브리모니딘타르타르산염

Brimonidine tartrate ophthalmic solution 0.1% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine tartrate ophthalmic solution 0.1% is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 ) Hypersensitivity Reactions. ( 4.2 ) 4.1 Neonates and Infants (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate ophthalmic solution 0.1% is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )] . 4.2 Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution 0.1% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

Potentiation of vascular insufficiency. ( 5.1 ) 5.1 Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution 0.1% may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution 0.1% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. 5.2 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. 5.3 Contamination of Topical Ophthalmic Products After Use There have beenreports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers hadbeen inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Do not touchthe tip of the dispensing container to the eye or surrounding structures. Serious damage to the eye and subsequent loss of vision may result fromusing contaminated solutions [see Patient Counseling Information ( 17 )] .

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartate in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data) . Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution 0.1% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Data Human Data Limited …