DexaTobropt, eye drops 5 ml

A combination drug for topical use in ophthalmology with anti-inflammatory and antibacterial action.

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

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

Pharmacokinetics

After topical administration, tobramycin is absorbed through the cornea and conjunctiva. A very small amount reaches the aqueous humor. Tobramycin reaches the systemic bloodstream in very low concentrations. When applied topically, systemic absorption of dexamethasone is low. After injection into the eye, it penetrates well into the corneal epithelium and conjunctiva, aqueous humor of the eye. Maximum activity is reached within 10-20 min after application of the drug.

The distribution of the drug was observed in plasma, bile, liver, kidney and renal excretion after 30 min of administration.

Indications

Infectious eye diseases:

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

Active ingredient

Composition

The eye drops are in the form of a suspension of white or almost white color, a precipitate may be present, which quickly dissipates with slight shaking.

Associates:

tiloxapol – 0.5 mg,

Hypromellose (HPMC 4000 cP) – 5 mg,

sodium sulfate – 12 mg,

sodium chloride – 3.3 mg,

dinatrium edetate dihydrate – 0.1 mg,

benzalkonium chloride – 0.1 mg,

Sodium hydroxide 1M solution or sulfuric acid 1M solution – to pH 5.0-6.0,

Purified water – up to 1 ml.

How to take, the dosage

Topically. Dose 1-2 drops into the conjunctival sac of the affected eye (or eyes) every 4-6 hours.

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

In elderly patients, dose reduction is not required.

The bottle should be shaken before use.

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

Interaction

Drug interactions of the drug have not been established.

If used with other topical ophthalmic drugs, the interval between applications should be at least 5 minutes.

Special Instructions

DexaTobropt is for topical use only (not for injection).

Intraocular pressure should be measured regularly when using GCS-containing medications for more than 10 days.

When prescribing DexaTobropt concomitantly with antibiotics of the group of aminoglycosides for systemic use, the serum concentration of tobramycin should be monitored and should not exceed 8 µg/ml.

If allergic reactions develop, the drug should be discontinued.

Because the eye drops contain benzalkonium chloride as a preservative, this may cause irritation and this preservative is also known to discolor soft contact lenses. Therefore, patients should remove their contact lenses before using DexaTobropt and should be informed to wait 15 minutes after insertion of DexaTobropt before inserting contact lenses.

Influence on driving and operating ability

There have been no reports of adverse effects of the drug on the ability to drive vehicles and engage in other activities requiring concentration and quick psychomotor reactions. However, taking into account that the patient temporarily loses visual acuity after application, it is not recommended to drive vehicles or operate complex machinery immediately after application of the drug.

Contraindications

Side effects

Pregnancy use

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

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

Breastfeeding should be stopped during the treatment.

Pediatric use

The safety and effectiveness in children have not been established at this time. It is contraindicated in children and adolescents under 18 years of age.

Similarities