Composition:
Per 1 ml: active substance: dexamethasone sodium phosphate (in terms of anhydrous and alcohol-free dexamethasone sodium phosphate) - 1 mg; excipients: boric acid - 15 mg, sodium tetraborate decahydrate - 0.6 mg, disodium edetate dihydrate - 0.5 mg, benzalkonium chloride - 0.04 mg, water for injection - up to 1 ml.
Pharmacodynamics:
Dexamethasone is a synthetic fluorinated glucocorticosteroid, does not have mineral corticoid activity. It has a pronounced anti-inflammatory, anti-allergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, inhibiting the release of inflammatory mediators by eosinophils, mast cell migration and reducing capillary permeability, vasodilation.
Pharmacokinetics:
When applied topically, it penetrates well into the corneal epithelium and conjunctiva: therapeutic concentrations are achieved in the aqueous humor of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases.
Side effects:
Adverse reactions are listed using the following frequency designations: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥ 1/10000 to <1/1000), very rarely (<1/10000).
Within one frequency category, adverse reactions are listed in decreasing order of severity. The following adverse reactions were discovered during clinical trials: Disorders of the nervous system: infrequently: dysgeusia.
Disorders of the organ of vision: often: discomfort in the eyes. Infrequently: keratitis, conjunctivitis, "dry" keratoconjunctivitis, staining of the cornea, photophobia, blurred vision, itching in the eye, a feeling of a foreign body in the eyes, increased lacrimation, unusual sensations in the eye, the formation of crusts on the edges of the eyelids, eye irritation, eye hyperemia.
Adverse reactions whose frequency has not been established (post-marketing experience): Immune system disorders: hypersensitivity.
Violations of the nervous system: dizziness, headache. Disorders of the organ of vision: increased intraocular pressure, decreased visual acuity, erosion of the cornea, ptosis of the eyelids, eye pain, mydriasis.
Very rare cases of the development of calcification of the cornea have been reported with a previous significant damage to it due to the presence of phosphates in the preparation. Recipe for sale specifics Special storage conditions Freezing is not permitted. After opening, store the bottle at a temperature not exceeding 25 ° C, in a place protected from light.
Special conditions:
Storage Freezing unacceptable. After opening, store the bottle at a temperature not exceeding 25 ° C, in a place protected from light. Special conditions Prolonged use of glucocorticosteroids for topical administration can lead to an increase in intraocular pressure and / or glaucoma with damage to the optic nerve, to a decrease in visual acuity and visual field defects, to the formation of posterior subcapsular cataract.
Therefore, in patients for a long time (more than 10 days) using drugs containing glucocorticosteroids, intraocular pressure should be regularly measured. The risk of increased intraocular pressure and / or cataract formation due to corticosteroids in patients with a predisposition (e.g., with diabetes) is higher.
The risk of increased intraocular pressure is increased in patients with concomitant ophthalmic hypertension and / or glaucoma, as well as in patients with a family history of glaucoma, weekly monitoring of intraocular pressure in such patients is required.
Care must be taken and periodically conduct biomicroscopy when using the drug in the treatment of deep keratitis caused by Herpes simplex. In the absence of improvement within 7-8 days, it is necessary to reconsider the choice of therapy.
Glucocorticosteroids can reduce resistance to bacterial, viral or fungal infections and contribute to their development, as well as mask the clinical signs of infection. With concomitant bacterial infections, appropriate antibacterial therapy should be prescribed.
The appearance of nonhealing ulcers on the cornea may indicate the development of fungal invasion. If fungal invasion occurs, glucocorticosteroid therapy should be discontinued. Topical glucocorticosteroids can slow the healing process of the cornea.
Non-steroidal anti-inflammatory drugs for topical use are known to slow or delay healing. The simultaneous use of non-steroidal anti-inflammatory drugs for topical use and steroids for topical use may increase the likelihood of healing disorders (see section "Interaction with other drugs").
It is known that for diseases that cause thinning of the cornea or sclera, perforation may occur as a result of the use of glucocorticosteroids for topical use. With a duration of therapy of more than 2 weeks should monitor the condition of the cornea.
The use of dexamethasone in the complex therapy of Schengen syndrome is possible only with moderate to severe keratoconjunctivitis, the duration of the course of therapy should be no more than 2 weeks due to the possibility of developing undesirable reactions (see the section "Side effects"). After use, it is recommended to perform nasolacrimal occlusion or carefully close the eye.
This can reduce the systemic absorption of the drug when applied topically, and thereby reduce the likelihood of systemic adverse reactions.
The drug contains benzalkonium chloride, which can cause eye irritation and stain soft contact lenses. Contact with soft contact lenses should be avoided.
If patients are allowed to wear contact lenses, they should be instructed to remove contact lenses before using the drug and set them back no earlier than 15 minutes after instillation of the drug. Shake the bottle before use. The bottle must be closed after each use. Do not touch the tip of the pipette to any surface.
Effect of the drug on the ability to drive vehicles and mechanisms: A temporary decrease in the clarity of vision or other visual impairments may affect the ability to drive vehicles or operate mechanisms.
If the patient's vision clarity temporarily decreases after using the drug, then he should wait until his eyesight is restored before driving or operating machinery.
Indications:
Treatment of non-infectious inflammatory diseases of the anterior chamber of the eye.
Contraindications:
An increase in intraocular pressure caused by the use of glucocorticosteroids in history; hypersensitivity to any of the components of this drug; acute purulent eye diseases without concomitant antimicrobial therapy; amoebic keratitis; superficial forms of keratitis caused by Herpes simplex, in particular treelike keratitis, vaccine, chickenpox and other viral diseases of the cornea and conjunctiva; fungal eye diseases or previously untreated parasitic eye infections; mycobacterial infections of the eyes (including mycobacterial tuberculosis); violation of the integrity of the corneal epithelium, including after removal of a foreign body; age up to 18 years (safety and efficacy of the drug in children have not been investigated).
Pregnancy and lactation: Fertility No studies have been conducted to evaluate the effects of dexamethasone when applied topically to human fertility. Pregnancy There is no sufficient experience with the use of the drug during pregnancy. Animal studies have shown reproductive toxicity.
It is possible to use it for the treatment of pregnant women as prescribed by the attending physician if the expected therapeutic effect exceeds the risk of developing possible side effects. Breastfeeding With systemic use, glucocorticosteroids may be present in breast milk in amounts that can cause effects on a breastfed baby.
When applied as instillations, the system exposure is low. It is not known whether dexamethasone is excreted in breast milk. However, the risk to the infant cannot be excluded; it is necessary to decide whether to stop breastfeeding or to stop / suspend therapy with Dexamethasone, taking into account the benefits of breastfeeding for the baby and the benefits of the therapy for the mother.
Drug Interactions:
The simultaneous use of steroids for topical use and non-steroidal anti-inflammatory drugs for topical use can increase the likelihood of corneal healing disorders.
The risk of an additional increase in intraocular pressure cannot be ruled out if dexamethasone is used together with anticholinergics, which can also cause an increase in intraocular pressure in susceptible patients.
In case of combined use with antiglaucoma drugs, a decrease in the hypotensive effect of the latter is possible. In case of use with other local ophthalmic preparations, the interval between their use should be at least 10 minutes. Eye ointments should be used last.
Dosage:
Use in adults, including elderly patients: in the presence of acute inflammation, Dexamethasone must be instilled 1 drop in the conjunctival sac after 1-2 hours, after improvement, 1 drop every 4-6 hours. For the prevention of inflammatory processes after ophthalmic surgery and injuries: during the first 24 hours after surgery - 1-2 drops 4 times a day, then - 3 times a day for 2 weeks.
The treatment regimen in other cases - 1 drop 3-4 times a day for 2-5 weeks. The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of symptoms, the possibility of side effects.
The maximum duration of the drug should not exceed 14 days. Recommendations for the use of bottles with dropper caps: before using the drug, remove the aluminum cap from the bottle, remove the rubber stopper and close the bottle with a dropper cap, previously released from the packaging.
Then remove the cap from the dropper cap, turn the bottle over, drip the required number of drops of the drug. After use, return the bottle to a vertical position and put the cap on the dropper cap. Recommendations for using a dropper tube (t / c): remove the protective cap, cut off the membrane of the neck of the body with scissors without damaging the threaded part.
Turn the t / c case with the medicine with the mouth down and gently press the t / c case using it as a pipette. After applying the dose recommended by the doctor’s prescription or indicated in the instructions for use of the drug, turn the t / c case upside down with the threaded part and screw on the protective cap.
Overdose:
In case of excessive eye contact, rinse eyes with warm water. No toxic effects are expected in case of overdose when applied topically or if the contents of one vial are accidentally swallowed. Overdose symptoms may be local manifestations. Treatment for an overdose is symptomatic.
