DEKSALIV [Dexamethasone] 1 mg Eye and ear drops
instructions for the medical use of
the medicinal product
DEKSALIV
Tradename: Deksaliv, Дексалив
International non-proprietary name
or generic name: dexamethasone, дексаметазон
Dosage form: eye and ear drops.
1 ml of the
preparation contains:
active substance: dexamethasone
1 mg;
excipients: Benzalkonium chloride, sodium dibasic
phosphate anhydrous, disodium edetate, HPMC E4, citric acid anhydrous, sodium
chloride, polysorbate 80, water for injection.
Pharmacotherapeutic
group: Glucocorticosteroid.
Pharmacological properties
Pharmacodynamics
This
medication is a synthetic fluorinated glucocorticosteroid. It exhibits
pronounced anti-inflammatory activity with reduced mineralocorticoid effects
compared to some other steroids and is one of the most potent anti-inflammatory
agents. Its mechanism of action is similar to that of other fluorinated
glucocorticosteroids, differing only in its greater potency and duration of
action. It exerts its anti-inflammatory effect by inhibiting vascular adhesion
molecules of endothelial cells, cyclooxygenase I or II, and cytokine release.
This reduces the formation of inflammatory mediators and inhibits leukocyte
adhesion to the vascular endothelium, thereby preventing their penetration into
inflamed ocular tissue.
Pharmacokinetics
Following
instillation into the conjunctival sac, peak dexamethasone concentrations in
the aqueous humor are observed after 2 hours and are 30 ng/mL. Plasma protein
(albumin) binding is 77-84%. The half-life is 3-4 hours. Clearance ranges from
0.111 to 0.225 L/h/kg, and the volume of distribution ranges from 0.576 to 1.15
L/kg. It is metabolized in the liver. Approximately 60% of the dose is excreted
in the urine as 6-β-hydroxydexamethasone. The overall resorptive effect of
dexamethasone is insignificant.
Indications for
use
Allergic and inflammatory eye
diseases: non-purulent and allergic conjunctivitis, keratitis,
keratoconjunctivitis without epithelial damage, iritis, iridocyclitis,
blepharoconjunctivitis, blepharitis, episcleritis, scleritis, inflammation
following eye trauma and surgery, sympathetic ophthalmia.
Allergic and inflammatory ear
diseases, otitis.
Contraindications
Hypersensitivity to the active
substance or to other components of the drug;
keratitis caused by herpes simplex;
chickenpox and other viral diseases of the cornea and conjunctiva;
mycobacterial eye infections; fungal eye diseases; acute purulent eye diseases
with damage to the corneal epithelium; corneal epitheliopathy; increased
intraocular pressure (with long-term use); trachoma, ocular tuberculosis;
condition after removal of a corneal foreign body; perforation of the eardrum.
Method of administration
and dosage
Apply 1-2 drops into the
conjunctival sac 3-5 times daily.
Apply 3-4 drops into the
affected ear 2-3 times daily.
Once the desired effect is
achieved, gradually reduce the frequency of administration to the required
frequency to control symptoms.
Treatment duration should not
exceed 2-3 weeks.
The decision on treatment
duration is based on objective data, including the drug's effectiveness, the
severity of symptoms, and the potential for side effects.
If multiple topical ophthalmic
medications are used concurrently, the interval between applications should be
at least 15 minutes. Eye ointments should be applied last.
Instructions
for use:
Wash your hands thoroughly
before using the medication.
Avoid contact of the tip of
the opened bottle with the eye or your hands.
Tilt your head back, place
the tip of the bottle over your eye, and pull down your lower eyelid with the
index finger of your other hand. Apply gentle pressure to the bottle and
instill the required amount of medication into the conjunctival sac.
After instillation, close
your eyes and do not blink or open them for about 2 minutes to ensure optimal
contact between the mucous membrane and the medication.
Close the bottle tightly
after each use.
Special instructions and precautions
Consult a physician before using this medication.
Side effects observed during instillation
disappear within 5-15 seconds and are not an indication for discontinuing the
medication.
To prevent possible systemic absorption after
instillation, hold the lacrimal ducts with your fingers for 2-3 minutes.
When using the medication, avoid touching the
dropper tip to prevent contamination.
Long-term topical use of corticosteroids may
cause ocular hypertension and/or glaucoma, resulting in damage to the optic
nerve, decreased visual acuity, visual field impairment, and the formation of
posterior subcapsular cataracts. Intraocular pressure should be monitored
regularly with long-term use.
Topical ocular corticosteroids may delay corneal
wound healing and, in the presence of conditions characterized by thinning of
the cornea or sclera, may lead to perforation. When using this medication,
corneal health should be monitored (fluorescein tests should be performed).
Corticosteroids may reduce resistance to
bacterial, viral, or fungal infections, hinder the detection of such
infections, and mask their clinical signs, preventing the detection of
antibiotic ineffectiveness.
In cases of persistent corneal ulceration, the
possibility of developing a fungal infection should be considered in patients
who have been or are being treated with corticosteroids. If a fungal infection
develops, treatment with this medication should be discontinued.
This medication should be used with caution and
only in combination with antiviral therapy in the treatment of stromal
keratitis or uveitis caused by herpes simplex. Slit lamp biomicroscopy
should be performed periodically.
Contact lenses are not recommended during
treatment for eye inflammation. If necessary, soft contact lenses should be
removed before using this medication and reinserted no sooner than 15 minutes
after instillation. This product contains benzalkonium chloride, which may
cause eye irritation and is known to discolor soft contact lenses. Avoid
contact with soft contact lenses.
Influence on the
ability to drive vehicles and mechanisms
After using eye drops, visual acuity may decrease, so
it is not recommended to drive a car or engage in activities that require
increased attention and quick psychomotor reactions immediately after
instillation.
Use during pregnancy and breastfeeding
Contraindicated for use during pregnancy and
breastfeeding.
Side effect
Eye disorders: keratitis,
conjunctivitis, keratoconjunctivitis sicca, eyelid ptosis, corneal
discoloration, photophobia, blurred vision, mydriasis, eye pain, eye
irritation, foreign body sensation, unusual eye sensations, scaling of the
eyelid margins;
Immediately after
instillation, the following may occur: short-term burning, stinging, eye
discomfort, itching and hyperemia, increased lacrimation;
With prolonged
use, increased intraocular pressure with subsequent optic nerve damage,
decreased visual acuity, visual field impairment, posterior subcapsular
cataract formation, glaucoma, corneal erosion; in the presence of diseases
leading to thinning of the cornea or sclera, increased risk of perforation.
Nervous system disorders: dysgeusia (taste
disturbance), headache, dizziness.
Immune system, skin, and subcutaneous tissue
disorders: hypersensitivity reactions; patients with hypersensitivity to
benzalkonium chloride may develop allergic blepharitis or conjunctivitis.
Glucocorticosteroids
may reduce resistance to infections.
If any of the side effects listed in the
instructions worsen, or you notice any other side effects not listed in the
instructions, notify your doctor.
Interaction
with other medicinal products
Interactions with other drugs are primarily due to the
involvement of the same cytochrome-containing enzymes in elimination.
Dexamethasone may enhance the effects of phenytoin, barbiturates, and warfarin.
It induces the CYP3A4 isoenzyme, thereby reducing the effectiveness of calcium
channel blockers, quinidine, and erythromycin. With typical topical
administration, the dose is insufficient to induce or saturate liver enzymes.
Long-term use with iodoxuridine may increase
destructive processes in the corneal epithelium.
Local reactions may worsen. There is no specific antidote. The drug
should be discontinued and symptomatic therapy prescribed.
Storage conditions
Store at temperatures
below 30°C.
Keep out of reach of
children!
Shelf life
3 years. Do not use
after the expiration date printed on the package.
Vacation conditions
By prescription.
Release form
5 ml of the product in LDPE dropper
bottles with a screw-on protective cap.
1 bottle with instructions for use in a cardboard box.