Luxfen, eye drops 0.2% eye dropper bottle 5ml

Composition

1 ml-brimonidine tartrate 2 mg.

Auxiliary substances:

Benzalkonium chloride-0.052 mg,

polyvinyl alcohol-14 mg,

sodium chloride-6.9 mg,

sodium citrate dihydrate-4.7 mg,

citric acid monohydrate-0.48 mg,

hydrochloric acid – up to pH 6.45,

sodium hydroxide – up to pH 6.45,

water – up to 1 ml

Pharmacological action

Brimonidine is a selective agonist of α2-adrenergic receptors.

When instilling a 0.2% solution of brimonidine, the decrease in intraocular pressure is 10-12 mm Hg, the maximum effect is noted after 2 hours, the duration of action is 12 hours.

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

Pharmacokinetics

When instilling eye drops, Cmax of the drug in blood plasma is reached after 0.5-2.5 hours. Binding to blood proteins with topical application is 29%. Systemic absorption of brimonidine is slowed. After applying the drug 2 times/day for 10 days, the concentration of brimonidine in plasma remains low (on average 0.06 ng / ml).

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

Indications

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

Contraindications

• Hypersensitivity to the components of the drug;
• simultaneous therapy with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants;
• children under 2 years of age;
• breast-feeding period.

With caution:  when using the drug in patients with severe, unstable and uncontrolled cardiovascular diseases, with cerebral or coronary insufficiency, depression, orthostatic hypotension, Raynaud’s disease, obliterating thrombangiitis; with impaired liver or kidney function; children aged 2 to 18 years.

Side effects

The frequency of side effects is classified as follows: very common (>1/10), common (>>1/100 to 1/1000 to 1/10 000 to>>

From the side, organs of vision:

very often, allergic conjunctivitis, conjunctival hyperemia, itching of the skin of the eyelids and mucous membranes;

often burning sensation; follicules the conjunctiva of the eye and follicular conjunctivitis, local allergic reactions of the mucous membrane of the eye (including keratoconjunctivitis); blepharitis, blepharoconjunctivitis, impaired clarity of vision, cataract, conjunctival edema, hemorrhage in the conjunctiva, conjunctivitis, watery eyes, mucous 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, eyelid, photosensitivity, surface, spotted keratopathy, tearing, loss of visual field, the functional defeat of vitreous hemorrhage in a vitreous body floating opacities in the vitreous body, and reduced visual acuity;

rarely, corneal erosion, and barley.

From the central nervous system:

often — headache, drowsiness, insomnia, dizziness.

From the cardiovascular system:

often-an increase in blood pressure;

infrequently-a decrease in blood pressure.

Respiratory system disorders:

often — bronchitis, cough, shortness of breath;

infrequently — dryness of the nasal mucosa, apnea.

From the gastrointestinal tract:

often — gastrointestinal disorders-dyspepsia, dryness of the oral mucosa

Skin and subcutaneous fat disorders:

often — rashes.

Infectious and parasitic diseases:

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

Laboratory parameters:

often — hypercholesterolemia.

Other:

often — general allergic reactions, asthenia, fatigue;

infrequently-changes in taste sensations.

In children, apnea, bradycardia, decreased blood pressure, hypothermia, and muscle hypotension were noted.

Additionally, we obtained data on the following effects: :

From the side of the visual organs: the frequency is unknown — iritis, keratoconjunctivitis, miosis.

Central nervous system disorders: depression.

From the cardiovascular system: bradycardia, tachycardia.

From the gastrointestinal tract: nausea.

From the skin and subcutaneous fat: local skin reactions (erythema, pruritus, facial edema, rash and vasodilation of the eyelid skin vessels).

Interaction

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

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

When concomitant systemic use of agonists or antagonists of adrenergic receptors (for example, isoprenaline or prazosine) for the first time, as well as when changing the dose of these simultaneously administered systemic drugs (regardless of the method of use), interactions with alpha-adrenergic agonists or effects on their effects may occur.

How to take, course of use and dosage

Locally.

Instill one drop of the drug 2 times a day.

The duration of treatment is determined by the doctor.

Overdose

If the drug is accidentally taken orally, the following symptoms may occur: depression of the central nervous system, drowsiness, depression and loss of consciousness, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea.

In case of accidental ingestion of the drug: maintenance symptomatic therapy, monitoring of airway patency.

Special instructions

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

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

The drug can cause a state of fatigue or drowsiness, reduced visual clarity, so during treatment with the drug, you should refrain from driving vehicles and servicing moving mechanisms.

Form of production

Eye drops 0.2% in the form of a clear solution of greenish-yellow color.

Storage conditions

Keep out of the reach of children at a temperature not exceeding 25 ° C.

Shelf

life is 2 years, after opening the bottle-4 weeks.

Active ingredient

Brimonidine

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

For adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 2 years of age

Indications

Glaucoma