediately after removal of a foreign object of the cornea;
  • breastfeeding period;
  • hypersensitivity to individual components of the drug.

In pregnant women, Tobradex is used only as directed by the attending physician and in cases where the expected benefit to the mother outweighs the risk of potential side effects at the fetus.

Method of application and dosage

Eye drops

Tobradex in the form of eye drops is applied topically. The bottle must be shaken before each use.

For adults and children over 12 years of age, the drug is instilled into the conjunctival sac every 4-6 hours, 1-2 drops. In the first two days of treatment, you can increase the frequency of instillations by instilling Tobradex every 2 hours. As inflammation decreases, the frequency of instillation is reduced.

In an acute severe infectious process, the drug is instilled every hour until the condition improves. After that, for 3 days, instillations are carried out every 2 hours, on days 5–8 - every 4 hours. If necessary, the use of the drug is continued for another 5-8 days. A single dose remains unchanged - 1-2 drops in the conjunctival sac.

To prevent inflammatory processes after surgery, Tobradex is instilled 4 times a day, 1 drop into the conjunctival sac, starting from the day of surgery and up to 24 days. Treatment can be started 1 day before the planned surgical intervention (1 drop 4 times a day), then instill 1 drop into the conjunctival sac on the day of surgery, and then use the drug 1 drop 4 times a day for 23 days.

To reduce the systemic absorption of Tobradex and reduce the risk of systemic adverse reactions, it is recommended to lightly press your fingers on the area of ​​the lacrimal sacs closer to the inner corner of the eye within 1-2 minutes after instillation.

Eye ointment

Tobradex ophthalmic ointment is applied topically.

A single dose of the drug is a strip of ointment 1.5 cm long. It is placed in the conjunctival sac 3-4 times a day. With a decrease in inflammation, the frequency of application of the ointment is reduced.

Drops can be combined with the use of Tobradex ointment: drops are used during the day, ointment - at bedtime. At the same time, the frequency of using the drug should be maintained, that is, there should be at least 3-4 procedures per day.

Side effects

Local side effects:

  • 1-10% of cases - pain, discomfort and irritation in the eyes;
  • 0.1-1% of cases - increased intraocular pressure, eyelid erythema, increased lacrimation, conjunctival hyperemia, blurred vision, keratitis (including pinpoint), itching, swelling of the conjunctiva and eyelids, sensation of a foreign object in the eye, dry eye syndrome, allergic reactions and hypersensitivity;
  • frequency unknown - decreased visual acuity, photophobia, development of cataracts and glaucoma, mydriasis.

Systemic side effects:

  • 0.1-1% of cases - laryngospasm, headache, rhinorrhea, impaired taste perception;
  • an increase in the frequency of instillations or treatment for more than 24 days - a slowdown in the healing process of wounds (perforation of the cornea is possible in diseases that cause its depletion), posterior subcapsular cataracts, an increase in intraocular pressure (steroid glaucoma may develop in the future).

During treatment with Tobradex, especially long-term, a secondary bacterial infection may occur, since glucocorticosteroids have a local immunosuppressive effect. Non-healing ulcers on the cornea, which appeared after prolonged therapy with glucocorticosteroids, may be signs of the development of a fungal infection. The drug can mask or increase the existing inflammation in acute purulent infections of the eye.

special instructions

Tobradex drops contain benzalkonium chloride, which can be absorbed by contact lenses. Before instillation of the drug, it is necessary to remove contact lenses and install them back 20 or more minutes after instillation.

When using the drug for more than 14 days, monitoring of the condition of the cornea is required.

Do not touch the tip of the dropper bottle or tube to any surfaces, otherwise the dropper bottle or tip of the tube and their contents may be contaminated.

The bottle or tube must be closed each time after use.

In adolescents aged 12-18 years, the duration of treatment with Tobradex drops should not exceed 7 days.

With a temporary decrease in visual clarity after the use of the drug, it is necessary to refrain from driving vehicles and other mechanisms until normal vision is fully restored.

drug interaction

There should be an interval of at least 5 minutes between the instillation of Tobradex drops and the use of other local ophthalmic agents.

With simultaneous use with systemic aminoglycosides, it is necessary to control hematological blood counts.

Terms and conditions of storage

Store at +8… +27 °C. Keep away from children. The opened vial must be used within 1 month.

Shelf life - 2 years.

3164 09/18/2019 4 min.

For eye inflammation, doctors often prescribe eye drops Tobradex. This drug has a combined effect. It is also recommended for the prevention of the development of secondary infections in the postoperative period.

This article will discuss in detail the instructions for using Tobradex eye capellas. You will learn about the indications and contraindications for their use, as well as possible side effects.

Description of the drug

Tobradex- These are eye drops with antibacterial and anti-inflammatory effects for topical use in ophthalmology. They include a broad-spectrum antibiotic (toramycin) and a glucocorticosteroid (dexamethasone). These are the two main active ingredients of the drug.

During the instillation of Tobradex into the eyes, contact lenses should be removed, as they create a barrier to the penetration of the active substances of the drug. You can put them on in fifteen to twenty minutes.

It must be remembered that with the simultaneous use of Tobradex with antibiotics of the aminoglycoside group, it is required to control the picture of peripheral blood.

One to two drops should be instilled every four to six hours, the medicine should fall into the conjunctival sac. In the first two days, the dosage can be increased to one or two drops with a time interval of two hours (if there are special indications).

Treatment lasts until the symptoms of eye inflammation disappear completely. Its duration is determined by the doctor. Looks like eye drops

You can buy Tobradex by prescription at a pharmacy.

After opening, the drug can be used for no longer than one month. Tobradex should be stored at room temperature, shelf life is two years.

Pharmacological action and group

Tobradex is prescribed for the treatment of bacterial inflammation of the eyes. As mentioned earlier, it contains the antibiotic tobramycin and the glucocorticosteroid dexamethasone. The action of this drug is based on the properties of its constituent components. Tobramycin has an antimicrobial effect against gram-negative and gram-positive bacteria, and dexamethasone has an anti-inflammatory, desensitizing and antihistamine effect.

Tobradex does not slow down the processes of restoration of the cornea of ​​the eyes, therefore it can be used in the postoperative period.

Tobradex is effective against the following bacteria:

  • Staphylococci (golden, epidermal).
  • Hemolytic species of type A streptococci and microorganisms of this family (the causative agent of typical lobar pneumonia).
  • Pseudomonas aeruginosa, hemophilic, Escherichia coli.
  • Klebsiella pneumonia.
  • Enterobacteriaceae are anaerobic.
  • Morganella blinking.
  • Koch-Wicks bacteria and so on.

This drug has low systemic absorption when used topically.

Indications and contraindications for use

Indications for the use of Tobradex eye drops:

  1. Bacterial eye infections.
  2. (inflammation of the eyelid).
  3. conjunctivitis ().
  4. Keratitis without damage to the epithelium, viral keratitis.
  5. Traumatic eye injuries.
  6. Prevention of infections in the postoperative period.

If you do not know where to go with an eye injury, read on.

Contraindications for use:

  1. Individual intolerance to the components that make up the drug.
  2. Viral diseases of the eye (keratitis caused by the smallpox or herpes virus).
  3. Mycobacterial eye infection (causative agent is Koch's bacillus or Mycobacterium tuberculosa).
  4. Conservative treatment after surgery to remove a foreign body from the cornea.
  5. Fungal diseases of the eyes.
  6. Purulent pathologies.

What not to do after eye surgery, read.

Tobradex should be used with extreme caution and only under the supervision of a specialist in glaucoma and hereditary or acquired thinning of the cornea.

During pregnancy

There is not enough information on the use of Tobradex eye drops during pregnancy.

It is allowed to use this drug only if the expected therapeutic effect for a pregnant woman outweighs the risk of possible side effects in the fetus. The same applies to the period of breastfeeding.

To small children

Tobradex can be used by children from the age of twelve. The drug is completely contraindicated for babies under one year old.

The duration of treatment with Tobradex eye drops should not exceed seven days.

Children over twelve years of age are instilled one or two drops into the conjunctival sac every four to six hours.

Possible complications caused by the drug

Most often, eye treatment with this drug passes without any complications, since the main active substances are well tolerated by the body.

Rarely, the following side effects may occur:

  1. An allergic reaction, accompanied by itching, redness, swelling of the eyelids, conjunctiva, face, as well as the appearance of a rash.
  2. Increased intraocular pressure.
  3. Sensation of a foreign body in the eye.
  4. Decreased visual acuity.
  5. Fear of the world.
  6. Prolonged pupil dilation ().
  7. subcapsular cataract.
  8. Slowdown of reparative and regenerative processes in open wounds.
  9. Dizziness, headaches.
  10. Bitter taste in the mouth.
  11. Laryngospasm.
  12. Rhinorrhea.
  13. Perforation of the sclera (in the presence of hereditary or acquired thinning of the sclera).
  14. Secondary infection (the drug may weaken the immune system in relation to fungal infections).

In case of an overdose, conjunctival hyperemia, punctate keratitis, erythema, increased lacrimation, edema and itching of the eyelids may occur. In this case, it is recommended to rinse the eyes with warm water and carry out symptomatic treatment.

Video

conclusions

Tobradex combined eye drops have an antibacterial anti-inflammatory effect. Their use can significantly reduce the risk of infection and eliminate the main cause of inflammatory eye disease.

It must be remembered that when using this drug with other eye drops or ointments, the interval between their applications should be at least five minutes.

The bottle with drops must be closed after each use. And it needs to be shaken before use. When instilling, do not touch the tip of the pipette to the eye.

Indications for the use of Tobradex are inflammatory diseases anterior eye caused by tobramycin-sensitive bacteria, as well as the prevention of post-traumatic and postoperative bacterial infections of the anterior eyeball.

Also read about Tsiprolet's drops.

Compound

Active ingredients: tobramycin, dexamethasone; 1 ml suspension contains tobramycin 3 mg and dexamethasone 1 mg

Excipients: benzalkonium chloride, sodium edetate, sodium chloride, anhydrous sodium sulfate, tyloxapol, hydroxyethylcellulose, sulfuric acid and / or sodium hydroxide, purified water.

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Dosage form

Eye drops.

Basic physical and chemical properties: white or almost white suspension.

Pharmacological group

Anti-inflammatory and antimicrobials in combination. Corticosteroids and antimicrobials in combination.

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Pharmacological properties

Pharmacological.

dexamethasone

The efficacy of corticosteroids for the treatment of anti-inflammatory conditions of the eye is well established. Corticosteroids achieve their anti-inflammatory action by suppressing the adhesion of molecules in vascular endothelial cells, cyclooxygenase I or II, and the release of cytokines. As a result, the formation of inflammatory mediators decreases and the adhesion of circulating leukocytes to vascular endothelium, which prevents their penetration into the inflamed tissues 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 drugs.

tobramycin

Tobramycin is a highly active fast-acting bactericidal aminoglycoside antibiotic that counteracts both gram-positive and gram-negative microorganisms. Its mechanism of action is associated with the inhibition of the complex of polypeptides and synthesis in the ribosomes of bacterial cells.

In general, the action of tobramycin is described in vitro by determining the minimum inhibitory concentration (MIC), which determines the activity of the antibiotic for each type of bacteria. Since the MIC of tobramycin is very low against most ocular pathogens, it is considered a broad-spectrum antibiotic. Critical MIC values ​​were determined, which determine the sensitivity or resistance of a bacterial culture to a particular antibiotic. The current critical MIC value for tobramycin is relative to certain types bacteria takes into account the sensitivity of the species, as well as the maximum concentration and pharmacokinetic values ​​of the time / concentration dependence, measured in serum after oral administration. The determination of these critical values, separating microorganisms into susceptible and resistant, was used to determine the clinical effectiveness of antibiotics that were used systemically. However, when topical application antibiotic in high concentrations directly to the site of infection, the definition of critical values ​​\u200b\u200bis not used. Most organisms that could be classified as resistant by systemic cut-off values ​​actually respond well to local treatment. The purpose of prevention is the ability to stop the development of such microorganisms that cause infection.

During clinical research Topically applied tobramycin solution was effective against many existing strains of eye pathogens in study patients. Some of these eye pathogens are believed to be resistant based on systemic cut-off values. Tobramycin has been shown in clinical studies to be effective in the treatment of superficial infections of the eye caused by the following pathogens.

Gram-positive bacteria:

Staphylococcus aureus (methicillin sensitive or resistant*)

Staphylococcus epidermidis (methicillin sensitive or resistant*)

Other coagulase-negative Staphylococcus species

Streptococcus pneumoniae (penicillin sensitive or resistant*)

Other types of Streptococcus

* Beta-lactam (ie, methicillin; penicillin) resistance phenotype is not associated with aminoglycoside resistance phenotype and both are not associated with pathogen virulence and phenotypes. Many methicillin-resistant staphylococci have been found to be resistant to tobramycin (and other aminoglycoside antibiotics). However, these resistant staphylococcal cultures (as defined by critical MIC values) generally respond well to topical tobramycin treatment.

Gram-negative bacteria:

Acinetobacter spp.

Citrobacter spp.

Enterobacter spp.

Escherichia coli

haemophilus influenzae

Klebsiella pneumoniae

Morganella morganii

Proteus mirabilis

Pseudomonas aeruginosa

Serratia marcescens

Bacterial susceptibility studies have shown that, in some cases, gentamicin-resistant organisms remain susceptible to tobramycin. In a significant part of the microflora, resistance to tobramycin has not yet developed; however, bacterial resistance may develop with long-term use.

Cross-sensitivity to other aminoglycoside antibiotics may occur. In the event of hypersensitivity when using the drug, stop using it and conduct appropriate treatment.

Pharmacokinetics.

dexamethasone

Systemic exposure to dexamethasone after topical ophthalmic application of tobradex ® eye drops is low. Peak plasma levels ranged from 220 to 888 pg/ml (mean 555 ± 217 pg/ml) after one drop of Tobradex ® was instilled into each eye 4 times daily for two consecutive days.

Dexamethasone is excreted from the body by metabolism. Approximately 60% of the dose is excreted in the urine as 6-β-hydroxydexamethasone. No unchanged dexamethasone was found in the urine. The plasma half-life is relatively short - 3-4 hours.

Dexamethasone is approximately 77-84% bound to serum albumin. Clearance ranges from 0.111 to 0.225 l/h/kg and volume of distribution ranges from 0.576 to 1.15 l/kg. Bioavailability at oral administration is approximately 70%.

tobramycin

Systemic exposure to tobramycin after topical ophthalmic use of Tobradex ® eye drops is low. Plasma levels of tobramycin were not quantifiable in 9 of 12 patients treated with Tobradex® Eye Drops, one drop in each eye 4 times daily for two consecutive days. The highest measured level was 0.25 µg/ml, which is 8 times lower than the 2 µg/ml concentration, which is known to be below the risk limit for nephrotoxicity.

Tobramycin is rapidly and actively excreted in the urine by glomerular filtration, mainly unchanged. The plasma elimination half-life is approximately 2:00 with a clearance of 0.04 l/h/kg and a volume of distribution of 0.26 l/kg. Plasma protein binding to tobramycin is insignificant - less than 10%. Oral bioavailability of tobramycin is low (<1%).

Preclinical safety data

Safety Data

Data on systemic toxicity of active substances are well studied. Systemic exposure to tobramycin at toxic doses far in excess of the topical ocular dose may be associated with nephrotoxicity and ototoxicity. Systemic exposure to dexamethasone may be associated with effects related to corticosteroid imbalance. Repeated dose toxicity studies with Tobradex® Eye Drops in rabbits have found systemic effects associated with corticosteroids, but even at doses substantially higher than the human dose, this is of little clinical relevance. When using Tobradex ® at the recommended doses, these effects are unlikely to occur.

mutagenicity

Studies in vitro and in vivo of each of the active substances did not reveal a mutagenic effect.

teratogenicity

Tobramycin crosses the placenta into the fetal circulation and amniotic fluid. Animal studies with systemic use of high doses of tobramycin in pregnant animals during organogenesis have found renal toxicity and fetal ototoxicity. Other studies in rats and rabbits using tobramycin at doses greater than 100 mg/kg/day parenterally (>400 times the maximum clinical dose) did not reveal any cases of impaired fertility or harmful effects on the fetus.

Corticosteroids have been found to be teratogenic in animal studies. The use of 0.1% dexamethasone in the eyes of pregnant rabbits has led to an increase in cases of fetal developmental disorders and intrauterine growth retardation. Fetal growth retardation and increased mortality have been observed in rats with long-term dexamethasone therapy.

Tobradex ® should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

No studies have been conducted to assess the carcinogenic effect of Tobradex ® .

Indications

Inflammation of the eyes in steroid-sensitive patients in whom corticosteroids are indicated and there is a superficial bacterial infection or risk of developing bacterial infection eyes. These inflammatory processes may occur after surgery or may be caused by an infection, a foreign body in the eye, or an eye injury.

Contraindications

  • Hypersensitivity to active ingredients or to any component of the drug.
  • Keratitis caused by the herpes simplex virus.
  • Cowpox, chicken pox and other viral infections of the cornea and conjunctiva.
  • Fungal diseases of the structures of the eye.
  • Mycobacterial infections of the eye.

Interaction with other medicinal products and other forms of interaction

The simultaneous administration of topical steroids and topical NSAIDs may increase the risk of complications in the healing of corneal wounds.

Concomitant and / or sequential use of aminoglycoside antibiotics (such as tobramycin) and other systemic oral or topical drugs that have a toxic (harmful) effect on nervous system, hearing organs or kidneys, may lead to additive toxicity, therefore, if possible, such use should be avoided.

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

Application features

For ophthalmic use only.

After opening the vial, remove the protective ring designed to control the opening.

Some patients may be hypersensitive to topical aminoglycosides. In the event of a hypersensitivity reaction, the drug should be discontinued.

Cross-sensitivity to other aminoglycosides may occur. Consideration should be given to the possibility that patients with hypersensitivity to topical tobramycin may also be sensitive to other topical or systemic aminoglycosides.

Serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity, have been reported in patients receiving systemic aminogligoside therapy. When used simultaneously with systemic aminoglycosides, caution should be exercised.

Long-term treatment with topical ophthalmic corticosteroids can lead to ocular hypertension and/or glaucoma with damage to the optic nerve, deterioration of visual acuity and visual field, and the formation of subcapsular cataracts of the posterior chamber of the eye. Patients receiving corticosteroid therapy in the eye should be monitored regularly and repeatedly. intraocular pressure. This is especially important in children, as the risk of corticosteroid-induced intraocular pressure may be greater in children and appear earlier than in adults.

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

GCS can reduce resistance to bacterial, fungal or viral infections and prevent the detection of such infections and mask Clinical signs infections.

With persistent formation of corneal ulcers, the possibility of a fungal infection should be considered. In the event of a fungal infection, corticosteroid therapy should be discontinued.

Long-term use of antibiotics such as tobramycin may cause overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Corticosteroids for ophthalmic use may delay the healing of corneal wounds. Topical NSAIDs are also known to slow or delay wound healing. The simultaneous appointment of topical NSAIDs and topical steroids may increase the risk of complications in wound healing (see Section "Interaction with other medicinal products and other forms of interaction").

In the presence of diseases leading to thinning of the cornea or sclera, topical steroids may cause perforation.

Tobradex ® , eye drops containing benzalkonium chloride, which can cause eye irritation and is known to discolor soft contact lenses. Contact with soft contact lenses should be avoided. If the patient is allowed to wear contact lenses, he should be warned to remove contact lenses before using Tobradex ® eye drops and wait at least 15 minutes before putting the contact lenses back on.

Use during pregnancy or lactation.

reproductive function

No studies have been conducted to evaluate the effect on human fertility with topical application of Tobradex ® , eye drops.

pregnancy

There are no or limited data from the use of tobramycin or dexamethasone in pregnant women. Animal studies of reproductive toxicity following systemic administration of corticosteroids and tobramycin. The use of Tobradex ® during pregnancy is not recommended.

lactation

It is not known whether tobramycin and dexamethasone are ingested breast milk with topical ophthalmic use. Corticosteroids and tobramycin pass into breast milk after systemic use. A risk to a breastfed baby cannot be ruled out.

Since many medicines pass into breast milk, consideration should be given to temporarily stopping breastfeeding while using Tobradex ® .

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Tobradex ® , eye drops, has no or negligible effect on the ability to drive vehicles or operate other mechanisms. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs during instillation, the patient should wait until the vision is clear before driving or using machines.

Dosage and administration

For ophthalmic use.

Use in adults, including elderly patients, children aged 12 to 18 years

Instill 1 or 2 drops into the conjunctival sac(s) every 4-6 hours. During the first 24-48 hours, the dose may be increased to 1 or 2 drops every 2 hours. The frequency of use of the drug should be gradually reduced with the improvement of clinical signs. You should be careful not to stop therapy prematurely.

At serious illnesses instill 1 or 2 drops every hour until inflammation is controlled, and gradually reduce the frequency of application to 1 or 2 drops every 2:00 for 3 days after that, instill 1-2 drops every 4:00 for 5-8 days and at the end - 1-2 drops every day for the last 5-8 days, if necessary.

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

It is recommended to press the site of the nasolacrimal opening and carefully close the eyelids after instillation. This reduces the systemic absorption of the drug injected into the eye, which reduces the likelihood of systemic side effects.

application to children

The data obtained confirm the safety and efficacy of the drug in children aged 1 year and older, who used the drug for 7 days to treat superficial inflammation of the eye of bacterial origin.

May be used in children who need cataract surgery.

In violation of the function of the liver and kidneys

Tobradex ® has not been studied for this category of patients. However, due to the low systemic absorption of tobramycin and dexamethasone after topical application of the drug, there is no need to adjust the dose.

mode of application

Shake the bottle well before use.

To prevent contamination of the dropper tip and the contents of the vial, care must be taken not to touch the eyelids and other surfaces with the tip of the dropper vial.

Store the vial in an upright position.

The data obtained confirm the safety and efficacy of the drug in children over the age of 1 year.

Safety and efficacy in children under 1 year of age have not been established.

Overdose

Given the characteristics of this drug, intended for topical use, no toxic effect is expected either when it is used in ophthalmology at recommended doses, or if the contents of the vial are accidentally swallowed. Possible clinical signs and symptoms of an overdose of the drug (punctate keratitis, erythema, increased lacrimation, swelling and itching of the eyelids) may be similar to the side effects that were observed in some patients.

In case of overdose with Tobradex ® when applied topically, wash the excess drug from the eye(s) with warm water.

Adverse reactions

In clinical studies, the most common adverse reactions were eye pain, increased intraocular pressure, eye irritation and eye itching, which occurred in less than 1% of patients.

When conducting clinical studies of eye drops tobradex ®, the following adverse reactions were reported, which were evaluated by 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 the results of post-marketing studies, the following adverse reactions have been found.

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

table 2

Description of some adverse reactions

Prolonged use of topical corticosteroids in the eye can lead to an increase in intraocular pressure with subsequent damage to the optic nerve, deterioration in visual acuity and visual field impairment, as well as the formation of posterior subcapsular cataracts and delayed wound healing (see section "Peculiarities of use").

Since the drug contains corticosteroids, in the presence of diseases leading to thinning of the cornea or sclera, the risk of perforation increases, especially after prolonged use (see section "Peculiarities of use").

Possible development of secondary infections after the use of combinations containing corticosteroids and antimicrobial substances. Fungal infections of the cornea develop especially actively with prolonged use of steroids. (See section “Application Features”).

Serious adverse reactions, including neurotoxicity, ototoxicity and nephrotoxicity, have occurred in patients treated with systemic therapy with tobramycin (see section "Peculiarities of use").

Some adverse reactions such as corneal abrasion, blurred vision, conjunctival edema, eyelid disorders, eye discharge, eyelid itching, urticaria, dermatitis, madarosis, leukoderma, dry skin have been observed during tobramycin therapy.

Package

5 ml of the drug is placed in a Drop-Taner® dropper bottle made of low-density polyethylene with a polypropylene cap. 1 bottle in a cardboard box made of packaging cardboard.