Universal reference book for medicines
Name of the preparation: OFTAN ® DEXAMETASON (OFTAN ®DEXAMETHASON)

Active substance: dexamethasone

Type: GCS for topical application in ophthalmology

Manufacturer: SANTEN (Finland)
Composition, form of production and packaging
Eye drops
in the form of a clear, colorless solution.

1 ml

dexamethasone sodium phosphate 1.32 mg,

which corresponds to the content of dexamethasone 1 mg

Excipients: benzalkonium chloride, boric acid, sodium tetraborate, disodium edetate, water d / u.

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Synthetic fluorinated GCS for topical application in ophthalmology.
The drug has a pronounced anti-inflammatory and anti-allergic effect.
Dexamethasone interacts with specific protein receptors in target tissues, thereby regulating the expression of corticosteroid-dependent genes and further influencing the synthesis of the protein.
Stabilizes the lysosomal enzymes of leukocyte membranes and inhibits the release of enzymes. It inhibits the synthesis of kinins, mitosis and migration of leukocytes. Inhibits the synthesis of antibodies and disrupts the recognition of the antigen. All these mechanisms are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage.
The duration of anti-inflammatory action after instillation of 1 drop of the drug is 4-8 hours.

PHARMACOKINETICS

Suction

With topical application, systemic absorption is low.
The breast implant in the conjunctival sac penetrates well into the corneal epithelium and conjunctiva. In this case, therapeutic concentrations are achieved in the aqueous humor of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases.
Distribution and Metabolism

About 60-70% of dexamethasone entering the systemic circulation communicates with plasma proteins.
Metabolized in the liver under the action of the isoenzyme CYP3A4.
Excretion

Metabolites are excreted through the intestine.
T 1/2 is an average of 3.6 ± 0.9 h.
INDICATIONS

Acute and chronic inflammatory processes:

- non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis;

scleritis and episcleritis;

- irit, iridocyclitis and other uveitis of various genesis;

- superficial corneal damage of various etiologies (chemical, physical or immune mechanisms) after complete epithelialization of the cornea;

- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);

- Edema, inflammation (including in the postoperative period);

- sympathetic ophthalmia.

Allergic eye diseases:

- allergic conjunctivitis or keratoconjunctivitis.

Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.

DOSING MODE

In acute conditions , 1-2 drops are prescribed per conjunctival sac every 1-2 hours.

After reducing inflammation, the drug is instilled in 1-2 drops in the conjunctival sac 3-5 times / day.

The duration of treatment should not exceed 2-3 weeks.

The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.

SIDE EFFECT

From the side of the organ of vision: after instillation, a rapid burning sensation, allergic reactions, is possible.
With prolonged use, it is possible to develop secondary glaucoma and steroid cataract, as well as ulceration, opacification, thinning and / and perforation of the cornea; rarely - the spread of bacterial or herpetic infections.The preparation contains in its composition a preservative of benzalkonium chloride, which can cause eye irritation.
CONTRAINDICATIONS

- keratitis associated with herpes simplex, chicken pox and other viral diseases of the cornea and conjunctiva;

- tuberculosis of the eye;

- mycobacterial infections of the eyes;

- fungal diseases of the eyes;

- acute purulent diseases of the eyes;

- damage to the epithelium of the cornea (including the condition after removal of the foreign body of the cornea);

- corneal epitheliopathy;

- increased intraocular pressure;

- glaucoma;

- age under 18 years (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years);

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

To date, clinical trials regarding the use of the drug Oftan ® Dexamethasone in pregnancy and lactation are absent.
Oftan ® Dexamethasone can be used during pregnancy and during breastfeeding only as prescribed by the doctor if the expected curative effect justifies the potential risk to the fetus and the baby. The duration of therapy is no more than 7-10 days.
APPLICATION FOR CHILDREN

Contraindicated at the age of 18 years (due to the lack of data on the efficacy and safety of the drug in children and adolescents under 18 years).

SPECIAL INSTRUCTIONS

Oftan ® Dexamethasone contains a preservative of benzalkonium chloride, which can be absorbed by soft contact lenses and cause a change in their color and have an adverse effect on the tissues of the eye.
If contact lenses are to be used during treatment with Ophtan® Dexamethasone, they should be removed before use and, if necessary, should be placed no earlier than 15 minutes after instillation.
If the drug treatment lasts more than 2 weeks, it is necessary to regularly monitor the intraocular pressure and the condition of the cornea.

Corticosteroid therapy can mask the current bacterial or fungal infection.
In the presence of infection, the use of drops with appropriate antimicrobial therapy should be combined.
Impact on the ability to drive vehicles and manage mechanisms

Due to possible lacrimation after instillation, the drug is not recommended to be used immediately before driving vehicles or operating mechanical equipment.

OVERDOSE

Overdosage with topical application of eye drops Ofthan ® Dexamethasone is unlikely.

Symptoms: Possible local irritation.

Treatment: there is no specific antidote.
The drug should be withdrawn and symptomatic therapy prescribed.
DRUG INTERACTION

Interaction with other drugs is mainly due to the participation in the excretion of dexamethasone isoenzyme CYP3A4.
Dexamethasone induces the isoenzyme CYP3A4, thus, reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. In the usual topical regimen, the dose of the drug is not sufficient to induce induction or saturation of the liver enzymes.
With prolonged use with iodoxuridine, destructive processes in the epithelium of the cornea can be intensified.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C.
Shelf life - 2 years.
After opening the vial-dropper, the expiration date is 1 month.

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