Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile, in white opaque LDPE plastic bottles and tips with purple high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle: NDC 42571-419-92 10 mL in 10 mL bottle: NDC 42571-419-56 15 mL in 15 mL bottle: NDC 42571-419-57 Storage: Store at 15° to 25°C (59° to 77°F).; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-419-92 Rx only Brimonidine Tartrate Ophthalmic Solution 0.2% For Topical Ophthalmic Use Sterile 5 mL Micro Labs Limited NDC 42571-419-92 Brimonidine Tartrate Ophthalmic Solution 0.2% For Topical Ophthalmic Use Sterile Rx only 5 mL Micro Labs Limited brimonidine-lbla.jpg brimonidine-carta.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile, in white opaque LDPE plastic bottles and tips with purple high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle: NDC 42571-419-92 10 mL in 10 mL bottle: NDC 42571-419-56 15 mL in 15 mL bottle: NDC 42571-419-57 Storage: Store at 15° to 25°C (59° to 77°F).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-419-92 Rx only Brimonidine Tartrate Ophthalmic Solution 0.2% For Topical Ophthalmic Use Sterile 5 mL Micro Labs Limited NDC 42571-419-92 Brimonidine Tartrate Ophthalmic Solution 0.2% For Topical Ophthalmic Use Sterile Rx only 5 mL Micro Labs Limited brimonidine-lbla.jpg brimonidine-carta.jpg
Overview
Brimonidine tartrate ophthalmic solution 0.2%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent). The structural formula of brimonidine tartrate is: Chemical name: 5-Bromo-6-(2-imidazoline-2-ylamino)quinoxaline L-tartrate (1:1) Molecular formula: C 15 H 16 BrN 5 O 6 Molecular weight: 442.22 g/mol. In solution, brimonidine tartrate ophthalmic solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 280 to 330 mOsml/kg and a pH of 5.9 to 6.5. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.2% (2 mg/mL) with the inactive ingredients benzalkonium chloride 0.005% (0.05 mg/mL) as a preservative; citric acid monohydrate; polyvinyl alcohol; sodium chloride; tri sodium citrate dihydrate; and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. brimonidine-str.jpg
Indications & Usage
Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored. Brimonidine tartrate ophthalmic solution 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Dosage & Administration
The recommended dose is one drop of brimonidine tartrate ophthalmic solution 0.2% 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. One drop in the affected eye(s), three times daily, approximately 8 hours apart. ( 2 )
Warnings & Precautions
Potentiation of vascular insufficiency. ( 5.1 ) 5.1 Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. 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. 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 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 [see Patient Counseling Information ( 17 )] . 5.4 Use with Contact Lenses The preservative in brimonidine tartrate ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling brimonidine tartrate ophthalmic solution to insert soft contact lenses.
Contraindications
Neonates and infants (under the age of 2 years). ( 4.1 ) 4.1 Neonates and Infants (under the age of 2 years) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years) [ see Use in Specific Populations ( 8.4 ) ]. 4.2 Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past [ see Adverse Reactions ( 6.1 ) and ( 6.2 ) ].
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Potentiation of Vascular Insufficiency [ see Warnings and Precautions ( 5.1 ) ] Severe Cardiovascular Disease [ see Warnings and Precautions ( 5.2 ) ] Contamination of Topical Ophthalmic Products after Use [ see Warnings and Precautions ( 5.3 ) ] Neonates and Infants (under the age of 2 years) [ see Contraindications ( 4.1 ) ] Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10 to 30% of the subjects (in descending order): oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Adverse reactions occurring in approximately 3 to 9% of the subjects (in descending order): 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. Adverse reactions reported < 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope. 6.2 Postmarketing Experience The following reactions have been identified during postmarketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: Bradycardia; conjunctivitis; hypersensitivity; hypotension; iritis; keratoconjunctivitis sicca; lacrimation increased; miosis; nausea; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia. Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence in infants receiving brimonidine tartrate ophthalmic solutions.
Drug Interactions
Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 ) 7.1 Antihypertensives/Cardiac Glycosides Because brimonidine tartrate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate ophthalmic solution is advised. 7.2 CNS Depressants 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. 7.3 Tricyclic Antidepressants 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. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines. 7.4 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.