Instructions Dexamethasone VFZ eye drops suspension 0.1% dropper bottle 5 ml
Composition
active ingredient: dexamethasone;
1 ml of suspension contains 1 mg of dexamethasone;
excipients: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate, benzalkonium chloride solution, polysorbate 80, ethanol 96%, sodium hydroxide 10% solution, purified water.
Dosage form
Eye drops, suspension.
Main physicochemical properties: white suspension, after shaking for 15 seconds, a homogeneous distribution of the stationary phase is observed, which persists for at least 2 minutes.
Pharmacotherapeutic group
Anti-inflammatory drugs used in ophthalmology. Corticosteroids, simple preparations. ATX code S01B A01.
Pharmacological properties
Pharmacodynamics
Dexamethasone is a synthetic glucocorticosteroid that has anti-inflammatory, antiallergic, and antipruritic effects. It affects all phases of the inflammatory process. It reduces the permeability of blood vessels, inhibits leukocyte migration, phagocytosis, the release of kinins, and the production of antibodies.
Pharmacokinetics
Dexamethasone, injected into the conjunctival sac, is absorbed into the aqueous humor of the eye, cornea, iris and choroid, ciliary body, and retina.
Absorption of dexamethasone from the conjunctival sac into the general circulatory system is insignificant, therefore the systemic effect is not significant.
The systemic toxicity data of the active substance are well established. The systemic effects of dexamethasone may be related to effects related to glucocorticosteroid imbalance. Repeated dose toxicity studies of Dexamethasone VFZ eye drops in rabbits have revealed systemic effects associated with corticosteroids, but even at doses significantly exceeding the human dose, this manifestation is of little clinical significance. When using Dexamethasone VFZ in recommended doses, these effects are unlikely to occur.
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 components of the medicinal product.
Acute untreated bacterial eye infections.
Acute superficial keratitis caused by herpes simplex.
Cowpox and chickenpox and other viral infections of the cornea and conjunctiva (except keratitis caused by herpes zoster).
Fungal diseases of the eye structures and untreated parasitic infections.
Mycobacterial infections of the eye.
Corneal perforations, ulcers and injuries with incomplete epithelialization (see also section "Special instructions for use").
Glucocorticoid-induced ocular hypertension.
Interaction with other medicinal products and other types of interactions
Dexamethasone should not be combined with medications used for glaucoma, especially not for long periods of time and in high doses - this can lead to increased intraocular pressure.
Prolonged use of the drug with anticholinergic agents (especially atropine and chemical compounds with a similar structure) causes an increase in intraocular pressure.
The simultaneous use of dexamethasone with agents that affect accommodation or dilate the pupil increases the risk of increased intraocular pressure (especially in patients prone to closed-angle filtration).
Concomitant use of topical steroids and topical nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of complications in corneal wound healing.
The therapeutic efficacy of dexamethasone may be reduced by phenytoin, phenobarbital, ephedrine, and rifampicin. Glucocorticoids may increase the requirement for salicylates as plasma clearance of salicylate increases.
CYP3A4 inhibitors (including ritonavir and cobicistat) may decrease dexamethasone clearance and/or increase the adrenal suppression/Cushing's syndrome effects. Such combinations should be avoided unless the benefit outweighs the risk of increased systemic corticosteroid side effects, in which case systemic corticosteroid effects should be closely monitored.
Wearing contact lenses increases the risk of infections.
Concomitant use with ophthalmic drugs containing phosphates increases the risk of corneal deposits or clouding, especially in patients with compromised corneas.
Application features
For ophthalmic use only.
Prolonged use of topical corticosteroids in the eye may lead to ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, deterioration of visual acuity and visual field defects, and the formation of posterior subcapsular cataracts in the posterior chamber of the eye. With prolonged use of topical corticosteroids in the eye, intraocular pressure should be monitored regularly (especially in patients who have already had an increase in intraocular pressure due to steroid use, in patients with high intraocular pressure before starting steroid use, and in patients with glaucoma). This is especially important in children, since the risk of ocular hypertension caused by corticosteroids is higher in children. The risk of corticosteroid-induced intraocular pressure increase and/or the risk of cataract formation caused by corticosteroid use is increased in predisposed patients (e.g., diabetic patients).
The use of topical corticosteroids should not last longer than a week, except under close supervision and measurement of intraocular pressure.
Given the potential for systemic absorption of dexamethasone, Cushing's syndrome and/or adrenal suppression may occur, especially after prolonged continuous use of dexamethasone eye drops in susceptible patients, including children and patients taking CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be gradually discontinued.
Corticosteroids may reduce resistance to bacterial, viral or fungal infections and may obscure the detection of such infections and mask clinical signs of infection, making it difficult to detect antibiotic failure. In patients who have had or are receiving corticosteroid treatment and persistent corneal ulcers, the possibility of fungal infection should be considered. Treatment should be discontinued if a fungal infection occurs.
Topical corticosteroids may delay the healing of corneal wounds. Concomitant use of topical NSAIDs and corticosteroids may contribute to the development of healing problems (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.
Visual disturbances may occur with systemic and topical corticosteroids. If blurred vision or other visual disturbances occur, an ophthalmologist should be consulted to determine possible causes, which may include cataracts, glaucoma, or other rare conditions such as central serous chorioretinopathy, which has been reported following systemic corticosteroid use.
The drug should be used with extreme caution and only in combination with antiviral therapy in the treatment of stromal keratitis or uveitis caused by herpes simplex. Ocular herpes simplex has occurred in patients receiving systemic or topical corticosteroids for other conditions. The use of corticosteroids in the treatment of herpes simplex, except for epithelial keratitis caused by herpes simplex, in which corticosteroids are contraindicated, requires special caution; periodic slit-lamp biomicroscopy is necessary.
It is not recommended to wear contact lenses during 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 VFZ eye drops and to wait 15 minutes after instillation before inserting contact lenses.
Benzalkonium chloride may cause eye irritation, especially if you have symptoms of dry eyes or diseases of the cornea (the transparent front layer of the eye).
Treatment should not be stopped prematurely, as sudden discontinuation of topical treatment with high doses of steroids may cause re-inflammation of the eye.
In acute purulent eye diseases, corticosteroids may mask infections or spread existing infections. If treatment lasts more than 10 days, intraocular pressure should be monitored.
During long-term treatment with dexamethasone, the condition of the cornea should be checked by fluorescence test and intraocular pressure should be monitored. In case of a positive fluorescence test or increased intraocular pressure, treatment with the drug should be discontinued.
Cases of corneal calcification requiring corneal transplantation to restore vision have been reported in patients receiving phosphate-containing ophthalmic agents such as Dexamethasone Hydrochloride. At the first sign of corneal calcification, the agent should be discontinued and the patient should be re-treated with phosphate-free agents.
Use during pregnancy or breastfeeding
Data on the use of Dexamethasone eye drops during pregnancy are limited. There have been reports of effects on the fetus/neonate after systemic use of corticosteroids at higher doses (intrauterine growth retardation, adrenal dysfunction). There are no reports of such effects with topical application to the eyes. Reproductive toxicity has been demonstrated in animal studies.
The use of the drug during pregnancy is not recommended.
Breast-feeding
Systemic administration of corticosteroids leads to their appearance in human breast milk in quantities that may affect the breast-fed child. However, with topical application of the drug, systemic exposure is low. It is not known whether this drug penetrates into breast milk. A risk to the breast-fed child cannot be excluded. Consideration should be given to temporarily discontinuing breast-feeding for the duration of drug use or to discontinuing/withdrawing from drug therapy, taking into account the potential benefit of drug use for the mother and the benefit of breast-feeding for the child.
Fertility.
Fertility studies with intraconjunctival dexamethasone have not been conducted. Clinical data on the effects of dexamethasone on male or female fertility are limited.
The ability to influence the reaction speed when driving or working with other mechanisms
Dexamethasone 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
For ophthalmic use only. Shake bottle before use. To prevent contamination of the dropper tip and suspension, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip.
The frequency of use of the drops and the duration of treatment depend on the severity of the underlying disease and the response to treatment.
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 daily 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 stopped prematurely.
After instillation, careful eyelid closure or nasolacrimal occlusion is recommended. This reduces systemic absorption of the drug administered into the eye, which reduces the likelihood of systemic side effects.
If several topical eye 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 liver and kidney dysfunction.
Dexamethasone VFZ has not been studied in patients with renal or hepatic disease. However, due to the low systemic absorption of dexamethasone after topical application of this drug, no dose adjustment is necessary.
Children
The effectiveness and safety of the drug for the treatment of children have not been established.
Overdose
Long-term topical use of the drug may lead to systemic effects. No cases of overdose have been reported.
In case of overdose with topical application, wash excess drug from the eye(s) with warm water.
Accidental ingestion of the drug into the digestive tract does not cause serious side effects, but it is recommended to drink sufficient fluids.
Side effects
The most common side effect observed during clinical studies was ocular discomfort.
Adverse reactions were classified by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), rare (< 1/10,000) or unknown frequency (cannot be estimated from the available data). Within each grouping, adverse reactions are presented in order of decreasing seriousness. Adverse reactions have been identified during clinical trials and during post-marketing experience with dexamethasone eye drops and/or eye ointment.
| Organ systems | Adverse reactions according to MedDRA classification |
| On the part of the immune system | Frequency unknown: hypersensitivity, allergic reactions. |
| Frequency unknown: Cushing's syndrome, adrenal suppression (see section "Special warnings and precautions for use"). |
| From the nervous system | Uncommon: dysgeusia. Frequency unknown: dizziness, headache. |
| Ophthalmological disorders | Common: feeling of discomfort in the eyes, burning, tingling. Uncommon: keratitis, conjunctivitis, keratoconjunctivitis sicca, corneal staining, photophobia, blurred vision, eye itching, foreign body sensation in the eyes, lacrimation increased, unusual sensation in the eyes, eyelid margin scaling, eye irritation, eye hyperaemia, delayed healing of corneal wounds, opportunistic infections. Frequency unknown: glaucoma, ulcerative keratitis, increased intraocular pressure, decreased visual acuity, corneal erosion, eyelid ptosis, eye pain, mydriasis, corneal thinning, corneal perforation, optic nerve changes, posterior subcapsular cataract, visual acuity and visual field defects (blurred vision, vision loss), corticosteroid-induced uveitis, corneal calcification, crystalline keratopathy, eye infection (exacerbation or occurrence of secondary infection). |
Description of some adverse reactions.
Increased intraocular pressure, glaucoma, and cataracts may occur. Prolonged use of corticosteroids may lead to ocular hypertension/glaucoma (especially in patients who already have elevated intraocular pressure after steroid use, in patients with high intraocular pressure before steroid use, and in patients with glaucoma), as well as the development of cataracts. Children and the elderly are particularly susceptible to steroid-induced increases in intraocular pressure.
An increase in intraocular pressure with topical corticosteroid treatment is usually observed within 2 weeks of treatment.
Diabetic patients are prone to developing subcapsular cataracts with topical steroid use.
Immediately after using the drug, discomfort, irritation, burning, tingling, itching and blurred vision may occur. These manifestations are usually mild and short-lived and have no consequences.
In diseases that cause a decrease in corneal thickness, topical steroid use can lead to perforation in some cases.
Systemic absorption and associated adrenal suppression may occur with frequent instillation. Isolated cases of corneal calcification have been reported with the use of phosphate-containing eye drops in some patients with significant corneal lesions.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
The shelf life after first opening is 4 weeks.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 ml of suspension in a polyethylene dropper bottle with tamper-evident No. 1 in a cardboard box.
Vacation category
According to the recipe.
Producer
Warsaw Pharmaceutical Plant Polfa JSC.
Warsaw Pharmaceutical Works Polfa SA.
Location of the manufacturer and its business address
St. Karolkova 22/24, 01-207 Warsaw, Poland.
22/24 Karolkowa Str., 01-207 Warsaw, Poland.
