Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Monotherapy in patients whose treatment with topical beta-blockers is contraindicated. As an adjunctive treatment in combination with other intraocular pressure lowering drugs, when the intraocular pressure is insufficiently reduced with a single drug.
Composition:
1 ml of solution contains 2 mg of brimonidine tartrate (equivalent to 1.3 mg of brimonidine).
Action:
A selective α receptor agonist2-adrenergic for topical use. It lowers intraocular pressure by reducing aqueous humor production and increasing choroidal scleral outflow. Affinity of the drug for α receptors1-adrenergic is 1000 times smaller compared to affinity for α receptors2, thanks to which the drug does not dilate pupils or shrinkage capillaries of human retinal xenografts. The product reduces intraocular pressure, minimally affecting the activity of the cardiovascular and respiratory system. The drug shows a rapid onset of action, and the maximum antihypertensive effect occurs 2 hours after administration. The degree of binding to plasma proteins is approximately 29%. After topical administration T0,5 in the circulating blood is about 3 hours. Brimonidine binds reversibly to the melanin of the eye tissues without side effects. In the absence of melanin, there is no accumulation of the drug.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Newborns and children under 2 years old. Concomitant use of MAO inhibitors. Concomitant use of antidepressants that affect noradrenergic prescription (eg tricyclic antidepressants and mianserin).
Precautions:
There are no clinical trials on the use of the preparation in adolescents aged 12-17. It is not recommended for children under 12 years of age. In children aged 2 years or older, especially those aged 2-7 years and / or ≤ 20 kg, the preparation should be used with caution during careful observation, due to the high frequency and high intensity of drowsiness. It should be used with caution in patients with severe or unstable and non-responsive coronary artery disease, in patients with depression, cerebral or coronary circulation, Raynaud's syndrome, orthostatic hypotension or thromboangiitis obliterans, and in patients with impaired liver or kidney function. The preparation should be discontinued if an allergic reaction occurs. The preparation contains benzalkonium chloride, which may cause eye irritation.
Pregnancy and lactation:
The safety of use during pregnancy has not been established. The preparation can be used during pregnancy only if the benefit for the mother outweighs the potential risk to the fetus. Do not use during breast-feeding.
Side effects:
Very common: headache, drowsiness, eye irritation, (irritation, burning and stinging, itching, feeling of a foreign body, conjunctival papules), blurred vision, allergic blepharitis, allergic blepharitis and conjunctivitis, allergic conjunctivitis, allergic eye reactions and follicular conjunctivitis, dry mouth, fatigue. Common: dizziness, taste disturbances, local irritation (congestion and swelling of the eyelids, blepharitis, conjunctival edema, presence of secretion in the conjunctival sac, eye pain and tearing), photophobia, erosion and corneal color, dry eye, conjunctivitis, visual impairment, conjunctivitis, symptoms from the upper respiratory tract, gastrointestinal symptoms, weakness. Uncommon: palpitations / arrhythmias (including bradycardia, tachycardia), dry mouth, general allergic reaction, depression. Rarely: shortness of breath. Very rare: fainting, iritis, miosis, hypertension, hypotension, insomnia.Not known: iritis and ciliary inflammation (anterior uveitis), eyelid itching, skin reactions including erythema, facial swelling, itching, rash and vasodilation. Newborns and infants who have been treated with brimonidine for congenital glaucoma have reported symptoms of brimonidine overdose, such as loss of consciousness, lethargy, drowsiness, hypotension, decreased muscle tone, bradycardia, hypothermia, cyanosis, paleness, suppressed breathing and apnea. In studies with children aged 2-7 years with insufficiently controlled glaucoma with β-blockers, drowsiness was frequently reported (55%) after the use of the preparation as adjuvant therapy. In 8% of children, this symptom was severe and in 13% lead to discontinuation of therapy. The occurrence of drowsiness diminished with the age of children.
Dosage:
Adults: 1 drop to the affected eye (eyes) 2 times a day, at a distance of about 12 hours. Immediately after instillation of the drug, it is recommended to compress the tear sac in the medial angle of the eye for 1 min. If more than one topical ophthalmic drug is administered, individual medicines should be instilled at intervals of 5-15 minutes.