Universal reference book for medicines
Product name: DEXATOBROPT (DEXATOBROPT)

Active substance: dexamethasone, tobramycin

Type: The drug with antibacterial and anti-inflammatory action for topical application in ophthalmology

Manufacturer: ROMFARMA (Russia) manufactured by SC ROMPHARM Company (Romania)
Composition, form of production and packaging
Drops of the eye
in the form of a suspension of white or almost white color, possibly the presence of a precipitate, which quickly dissipates with mild agitation.

1 ml

dexamethasone 1 mg

tobramycin 3 mg

Excipients: tyloxapol - 0.5 mg, hypromellose (HPMC 4000 cP) - 5 mg, sodium sulfate - 12 mg, sodium chloride - 3.3 mg, disodium edetate dihydrate - 0.1 mg, benzalkonium chloride - 0.1 mg, sodium hydroxide solution 1M or sulfuric acid solution 1M - up to pH 5.0-6.0, purified water - up to 1 ml.

5 ml - a bottle-droppers polymer (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Combination drug with antibacterial and anti-inflammatory action for topical application in ophthalmology.

Tobramycin is a broad-spectrum antibiotic from the aminoglycoside group.
It is active against Gram-positive and Gram-negative microorganisms: Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis, including strains resistant to penicillin); Streptococcus spp. (including some beta-hemolytic species of group A, some non-hemolytic 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 also some species of Neisseria spp.
Dexamethasone - GCS.
Has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, inhibiting eosinophilic ejection of inflammatory mediators, migration of mast cells and decreasing capillary permeability. Does not have mineralocorticoid activity.
PHARMACOKINETICS

After topical application, tobramycin is absorbed through the cornea and conjunctiva.
Very small amounts reach watery moisture. Tobramycin reaches the systemic blood flow at very low concentrations. With topical application, systemic absorption of dexamethasone is low. After instillation into the eye, it penetrates well into the epithelium of the cornea and conjunctiva, the watery moisture of the eye. Maximum activity is achieved within 10-20 minutes after application of the drug.
The distribution of the drug was observed in blood plasma, bile, liver, kidney and renal excretion after 30 minutes from the time of admission.

INDICATIONS

- infectious diseases of the eyes, incl.
blepharitis, conjunctivitis, blepharoconjunctivitis, keratitis (without epithelial damage);
- prevention and treatment of inflammatory phenomena in the postoperative period after cataract extraction.

DOSING MODE

The drug is used topically.

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

After the operation to remove cataracts, the dose can be increased to 1-2 drops every 2 hours, within 24 hours. The frequency of application of the drug should be gradually reduced with the improvement of clinical signs.

In elderly patients, dose reduction is not required.

Before use, the vial should be shaken.

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

Local allergic reactions: puffiness, itchy eyelids, conjunctival hyperemia.

From the side of the organ of vision: increased intraocular pressure (with prolonged use).
With continued use, for more than 3 months, the development of mycosis of the cornea is possible. Possible slowing of regeneration processes, development of posterior subcapsular cataract, secondary infection.
Systemic reactions: headache, increased blood pressure.

CONTRAINDICATIONS

- viral diseases of the eyes (including keratitis caused by Herpes simplex, chicken pox);

- mycobacterial infections of the eyes;

- fungal diseases of the eyes;

- children and adolescence under 18;

- condition after removal of the foreign body from the cornea;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

There is no sufficient experience in the use of the drug during pregnancy and 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.

For the duration of treatment, breastfeeding should be discontinued.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under the age of 18 years (safety and efficacy of the drug in children are not established).

APPLICATION IN ELDERLY PATIENTS

In elderly patients, dose reduction is not required.

SPECIAL INSTRUCTIONS

DexaTobroth is for local use only (not for injection).

When using preparations containing GCS, the intraocular pressure should be measured regularly for more than 10 days.

When prescribing DexaTobropt simultaneously with the antibiotics of the aminoglycoside group for systemic administration, the concentration of tobramycin in serum should be controlled, which should not exceed 8 μg / ml.

With the development of allergic reactions, the drug should be discontinued.

Because
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, before using DexaTobropt, the patient should take out contact lenses and wait 15 minutes after instillation of the drug before installing contact lenses.
Use in Pediatrics

At the moment, the safety and effectiveness of the drug in children are not established.

Impact on the ability to drive vehicles and manage mechanisms

The adverse effect of the drug on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions were not reported.
However, taking into account that the patient temporarily loses his vision after application, it is not recommended to drive vehicles or work with complex equipment immediately after instillation of the drug.
OVERDOSE

To date, there have been no reports of an overdose of DexaTobrot.

DRUG INTERACTION

Drug interaction of the drug DexaTobrot is not established.

In case of application with other local ophthalmic preparations, the interval between their use should be at least 5 minutes.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
After opening, the vial should be stored at a temperature of no higher than 25 ° C and used for 4 weeks.

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