Dexamethasone, Tobramycin

Brand K.O.Romparm Company S.R.L.

In stock 1004 Items

Available since: 2019-09-19

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Clinical Pharmacology

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

Tobramycin broad-spectrum antibiotic from the group of aminoglycosides. 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 group A types, some types of non-hemolytic and some strains of Streptococcus pneumoniae), Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most of the species Proteus vulgaris, Haemophilus influenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginacola), and also some species of Neisseria spp.

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

Indications

Infectious diseases of the eye, incl. blepharitis, conjunctivitis, blepharoconjunctivitis, keratitis (without damage to the epithelium);
prevention and treatment of inflammation in the postoperative period after cataract extraction.

Composition

Eye drops in the form of a suspension of white or almost white color, the presence of sediment is possible, which quickly disperses with slight 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 1M solution or sulfuric acid 1M solution - to pH 5.0-6.0, purified water - up to 1 ml.

Dexamethasone, Tobramycin is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Dexatobropt	K.O.Romparm Company S.R.L	Romania	eye drops
Tobradex	Alcon	USA	eye drops

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Dosage and Administration

Apply topically.

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 improved clinical signs.

Have elderly patients dose reduction is not required.

Before use, the bottle should be shaken.

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

Adverse reactions

Local allergic reactions: swelling, itching of the eyelids, conjunctival hyperemia.

On the part of the organ of vision: increased intraocular pressure (with prolonged use). With continued use, for more than 3 months, the development of corneal mycosis is possible. Perhaps slowing down the regeneration processes, the development of posterior subcapsular cataracts, secondary infection.

Systemic reactions: headache, increased blood pressure.

Contraindications

viral diseases of the eye (including keratitis caused by Herpes simplex, chicken pox);
mycobacterial infections of the eye;
fungal diseases of the eye;
children and adolescents up to 18 years;
conditions after removal of a foreign body from the cornea;
hypersensitivity to the drug.

Drug interactions

Drug interactions drug DexTobropt not installed.

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

Pregnancy and Lactation

Sufficient experience in the use of the drug during pregnancy and lactation (breastfeeding) is not.

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

At the time of treatment should stop breastfeeding.

Special instructions

DexTobropt is intended for topical use only (not applicable for injections).

When using drugs containing GKS, more than 10 days should be regularly measured intraocular pressure.

When prescribing the drug DexTobropte, along with aminoglycoside group antibiotics for systemic use, it is necessary to control the concentration of tobramycin in the blood serum, which should not exceed 8 μg / ml.

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

Since eye drops contain benzalkonium chloride as a preservative, it can cause irritation, and it is well known that this preservative may discolor soft contact lenses. Thus, before using the drug DexTobropt, patients should remove contact lenses and should be informed that it is necessary to wait 15 minutes after installing the drug DexTobropt before inserting contact lenses.

Use in Pediatrics

Currently, the safety and efficacy of the drug in children have not been established.

Influence on ability to drive motor transport and control mechanisms

The adverse effect of the drug on the ability to drive and other activities that require concentration and speed of psychomotor reactions has not been reported. However, given that the patient after the application temporarily loses the clarity of vision, it is not recommended to drive vehicles or work with complex technology immediately after instillation of the drug.

Studies and clinical trials of Dexamethasone, Tobramycin (Click to expand)