LUXUFEN EYE DROPS DROPPER BOTTLE 0.2% 5ML

Packaging

Bottle dropper 5 ml.

5 ml

Mechanism of action

Antiglaucoma drug. Brimonidine - selective α agonist2-adrenoreceptors.

With instillation of a 0.2% solution of brimonidine, the reduction in intraocular pressure is 10–12 mm Hg. Art., the maximum effect is observed after 2 hours, the duration of action is 12 hours.

Brimonidine has a dual mechanism of action: lowers intraocular pressure by reducing the synthesis of intraocular fluid and enhancing uveoscleral outflow.

Pharmacokinetics

Suction and distribution

With instillation of eye drops Cmax drug in blood plasma is achieved in 0.5-2.5 hours. Binding to blood proteins when applied topically is 29%. Systemic absorption of brimonidine slowed down. After using the drug 2 times / day for 10 days, plasma concentration of brimonidine remains low (on average, 0.06 ng / ml).

Metabolism and distribution

Metabolized drug mainly in the liver. Brimonidine and its metabolites are excreted by the kidneys. T1/2 is about 2 hours

Indications and usage

Open-angle glaucoma, ophthalmic hypertension (in monotherapy and in combination with other drugs that reduce intraocular pressure).

Contraindications

• Hypersensitivity to the drug;
• simultaneous therapy with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants;
• children's age up to 2 years;
• breastfeeding period.

Carefully: when used in patients with severe, unstable and uncontrolled forms of cardiovascular diseases, with cerebral or coronary insufficiency, depression, orthostatic hypotension, Raynaud's disease, thromboangiitis obliterans; in violation of the function of the liver or kidneys; Children age from 2 to 18 years.

Pregnancy and Breastfeeding

Studies on the safety and efficacy of brimonidine in pregnant and lactating have not been conducted. In animal studies, local application of brimonidine did not lead to disruption of fetal development.There is no accurate data on the penetration into breast milk of brimonidine when applied topically. However, risk cannot be excluded completely. The use of brimonidine during pregnancy is allowed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

When prescribing during lactation, breastfeeding is recommended to stop at the time of treatment.

Before using the drug should be removed contact lenses. The time interval between the use of the drug and the re-installation of contact lenses should be at least 15 minutes.

Impact on ability to drive vehicles and other mechanisms requiring increased concentration

The drug can cause a state of fatigue or drowsiness, a decrease in the clarity of vision, therefore during the period of drug treatment one should refrain from driving vehicles and maintaining moving mechanisms.

Composition

1 ml of eye drops contains:

Active substance: brimonidine tartrate - 2.0 mg.

Excipients: benzalkonium chloride (in terms of 100% substance) - 0.052 mg, polyvinyl alcohol - 14.0 mg, sodium chloride - 6.90 mg, sodium citrate dihydrate - 4.70 mg, citric acid monohydrate - 0.48 mg, hydrochloric acid - to pH 6.45, sodium hydroxide - to pH 6.45, water - up to 1 ml.

Dosage and administration

Locally.

Instill 1 drop of the drug 2 times a day.

The duration of treatment is determined by the doctor.

Adverse reactions

The incidence of side effects is classified as follows:

• very often (> 1/10);
• often (from> 1/100 to <1/10);
• sometimes (from> 1/1000 to <1/100);
• rarely (from> 1/10 000 to <1/1000);
• very rarely (<1/10 000);
• frequency unknown (side effects with unknown frequency).

From the organs of vision: very often - allergic conjunctivitis, conjunctival hyperemia, itchy skin of the eyelids and eye mucosa; often - burning sensation, follicle conjunctival eye and follicular conjunctivitis, local allergic afflictions of the mucous membrane of the eye (including keratoconjunctivitis), blepharitis, blepharoconjunctivitis, impaired clarity of visual perception, cataract, conjunctival edema, hemorrhage, ocular disruption, hemorrhagic discharge, impaired visual perception, cataract, conjunctivitis, blood flowmucous discharge from the eyes, dryness and irritation of the mucous membrane of the eyes, pain, swelling of the eyelids, redness of the eyelids, foreign body sensation in the eyes, keratitis, damage to the eyelids, photosensitivity, superficial spotted keratopathy, tearing, loss of the visual field, functional affection of the vitreous, hemorrhage in vitreous body, floating turbidity in the vitreous body and reduced visual acuity; infrequently - erosion of the cornea, barley.

From the side of the central nervous system: often - headache, drowsiness, insomnia, dizziness.

Cardiovascular: often - increase in blood pressure; infrequently - lowering blood pressure.

Respiratory: often - bronchitis, cough, shortness of breath; infrequently - dry nasal mucosa; apnea.

From the gastrointestinal tract: often - gastrointestinal disorders - dyspepsia, dryness of the oral mucosa.

On the part of the skin and subcutaneous fat: often - rashes.

Infection: often - flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, including infectious.

Laboratory values: often - hypercholesterolemia.

Others: often - common allergic reactions, asthenia, fatigue; Infrequently - a change in taste.

Children marked: apnea, bradycardia, lowering blood pressure, hypothermia, muscular hypotension.

Additionally obtained data on the following effects:

From the organs of vision: frequency is unknown - iritis, keratoconjunctivitis, miosis.

From the side of the central nervous system: depression.

Cardiovascular: bradycardia, tachycardia.

From the gastrointestinal tract: nausea.

On the part of the skin and subcutaneous fat: local skin reactions (erythema, pruritus, swelling of the face, rash and vasodilation of the eyelid skin vessels).

Drug interactions

Brimonidine at a concentration of 2 mg / ml may enhance the effect of substances affecting the central nervous system (alcohol, barbiturates, opioids, sedatives and anesthetics). Caution should be exercised in the case of taking drugs that can affect the absorption into the blood and the metabolism of adrenaline, norepinephrine and other so-called biogenic amines (chlorpromazine, methylphenidate, reserpine).

In some patients, after applying brimonidine solution at a concentration of 2 mg / ml, a slight decrease in blood pressure is observed.Caution should be exercised when used concomitantly with antihypertensive drugs and / or cardiac glycoside (foxglove) drugs.

With the simultaneous systemic administration of adrenoceptor agonists or antagonists (for example, isoprenaline or prazosin) for the first time, as well as changing the dose of these simultaneously administered systemic drugs (regardless of the method of their administration), interactions with alpha adrenergic receptors or effects on their effects can occur.

Overdosage

Overdose is extremely rare.

Symptoms: in case of accidental ingestion of the drug inside - the depression of the central nervous system, drowsiness, depression and loss of consciousness, decrease in blood pressure, bradycardia, decrease in body temperature, skin cyanosis, apnea are possible.

Treatment: supportive symptomatic therapy, control of airway patency.

Store at a temperature not higher than 25 ºС.

Keep out of the reach of children.

2 years. Shelf life after opening the bottle - 4 weeks.