Alfagan R, eye drops 0.15%, 5ml

Composition

1 ml-brimonidine tartrate 1.5 mg

auxiliary components: oxy-chloro complex stabilized (sodium chloride, sodium chlorate, chlorine dioxide), sodium carmellose, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, boric acid, sodium tetraborate decahydrate, hydrochloric acid or sodium hydroxide, water.

Pharmacological action

Pharmaceutical group: Anti-glaucoma drug. Pharmaceutical action: Brimonidine is a selective alpha-2-adrenomimetic that has a stimulating effect on alpha-2-adrenergic receptors. When used in the dosage form of eye drops 0.15%, the maximum reduction in intraocular pressure (IOP) is achieved after 2 hours. The hypotensive effect of brimonidine is ensured by reducing the formation and increasing the outflow of intraocular fluid along the uveoscleral pathway.

Indications

• Open-angle glaucoma.
• Ophthalmic hypertension (in monotherapy or in combination with other drugs that reduce IOP).

Use during pregnancy and lactation

Pregnancy

In preclinical studies, no effect on reproductive function was found.

However, it has been established that brimonidine penetrates the placental barrier, and is contained in a small amount in fetal blood plasma. Damaging effect on the fetus has not been established.

No controlled trials were conducted in pregnant women.

During pregnancy, ALFAGAN R should be used with extreme caution, only in cases where the expected benefit to the mother significantly exceeds the possible risk to the fetus.

Lactation

Animal studies have shown that brimonidine tartrate penetrates into breast milk. Breast-feeding should be discontinued for the duration of the drug use.

Use in children

Contraindicated in children under 2 years of age, with caution in children aged 2 to 7 years.

Contraindications

• hypersensitivity to brimonidine and other components of the drug;
• concomitant therapy with MAO inhibitors;
• children under 2 years of age, low body weight (up to 20 kg);
• breast-feeding period.

With caution: orthostatic hypotension, heart failure, cerebrovascular diseases leading to cerebral circulatory failure, renal failure (creatinine clearance below 40 ml / min), liver failure, depression, Raynaud’s syndrome, thrombangiitis obliterans, children aged 2 to 7 years.

Side effects

The frequency of side effects identified in the studies was estimated as follows: very common (>10%), common (>>1% and 0.1% and 0.01% and>>

In clinical studies of Alfagan R, the following side effects were identified: :

On the part of the organ of vision: often – allergic conjunctivitis, conjunctival hyperemia, itching of the mucous membrane of the eyes and eyelids, and often stinging sensation, conjunctival follicles or follicular conjunctivitis, local allergic reaction on the part 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, lesions of the eyelids, photosensitivity, acupressure superficial keratopathy, tearing, loss of visual fields, functional disorders of vitreous hemorrhage in a vitreous body floating opacities in the vitreous body, and reduced visual acuity; rarely, corneal erosion, barley;

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

From the cardiovascular system: often-increased blood pressure; infrequently-decreased blood pressure.

From the respiratory system: 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.

From the skin and subcutaneous fat: often-rash.

Infectious and parasitic diseases: often – flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, including infectious.

Laboratory parameters: often-hypercholesterolemia.

Others: often-general allergic reactions, asthenia, fatigue; infrequently-perversion of taste.

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

In the post-marketing period, the following side effects were additionally reported: :

From the side of the organ of vision: the frequency is unknown – iritis, dry keratoconjunctivitis, miosis;

From the central nervous system: depression;

From the cardiovascular system: bradycardia, tachycardia.

From the gastrointestinal tract: nausea.

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

Interaction

Studies on the drug interaction of Alfagan R have not been conducted, however, when it is used simultaneously, the possibility of enhancing the effect of drugs that depress the central nervous system (alcohol, barbiturates, opium derivatives, sedatives, general anesthetics) should be taken into account. Given the ability of alpha-adrenomimetic drugs to reduce blood pressure and heart rate, antihypertensive drugs and cardiac glycosides should be used with caution at the same time.

Due to the known decrease in the severity of the hypotensive effect of clonidine (alpha 2-adrenomimetic) when co-administered with tricyclic antidepressants, it is impossible to exclude a possible decrease in the effectiveness of Alfagan R with concomitant treatment with tricyclic antidepressants.

Caution should be exercised when using Alfagan R with tricyclic antidepressants, which may affect the metabolism of amines and their distribution in the vascular bed.

How to take, course of use and dosage

Locally.

In the conjunctival sac of the affected eye,1 drop 3 times a day with an interval between injections of about 8 hours

. Alfagan R can be used with other ophthalmic drugs to reduce IOP. If more than 2 medications are used, then you need to take a 5-minute break between installations.

Overdose

• Symptoms: if the drug is accidentally taken orally, the following may occur: depression of the central nervous system, drowsiness, depression and fainting, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea.
• Treatment: if symptoms of overdose are detected, it is necessary to conduct symptomatic therapy, monitor the patency of the respiratory tract.

Special instructions

Use in patients with liver function disorders

With caution: liver failure.

Use in patients with impaired renal function

With caution: renal failure (creatinine clearance below 40 ml / min).

Influence on the ability to drive motor vehicles and manage mechanisms

Taking the drug Alfagan R may be accompanied by episodes of weakness and drowsiness in some patients. In the event that the patient’s work is associated with potentially dangerous activities, such as driving motor vehicles, he should be warned in advance about a possible decrease in concentration and speed of psychomotor reactions, and recommended to refrain from these activities.

Form of production

Eye drops are transparent, yellowish-green in color.

Storage conditions

At a temperature not exceeding 25 °C

Shelf

life is 2 years.

Active ingredient

Brimonidine

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

For adults, Children over 2 years of age

Indications

Glaucoma