Oftan Dexamethasone - instructions for use, dose, side effects, contraindications

Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes; inhibits the synthesis of kinins, mitosis and migration of leukocytes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen.All these effects 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 solution is from 4 to 8 hours.

Pharmacokinetics:

With topical application, systemic absorption is low. After instillation into the conjunctival sac it penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation communicates with plasma proteins. Metabolized in the liver by the action of cytochrome P450 containing enzymes (CYP3A4); metabolites are excreted through the intestine. The half-life in plasma (T_1/2) averagely 3.6 ± 0.9 hours.

Indications:

Acute and chronic inflammatory processes:

- non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium 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 corneal epithelialization; inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);

- sympathetic ophthalmia.

Allergic eye diseases:

- allergic conjunctivitis or keratoconjunctivitis.

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

Contraindications:

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

- tuberculosis of the eye;

- mikobacterial infections of the eyes;

- fungal diseases of the eyes;

- acute purulent eye diseases;

- 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;

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

- hypersensitivity to any of the components of the drug.

Pregnancy and lactation:

To date, clinical trial data regarding the use of Oftan® Dexamethasone during pregnancy, lactation is absent.

Oftan® Dexamethasone can be used during pregnancy and during breastfeeding only for the purpose of the attending physician, unless the expected curative effect justifies the potential risk to the fetus and to the baby.

Duration of therapy: no more than 7-10 days.

Dosing and Administration:

In acute conditions: 1-2 drops in the conjunctival sac every 1-2 hours.

After reducing inflammation, eye drops Oftan® Dexamethasone Bury 1-2 drops in the conjunctival sac 3-5 times a day.

Duration of treatment with eye drops Oftan® Dexamethasone 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 effects:

After instillation of eye drops Ofthan® Dexamethasone may occur rapidly burning sensation, allergic reactions.

Long-term use (more than 3 weeks) of dexamethasone may cause secondary glaucoma and steroid cataracts, as well as ulceration, opacification, thinning or perforation of the cornea; in rare cases dexamethasone can promote the spread of herpetic and bacterial infection.

Oftan® Dexamethasone contains a preservative benzalkonium chloride, which can cause eye irritation.

In case of side effects, you should contact your doctor as soon as possible.

Overdose:

Overdose with topical application of eye drops Ofthan® Dexamethasone unlikely.

Symptoms: possibly local irritation.

There is no specific antidote. The drug should be withdrawn and symptomatic therapy prescribed.

Interaction:

Interaction with other drugs is mainly due to the participation in the excretion of dexamethasone by cytochrome P450 containing enzymes (CYP3A4). It induces an enzyme CYP3A4, thereby 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, the destructive processes in the corneal epithelium can be intensified.

Special instructions:

Oftan® Dexamethasone contains a preservative 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 you need to use contact lenses during treatment with Oftan® Dexamethasone, they should be removed before using the drug and, if necessary, dressed not earlier than 15 minutes after instillation.

During treatment with the drug for 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.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Eye drops, 1 mg / ml.

Packaging:

To 5 ml in a plastic bottle-dropper, ukuporenny plastic cap with a screw cap.

The bottle-dropper along with the instruction for use is placed in a cardboard box.

Storage conditions:

Store at temperatures from 2 to 8 ° C, out of the reach of children.

Shelf life:

2 years.

After opening the bottle - 1 month.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015347 / 01

Date of registration:15.12.2008 / 17.02.2015

Expiration Date:Unlimited

The owner of the registration certificate: Santen, AO Santen, AO Finland

Manufacturer: & nbsp

SANTEN, OY Finland

Representation: & nbspSANTEN AS SANTEN AS Finland

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Oftan® Dexamethasone (Oftan® Dexamethason)