Dexa-Gentamicin, eye ointment 2.5g

Pharmacotherapeutic Group: Glucocorticosteroid for topical use + antibiotic aminoglycoside

ATX code: D07CB04.

Pharmacological properties

Pharmacodynamics

A combined agent, the action of which is due to its constituent components, has anti-allergic, anti-inflammatory and antibacterial effects. Dexamethasone is a glucocorticosteroid with a strong anti-inflammatory activity: its relative anti-inflammatory activity index is 30.

Gentamicin sulfate – antibiotic of aminoglycoside group, has a broad spectrum of action: it is active against most gram-negative and gram-positive micro-organisms (Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serrata spp., Salmonella spp.). Moderately active against strains of Staphylococcus spp.

Pharmacokinetics

When applied topically, dexamethasone penetrates well into the corneal epithelium and conjunctiva; therapeutic concentrations are achieved in the aqueous humor of the eye; when inflammation or damage to the mucosa the rate of penetration increases.

Gentamicin sulfate when applied topically has therapeutic concentrations in the corneal stroma, anterior chamber humor, vitreous humor within 6 hours. Gentamicin sulfate does not penetrate into the systemic bloodstream through the intact corneal epithelium.

Indications

infections of the anterior segment of the eye caused by microflora sensitive to gentamicin (conjunctivitis, keratitis, blepharitis, barley);
allergic processes in the anterior segment of the eye, accompanied by bacterial infection;
prevention and treatment of inflammatory phenomena in the postoperative period (cataract removal, antiglaucomatous operations).

Pharmacological effect

Pharmacotherapeutic group: glucocorticosteroid for local use + aminoglycoside antibiotic

ATX code: D07CB04.

Pharmacological properties

Pharmacodynamics

The combined agent, the effect of which is determined by the components included in its composition, has antiallergic, anti-inflammatory and antibacterial effects. Dexamethasone is a glucocorticosteroid that has a pronounced anti-inflammatory effect: the index of its relative anti-inflammatory activity is 30.

Gentamicin sulfate is an antibiotic of the aminoglycoside group, characterized by a wide spectrum of action: it is active against most gram-negative and gram-positive microorganisms (Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serrata spp., Salmonella spp.). Moderately active against strains of Staphylococcus spp.

Pharmacokinetics

When applied topically, dexamethasone penetrates well into the corneal epithelium and conjunctiva; at the same time, therapeutic concentrations are achieved in the aqueous humor of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases.

Gentamicin sulfate, when applied topically, is found in therapeutic concentrations in the corneal stroma, in the anterior chamber humor, and vitreous body within 6 hours. Gentamicin sulfate does not penetrate into the systemic circulation through intact corneal epithelium.

Special instructions

Immediately after applying Dex-Gentamicin ophthalmic ointment, a short-term disturbance in visual acuity may occur, leading to a slowdown in mental and physical reactions. Therefore, it is not recommended to use the drug immediately before working with machinery or driving vehicles. For 30 minutes after instillation, you must refrain from activities that require increased attention.

Active ingredient

Gentamicin, Dexamethasone

Composition

1 g eye ointment contains:

Active components:

Dexamethasone 0.3 mg
Gentamicin sulfate 5.0 mg equivalent to gentamicin 3.0 mg

Excipients:
Vaseline white 775.98 mg

Liquid paraffin 149.13 mg

Lanolin 69.9 mg.

Pregnancy

To date, there are no clinical trial data regarding the use of Dex-Gentamicin during pregnancy, lactation, or in children. However, the drug can be used in the 2nd – 3rd trimester of pregnancy if the expected benefit to the mother outweighs the possible risk to the fetus.

Contraindications

hypersensitivity to any of the components of this drug.
keratitis caused by herpes zoster (dendritic keratitis), chickenpox and other viral diseases of the cornea and conjunctiva;
fungal eye diseases;
mycobacterial eye infections;
acute purulent eye diseases with damage to the corneal epithelium;
corneal epitheliopathy;
injuries and ulcerative lesions of the cornea;
wearing contact lenses;
increased intraocular pressure;
I trimester of pregnancy;
children under 18 years of age (due to lack of data on effectiveness and safety)

Side Effects

In rare cases, after applying the ointment, an allergic reaction and burning sensation are possible.

Long-term use of the drug can cause secondary glaucoma and steroid cataracts, therefore, when using the drug for more than 2 weeks, as well as in patients with a history of glaucoma, it is recommended to regularly monitor intraocular pressure.

Contact dermatitis, herpetic keratitis, corneal perforation in the presence of keratitis, fungal infection, increased severity of bacterial infection of the cornea, ptosis, and mydriasis may occur. When used after corneal injuries, it may slow down its healing.

If side effects occur, you should stop using the drug and consult an ophthalmologist as soon as possible.

Interaction

When used together with atropine, other cholinergic or mydriatic drugs, an increase in intraocular pressure may occur. When applied topically, Gentamicin is incompatible with amphotericin B, heparin, sulfadiazine, cephalothin and cloxacillin. Topical use of these drugs together with gentamicin may lead to the deposition of precipitates in the conjunctival cavity.

Overdose

When using the drug Dex-Gentamicin ophthalmic ointment topically, an overdose is unlikely.

Storage conditions

Store at a temperature not exceeding 25ºС. Keep out of the reach of children!

Shelf life

In unopened original packaging: 3 years.
Once opened, the ointment should be used within 4 weeks.
Do not use after the expiration date stated on the package.

Manufacturer

Ursafarm Arzneimittel GmbH, Germany