Instruction for use: Tobrason

Active substance Dexamethasone + Tobramycin

ATX code S01CA01 Dexamethasone in combination with antimicrobials

Pharmacological group

Glucocorticosteroids in combinations

Ophthalmic agents in combination

Nosological classification (ICD-10)

H01.0 Blepharitis

Blepharitis, Inflammation of the eyelids, Inflammatory diseases of the eyelids, Demodectic blepharitis, Superficial bacterial infection of the eyes, Superficial infection of the eye, Scaly blepharitis

H10.1 Acute atopic conjunctivitis

Allergic conjunctivitis, Allergic eye disease, Allergic conjunctivitis, Allergic conjunctivitis is caused by chemical and physical factors, Allergic rhinoconjunctivitis,Allergic inflammation of the eye, Spring catarrh, Spring keratitis, Spring conjunctivitis, allergic Conjunctivitis, Perennial allergic conjunctivitis,Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic keratoconjunctivitis, Acute allergic conjunctivitis,Superficial bacterial eye infections,rhinoconjunctivitis, Seasonal allergic conjunctivitis, Seasonal conjunctivitis, Sennoz, Chronic allergic keratoconjunctivitis, Chronic allergic conjunctivitis

H10.5 Blepharoconjunctivitis

Chronic Blepharoconjunctivitis, Blepharoconjunctivitis, Staphylococcal blepharoconjunctivitis

H10.9 Conjunctivitis, unspecified

Trahomny conjunctivitis, catarrhal conjunctivitis, Giperpapillyarny conjunctivitis, Non-infectious conjunctivitis, purulent conjunctivitis, Purulent conjunctivitis form, Year-round conjunctivitis, purulent conjunctivitis, Subacute conjunctivitis, Secondarily infected with conjunctivitis

H16 Keratitis

Adenoviral keratitis, Bacterial keratitis, Spring keratitis, Deep keratitis without epithelial damage, Discoid keratitis, Dendritic keratitis, Keratitis rosacea, Keratitis with destruction of the cornea, Superficial keratitis, Point keratitis, Traumatic keratitis, Superficial point keratitis

T81.4 Infection associated with the procedure, not elsewhere classified

Postoperative infections, Infection of a postoperative wound, Postoperative infection

Composition and form of release

1 ml of the solution contains tobramycin sulfate 3 mg, dexamethasone sodium phosphate 1 mg, as well as excipients: benzalkonium chloride, sodium dihydrogen phosphate, disodium EDTA (ethylenediaminetetraacetic acid), sodium chloride, creatinine, propylene glycol, sodium hydroxide, sulfuric acid, water for injection; In a polyethylene bottle 5 ml, in a cardboard bundle 1 bottle.

pharmachologic effect

Pharmacological action - antibacterial broad spectrum, anti-inflammatory local.

Tevomycin (II generation aminoglycoside) blocks the 30-S subunit of ribosomes and stops protein synthesis, at higher concentrations disrupts the function of cytoplasmic membranes, causing cell death. It is active against Gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis, Citrobacter spp., Enterobacter spp.) And Gram-negative bacteria (Escherichia coli, Klebsiella spp., Morganella morganii, Pseudomonas aeruginosa, Proteus mirabilis, Proteus vulgaris, Providencia spp., Serratia spp. ). Dexamethasone (fluorinated glucocorticoid) interacts with specific cytoplasmic receptors, forms a complex penetrating the nucleus of the cell and stimulating the synthesis of mRNA. Prevents the release of inflammatory mediators from eosinophils and mast cells. Reduces the activity of hyaluronidase, collagenase, protease and capillary permeability, stabilizes cell membranes, has anti-inflammatory, antiallergic and immunosuppressive action, local antipruritic and vasoconstrictive effect.

Indications

Infectious diseases of the eye and paraorbital area, incl. Blepharitis, conjunctivitis, blepharoconjunctivitis; Keratitis (without epithelial damage); Prevention of postoperative infections in ophthalmic surgery.

Contraindications

Hypersensitivity to the components of the drug; Viral diseases of the cornea and conjunctiva (Herpes simplex, chicken pox); Tuberculosis of the eye; Fungal diseases of the eyes; Condition after removal of the foreign body of the cornea, pregnancy, lactation, children's age.

pregnancy and lactation

It is possible only according to the doctor's prescription, if the expected effect of therapy exceeds the potential risk to the fetus. For the duration of treatment, breastfeeding should be stopped.

Side effects

Local allergic reactions: puffiness, itchy eyelid, conjunctival erythema;

Increased intraocular pressure (with prolonged use); With constant use for more than 3 months, the development of cataracts, mycoses of the cornea; Slowing down the regeneration process.

Interaction

At the simultaneous systemic administration of aminoglycosides or steroids, the appropriate total serum concentration should be monitored.

Dosing and Administration

Conjunctival, 1-2 drops in the affected eye / eye every 4-6 hours. In severe infections - 2 drops every hour until the clinical effect is obtained, then the dose of the drug is gradually reduced to cancellation.

Overdose

Symptoms: punctate keratitis, erythema, increased lachrymation, edema and itching of the eyelids.

Treatment: withdrawal of the drug and symptomatic therapy.

special instructions

If applied more than 10 days, intraocular pressure should be measured regularly.

During the treatment period, it is forbidden to wear soft contact lenses. When using hard lenses, they should be removed before instillation and re-put in 15-20 minutes after the procedure.

Patients who temporarily lose visual clarity after application are not advised to drive or work with complicated equipment immediately after instillation of the drug.

The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.

Storage Conditions

In a dry, the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.