Brimonidine
(Brimonidine Tartrate)Brimonidine Prescribing Information
Warnings and Precautions (
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. Do not touch the tip of the dispensing container to the eye or surrounding structures. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions
Brimonidine tartrate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The recommended dosage is one drop of brimonidine tartrate ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart. Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
Ophthalmic solution containing (0.1%) 1 mg/mL brimonidine tartrate.
Use with caution in pediatric patients aged 2 years and older. (
Brimonidine tartrate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old
In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7 years old, the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% to 83% in pediatric patients aged 2 to 6 years old) and decreased alertness. In pediatric patients aged 7 years and older (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of pediatric patients on brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.
• Neonates and infants (pediatric patients younger than 2 years old). ()4.1 Neonates and Infants (Pediatric Patients Younger than 2 Years Old)Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (pediatric patients younger than 2 years old)
[see Use in Specific Populations ].• Hypersensitivity Reactions. ()4.2 Hypersensitivity ReactionsBrimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.