Alphagan P Ophthalmic Solution 5 ml drop

Brimonidine Tartrate ophthalmic solution 0.15% w/v is indicated for the control of intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Brimonidine tartrate is a relatively selective alpha-2 adrenergic receptor agonist that, in radioligand binding assays and in functional assays, is approximately 1000 times more selective for the alpha-2 adrenoceptor than the alpha-1 adrenoceptor. This selectivity results in the absence of vasoconstriction in microvessels associated with human retinal xenografts.

Topical administration of brimonidine decreases IOP in humans. When used as directed, brimonidine tartrate ophthalmic solutions reduce elevated IOP with minimal effect on cardiovascular parameters.

Brimonidine tartrate has a rapid onset of action, with the peak ocular hypotensive effect occurring at approximately 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 ophthalmic solution 0.15% lowers IOP by reducing aqueous humor production and increasing uveoscleral outflow.

The recommended dose is one drop of Brimonidine Tartrate ophthalmic solution 0.15% in the affected eye(s) three times daily, approximately 8 hours apart.

Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures, because this could cause eye injury or contaminate the tip with common bacteria known to cause eye infections. Serious damage to the eye with subsequent loss of vision may result if you use eye drop solutions that have become contaminated. If you experience any type of eye condition or have surgery, immediately seek your doctor’s advice concerning the continued use of the bottle you are using.

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 can lead to an interference in intraocular pressure (IOP) lowering effect. No data are available on the level of circulating catecholamines after Brimonidine Tartrate is instilled. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines. Although specific drug interaction studies have not been conducted with Brimonidine Tartrate, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

Brimonidine Tartrate ophthalmic solution 0.15% is contraindicated in:

• patients with hypersensitivity to brimonidine tartrate or any component of this medication.
• Patients receiving monoamine oxidase (MAO) inhibitor therapy
• Neonates and infants (children under the age of 2 years)

Very common side effects are Red eye. Common side effects are Eye allergy, Itchy eyes, Visual disturbance, Small bumps on the eye surface, Dryness of the mouth, Burning and stinging of the eye, Dry eyes, A feeling that something is in your eye, Watery eyes, Eye and eyelid swelling, Red, itchy eyelids

There are no studies of Brimonidine Tartrate in pregnant women. Studies in rats have indicated brimonidine is excreted in the milk of the lactating rat. Since it is not known whether this drug is excreted in human 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.

Potentiation of Vascular Insufficiency: Brimonidine Tartrate may potentiate syndromes associated with vascular insufficiency. Brimonidine Tartrate should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

Severe Cardiovascular Disease: 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.

Contamination of Topical Ophthalmic Products After Use: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface

Geriatrics (> 65 years of age): No overall difference in safety and effectiveness has been observed between elderly and other adult patients.

Children under the age of 2 years: The use of Brimonidine Tartrate ophthalmic solution 0.15% in neonates and infants is contraindicated.

Children (2-18 years of age): The use of Brimonidine Tartrate ophthalmic solution 0.15% is currently not recommended in children

Drugs for miotics and glaucoma