DEXAMETHASONE-STADA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEXAMETHASONE-STADA (Dexamethasone-STADA)

Composition:

Active substance: dexamethasone sodium phosphate;

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

Excipients: boric acid, sodium tetraborate, disodium edetate (EDTA), benzalkonium chloride, water for injections.

Pharmaceutical form. Eye drops.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-inflammatory agents. Corticosteroids. Dexamethasone. ATC code S01B A01.

Pharmacological properties.

Pharmacodynamics.

Exerts pronounced anti-inflammatory and anti-allergic effects, due to suppression of inflammatory mediators released by eosinophils; induction of lipocortin production and reduction in the number of mast cells producing histamine and hyaluronic acid, resulting in decreased capillary permeability; stabilization of cellular membranes (particularly lysosomal) and organelle membranes.

Pharmacokinetics.

When instilled into the eye, dexamethasone is absorbed through the cornea with intact epithelium into the aqueous humor of the anterior chamber. Inflammation of ocular tissues or damage to the mucous membrane and cornea increases the absorption rate of dexamethasone.

Clinical characteristics.

Indications.

Treatment of steroid-sensitive noninfectious 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 excipients of the medicinal product.
• Acute untreated bacterial infections.
• Acute superficial keratitis caused by herpes simplex.
• Vaccinia, smallpox, and other viral infections of the cornea and conjunctiva (except keratitis caused by herpes zoster).
• Fungal diseases of ocular structures.
• Mycobacterial infections of the eye.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of topically applied steroids and nonsteroidal anti-inflammatory drugs (NSAIDs) for topical use may increase the risk of corneal wound healing complications.

CYP3A4 inhibitors (including products containing ritonavir and cobicistat) may reduce dexamethasone clearance, leading to adverse reactions and adrenal suppression/Cushing's syndrome. Such combinations should be avoided if the risk of systemic corticosteroid side effects outweighs the benefit; in such cases, patients should be monitored.

Special precautions for use.

• For ophthalmic use only.
• The duration of therapy should not exceed 4 weeks. Prolonged local ocular use of corticosteroids may lead to ocular hypertension and/or glaucoma with subsequent optic nerve damage, decreased visual acuity, visual field defects, and the development of posterior subcapsular lenticular opacities. Patients undergoing prolonged local ocular corticosteroid therapy should be monitored regularly and frequently for intraocular pressure.

This is particularly important in children, as the risk of corticosteroid-induced ocular hypertension may be higher in children and may occur earlier than in adults.

• Cushing's syndrome and/or adrenal suppression related to systemic absorption of dexamethasone eye drops may occur following intensive or prolonged continuous therapy in predisposed patients, including children and adult patients receiving CYP3A4 inhibitors (including ritonavir and cobicistat). In such cases, treatment should be tapered gradually.
• In acute purulent ocular infections, corticosteroids may mask infection or promote the spread of existing infection. If treatment continues beyond 10 days, intraocular pressure should be monitored.
• The risk of corticosteroid-induced elevation of intraocular pressure and/or corticosteroid-induced cataract formation increases in susceptible patients (e.g., patients with diabetes mellitus).
• Corticosteroids may reduce resistance to bacterial, viral, or fungal infections and may interfere with the detection of such infections by masking clinical signs of infection, thus hindering recognition of antibiotic inefficacy. In cases of persistent corneal ulceration, fungal infection should be considered in patients who are or have been receiving corticosteroid therapy. Treatment should be discontinued if fungal infection develops.
• Topically administered ocular corticosteroids may delay corneal wound healing. Nonsteroidal anti-inflammatory drugs (NSAIDs) for topical use are also known to delay or impair corneal wound healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the risk of complications in wound healing (see section "Interaction with other medicinal products and other forms of interaction").
• Local use of corticosteroids may lead to perforation in patients with diseases causing thinning of the cornea or sclera.
• The drug should be used with particular caution and only in combination with antiviral therapy when treating stromal keratitis or uveitis caused by herpes simplex; periodic slit-lamp microscopy should be performed.
• Wearing contact lenses during ocular inflammatory treatment is not recommended.

Additionally, the product contains benzalkonium chloride, which may cause eye irritation and is known to discolor soft contact lenses. Contact with soft contact lenses should be avoided. Patients should be advised to remove contact lenses before instilling DEXAMETHASONE-STADA eye drops and to wait 15 minutes after instillation before reinserting contact lenses.

Use during pregnancy or breastfeeding.

Pregnancy.

The use of the drug during pregnancy is not recommended.

Breastfeeding period.

Consideration should be given to temporarily discontinuing breastfeeding during treatment with DEXAMETHASONE-STADA or to discontinuing/withholding treatment with the drug, taking into account the potential benefit of the drug for the mother and the benefit of breastfeeding for the child.

Ability to affect reaction speed when driving or operating machinery.

DEXAMETHASONE-STADA does not affect or has a negligible effect on the ability to drive or operate machinery. As with other eye drops, transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. If blurred vision occurs after instillation, patients should wait until vision clears before driving or operating machinery.

Administration and Dosage

Use in adults, including elderly patients

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

If a favorable response is observed, reduce dosage to 1–2 drops into the conjunctival sac of the affected eye(s) every 2–4 hours.

Subsequently, the dosage may be further reduced to 1 drop 3–4 times daily, if this dose is sufficient to control inflammation.

If the desired therapeutic effect is not achieved within 3–4 days, additional systemic or subconjunctival therapy may be considered.

For chronic inflammation, the dosage is 1–2 drops into the conjunctival sac of the affected eye(s) every 3–6 hours, or more frequently if necessary.

For allergy or mild inflammation, the dosage is 1–2 drops into the conjunctival sac of the affected eye(s) every 3–4 hours until the desired effect is achieved.

Treatment should not be discontinued prematurely (see section "Special Warnings and Precautions for Use").

Regular monitoring of intraocular pressure is recommended.

After instillation, gentle closure of the eyelids or nasolacrimal occlusion is advised. This reduces systemic absorption of ophthalmic medications, thereby decreasing the likelihood of systemic adverse effects.

If several ophthalmic medicinal products are used simultaneously, an interval of at least 5 minutes between administrations is recommended. Ophthalmic ointments should be applied last.

Use in hepatic and renal impairment

The use of DEXAMETHASONE-STADA has not been studied in patients with renal or hepatic disease. However, due to the low systemic absorption of dexamethasone following topical administration, dosage adjustment is not required.

Instructions for use

To prevent contamination of the dropper tip and the eye drops, care should be taken to avoid touching the eyelids, surrounding areas, or other surfaces with the dropper tip.

Children. The efficacy and safety of DEXAMETHASONE-STADA in children have not been established.

Overdose

No cases of overdose have been reported. In the event of overdose with DEXAMETHASONE-STADA following topical administration, wash the excess medication from the eye(s) with warm water.

Adverse Reactions

Endocrine system: Cushing's syndrome, adrenal gland suppression (see section "Special Warnings and Precautions for Use").

Immune system: hypersensitivity.

Nervous system: dysgeusia (taste disturbance), dizziness, headache.

Eye disorders: eye discomfort, keratitis, conjunctivitis, dry keratoconjunctivitis, corneal pigmentation, photophobia, blurred vision, eye itching, foreign body sensation in eyes, increased lacrimation, unusual sensation in eyes, scaling along eyelid margins, eye irritation, ocular hyperemia, increased intraocular pressure, decreased visual acuity, corneal erosion, ptosis of eyelids, eye pain, mydriasis.

Prolonged topical ocular use of corticosteroids may lead to elevated intraocular pressure with subsequent optic nerve damage, decreased visual acuity, visual field defects, as well as development of posterior subcapsular cataract in the posterior chamber of the eye (see section "Special Warnings and Precautions for Use").

Since the medicinal product contains corticosteroids, prolonged use increases the risk of perforation in patients with diseases causing thinning of the cornea or sclera.

Corticosteroids may reduce resistance to infections (see section "Special Warnings and Precautions for Use").

Reporting of Adverse Reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the product. Healthcare professionals are asked to report any suspected adverse reactions.

Shelf life. 2 years.

Shelf life after first opening of the container: 14 days.

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

Incompatibilities. The medicinal product must not be mixed with other concurrently administered medicinal products.

Packaging. 10 ml in a plastic bottle. 1 bottle per cardboard box.

Prescription status. Prescription only.

Manufacturer. LLC "FZ "STADA", Ukraine.

Manufacturer's address and place of business.
37, Kyivska Street, Bila Tserkva, Kyiv Oblast, 09100, Ukraine.