Universal reference book for medicines
Product name: LUXFEN ® (LUXFEN)

Active substance: brimonidine

Type: Antiglaucoma preparation

Manufacturer: VALEANT (Russia) manufactured by SANITAS AB (Lithuania)
Composition, form of production and packaging
Eye drops 0.2%
in the form of a transparent solution of a greenish-yellow color.

1 ml

Brimonidine tartrate 2 mg

Excipients: 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 to pH 6.45, sodium hydroxide to pH 6.45, water - up to 1 ml.

5 ml - polyethylene bottles with drip-nozzle (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antiglaucoma preparation.
Brimonidine is a selective agonist? 2- adrenoreceptors.
When instillation 0.2% solution of brimonidine, the decrease in intraocular pressure is 10-12 mm Hg.
The maximum effect is observed after 2 hours, the duration of the action is 12 hours.
Brimonidine has a dual mechanism of action: it lowers the intraocular pressure by decreasing the synthesis of the intraocular fluid and enhancing the uveoscleral outflow.

PHARMACOKINETICS

Suction and distribution

When instillation of eye drops C max drug in the blood plasma is achieved through 0.5-2.5 h. Binding to blood proteins with topical application is 29%.
The systemic absorption of brimonidine is slowed down. After applying the drug 2 times / day for 10 days, the concentration of brimonidine in the plasma remains low (on average 0.06 ng / ml).
Metabolism and distribution

The drug is metabolized primarily in the liver.
Brimonidine and its metabolites are excreted by the kidneys. T 1/2 is about 2 hours.
INDICATIONS

- open-angle glaucoma;

ophthalmic hypertension (as a monotherapy and in combination with other drugs that reduce intraocular pressure).

DOSING MODE

Locally.
Bury in 1 drop of the drug 2 times / day.
The duration of treatment is determined by the doctor.

SIDE EFFECT

The incidence of side effects is classified as follows: very often (> 1/10), often (> 1/100 to <1/10), sometimes (> 1/1000 to <1/100), rarely (> 1 / 10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown.

From the side of the organ of vision: very often - congestion hyperemia, itchy eyelid skin and eye mucosa;
often a burning sensation; folliculosis of the conjunctiva and follicular conjunctivitis, blepharitis, blepharoconjunctivitis, visual impairment, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, retention lacrimation, mucous discharge from the eyes, dryness and irritation of the eye mucosa, pain of the eyelid edema, redness of the eyelids, sensation of foreign body in the eyes, keratitis, eyelid lesion, photosensitivity, superficial spotted keratopathy, lacrimation, loss of visual fields, functional damage of the vitreous, vitreous voiding, floating opacities in the vitreous body and reduced visual acuity; infrequently - the erosion of the cornea, barley.
From the side of the central nervous system: often - headache, drowsiness, insomnia, dizziness.

From the cardiovascular system: often - increased blood pressure;
infrequently - a decrease in blood pressure.
From the respiratory system: often - bronchitis, cough, shortness of breath;
infrequently - dryness of the nasal mucosa, apnea.
On the part of the digestive system: often - gastrointestinal disorders (dyspepsia), dryness of the oral mucosa.

From the skin and subcutaneous fat: often - rashes.

Infectious and parasitic diseases: often - influenza-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, incl.
infectious.
From the laboratory indicators: often - hypercholesterolemia.

Allergic reactions: very often - allergic conjunctivitis;
often - local allergic reactions of the eye mucosa (including keratoconjunctivitis), general allergic reactions.
Other: often - asthenia, fatigue;
infrequently - a change in taste.
In children : apnea, bradycardia, decreased blood pressure, hypothermia, muscle hypotension.

In addition, data on the following effects were obtained.

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

From the side of the central nervous system: depression.

From the cardiovascular system: bradycardia, tachycardia.

From the side of the digestive system: nausea.

From the skin and subcutaneous fat: local skin reactions (erythema, itching, face swelling, rash and vasodilation of the skin of the eyelids).

CONTRAINDICATIONS

- simultaneous therapy with MAO inhibitors and tricyclic antidepressants;

- Children under 2 years;

- the period of lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

Caution should be given to patients with severe, unstable and uncontrolled forms of cardiovascular disease, with cerebral or coronary insufficiency, depression, orthostatic hypotension, Raynaud's disease, obliterating thromboangiitis, liver or kidney dysfunction, and also in childhood and adolescence. 2 to 18 years.

PREGNANCY AND LACTATION

Studies of the safety and efficacy of brimonidine in pregnant and lactating women have not been conducted.
In experimental animal studies, local application of brimonidine did not lead to a disruption of intrauterine development. There is no precise data on the isolation of brimonidine with breast milk in topical application.However, the risk can not be ruled out completely.
The use of the drug during pregnancy is possible only if the intended benefit for the mother exceeds the potential risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be stopped for the duration of treatment.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for violations of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for violations of liver function.

APPLICATION FOR CHILDREN

Contraindicated use of the drug in childhood to 2 years.

With caution should be used in childhood and adolescence from 2 to 18 years.

SPECIAL INSTRUCTIONS

Before using the drug, you need to remove the contact lenses.
The time interval between use of the drug and the re-installation of contact lenses should be at least 15 minutes.
Impact on the ability to drive vehicles and manage mechanisms

The drug can cause fatigue or drowsiness, reduced vision, so during drug treatment should refrain from driving vehicles and servicing moving mechanisms.

OVERDOSE

Overdose is extremely rare.

With the occasional intake of the drug inside, the following symptoms are possible : depression of the central nervous system, drowsiness, depression and loss of consciousness, lowering of blood pressure, bradycardia, lower body temperature, cyanosis of the skin, apnea.

Treatment: maintenance of symptomatic therapy, control of airway patency.

DRUG INTERACTION

Brimonidine in a concentration of 2 mg / ml can enhance the effect of substances that affect the central nervous system (ethanol, barbiturates, opioids, sedatives and anesthetics).

Caution should be exercised when using simultaneously with drugs that can affect the absorption and metabolism of epinephrine, norepinephrine and other so-called biogenic amines (chlorpromazine, methylphenidate, reserpine).

In some patients, after a brimonidine solution at a concentration of 2 mg / ml, there is a slight decrease in blood pressure.
Caution should be exercised when used simultaneously with antihypertensive drugs and / or cardiac glycosides (digitalis preparations).
With simultaneous systemic administration of agonists or antagonists of adrenergic receptors (for example, isoprenaline or prazosin) for the first time, as well as changing the dose of these simultaneously administered systemic preparations (regardless of the way they are administered), there may be interaction with β-adrenoreceptor agonists or effects on their effects .

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years. Shelf life after opening the bottle is 4 weeks.
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