Deksametazon-Biofarma cap. eye. 0.1% fl. 10 ml

Translation of the instruction Mose

DEKSAMETAZON-BIOFARMA of a drop eye 0.1%

Instruction

On medical use of medicine

Deksametazon-biofarma

(dexamethasone-biopharma)

Ingredients:

Active ingredient: sodium dexamethasone phosphate;

1 ml of medicine dexamethasone of sodium of phosphate;

excipients: boric acid, sodium pyroborate, dinatrium edetat (Trilonum B), a benzalkoniya chloride, water for injections.

Dosage form.

Drop eye.

Main physical and chemical properties: transparent colourless liquid.

Pharmacotherapeutic group.

Means, applied in ophthalmology. anti-inflammatory drugs. corticosteroids. dexamethasone.

ATX S01B A01 Code.

Pharmacological properties.

Pharmacodynamics.

Has the expressed anti-inflammatory and antiallergic effect caused by release oppression by eosinophils of mediators of inflammation; induction of formation of lipokortin and reduction of quantity of mast cells which produce a histamine and hyaluronic acid, with reduction of permeability of capillaries; stabilization of cellular membranes (especially lizosomalny) and membranes of organellas.

Pharmacokinetics.

At instillations in an eye through a cornea with an intact epithelium in moisture of an anterior chamber. At inflammation of tissues of eye or injury of a mucous membrane and a cornea the speed of absorption of dexamethasone increases.

Clinical characteristics.

Indication.

Treatment of non-infectious inflammatory and allergic conditions of a conjunctiva, a cornea and a front segment of an eye, sensitive to steroids, including reactions of inflammation in the postoperative period.

Contraindication.

• Hypersensitivity to active substance or to any of auxiliary components of medicine. sharp not treated bacterial infections. the sharp superficial keratitis caused by herpes simplex. cow and chicken pox and other viral infections of a cornea and conjunctiva (except for the keratitis caused by herpes zoster). fungus diseases of structures of an eye. mikobakterialny infections of an eye.

Interaction with other medicines and other types of interactions.

Simultaneous use of steroids for topical administration and non-steroidal anti-inflammatory medicaments (npvp) for topical administration can increase risk of emergence of complications when healing wounds of a cornea.

CYP3A4 Inhibitors (including the products containing ritonavir and kobitsistat) can reduce clearance of dexamethasone that leads to emergence of side reactions, suppression to Cushing's adrenal glands/syndrome. The combination of medicines should be avoided if the risk of system side reactions of corticosteroids exceeds advantage, in this case it is necessary to control patients.

Feature of application.

• Only for ophthalmologic application. duration of a course of therapy should not exceed 4 weeks. prolonged use of corticosteroids locally in an eye can lead to eye hypertensia and/or to glaucoma with the subsequent injury of an optic nerve, decrease in visual acuity and violation of a field of vision and also to formation of a back subkapsulyarny cataract of a back chamber of the eye. to patients at prolonged use of corticosteroids locally in an eye it is necessary to control constantly and regularly intraocular pressure.

in children as the risk of the eye hypertensia caused by corticosteroids can be higher in children and can arise earlier, than in adults.

• Cushing's Syndrome and/or suppression of adrenal glands that is connected with system absorption of eye drops of dexamethasone, can arise after intensive or long-term continuous care in predisposed patients, including the children and adult patients receiving CYP3A4 inhibitors (including ritonavir and kobitsistat). In these cases the treatment should be stopped gradually.
• In sharp purulent diseases of eyes the corticosteroids can mask infections or extend the existing infection. If treatment continues more than 10 days, it is necessary to control intraocular pressure.
• Risk of increase in the intraocular pressure caused by corticosteroids and/or risk of formation of the cataract caused by application of corticosteroids increases in predisposed patients (for example, in patients with diabetes).
• Corticosteroids can reduce resistance to a bacterial, viral or fungal infection, interfere with detection of such infections and mask clinical signs of an infection, interfering with identification of inefficiency of antibiotics. At permanent formation of helcomas it is necessary to consider a possibility of a fungal infection in patients to whom treatment was carried out or performed by corticosteroids. Treatment should be stopped in case of developing of a fungal infection.
• Corticosteroids applied locally in an eye can slow down healing of wounds of a cornea. It is also known that NPVP for topical administration slow down or delay healing of wounds. Simultaneous application of NPVP for topical administration and steroids for topical administration can increase risk of emergence of complications when healing wounds (see the section "Interaction with Other Medicines and Other Types of Interactions").
• Knows that in the presence of diseases which lead to thinning of a cornea or sclera the topical administration of corticosteroids can cause perforation.
• should use Drug with extra care and only in combination with anti-virus therapy during treatment of the stromal keratitis or a uveitis caused by herpes simplex; it is necessary to carry out periodically microscopy using a slit lamp.
• is not recommended to carry contact lenses at treatment of inflammations of an eye.

besides, medicine the benzalkoniya contains chloride which can cause irritation of eyes and, as we know, decolour soft contact lenses. It is necessary to avoid contact with soft contact lenses. Patsiyentov it is necessary to warn that it is necessary to remove contact lenses before application of eye drops of DEKSAMETAZON-BIOFARMA and to wait 15 minutes after instillation before inserting contact lenses.

Use during pregnancy or feeding by a breast.

Pregnancy

is not recommended to use medicament during pregnancy.

feeding Period a breast

Should consider the possibility of the temporary termination of feeding by a breast for the period of use of medicine DEKSAMETAZON-BIOFARMA or termination/abstention from therapy by medicine, considering potential advantage of use of medicine for mother and advantage of feeding by a breast for the child.

Ability to influence speed of response at control of motor transport or other mechanisms.

Deksametazon-biofarma does not influence or slightly affects ability to steer motor transport or other mechanisms. as well as in case of application of other eye drops, temporary turbidity of sight or other disorders of vision can affect ability to steer motor transport or other mechanisms. if misting of sight arises during burying, the patient needs to wait until clearness is restored before steering motor transport or other mechanisms.

Route of administration and doses.

Use by the adult, including patients of advanced age

At a heavy or acute inflammation it is necessary to dig in 1–2 drops in a conjunctival sac of the affected eye (eyes) each 30–60 minutes as initial therapy.

in case of positive effect should reduce a dose to 1–2 drops in a conjunctival sac of the affected eye (eyes) each 2–4 hours.

can reduce Further a dose to 1 drop 3–4 times a day if this dose is enough to control inflammation.

If the desirable result is not achieved within 3–4 days, purpose of additional system or subconjunctival therapy is possible.

At chronic inflammations the dose makes 1–2 drops in a conjunctival sac of the affected eye (eyes) each 3–6 hours or is more often if it is necessary.

In an allergy or insignificant inflammation the dose makes 1–2 drops in a conjunctival sac of the affected eye (eyes) each 3–4 hours before achievement of desirable effect.

should not stop therapy prematurely (see the section "Features of Application").

constantly intraocular pressure.

After instillation recommends careful closing a century or lacrimonasal occlusion. It reduces system absorption of the medicaments entered into eyes that reduces the probability of emergence of system side effects.

If are at the same time applied by several medicines to topical administration in eyes, the interval between their application has to make not less than 5 minutes. Oculentums should be applied the last.

Use of medicine DEKSAMETAZON-BIOFARMA was not investigated by

in the patients having diseases of kidneys and a liver. However because of low system absorption of dexamethasone after topical administration of need for dose adjustment is not present.

Route of administration

to prevent pollution of the region of a dropper and eye drops, it is necessary to be careful and not to touch centuries, adjacent sites or other surfaces with edge of a dropper.

Children.

.

Overdose.

it was not reported about any cases of overdose. in case of overdose by medicine dexamethasone-biofarma at topical administration to wash up surplus of medicine from an eye warm water.

Side reactions.

from an endocrine system: Cushing's syndrome, suppression of adrenal glands (see the section of "feature of application").

from the immune system: hypersensitivity.

from nervous system: dysgeusia (disorder of perception of taste), dizziness, headache.

from organs of sight: sensation of discomfort in eyes, a keratitis, conjunctivitis, a keratoconjunctivitis dry, coloring of a cornea, photophobia, misting of sight, an itch of eyes, feeling of a foreign body in eyes, the increased lachrymation, unusual feeling in eyes, formation of scales at the edges a century, irritation of eyes, hyperaemia of eyes, increase in intraocular pressure, decrease in visual acuity, a cornea erosion, a ptosis a century, eye pain, a mydriasis.

to increase in eye pressure with the subsequent injury of an optic nerve, decrease in visual acuity and violation of a field of vision and also to formation of a back subkapsulyarny cataract of a back chamber of the eye (see the section "Features of Application").

As medicine contains corticosteroids, in the presence of the diseases leading to thinning of a cornea or sclera the risk of perforation after prolonged use increases.

Corticosteroids can reduce resistance to infections (see the section "Features of Application").

Reporting after side reactions

Reporting after side reactions after registration of medicine is important. It allows to continue monitoring of balance advantage/risk of medicine. Health workers are asked to report about any expected side reactions.

Expiration date.

2 years.

Expiration date after opening of a bottle — 14 days.

Storage conditions.

in original packing for protection against influence of light at a temperature from 2 to 8 ºс. to store out of children's reach.

Incompatibility.

does not allow mixing of medicine with other at the same time appointed medicines.

Packing.

On 10 ml in a plastic bottle. on 1 bottle in a pack from cardboard.

Category of a holiday.

According to the prescription.

Producer.

LLC fz «biofarma, Ukraine.

Location of the producer and address of the place of implementation of its activity.

Ukraine, 09100, Kiev region, white church, st. Kiev, 37.