Composition, form of production and packaging
Eye drops 0.1% 1 ml
dexamethasone 1 mg
5 ml - bottles (1) - packs cardboard.
5 ml - polymer bottles (1) with a dispenser - packs cardboard.
5 ml - a bottle-droppers polymer (1) - packs cardboard.
10 ml - bottles (1) - packs of cardboard.
10 ml - polymer bottles (1) with a dispenser - packs cardboard.
10 ml - a vial of a dropper (1) - packs cardboard.
1 ml - a tube-dropper polyethylene (1) - packs cardboard.
1 ml - a tube-droppers polyethylene (2) - packs cardboard.
1 ml - a tube-dropper polyethylene (5) - packs cardboard.
1 ml - a tube-dropper polyethylene (10) - packs cardboard.
1.5 ml - a tube-droppers polyethylene (1) - packs cardboard.
1.5 ml - a tube-droppers polyethylene (2) - packs cardboard.
1.5 ml - a tube-dropper polyethylene (5) - packs cardboard.
1.5 ml - a tube-dropper polyethylene (10) - packs cardboard.
2 ml - a tube-dropper polyethylene (1) - packs cardboard.
2 ml - a tube-dropper polyethylene (5) - packs cardboard.
2 ml - a tube-dropper polyethylene (2) - packs cardboard.
2 ml - a tube-dropper polyethylene (10) - packs cardboard.
5 ml - a tube-dropper polyethylene (1) - packs cardboard.
5 ml - a tube-dropper polyethylene (2) - packs cardboard.
5 ml - a tube-dropper polyethylene (5) - packs cardboard.
5 ml - a tube-dropper polyethylene (10) - packs cardboard.
10 ml - a tube-dropper polyethylene (2) - packs cardboard.
10 ml - a tube-dropper polyethylene (1) - packs cardboard.
10 ml - a tube-dropper polyethylene (5) - packs cardboard.
10 ml - a tube-droppers polyethylene (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Fluorinated GCS, has a pronounced anti-inflammatory, anti-allergic and anti-exsudative action. Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus influences protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, bradykinin, prostaglandin, lysosomal enzymes). Suppresses the migration of cells to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen.It inhibits the release of interleukin-1 and interleukin-2, interferon gamma from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of eosinophils by inflammatory mediators and stabilizes the membranes of mast cells. 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
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. Metabolised in the liver by the action of cytochrome-containing enzymes; metabolites are excreted through the intestine. T 1/2 is an average of 3 hours.
INDICATIONS
- conjunctivitis (non-inflammatory and allergic);
- keratitis;
- keratoconjunctivitis (without epithelial damage);
- blepharitis;
- sclerite;
- episcleritis;
- irit;
- Iridocyclitis and other uveitis of various genesis;
- Blepharoconjunctivitis;
- superficial injuries of the cornea of ​​various etiologies (after complete corneal epithelialization);
- prevention of inflammation after surgical interventions;
- sympathetic ophthalmia.
DOSING MODE
Adults with a pronounced inflammatory process during the first 24-48 hours of treatment are instilled into the conjunctival sac by 1-2 drops every 2 hours, with a decrease in inflammation - every 4-6 hours.
For prevention of inflammatory processes after eye operations and injuries within the first 24 hours after the operation, the drug is instilled 4 times / day, then for 2 weeks - 3 times / day.
SIDE EFFECT
With prolonged use (more than 3 weeks), an increase in intraocular pressure is possible; the development of glaucoma with optic nerve damage, reduced visual acuity and loss of visual fields, as well as the formation of posterior subcapsular cataract, and also thinning and perforation of the cornea; very rarely - the spread of herpetic and bacterial infection. In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic conjunctivitis and blepharitis. Irritation, itching and burning of the skin are possible; dermatitis.
CONTRAINDICATIONS
- viral and fungal diseases of the eyes;
- Purulent infection of the eyes (without concomitant antimicrobial therapy);
- trachoma;
- glaucoma;
- damage to the integrity of the epithelium of the cornea (including the condition after removal of the foreign body of the cornea);
- tuberculosis of the eye;
- Children's age (up to 18 years);
- Hypersensitivity.
PREGNANCY AND LACTATION
Studies on the safety and efficacy of dexamethasone in pregnant and lactating mothers have not been conducted. The drug can be used only if the significance of the effect for the mother exceeds the risk of side effects of the fetus and the child.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under the age of 18 years.
SPECIAL INSTRUCTIONS
During treatment (with a duration of more than 2 weeks), it is necessary to monitor the intraocular pressure and the condition of the cornea. At instillation soft contact lenses should be removed, they can be put on again not earlier than in 15-20 minutes. Within 30 minutes after installation, it is necessary to refrain from occupations requiring increased attention.
Treatment with the drug can mask the picture of a bacterial or fungal infection, so when treating infectious eye diseases the drug should be combined with adequate antimicrobial therapy.
OVERDOSE
Symptoms: it is possible to strengthen the dose-dependent described side effects.
Treatment: there is no specific antidote. The drug should be withdrawn and symptomatic therapy should be performed.
DRUG INTERACTION
With prolonged use with idoxuridine, it is possible to intensify destructive processes in the corneal epithelium.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store the product protected from light at a temperature of 8 В° to 15 В° C. Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiry date printed on the package.
