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

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.

Description:A clear, colorless liquid.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.02 Dexamethasone

S.01.B.A.01 Dexamethasone

H.02.A.B Glucocorticoids

S.01.B.A Corticosteroids

Pharmacodynamics:

Dexamethasone is a synthetic fluorinated glucocorticosteroid that does not possess mineral corticoid activity. Has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, suppressing eosinophilic ejection of inflammatory mediators, migration of mast cells and decreasing capillary permeability, vasodilation.

Pharmacokinetics:

With topical application, it penetrates well into the corneal epithelium and conjunctiva: in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases.

Indications:

Treatment of non-infectious inflammatory diseases of the anterior chamber of the eye.

Contraindications:

Increase in intraocular pressure caused by the use of glucocorticosteroids in the anamnesis; hypersensitivity to any of the components of this drug; acute purulent diseases of the eye without concomitant antimicrobial therapy; amoebic keratitis; surface forms of keratitis caused by Herpes simplex, in particular dendritic keratitis, vaccinia, chicken pox and other viral diseases of the cornea and conjunctiva; Fungal eye diseases or previously untreated parasitic eye infections; mycobacterial eye infections (including mycobacterial tuberculosis); violation of the integrity of the epithelium of the cornea, including after removal of the foreign body; age to 18 years (safety and efficacy of the drug in children have not been studied).

Pregnancy and lactation:

Fertility

Studies to assess the effect of dexamethasone in local application to human fertility have not been conducted.

Pregnancy

Sufficient experience in the use of the drug during pregnancy is not present. Studies in animals have shown reproductive toxicity.

It is possible to use the treatment for pregnant women on prescription of the attending physician if the expected curative effect exceeds the risk of development of possible side effects.

Breast-feeding

In the systemic application of corticosteroids may be present in breast milk in amounts which can cause effects on a child who is breastfed. When used as instillations, the system exposure is low.

It is not known whether the blood is excreted dexamethasone in breast milk. However, the risk to an infant may not be excluded; to decide on the termination of breastfeeding or the termination / suspension of drug therapy DexamethasoneTaking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.

Dosing and Administration:

Application in adults, including elderly patients: in the presence of acute inflammation Dexamethasone it is necessary to instill 1 drop into the conjunctival sac 1-2 hours after the improvement of 1 drop every 4 to 6 hours.

For the prevention of inflammatory processes after ophthalmic surgery and trauma: during the first 24 hours after the operation - 1 -2 drops 4 times a day, then 3 times a day for 2 weeks.

Treatment scheme 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 the symptoms, the possibility of side effects.

The maximum duration of the drug should not exceed 14 days.

Recommendations for the use of vials 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, previously released from the package. Then remove the cap from the cap-dropper, turn the bottle, drip the required number of drops of the drug. After applying the bottle, return to the vertical position and put the cap on the lid-dropper.

Recommendations for the use of a tube-dropper (t / k): Remove the protective cap, use a pair of scissors to cut off the membrane of the neck of the housing, without damaging the threaded part. Turn the body t / k with the drug throat down and gently move the body t / k, using it as a pipette. After applying the recommended dose for the doctor's prescription or specified in the instructions for the use of the medicinal product, the body of the t / k must be turned with the threaded part upwards and the protective cap screwed.

Side effects:

Undesirable 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 the same frequency category, unwanted reactions are given in order of severity.

The following adverse reactions were detected during clinical trials:

Disturbances from the nervous system: infrequently: dysgeusia.

Disturbances on the part of the organ of sight: often: discomfort in the eyes. Infrequent: keratitis, conjunctivitis, dry keratoconjunctivitis, corneal staining, photophobia, blurred vision, pruritus in the eye, foreign body sensation in the eyes, increased tear, unusual sensations in the eye, crust formation on the edges of the eyelids, eye irritation, eye hyperemia.

Undesirable reactions, the frequency of which is not established (postmarketing experience):

Immune system disorders: hypersensitivity.

Disturbances from the nervous system: dizziness, headache.

Disturbances on the part of the organ of sight: increased intraocular pressure, reduced visual acuity, corneal erosion, ptosis of the eyelids, pain in the eye, mydriasis.

Very rare cases of development of calcification of the cornea have been reported in the case of a prior significant damage due to the presence of phosphates in the formulation.

Overdose:

In case of contact with excess amounts of the product, it is recommended that the eyes be washed with warm water. No toxic effects are expected in case of an overdose with topical application or with accidental ingestion of the contents of one vial. Symptoms of overdose can be local manifestations.

Treatment for overdose symptomatic.

Interaction:

Simultaneous use of topical steroids and non-steroidal anti-inflammatory agents for topical administration may increase the likelihood of corneal healing disorders.

It is impossible to exclude the risk of an additional increase in intraocular pressure, if dexamethasone It is used in conjunction with anticholinergics, which can also cause increased intraocular pressure in predisposed patients. In the case of joint use with antiglaucoma drugs, hypotensive effect of the latter may be reduced.

In the 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.

Special instructions:

Long-term use of glucocorticosteroids for topical administration may result in increased intraocular pressure and / or glaucoma with optic nerve damage, reduced visual acuity and visual field defects, and the formation of posterior subcapsular cataract.

Therefore, patients with long-term (more than 10 days) using drugs containing glucocorticosteroids should regularly monitor intraocular pressure.

The risk of increased intraocular pressure and / or cataract formation due to the use of corticosteroids in patients with a predisposition (eg, with diabetes) is higher.

The risk of increased intraocular pressure increases 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 these patients is necessary.

Care must be taken and periodic biomicroscopy should be performed when the drug is used in the therapy of deep keratitis caused by Herpes simplex. If there are no improvements within 7-8 days, the choice of therapy should be reviewed.

Glucocorticosteroids can reduce resistance to bacterial, viral or fungal infections and promote their development, as well as mask the clinical signs of infection.

With concomitant bacterial infections, appropriate antibiotic therapy should be prescribed.

The appearance of non-healing ulcers on the cornea may indicate the development of fungal infestation. If fungal invasion occurs, glucocorticosteroid therapy should be discontinued.

Glucocorticosteroids with local application may slow the healing process of the cornea. It is known that non-steroidal anti-inflammatory agents for topical application also slow or delay healing.The simultaneous use of non-steroidal anti-inflammatory drugs for topical application and steroids for topical application may increase the likelihood of healing disorders (see section "Interaction with other drugs").

It is known that in diseases that cause thinning of the cornea or sclera, perforations can result from the use of glucocorticosteroids for topical application.

If the duration of therapy is more than 2 weeks, the condition of the cornea should be monitored.

The use of dexamethasone in the complex therapy of Shengren's syndrome is possible only with moderate to severe keratoconjunctivitis, the duration of the course of therapy should not be more than 2 weeks because of the possibility of developing unwanted reactions (see section "Side effect").

After application, it is recommended to perform nasolacrimal occlusion or gently close the eye. This can reduce the systemic absorption of the drug with topical application, and thereby reduce the likelihood of systemic adverse reactions.

The preparation contains benzalkonium chloride, which can cause eye irritation and stain soft contact lenses.Avoid contact with soft contact lenses. If patients are allowed to wear contact lenses, they should be instructed that it is necessary to remove contact lenses before using the drug and install 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 with any surfaces.

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

Temporary reduction in vision clarity or other visual impairments may affect the ability to drive vehicles or control mechanisms. If the patient after application of the drug temporarily reduces the clearness of vision, then before driving a vehicle or controlling the mechanisms, he should wait until the vision is restored.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

5 ml in bottles of neutral glass. One bottle together with a dropper and instructions for use are placed in a pack of cardboard.

1 ml per tube-dropper. On 2 tubes of a dropper together with the instruction on application place in a pack from a cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 10 ° C. Freezing is unacceptable.

After opening, the bottle should be stored at a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

2 years.

4 weeks for vial after autopsy.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-000621

Date of registration:21.09.2011 / 10.01.2017

Expiration Date:Unlimited

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Representation: & nbsp"Belmedpreparaty" RUP "Belmedpreparaty" RUP

Information update date: & nbsp22.04.2017

Illustrated instructions

Instructions

Dexamethasone (Dexamethasone)