Instructions for use Pharmadex eye drops 1 mg/ml bottle 10 ml
Composition
active ingredient: dexamethasone;
1 ml of solution contains 1 mg of dexamethasone sodium phosphate, calculated on 100% dry matter;
Excipients: boric acid, sodium tetraborate, disodium edetate, benzalkonium chloride, water for injections.
Dosage form
Eye drops.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Anti-inflammatory drugs used in ophthalmology. Corticosteroids, simple preparations. Dexamethasone. ATX code S01B A01.
Pharmacological properties
Pharmacodynamics
Corticosteroids exert their anti-inflammatory effects by inhibiting vascular endothelial cell adhesion molecules, cyclooxygenase I or II, and cytokine release. This results in reduced formation of inflammatory mediators and inhibition of leukocyte adhesion to vascular endothelium, thereby preventing their entry into inflamed ocular tissues. Dexamethasone has a pronounced anti-inflammatory effect with reduced mineralocorticoid effects compared to some other steroids and is one of the most potent anti-inflammatory agents.
Pharmacokinetics
The ophthalmic bioavailability of dexamethasone after topical ocular administration was studied in patients undergoing cataract surgery. Peak intraocular fluid concentrations of dexamethasone, approximately 30 ng/mL, were reached within 2 hours. Concentrations then declined with a half-life of 3 hours.
Dexamethasone is eliminated from the body by metabolism. Approximately 60% of the dose is excreted in the urine as 6-β-hydroxydexamethasone. Unchanged dexamethasone was not detected in the urine. The plasma half-life is relatively short - 3-4 hours. Dexamethasone is approximately 77-84% bound to serum albumin. Clearance ranges from 0.111 to 0.225 l/h/kg, volume of distribution ranges from 0.576 to 1.15 l/kg. The bioavailability of dexamethasone when administered orally is approximately 70%.
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 drug.
· Acute untreated bacterial 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.
Mycobacterial infections of the eye.
Interaction with other medicinal products and other types of interactions
Studies of the interaction of Pharmadex with other drugs have not been conducted.
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, as well as the formation of posterior subcapsular cataracts. Patients receiving prolonged topical corticosteroids in the eye should have their intraocular pressure monitored regularly.
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 with persistent corneal ulcers, the possibility of fungal infection should be considered in patients who have been or are being treated with corticosteroids. Treatment should be discontinued if a fungal infection occurs.
· Corticosteroids applied topically to the eye may slow the healing of corneal wounds.
· 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 in the treatment of stromal keratitis or uveitis caused by herpes simplex; it is necessary to periodically perform biomicroscopy using a slit lamp.
· It is not recommended to wear contact lenses during treatment of eye inflammation.
· In addition, 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 using Pharmadex eye drops and to wait 15 minutes after instillation before reinserting contact lenses.
· Treatment should not be stopped prematurely, as sudden discontinuation of topical treatment with high doses of steroids may cause re-inflammation of the eye.
Use during pregnancy or breastfeeding
Systemic administration of corticosteroids leads to their appearance in human breast milk in quantities that may affect the breastfed child. However, with topical application of the drug, systemic exposure is low. It is not known whether Pharmadex penetrates into breast milk. A risk to the breastfed child cannot be excluded. The possibility of temporarily discontinuing breast-feeding during the use of Pharmadex or discontinuing/abstaining from drug therapy should be considered, taking into account the potential benefit of the drug for the mother and the benefit of breast-feeding for the child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Pharmadex 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
Use in 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 or 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 precautions for use").
It is recommended to constantly monitor intraocular pressure.
After instillation, 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 ocular 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
Pharmadex has not been studied in patients with kidney or liver disease. However, due to the low systemic absorption of dexamethasone after topical application of this drug, dose adjustment is not necessary.
Method of application
The bottle should be shaken well 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 tip of the dropper bottle.
Attention! Do not screw the cap tightly before use! Before the first use, screw the bottle cap as tightly as possible. In this case, the spike located on the inside of the cap pierces the hole. Immediately before use, hold the bottle with the drug in the palm of your hand to warm it to body temperature. Unscrew the cap, remove it and, slightly pressing on the bottle body, drip the solution into the eye. After instilling the drug, screw the cap tightly and store the drug according to the recommendations given in the instructions.
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 an overdose of Pharmadex when applied topically, wash the excess drug from the eye(s) with warm water.
Adverse reactions
On the part of the immune system: hypersensitivity.
From the nervous system: dysgeusia, dizziness, headache.
On the part of the organs of vision: feeling of discomfort in the eyes, keratitis, conjunctivitis, keratoconjunctivitis sicca, corneal discoloration, photophobia, blurred vision, itching of the eyes, sensation of a foreign body in the eyes, increased lacrimation, unusual sensation in the eyes, formation of scales on the edges of the eyelids, eye irritation, eye hyperemia, increased intraocular pressure, decreased visual acuity, corneal erosion, eyelid ptosis, eye pain, mydriasis.
Prolonged use of topical corticosteroids in the eye may lead to increased intraocular pressure with subsequent damage to the optic nerve, deterioration of visual acuity and visual field disturbances, as well as the formation of posterior subcapsular cataracts (see section "Special instructions").
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 long-term use.
Corticosteroids may reduce resistance to infections (see section "Special warnings and precautions for use").
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature of 2°C to 8°C. Keep out of the reach of children.
Packaging
5 ml or 10 ml in a bottle. 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 63.
