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Drug Catalog - Product Detail

BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOL 0.002 15ML

NDC Mfr Size Str Form
24208-0411-15 BAUSCH HEALTH 15 0.2% SOLUTION
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PACKAGE FILES

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Generic Name
BRIMONIDINE TARTRATE
Substance Name
BRIMONIDINE TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA076260
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: Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate In solution, brimonidine tartrate ophthalmic solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 270 - 325 mOsml/kg and a pH range between 5.8 and 6.6. Each mL contains ACTIVE: brimonidine tartrate: 0.2% (2 mg/mL). INACTIVES: citric acid, polyvinyl alcohol, purified water, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.005% (0.05 mg/mL). CHEM
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile in a plastic bottle with a purple cap and controlled drop tip in the following sizes: 5 mL - NDC 24208-411-05 10 mL - NDC 24208-411-10 15 mL - NDC 24208-411-15 Storage: Store between 15°C to 25°C (59°F to 77°F). Keep out of reach of children. DO NOT
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 )