DexaTobropt eye drops, 5 ml

Composition

Eye drops in the form of a suspension of white or almost white color, the presence of sediment is possible, which quickly dissipates with light shaking.

Auxiliary substances:

tyloxapol – 0.5 mg,

hypromellose (HPMC 4000 cP) 5 mg,

sodium sulphate 12 mg,

sodium chloride 3.3 mg

of disodium edetate dihydrate – 0.1 mg

benzalkonium chloride 0.1 mg,

sodium hydroxide 1 M solution of sulfuric acid or 1 m solution of up to pH 5.0-6.0,

purified water to 1 ml.

Pharmacological action

Combined drug for topical use in ophthalmology with anti-inflammatory and antibacterial effects.

Tobramycin is a broad-spectrum antibiotic from the aminoglycoside group. Active against gram-positive and gram-negative microorganisms: Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis, including penicillin-resistant strains); Streptococcus spp. (including some beta-hemolytic species of the group And some negeroicheskie species and some strains of Streptococcus pneumoniae), Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most species Proteus vulgaris, Haemophilus influenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginacola), a certain species of Neisseria spp.

Dexamethasone – corticosteroids. It has a pronounced anti-inflammatory, anti-allergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, inhibiting the release of inflammatory mediators by eosinophils, mast cell migration, and reducing capillary permeability. It does not have mineralocorticoid activity.

Pharmacokinetics

After topical application, tobramycin is absorbed through the cornea and conjunctiva. A very small amount reaches watery moisture. Tobramycin reaches the systemic circulation in very low concentrations. When applied topically, the systemic absorption of dexamethasone is low. After instillation in the eye, it penetrates well into the corneal epithelium and conjunctiva, the watery moisture of the eye. Maximum activity is achieved within 10-20 minutes after the drug is applied.

Distribution of the drug was observed in blood plasma, bile, liver, kidneys and renal excretion after 30 minutes from the time of administration.

Indications

Infectious eye diseases:

• blepharoconjunctivitis,
• blepharitis,
• conjunctivitis,
• keratitis (without damage to the epithelium);

Treatment and prevention of inflammatory phenomena in the postoperative period after cataract extraction.

Use during pregnancy and lactation

There is no sufficient experience with the use of the drug during pregnancy and lactation (breastfeeding).

The use of Dexatobropt during pregnancy is possible only if the expected effect of therapy for the mother exceeds the potential risk to the fetus.

Breast-feeding should be discontinued for the duration of treatment.

Use in pediatrics

Currently, the safety and efficacy of the drug in children have not been established. Contraindicated in children and adolescents under 18 years of age.

Contraindications

• viral eye diseases (including keratitis caused by Herpes simplex, chickenpox);
• fungal eye diseases;
• mycobacterial eye infections;
• conditions after removal of a foreign body from the cornea;
• hypersensitivity to the components of the drug.

Side effects

• : swelling, itching of the eyelids, conjunctival hyperemia.
• increased intraocular pressure (with prolonged use). With constant use, for more than 3 months, it is possible to develop corneal mycosis. It is possible to slow down the regeneration processes, develop posterior subcapsular cataracts, and secondary infection.
• headache, increased blood pressure.

Interaction

Drug interaction of the drug has not been established.

In the case of use with other topical ophthalmic drugs, the interval between their use should be at least 5 minutes.

How to take, course of administration and dosage

Locally. Instill 1-2 drops in the conjunctival sac of the affected eye (or eyes) every 4-6 hours.

After cataract surgery, the dose can be increased to 1-2 drops every 2 hours, within 24 hours The frequency of use of the drug should be gradually reduced with improvement in clinical signs.

No dose reduction is required in elderly patients.

The bottle should be shaken before use.

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

Special instructions

Dexatobropt is intended for topical use only (not for injection).

If corticosteroid-containing medications are used for more than 10 days, intraocular pressure should be measured regularly.

When prescribing the drug Dexatobropt simultaneously with antibiotics of the aminoglycoside group for systemic use, it is necessary to monitor the concentration of tobramycin in the blood serum, which should not exceed 8 micrograms/ml.

If allergic reactions develop, the drug should be discontinued.

Since eye drops contain benzalkonium chloride as a preservative, this can lead to irritation, and it is also known that this preservative can discolor soft contact lenses. Therefore, patients should remove their contact lenses before using Dexatobropt and should be informed to wait 15 minutes after Dexatobropt is installed before inserting contact lenses.

Influence on the ability to drive motor vehicles and manage mechanisms

No adverse effects of the drug on the ability to drive vehicles and engage in other activities that require concentration of attention and speed of psychomotor reactions have been reported. However, given that the patient temporarily loses visual clarity after the application, it is not recommended to drive vehicles or work with complex equipment immediately after instillation of the drug.

Form of production

Dexatobropt. Eye drops.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Dexamethasone, Tobramycin

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Conjunctivitis, Eye Infections, Inflammatory Eye Diseases, Blepharitis

Weight

Weight: 16 gr.