Alphagan P 0.0015

INDICATIONS

Brimonidine Tartrate 0.2% ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.Brimonidine Tartrate 0.15% ophthalmic solution is indicated for the control of intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.Brimonidine Tartrate 0.025% ophthalmic solution relieves redness of the eye due to minor eye irritations.

PHARMACOLOGY

Brimonidine is an α-2 adrenoreceptor agonist that is more selective for the α-2 adrenoreceptor than α-1. Topical administration of Brimonidine Tartrate eye drops decreases intraocular pressure (IOP) in humans. When used as directed Brimonidine Tartrate have the action of reducing elevated IOP with minimal effect on cardiovascular parametres. Brimonidine Tartrate eye drops have a rapid onset of action with the peak ocular hypotensive effect occurring at two hours post-dosing. The duration of effect is 12 hours or greater. Fluorophotometric studies in animals and humans suggest that Brimonidine Tartrate has a dual mechanism of action. Brimonidine Tartrate eye drops lower IOP by reducing aqueous humor production and enhancing uveoscleral outflow.

DOSAGE & ADMINISTRATION

0.2% ophthalmic solution: The recommended dose is one drop of 0.2% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart. This ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.0.15% ophthalmic solution: The recommended dose is one drop of 0.15% ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart.0.025% ophthalmic solution: Instill 1 drop in the affected eye(s) every 6-8 hours. Do not use it more than 4 times daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

INTERACTION

Although specific drug interaction studies have not been conducted with Brimonidine Tartrate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine Tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after administration of Brimonidine Tartrate ophthalmic solution are available. Caution, however, is advised in patients taking Tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

SIDE EFFECTS

Adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Events occurring in approximately 3-9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. The following adverse reactions were reported in less than 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

PREGNANCY & LACTATION

There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine Tartrate ophthalmic solution 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk; in animal studies Brimonidine Tartrate was excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PRECAUTIONS & WARNINGS

Although Brimonidine Tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Brimonidine Tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.

THERAPEUTIC CLASS

Drugs for miotics and glaucoma

STORAGE CONDITIONS

Store below 30°C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.