Drug Catalog - Product Detail
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOL 0.002 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0715-11 | AKORN | 10 | 0.2% | SOLUTION |
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Description
11 DESCRIPTION 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: 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 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 5.6 to 6.6. 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; polyvinyl alcohol; sodium chloride; sodium citrate; and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile, in white opaque plastic dropper bottles as follows: 5 mL NDC 17478-715-10 10 mL NDC 17478-715-11 15 mL NDC 17478-715-12 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND 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 and Administration
2 DOSAGE AND 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 )