Translation of the instructions can be
DEXAMETHASONE-BIOPHARMA eye drops 0.1%
Instruction
For medical use of the medicinal product
Dexamethasone-Biopharma
(Dexamethasone-biopharma)
Composition:
Active ingredient: dexamethasone sodium phosphate;
1 ml of the drug contains dexamethasone sodium phosphate 1 mg;
excipients: boric acid, sodium tetraborate, disodium edetate (Trilon B), benzalkonium chloride, water for injection.
Dosage form.
Eye drops.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group.
Drugs used in ophthalmology. anti-inflammatory drugs. corticosteroids. dexamethasone.
PBX code S01B A01.
Pharmacological properties.
Pharmacodynamics.
It has a pronounced anti-inflammatory and anti-allergic effect, due to the inhibition of the release of inflammatory mediators by eosinophils; induction of the formation of lipocortins and a decrease in 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 intact epithelium into the moisture of the anterior chamber. In case of inflammation of the eye tissues or damage to the mucous membrane and cornea, the rate of absorption of dexamethasone increases.
Clinical characteristics.
Indication.
Treatment of steroid-responsive non-infectious inflammatory and allergic conditions of the conjunctiva, cornea and anterior segment of the eye, including inflammatory reactions in the postoperative period.
Contraindication.
Hypersensitivity to the active substance or to any of the excipients. Acute untreated bacterial infections. Acute superficial keratitis caused by herpes simplex. Cowpox and chickenpox and other viral infections of the cornea and conjunctiva (except for 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.
Concomitant use of topical steroids and topical nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of corneal wound healing complications.
CYP3A4 inhibitors (including products containing ritonavir and cobicistat) may reduce the clearance of dexamethasone, leading to adverse reactions, adrenal suppression/Cushing's syndrome. The combination should be avoided if the risk of systemic corticosteroid adverse reactions outweighs the benefit, in which case patients should be monitored.
Application features.
For ophthalmic use only. The duration of the course of therapy should not exceed 4 weeks. Prolonged use of topical corticosteroids in the eye can lead to ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, decreased visual acuity and visual field impairment, as well as the formation of posterior subcapsular cataracts in the posterior chamber of the eye. Patients with prolonged use of topical corticosteroids in the eye should have their intraocular pressure monitored continuously and regularly.
Topical corticosteroids used in the eye may slow the healing of corneal wounds. Topical NSAIDs are also known to slow or delay wound healing. Concomitant use of topical NSAIDs and topical steroids may increase the risk of wound healing complications (see section 4.5).
It is known that in the presence of diseases that lead to thinning of the cornea or sclera, topical use of corticosteroids can cause perforation. The drug should be used with extreme caution and only in combination with antiviral therapy during the treatment of stromal keratitis or uveitis caused by herpes simplex; it is necessary to periodically perform microscopy using a slit lamp. It is not recommended to wear contact lenses during the treatment of eye inflammation.
In addition, the drug 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 using DEXAMETHASONE-BIOPHARMA eye drops and to wait 15 minutes after instillation before inserting contact lenses.
Use during pregnancy or breastfeeding.
pregnancy
It is not recommended to use the drug during pregnancy.
Breastfeeding period
A decision should be made whether to temporarily discontinue breastfeeding during treatment with DEXAMETHASONE-BIOPHARMA or to discontinue/abstain from therapy with the drug, taking into account the potential benefit of the drug to the mother and the benefit of breastfeeding to the child.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Dexamethasone-Biopharma has no or negligible influence on the ability to drive or use machines. As with other eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs during instillation, the patient should wait until the vision clears before driving or using machines.
Method of administration and doses.
Adults, including elderly patients
For 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.
The dose can then be reduced to 1 drop 3-4 times a day if this dose is sufficient to control inflammation.
If the desired result is not achieved within 3-4 days, additional systemic or subconjunctival therapy may be prescribed.
In chronic inflammations, the dose is 1-2 drops in the conjunctival sac of the affected eye(s) every 3-6 hours or more often if necessary.
For allergies or minor inflammation, the dose is 1-2 drops into the conjunctival sac of the affected eye(s) every 3-4 hours until the desired effect is achieved.
Therapy should not be discontinued prematurely (see section "Special warnings and precautions for use").
It is recommended to constantly monitor intraocular pressure.
After application, careful eyelid closure or nasolacrimal occlusion is recommended. This reduces systemic absorption of drugs administered into the eye, which reduces the likelihood of systemic side effects.
If several topical ophthalmic medications are used simultaneously, the interval between their applications should be at least 5 minutes. Eye ointments should be applied last.
Use in case of impaired liver and kidney function
The use of DEXAMETHASONE-BIOPHARMA has not been studied in patients with kidney or liver disease. However, due to the low systemic absorption of dexamethasone after topical application, there is no need for dose adjustment.
Method of application
To prevent contamination of the tip of the dropper and the eye drops, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the tip of the dropper.
Children.
The efficacy and safety of the drug in children have not been established.
Overdose.
No cases of overdose have been reported. In case of overdose with the drug Dexamethasone-Biopharma when applied topically, wash the excess drug from the eye(s) with warm water.
Adverse reactions.
On the part of the endocrine system: Cushing's syndrome, adrenal suppression (see section "Special warnings and precautions for use").
On the part of the immune system: hypersensitivity.
From the nervous system: dysgeusia (taste disorder), dizziness, headache.
Prolonged use of topical corticosteroids in the eye may lead to increased intraocular pressure with subsequent damage to the optic nerve, decreased visual acuity and visual field impairment, as well as the formation of posterior subcapsular cataracts of the posterior chamber of the eye (see section "Special precautions for use").
Since the drug contains corticosteroids, in the presence of diseases that lead to thinning of the cornea or sclera, the risk of perforation increases after prolonged use.
Corticosteroids may reduce resistance to infections (see section "Special warnings and precautions for use").
Adverse reaction reporting
Reporting of adverse reactions after the registration of a medicinal product is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Expiration date.
2 years.
The shelf life after opening the bottle is 14 days.
Storage conditions.
Store in the original packaging to protect from light at a temperature of 2 to 8 °C. Keep out of the reach of children.
Incompatibility.
Mixing the drug with other simultaneously prescribed medications is not allowed.
Packaging.
10 ml in a plastic bottle. 1 bottle in a cardboard pack.
Vacation category.
According to the recipe.
Producer.
LLC "FZ" Biofarma ", Ukraine.
Location of the manufacturer and address of its place of business.
Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.
