Dexamethasone

Instruction manual

For medical use of the drug

Dexamethasone Biopharma

(dexamethasone-biopharma)

Structure:

Active substance: dexamethasone sodium phosphate;

1 ml of the drug contains 1 mg dexamethasone sodium phosphate;

excipients: boric acid, sodium tetraborate, disodium edetate (Trilon B), benzalkonium chloride, water for injection.

Dosage form.

Eye drops.

Basic physical and chemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

Means used in ophthalmology. anti-inflammatory drugs. corticosteroids. dexamethasone.

ATX code S01B A01.

Pharmacological properties.

Pharmacodynamics

It has a pronounced anti-inflammatory and anti-allergic effect, due to inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortins and reducing the number of mast cells that produce histamine and hyaluronic acid, with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes.

Pharmacokinetics

When instilled into the eye, dexamethasone is absorbed through the cornea with an intact epithelium into the moisture of the anterior chamber. With inflammation of the tissues of the eye or damage to the mucous membrane and cornea, the absorption rate of dexamethasone increases.

Clinical characteristics.

Indications.

Treatment of steroid-sensitive non-infectious inflammatory and allergic conditions of the conjunctiva, cornea, and anterior segment of the eye, including inflammatory reactions in the postoperative period.

Contraindications

• Hypersensitivity to the active substance or to any of the auxiliary components of the drug. acute untreated bacterial infections. acute superficial keratitis caused by herpes simplex. cow and chickenpox and other viral infections of the cornea and conjunctiva (with the exception of keratitis caused by herpes zoster). fungal diseases of the eye structures. mycobacterial infections of the eye.

Interaction with other drugs and other types of interactions.

The simultaneous use of steroids for topical use and non-steroidal anti-inflammatory drugs (NSAIDs) for topical use can increase the risk of complications in the healing of corneal wounds.

CYP3A4 inhibitors (including products containing ritonavir and cobicistat) can reduce dexamethasone clearance, which leads to adverse reactions, suppression of the adrenal gland / Cushings syndrome. Combinations of drugs should be avoided if the risk of systemic adverse reactions of corticosteroids exceeds the benefit, in which case patients should be monitored.

Features of the application.

• For ophthalmic use only. the duration of the course of therapy should not exceed 4 weeks. prolonged use of corticosteroids locally in the eye can lead to ocular hypertension and / or glaucoma, followed by damage to the optic nerve, decreased visual acuity and visual field disturbance, as well as the formation of the posterior subcapsular cataract of the posterior chamber of the eye. patients with prolonged use of corticosteroids locally in the eye should constantly and regularly monitor intraocular pressure.

This is especially important in children, because the risk of ocular hypertension caused by corticosteroids may be higher in children and may occur earlier than in adults.

• Cushings syndrome and / or suppression of the adrenal glands, which is associated with systemic absorption of dexamethasone eye drops, may occur after intensive or long-term continuous therapy in susceptible patients, including children and adult patients, who have received CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be gradually discontinued.
• In acute purulent eye diseases, corticosteroids can mask infections or spread an existing infection. If treatment continues for more than 10 days, intraocular pressure should be monitored.
• The risk of increased intraocular pressure caused by corticosteroids, and / or the risk of cataracts due to the use of corticosteroids, increases in predisposed patients (for example, in patients with diabetes mellitus).
• Corticosteroids can reduce resistance to bacterial, viral, or fungal infections, interfere with the detection of such infections, and mask the clinical signs of infection, preventing the detection of antibiotic failure. With persistent formation of corneal ulcers, the possibility of fungal infection in patients who have been treated with corticosteroids should be considered. Treatment should be discontinued if a fungal infection occurs.
• Topical corticosteroids in the eye can slow the healing of corneal wounds. It is also known that topical NSAIDs slow or delay wound healing. The simultaneous use of NSAIDs for topical use and steroids for topical use may increase the risk of complications in wound healing (see section “Interaction with other drugs and other types of interactions”).
• It is known that in the presence of diseases that lead to thinning of the cornea or sclera, topical application of corticosteroids can cause perforation.
• The drug should be used with extreme caution and only in combination with antiviral therapy during treatment of stromal keratitis or uveitis caused by herpes simplex; it is necessary to periodically perform microscopy using a slit lamp.
• Contact lenses are not recommended for treating eye inflammation.

In addition, the drug contains benzalkonium chloride, which can cause eye irritation and, as you know, discolor soft contact lenses. Contact with soft contact lenses should be avoided. Patients should be warned that contact lenses must be removed before using DEXAMETASONE-BIOPHARM eye drops and wait 15 minutes after installation before inserting contact lenses.

Use during pregnancy or lactation.

Pregnancy

It is not recommended to use the drug during pregnancy.

Lactation period

Consideration should be given to temporarily discontinuing breast-feeding while using DEXAMETASONE-BIOPHARM or discontinuing treatment with the drug, given the potential benefits of using the drug for the mother and the benefits of breast-feeding for the baby.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Dexamethasone-biopharma does not affect or slightly affects the ability to drive vehicles or other mechanisms. as with other eye drops, temporary blurred vision or other visual impairment can affect the ability to drive vehicles or other mechanisms. if blurred vision occurs during instillation, the patient must wait until the clarity is restored before driving or using other mechanisms.

Dosage and administration.

Adult use, including elderly patients

In severe or acute inflammation, 1-2 drops should be instilled into the conjunctival sac of the affected eye (s) every 30-60 minutes as initial therapy.

In case of a positive effect, the dose should be reduced to 1-2 drops in the conjunctival sac of the affected eye (s) every 2-4 hours.

Further, the dose can be reduced to 1 drop 3-4 times a day, if this dose is enough to control inflammation.

If the desired result is not achieved within 3-4 days, the appointment of additional systemic or subconjunctival therapy.

In chronic inflammation, the dose is 1–2 drops in the conjunctival sac of the affected eye (s) every 3–6 hours or more often if necessary.

In case of allergies or minor inflammation, the dose is 1-2 drops in the conjunctival sac of the affected eye (s) every 3-4 hours until the desired effect is achieved.

The therapy should not be stopped prematurely (see the section "Peculiarities of Use").

It is recommended to constantly monitor intraocular pressure.

After instillation, careful closure of the eyelids or nasolacrimal occlusion is recommended. This reduces the systemic absorption of drugs injected into the eyes, which reduces the likelihood of systemic side effects.

If several drugs are used at the same time for topical application in the eyes, the interval between their use should be at least 5 minutes. Eye ointments should be applied last.

Use for impaired liver and kidney function

The use of the drug DEXAMETASONE-BIOFARMA has not been studied in patients suffering from kidney and liver diseases. However, due to the low systemic absorption of dexamethasone after topical application, there is no need for dose adjustment.

Mode of application

To prevent contamination of the dropper edge and eye drops, care must be taken not to touch the eyelids, adjacent areas or other surfaces with the dropper edge.

Children.

The effectiveness and safety of the drug to children have not been established.

Overdose.

No cases of overdose have been reported. in case of an overdose of the drug dexamethasone-biopharma with topical application, wash the excess of the drug from the eye (s) with warm water.

Adverse Reactions

From the endocrine system: Cushings syndrome, suppression of the adrenal glands (see. Section "application features").

From the immune system: hypersensitivity.

From the side of the nervous system: dysgeusia (disorder of taste perception), dizziness, headache.

From the side of the organs of vision: discomfort in the eyes, keratitis, conjunctivitis, keratoconjunctivitis dry, coloration of the cornea, photophobia, blurred vision, itching of the eyes, sensation of a foreign body in the eyes, increased tearing, unusual sensation in the eyes, the formation of scales along the edges of the eyelids, eye irritation , eye hyperemia, increased intraocular pressure, decreased visual acuity, corneal erosion, ptosis of the eyelids, eye pain, mydriasis.

Long-term use of corticosteroids locally in the eye can lead to an increase in ocular pressure followed by damage to the optic nerve, a decrease in visual acuity and a disturbance in the visual field, as well as to the formation of posterior subcapsular cataracts of the posterior chamber of the eye (see section “Peculiarities of use”).

Since the drug contains corticosteroids, in the presence of diseases that lead to thinning of the cornea or sclera, the risk of perforation after prolonged use increases.

Corticosteroids can reduce resistance to infections (see section "Features of use").

Adverse Reaction Reporting

Reporting on adverse reactions after drug registration is important. This allows you to continue monitoring the benefit / risk balance of the drug. Health professionals are asked to report any suspected adverse reactions.

Shelf life.

2 years.

Shelf life after opening the bottle is 14 days.

Storage conditions.

Store in the original packaging to protect from exposure to light at a temperature of 2 to 8 °С. Keep out of the reach of children.

Incompatibility.

Mixing the drug with other simultaneously prescribed drugs is not allowed.

Packaging.

10 ml in a plastic bottle.1 bottle in a pack from cardboard.

Vacation category.

On prescription.

Manufacturer.

Ooo "fz" biopharma ", Ukraine.

The location of the manufacturer and the address of the place of business.

Ukraine, 09100, Kiev region, Bila Tserkva, st. Kiev, 37.