Alphagan R drops 0.15%, 5 ml

• Open-angle glaucoma;

• ophthalmic hypertension (in monotherapy or in combination with other drugs that lower IOP).

Locally. Into 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 lower IOP. If more than 2 drugs are used, then it is necessary to take a 5-minute break between installations.

Eye drops are transparent, yellowish-green in color.

1 ml

brimonidine tartrate 1.5 mg

• Hypersensitivity to brimonidine and other components of the drug;

• simultaneous therapy with MAO inhibitors;

• children under 2 years of age, low body weight (up to 20 kg);

• lactation period.

  With care: orthostatic hypotension, heart failure, cerebrovascular diseases leading to cerebrovascular insufficiency, renal failure (CC below 40 ml / min), hepatic failure, depression, Raynaud's syndrome, thromboangiitis obliterans, children's age from 2 to 7 years.

pharmachologic effect

Brimonidine is a selective alpha2-adrenergic agonist that has a stimulating effect on alpha2-adrenergic receptors. When used in a dosage form of 0.15% eye drops, the maximum decrease in intraocular pressure (IOP) is achieved after 2 hours. The hypotensive effect of brimonidine is provided by reducing the formation and increasing the outflow of intraocular fluid along the uveoscleral pathway.

Pharmacokinetics

When installing eye drops, Cmax in blood plasma is achieved after 0.5-2.5 hours, T1 / 2 is about 2 hours. Systemic absorption of brimonidine is slow. The drug is metabolized mainly in the liver. Brimonidine and its metabolites are excreted by the kidneys.

Side effect

In clinical studies of the drug Alphagan R, the following side effects have been identified:

From the side of the organ of vision: very often - allergic conjunctivitis, conjunctival hyperemia, itching of the mucous membrane of the eyes and skin of the eyelids; often - burning sensation, follicular conjunctival follicle or follicular conjunctivitis, local allergic reactions from the eyes (including keratoconjunctivitis), blepharitis, blepharoconjunctivitis, blurred vision, cataract, conjunctival edema, conjunctival lacrimation, hemorrhagic conjunctivitis discharge from the eyes, dryness and irritation of the mucous membrane of the eyes, pain, edema of the eyelids, redness of the eyelids, sensation of a foreign body in the eyes, keratitis, lesions of the eyelids, photosensitivity, superficial punctate keratopathy, lacrimation, loss of visual fields, functional disorders of the vitreous humor, hemorrhage in the vitreous body,floating opacities in the vitreous body and decreased visual acuity; infrequently - corneal erosion, barley;

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

From the side of the cardiovascular system: often - increased blood pressure; infrequently - a decrease in blood pressure.

On the part of 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.

On the part of the skin and subcutaneous fat: often - a rash. Infectious and parasitic diseases: often - flu-like syndrome, infectious disease (chills and respiratory infection), rhinitis, sinusitis, incl. infectious.

Laboratory indicators: often - hypercholesterolemia.

Others: often - general allergic reactions, asthenia, fatigue; infrequently - a perversion of taste. In children, it was noted: apnea, bradycardia, decreased blood pressure, hypothermia, muscle hypotension. In the post-marketing period, additional reports of the following side effects were received:

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

From the side of the central nervous system: depression;

From the side of the cardiovascular system: bradycardia, tachycardia.

From the gastrointestinal tract: nausea.

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

Application during pregnancy and lactation

In preclinical studies, no effect on reproductive function was found. However, it was found that brimonidine crosses the placental barrier, and is contained in a small amount in the fetal blood plasma. The damaging effect on the fetus has not been established. No controlled studies have been conducted in pregnant women. During pregnancy, Alphagan R should be used with extreme caution, only in cases where the expected benefit to the mother significantly outweighs the possible risk to the fetus. In animal studies, it was found that brimonidine tartrate passes into breast milk. While using the drug, breastfeeding should be discontinued.

Application for violations of liver function

With care: liver failure.

Application for impaired renal function

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

Application in children

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

special instructions

Impact on the ability to drive vehicles and control mechanisms Taking 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 hazardous activities, driving vehicles, it is necessary to warn him in advance about a possible decrease in concentration of attention and the speed of psychomotor reactions, and to recommend refraining from these activities.

Overdose

There are no reports of drug overdose cases. In case of accidental ingestion of the drug, the following symptoms are possible: depression of the central nervous system, drowsiness, depression and loss of consciousness, decreased blood pressure, bradycardia, decreased body temperature, cyanosis of the skin, apnea. If symptoms of an overdose are detected, it is necessary to carry out symptomatic therapy, control the patency of the airways.

Drug interactions

Studies on the study of drug interactions of the drug Alfagan R have not been conducted, however, with its simultaneous use, one should take into account the possibility of enhancing the effect of drugs that depress the central nervous system (alcohol, barbiturates, opium derivatives, sedatives, general anesthetics). Given the ability of drugs of the alpha-adrenergic agonist group to reduce blood pressure and heart rate, caution should be taken simultaneously with the use of antihypertensive drugs and cardiac glycosides. Due to the known decrease in the severity of the hypotensive effect of clonidine (alpha2-adrenergic agonist) when used together with tricyclic antidepressants, a possible decrease in the effectiveness of the drug Alfagan R with concomitant treatment with tricyclic antidepressants cannot be ruled out.Alfagan R should be used with caution with tricyclic antidepressants, which can affect the metabolism of amines and their distribution in the vascular bed.